<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03263585</url>
  </required_header>
  <id_info>
    <org_study_id>dnr 2011/142-31/3</org_study_id>
    <nct_id>NCT03263585</nct_id>
  </id_info>
  <brief_title>Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group</brief_title>
  <official_title>Identification and Treatment of Back Pain in Elderly Women With Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helena Salminen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medi GmbH &amp; Co.KG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Back pain and osteoporosis with vertebral fractures are common conditions in&#xD;
      elderly women and significantly affect their quality of life. A common complication of&#xD;
      osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help&#xD;
      the pain condition caused by the vertebral fractures even when the progress of the disease&#xD;
      has decreased. Vertebral fractures often result in deformation of the spine and poorer&#xD;
      quality of life of the individual. The spinal kyphosis also affects the lung function and the&#xD;
      effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to&#xD;
      reduced drug demand for pain. Physical activity is one of the most important factors that&#xD;
      regulates bone mass and can also affect balance and fall risk positively. The back orthosis&#xD;
      that we intend to use in the treatment study has been shown in some previous scientific&#xD;
      studies to strengthen the muscles in the back and also decrease the pain.&#xD;
&#xD;
      Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in&#xD;
      elderly women with an activating functional orthosis versus treatment with a group of&#xD;
      physiotherapeutic tools and a control group for a six-month treatment period and follow-up&#xD;
      after 12 months from the start of study. The aim was also to study elderly women with&#xD;
      osteoporosis and back pain in a follow-up study of a cohort of women at high risk of&#xD;
      osteoporotic fractures, with focus on back pain, functional capacity and quality of life.&#xD;
&#xD;
      The aim was to study the effect of treatment with activating functional orthosis versus&#xD;
      physiotherapeutic treatment in a group and a control group without treatment. The main&#xD;
      outcomes will be the experienced perceived back pain and back extensor strength. Additional&#xD;
      outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers&#xD;
      for pain will be measured in the RCT (Randomized Controlled Trial).&#xD;
&#xD;
      Significance: Evaluation of alternative treatment methods such as exercise by a&#xD;
      physiotherapist and treatment with a functional orthosis will give new additional treatment&#xD;
      options for our patients. An activating functional orthosis could reduce the use of&#xD;
      analgesics and increase the quality of life of the affected women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims: 1. Identification in a population-based cohort of elderly women the occurrence of&#xD;
      vertebral fractures, back pain and their impact on quality of life.&#xD;
&#xD;
      2. To study the effect of treatment with a functional activating orthotic and physiotherapy&#xD;
      in an equipment training group, both in comparison with a control group, on the perceived&#xD;
      pain, back extensor muscle strength, quality of life, balance and incidence of falls, lung&#xD;
      function and kyphosis.&#xD;
&#xD;
      3. Qualitative study of how participants experienced treatment and exercise in an activating&#xD;
      orthotic. The investigators hypothesis was that a functional orthotic could be a&#xD;
      complementary treatment method that could reduce the use of analgesics and increase the&#xD;
      quality of life.&#xD;
&#xD;
      The purpose of the study was to evaluate the effect of treatment of back pain in elderly&#xD;
      women with an activating spinal orthotic versus treatment with a physiotherapy equipment&#xD;
      training group and a control group for a six-month treatment period and a follow-up six&#xD;
      months after the end of treatment. The aim was also to identify the occurrence of vertebral&#xD;
      fractures in a cohort of elderly women and to investigate their perceived quality of life.&#xD;
&#xD;
      Background: Osteoporosis is a condition in the skeleton that is characterized by reduced bone&#xD;
      density and an increased risk of fractures [1]. Back pain and osteoporosis with vertebral&#xD;
      fractures are common conditions in elderly women that significantly affect their quality of&#xD;
      life. Vertebral fractures are the most common type of osteoporotic fracture [2]. Vertebral&#xD;
      fractures are underdiagnosed and are a major problem. It is estimated that only one third of&#xD;
      vertebral fractures are clinically detected [3]. The lifetime risk for a Swedish&#xD;
      postmenopausal woman to get a clinically detected vertebral fracture is approximately 15%&#xD;
      [4].&#xD;
&#xD;
      In the acute phase, a vertebral fracture is very painful and in the aftermath the vertebral&#xD;
      fracture often leads to chronic back pain, increased kyphosis mainly located to the thoracic&#xD;
      and lumbar spine, reduction in body height and impaired lung function. There exists a&#xD;
      correlation between increased kyphosis and increased risk of falls [5]. Vertebral fractures&#xD;
      can affect important daily activities and provide a lower health-related quality of life&#xD;
      [6-8].&#xD;
&#xD;
      Treatment with bone-specific drugs does not relieve the back pain caused by the vertebral&#xD;
      fractures despite improvement in the state of the disease. The kyphosis also affects lung&#xD;
      function, and the effects of the kyphosis itself have previously been considered as very&#xD;
      severe.&#xD;
&#xD;
      An important part in the treatment of patients with osteoporosis is physical therapy with an&#xD;
      equipment training group. The goal is to maintain or increase mobility, strength and balance&#xD;
      that can improve health-related quality of life and prevent fractures. Training of the back&#xD;
      extensor muscles have shown to have a positive impact on health-related quality of life,&#xD;
      reduce back pain, and training could also affect fear of falling positively [5, 9].&#xD;
&#xD;
      A German randomized controlled study from 2004 and one from 2011 has shown a positive effect&#xD;
      of treatment with an activating spinal orthotic on body posture, back extensor muscular&#xD;
      strength and quality of life in elderly women with osteoporosis and vertebral fractures [10,&#xD;
      11]. It was shown that wearing the spinal orthotic, back extensor muscle strength was&#xD;
      increased through biofeedback. Training with the spinal orthotic also resulted in a&#xD;
      significant decrease of the kyphosis, which also affected lung function and body height&#xD;
      positively.&#xD;
&#xD;
      The investigators now intend, in a randomized controlled study, to compare training in an&#xD;
      activating spinal orthotic with training in an equipment training group, led by a&#xD;
      physiotherapist, to see if positive results can be obtained in reduced back pain, increased&#xD;
      muscle strength in back extensor muscle, increasing mobility, and decreased kyphosis in the&#xD;
      thoracic and lumbar spine. It can also lead to improved lung capacity, and further increased&#xD;
      health-related quality of life. If the training method in the activating spinal orthotic&#xD;
      appears to work, it would improve the possibilities to train and treat patients with&#xD;
      osteoporosis, vertebral fractures and back pain.&#xD;
&#xD;
      Design A. A cross-sectional study of cohort elderly women regarding the occurrence of&#xD;
      vertebral fractures and their impact on health related quality of life and back pain.&#xD;
&#xD;
      B. A randomized controlled study where the effect of treatment with an activating spinal&#xD;
      orthotic is compared with training in an equipment training group led by a physiotherapist&#xD;
      and with an untreated control group for a six-month treatment period and a follow-up six&#xD;
      months after the end of the treatment period.&#xD;
&#xD;
      C. A qualitative study with interviews in focus groups were the participating women may&#xD;
      describe their experiences of training in an activating spinal orthotic and how they&#xD;
      experience health related quality of life during the treatment period.&#xD;
&#xD;
      Methods Cross-sectional study All 186 women who participated in the follow-up study of the&#xD;
      Primos project, a population-based cohort study in Stockholm were invited to participate in&#xD;
      the current study [12-15]. All these women have been re-examined clinically in a longitudinal&#xD;
      follow-up study with bone density measurements of the hip, lumbar spine, whole body and heel,&#xD;
      clinical risk markers for osteoporosis and metabolic disease, nutritional status and a&#xD;
      balance tests in 2007-2009.&#xD;
&#xD;
      Women interested in participating in the study got an invitation to a study visit. During the&#xD;
      study visit, written and oral information about the study was being given and then the women&#xD;
      signed an informed consent.&#xD;
&#xD;
      Examinations in the cross sectional study&#xD;
&#xD;
        1. Clinical examination of the back, assessment of kyphosis, body weight and height,&#xD;
           assessment of quality of life with SF-36 (Short Form-36) Health Survey) [16, 17],&#xD;
           Qualeffo-41(Quality of life questionnaire of the European Foundation for Osteoporosis)&#xD;
           [18, 19, 20] and EQ-5D (EuroQol-5Dimensions) Manual Balance Test, assessment of Back&#xD;
           Extensor muscle strength. Evaluation of hand grip strength with a JAMAR hydraulic hand&#xD;
           dynamometer.&#xD;
&#xD;
           Assessment of physical performance and back pain using questionnaires, VAS (Visual&#xD;
           Analogue Scale) scale and Borg CR-10 (Categoric Rate). Previous frequency of falls. Use&#xD;
           of drugs and analgesics. Examination with spirometry and PEF (Peak Expiratory Flow).&#xD;
&#xD;
        2. Referral to X-ray of the thoracic and lumbar spine for assessment of the occurrence of&#xD;
           vertebral fractures.&#xD;
&#xD;
      Randomized controlled trial: The investigators expect to recruit at least 108 women,&#xD;
      randomized to three treatment arms with approximately 36 women in each arm.&#xD;
&#xD;
        1. Treatment with the activating spinal orthotic Spinomed (Medi-Bayreuth, Bayreuth&#xD;
           Germany), maximum of two hours per day with gradual escalation of the time initially.&#xD;
           Adaptation of the spinal orthotic is to be performed by an orthopedic technician.&#xD;
&#xD;
        2. Equipment training group led by a physiotherapist once a week with a special training&#xD;
           program tailored to elderly women with osteoporosis and back pain.&#xD;
&#xD;
        3. Control group. Power calculation Primary endpoints in the treatment study are a change&#xD;
           in experienced back pain, measured with VAS scale and Borg CR-10.&#xD;
&#xD;
      With a sample size of 99 subjects, I e 33 women in each arm analyzed by ANOVA, 88% power at&#xD;
      the alpha 5% level is able to detect if there is a difference between the groups. With a&#xD;
      possible anticipated drop-out of about 10% of the participants during the study, the&#xD;
      investigators have decided to include 36 women in each group, I e a total of 108 women.&#xD;
&#xD;
      Recruitment&#xD;
&#xD;
        1. Participation is offered to women aged ≥ 60 years from the Primos project.&#xD;
&#xD;
        2. Recruitment through an invitation of women aged ≥ 60 years who participated in&#xD;
           osteoporosis school in the last five years at Rehab City Kungsholmen.&#xD;
&#xD;
        3. Recruitment through advertisements in daily newspapers and ads in appropriate web forums&#xD;
           (eg website for the National Association of Osteoporotic ROP) Flow chart Baseline&#xD;
&#xD;
      1. Clinical examination of the back, assessment of spinal curvature and of muscle strength of&#xD;
      the back extensors, measurement of weight and height, assessment of health related quality of&#xD;
      life with SF-36 [16, 17], Qualeffo-41 [18, 19, 20] and EQ-5D [21]. Manual balance test.&#xD;
      Evaluation of hand grip strength with JAMAR dynamometer.&#xD;
&#xD;
      Assessment of physical performance and perceived pain using questionnaires, VAS scales and&#xD;
      Borg CR-10. Examination with spirometry and PEF. Assessment of previous falls during the last&#xD;
      year and other risk factors for osteoporotic fractures. Use of drugs and analgesics.&#xD;
&#xD;
      2. Referral to X-ray of the thoracic and lumbar spine for assessment of the occurrence of&#xD;
      vertebral fractures. 3. Blood sample of 20 ml venous blood for analysis of substance P and&#xD;
      CGRP (Calcitonin Gene Related Peptide) and IL-6 (Interleukin-6). Storage of samples: frozen&#xD;
      in -70gr freezer until analyzes at a special research laboratory where one of the co-worker&#xD;
      in the study is responsible for the analyzes.&#xD;
&#xD;
      Collaboration with the same radiological clinic at Karolinska University Hospital Solna for&#xD;
      all X-ray examinations.&#xD;
&#xD;
      Follow-up after 1 month Pain drawing, pain measured by VAS-scale and Borg CR-10. For the&#xD;
      spinal orthotic group adjustment of the spinal orthotic. Report of falls during last month.&#xD;
      Use of drugs and analgesics.&#xD;
&#xD;
      Visit 2 after 3 months Clinical examination: functional assessment of the back, muscle&#xD;
      strength of the back extensors, hand grip strength with JAMAR, pain drawing, manual balance&#xD;
      test, back pain measured by VAS scale and Borg CR-10, EQ-5D, SF-36, Qualeffo-41. Adjustment&#xD;
      of spinal orthotic. Spirometry. Weight and height. Report of falls since visit 1. Use of&#xD;
      drugs and analgesics.&#xD;
&#xD;
      Visit 3 after 6 months Clinical examination: Functional assessment of the back. Manual&#xD;
      balance test, muscle strength of the back extensors, grip strength with JAMAR, pain drawing,&#xD;
      back pain measured by VAS-scale and Borg CR-10, EQ-5D, SF-36, Qualeffo-41. Spirometry. Weight&#xD;
      and height. Assessment of spinal curvature. Report of falls since 3 month visit. Use of drugs&#xD;
      and analgesics. Blood sample for substance P, IL-6 and CGRP analysis (Calcitonin Gene Related&#xD;
      Peptide).&#xD;
&#xD;
      Qualitative group interviews in the Spinomed groups, using a semi-structured interview guide&#xD;
      will be performed after the participants have completed their participation in the RCT.&#xD;
&#xD;
      Follow-up 12 months after study start Women in the group treated with the spinal orthotic&#xD;
      Spinomed may continue to use the orthotic on their own initiative between 2 hours to a&#xD;
      maximum of 4 hours per day, but without follow-up until after six months. Follow-up with&#xD;
      reporting falls in a logbook once a week.&#xD;
&#xD;
      Women in the equipment training group receive a home exercise program they can continue at&#xD;
      home, but without follow-up until after six months Visit 4 six months after end of treatment&#xD;
      Clinical examination: Functional assessment of the back, manual balance test, muscle strength&#xD;
      of the back extensors, hand grip strength with JAMAR, pain drawing, back pain measured with&#xD;
      VAS scale and Borg CR-10. EQ-5D, Qualeffo-41, SF-36, Spirometry, Weight and height. Falls&#xD;
      frequency. Assessment of spinal curvature. Use of drugs and analgesics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2012</start_date>
  <completion_date type="Actual">December 22, 2014</completion_date>
  <primary_completion_date type="Actual">November 22, 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Back pain</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Measured with Visual Analogue Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Back muscle extensor strength</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Measured with DigiMax in newton, women press their back against a pad for 6 seconds, three times.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg CR-10</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Back pain measured by Borg CR-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kyphosis</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Measured by flexicurve ruler</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance P</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Biochemical markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGRP Calcitonin Gene Related Peptide</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Biochemical markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6 Interleukin</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Biochemical markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Manual balance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait speed</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Women walk 2x15 meter as fast as possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Health related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QUALEFFO-41</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Health related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Health related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand grip strength</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Measured by JAMAR Manometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Measured by stadiometer in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Log book</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Back pain measured by log book</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paindrawing</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Back pain measured by paindrawing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Self reported falls</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Vertebral Fracture</condition>
  <condition>Back Pain</condition>
  <condition>Elderly Women</condition>
  <arm_group>
    <arm_group_label>Spinal orthosis group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women wearing the spinal orthosis Spinomed for 6 months at least 2 hours a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Equipment training group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women training once a week in an equipment training group led by a physiotherapist for six months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women in the control group get no intervention for six months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spinal orthosis Spinomed</intervention_name>
    <arm_group_label>Spinal orthosis group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Equipment training</intervention_name>
    <arm_group_label>Equipment training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Woman aged ≥ 60 years&#xD;
&#xD;
          -  Osteoporosis according to DXA (Dual X-Ray Absorptiometry) hip (femoral neck or total&#xD;
             hip) or lumbar spine.&#xD;
&#xD;
          -  Back pain.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Diagnosed symptomatic spinal stenosis&#xD;
&#xD;
          -  Difficulty to participate in the activities included in the study due to health&#xD;
             problems.&#xD;
&#xD;
          -  Difficulty to participate in equipment training group.&#xD;
&#xD;
          -  Inability to be able to complete wearing the spinal orthosis.&#xD;
&#xD;
          -  Language difficulties&#xD;
&#xD;
          -  Cognitive difficulties&#xD;
&#xD;
          -  Visual problems&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eeva Helena S Salminen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehab City</name>
      <address>
        <city>Stockholm</city>
        <zip>11361</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liljeholmen Academic Health Centre</name>
      <address>
        <city>Stockholm</city>
        <zip>11763</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Report of a WHO Study Group. World Health Organ Tech Rep Ser. 1994;843:1-129. No abstract available.</citation>
    <PMID>7941614</PMID>
  </reference>
  <reference>
    <citation>Cauley JA, Hochberg MC, Lui LY, Palermo L, Ensrud KE, Hillier TA, Nevitt MC, Cummings SR. Long-term risk of incident vertebral fractures. JAMA. 2007 Dec 19;298(23):2761-7. doi: 10.1001/jama.298.23.2761.</citation>
    <PMID>18165669</PMID>
  </reference>
  <reference>
    <citation>Delmas PD, van de Langerijt L, Watts NB, Eastell R, Genant H, Grauer A, Cahall DL; IMPACT Study Group. Underdiagnosis of vertebral fractures is a worldwide problem: the IMPACT study. J Bone Miner Res. 2005 Apr;20(4):557-63. doi: 10.1359/JBMR.041214. Epub 2004 Dec 6.</citation>
    <PMID>15765173</PMID>
  </reference>
  <reference>
    <citation>Kanis JA, Johnell O, Oden A, Borgstrom F, Zethraeus N, De Laet C, Jonsson B. The risk and burden of vertebral fractures in Sweden. Osteoporos Int. 2004 Jan;15(1):20-6. doi: 10.1007/s00198-003-1463-7. Epub 2003 Oct 31.</citation>
    <PMID>14593450</PMID>
  </reference>
  <reference>
    <citation>Kasukawa Y, Miyakoshi N, Hongo M, Ishikawa Y, Noguchi H, Kamo K, Sasaki H, Murata K, Shimada Y. Relationships between falls, spinal curvature, spinal mobility and back extensor strength in elderly people. J Bone Miner Metab. 2010;28(1):82-7. doi: 10.1007/s00774-009-0107-1. Epub 2009 Aug 19.</citation>
    <PMID>19690799</PMID>
  </reference>
  <reference>
    <citation>Hallberg I, Bachrach-Lindstrom M, Hammerby S, Toss G, Ek AC. Health-related quality of life after vertebral or hip fracture: a seven-year follow-up study. BMC Musculoskelet Disord. 2009 Nov 3;10:135. doi: 10.1186/1471-2474-10-135.</citation>
    <PMID>19886998</PMID>
  </reference>
  <reference>
    <citation>Papaioannou A, Kennedy CC, Ioannidis G, Brown JP, Pathak A, Hanley DA, Josse RG, Sebaldt RJ, Olszynski WP, Tenenhouse A, Murray TM, Petrie A, Goldsmith CH, Adachi JD. Determinants of health-related quality of life in women with vertebral fractures. Osteoporos Int. 2006;17(3):355-63. doi: 10.1007/s00198-005-2020-3. Epub 2005 Dec 9.</citation>
    <PMID>16341623</PMID>
  </reference>
  <reference>
    <citation>Strom O, Borgstrom F, Zethraeus N, Johnell O, Lidgren L, Ponzer S, Svensson O, Abdon P, Ornstein E, Ceder L, Thorngren KG, Sernbo I, Jonsson B. Long-term cost and effect on quality of life of osteoporosis-related fractures in Sweden. Acta Orthop. 2008 Apr;79(2):269-80. doi: 10.1080/17453670710015094.</citation>
    <PMID>18484255</PMID>
  </reference>
  <reference>
    <citation>Francis RM, Aspray TJ, Hide G, Sutcliffe AM, Wilkinson P. Back pain in osteoporotic vertebral fractures. Osteoporos Int. 2008 Jul;19(7):895-903. doi: 10.1007/s00198-007-0530-x. Epub 2007 Dec 11.</citation>
    <PMID>18071648</PMID>
  </reference>
  <reference>
    <citation>Pfeifer M, Begerow B, Minne HW. Effects of a new spinal orthosis on posture, trunk strength, and quality of life in women with postmenopausal osteoporosis: a randomized trial. Am J Phys Med Rehabil. 2004 Mar;83(3):177-86. doi: 10.1097/01.phm.0000113403.16617.93.</citation>
    <PMID>15043351</PMID>
  </reference>
  <reference>
    <citation>Pfeifer M, Kohlwey L, Begerow B, Minne HW. Effects of two newly developed spinal orthoses on trunk muscle strength, posture, and quality-of-life in women with postmenopausal osteoporosis: a randomized trial. Am J Phys Med Rehabil. 2011 Oct;90(10):805-15. doi: 10.1097/PHM.0b013e31821f6df3.</citation>
    <PMID>21681065</PMID>
  </reference>
  <reference>
    <citation>Salminen H, Saaf M, Ringertz H, Strender LE. Bone mineral density measurement in the calcaneus with DXL: comparison with hip and spine measurements in a cross-sectional study of an elderly female population. Osteoporos Int. 2005 May;16(5):541-51. doi: 10.1007/s00198-004-1719-x. Epub 2004 Sep 21.</citation>
    <PMID>15448984</PMID>
  </reference>
  <reference>
    <citation>Salminen H, Saaf M, Johansson SE, Ringertz H, Strender LE. Nutritional status, as determined by the Mini-Nutritional Assessment, and osteoporosis: a cross-sectional study of an elderly female population. Eur J Clin Nutr. 2006 Apr;60(4):486-93. doi: 10.1038/sj.ejcn.1602341.</citation>
    <PMID>16391579</PMID>
  </reference>
  <reference>
    <citation>Salminen H, Saaf M, Ringertz H, Strender LE. The role of IGF-I and IGFBP-1 status and secondary hyperparathyroidism in relation to osteoporosis in elderly Swedish women. Osteoporos Int. 2008 Feb;19(2):201-9. doi: 10.1007/s00198-007-0463-4. Epub 2007 Sep 14.</citation>
    <PMID>17874030</PMID>
  </reference>
  <reference>
    <citation>Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.</citation>
    <PMID>1593914</PMID>
  </reference>
  <reference>
    <citation>Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA, Kellingray S, Leplege A, Liberman UA, McCloskey E, Minne H, Reeve J, Reginster JY, Scholz M, Todd C, de Vernejoul MC, Wiklund I. Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Working Party for Quality of Life of the European Foundation for Osteoporosis. Osteoporos Int. 1999;10(2):150-60. doi: 10.1007/s001980050210.</citation>
    <PMID>10501796</PMID>
  </reference>
  <reference>
    <citation>Lips P, van Schoor NM. Quality of life in patients with osteoporosis. Osteoporos Int. 2005 May;16(5):447-55. doi: 10.1007/s00198-004-1762-7. Epub 2004 Dec 18.</citation>
    <PMID>15609073</PMID>
  </reference>
  <reference>
    <citation>Lips P, Agnusdei D, Caulin F, Cooper C, Johnell O, Kanis J, Liberman U, Minne H, Reeve J, Reginster JY, de Vernejoul MC, Wiklund I. The development of a European questionnaire for quality of life in patients with vertebral osteoporosis. Scand J Rheumatol Suppl. 1996;103:84-5; discussion 86-8. doi: 10.3109/03009749609103757.</citation>
    <PMID>8966496</PMID>
  </reference>
  <reference>
    <citation>Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.</citation>
    <PMID>10158943</PMID>
  </reference>
  <reference>
    <citation>Sullivan M, Karlsson J, Ware JE Jr. The Swedish SF-36 Health Survey--I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med. 1995 Nov;41(10):1349-58. doi: 10.1016/0277-9536(95)00125-q.</citation>
    <PMID>8560302</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Helena Salminen</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Osteoporosis</keyword>
  <keyword>Vertebral Fracture</keyword>
  <keyword>Back Pain</keyword>
  <keyword>Spinal orthosis</keyword>
  <keyword>Elderly women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Spinal Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data is available only for the research group and available for other researchers only after new ethical review and in collaboration</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03263585
org study id: dnr 2011/142-31/3
nct id: NCT03263585
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Back pain and osteoporosis with vertebral fractures are common conditions in
      elderly women and significantly affect their quality of life. A common complication of
      osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help
      the pain condition caused by the vertebral fractures even when the progress of the disease
      has decreased. Vertebral fractures often result in deformation of the spine and poorer
      quality of life of the individual. The spinal kyphosis also affects the lung function and the
      effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to
      reduced drug demand for pain. Physical activity is one of the most important factors that
      regulates bone mass and can also affect balance and fall risk positively. The back orthosis
      that we intend to use in the treatment study has been shown in some previous scientific
      studies to strengthen the muscles in the back and also decrease the pain.

      Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in
      elderly women with an activating functional orthosis versus treatment with a group of
      physiotherapeutic tools and a control group for a six-month treatment period and follow-up
      after 12 months from the start of study. The aim was also to study elderly women with
      osteoporosis and back pain in a follow-up study of a cohort of women at high risk of
      osteoporotic fractures, with focus on back pain, functional capacity and quality of life.

      The aim was to study the effect of treatment with activating functional orthosis versus
      physiotherapeutic treatment in a group and a control group without treatment. The main
      outcomes will be the experienced perceived back pain and back extensor strength. Additional
      outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers
      for pain will be measured in the RCT (Randomized Controlled Trial).

      Significance: Evaluation of alternative treatment methods such as exercise by a
      physiotherapist and treatment with a functional orthosis will give new additional treatment
      options for our patients. An activating functional orthosis could reduce the use of
      analgesics and increase the quality of life of the affected women.
The aims: 1. Identification in a population-based cohort of elderly women the occurrence of
      vertebral fractures, back pain and their impact on quality of life.

      2. To study the effect of treatment with a functional activating orthotic and physiotherapy
      in an equipment training group, both in comparison with a control group, on the perceived
      pain, back extensor muscle strength, quality of life, balance and incidence of falls, lung
      function and kyphosis.

      3. Qualitative study of how participants experienced treatment and exercise in an activating
      orthotic. The investigators hypothesis was that a functional orthotic could be a
      complementary treatment method that could reduce the use of analgesics and increase the
      quality of life.

      The purpose of the study was to evaluate the effect of treatment of back pain in elderly
      women with an activating spinal orthotic versus treatment with a physiotherapy equipment
      training group and a control group for a six-month treatment period and a follow-up six
      months after the end of treatment. The aim was also to identify the occurrence of vertebral
      fractures in a cohort of elderly women and to investigate their perceived quality of life.

      Background: Osteoporosis is a condition in the skeleton that is characterized by reduced bone
      density and an increased risk of fractures [1]. Back pain and osteoporosis with vertebral
      fractures are common conditions in elderly women that significantly affect their quality of
      life. Vertebral fractures are the most common type of osteoporotic fracture [2]. Vertebral
      fractures are underdiagnosed and are a major problem. It is estimated that only one third of
      vertebral fractures are clinically detected [3]. The lifetime risk for a Swedish
      postmenopausal woman to get a clinically detected vertebral fracture is approximately 15%
      [4].

      In the acute phase, a vertebral fracture is very painful and in the aftermath the vertebral
      fracture often leads to chronic back pain, increased kyphosis mainly located to the thoracic
      and lumbar spine, reduction in body height and impaired lung function. There exists a
      correlation between increased kyphosis and increased risk of falls [5]. Vertebral fractures
      can affect important daily activities and provide a lower health-related quality of life
      [6-8].

      Treatment with bone-specific drugs does not relieve the back pain caused by the vertebral
      fractures despite improvement in the state of the disease. The kyphosis also affects lung
      function, and the effects of the kyphosis itself have previously been considered as very
      severe.

      An important part in the treatment of patients with osteoporosis is physical therapy with an
      equipment training group. The goal is to maintain or increase mobility, strength and balance
      that can improve health-related quality of life and prevent fractures. Training of the back
      extensor muscles have shown to have a positive impact on health-related quality of life,
      reduce back pain, and training could also affect fear of falling positively [5, 9].

      A German randomized controlled study from 2004 and one from 2011 has shown a positive effect
      of treatment with an activating spinal orthotic on body posture, back extensor muscular
      strength and quality of life in elderly women with osteoporosis and vertebral fractures [10,
      11]. It was shown that wearing the spinal orthotic, back extensor muscle strength was
      increased through biofeedback. Training with the spinal orthotic also resulted in a
      significant decrease of the kyphosis, which also affected lung function and body height
      positively.

      The investigators now intend, in a randomized controlled study, to compare training in an
      activating spinal orthotic with training in an equipment training group, led by a
      physiotherapist, to see if positive results can be obtained in reduced back pain, increased
      muscle strength in back extensor muscle, increasing mobility, and decreased kyphosis in the
      thoracic and lumbar spine. It can also lead to improved lung capacity, and further increased
      health-related quality of life. If the training method in the activating spinal orthotic
      appears to work, it would improve the possibilities to train and treat patients with
      osteoporosis, vertebral fractures and back pain.

      Design A. A cross-sectional study of cohort elderly women regarding the occurrence of
      vertebral fractures and their impact on health related quality of life and back pain.

      B. A randomized controlled study where the effect of treatment with an activating spinal
      orthotic is compared with training in an equipment training group led by a physiotherapist
      and with an untreated control group for a six-month treatment period and a follow-up six
      months after the end of the treatment period.

      C. A qualitative study with interviews in focus groups were the participating women may
      describe their experiences of training in an activating spinal orthotic and how they
      experience health related quality of life during the treatment period.

      Methods Cross-sectional study All 186 women who participated in the follow-up study of the
      Primos project, a population-based cohort study in Stockholm were invited to participate in
      the current study [12-15]. All these women have been re-examined clinically in a longitudinal
      follow-up study with bone density measurements of the hip, lumbar spine, whole body and heel,
      clinical risk markers for osteoporosis and metabolic disease, nutritional status and a
      balance tests in 2007-2009.

      Women interested in participating in the study got an invitation to a study visit. During the
      study visit, written and oral information about the study was being given and then the women
      signed an informed consent.

      Examinations in the cross sectional study

        1. Clinical examination of the back, assessment of kyphosis, body weight and height,
           assessment of quality of life with SF-36 (Short Form-36) Health Survey) [16, 17],
           Qualeffo-41(Quality of life questionnaire of the European Foundation for Osteoporosis)
           [18, 19, 20] and EQ-5D (EuroQol-5Dimensions) Manual Balance Test, assessment of Back
           Extensor muscle strength. Evaluation of hand grip strength with a JAMAR hydraulic hand
           dynamometer.

           Assessment of physical performance and back pain using questionnaires, VAS (Visual
           Analogue Scale) scale and Borg CR-10 (Categoric Rate). Previous frequency of falls. Use
           of drugs and analgesics. Examination with spirometry and PEF (Peak Expiratory Flow).

        2. Referral to X-ray of the thoracic and lumbar spine for assessment of the occurrence of
           vertebral fractures.

      Randomized controlled trial: The investigators expect to recruit at least 108 women,
      randomized to three treatment arms with approximately 36 women in each arm.

        1. Treatment with the activating spinal orthotic Spinomed (Medi-Bayreuth, Bayreuth
           Germany), maximum of two hours per day with gradual escalation of the time initially.
           Adaptation of the spinal orthotic is to be performed by an orthopedic technician.

        2. Equipment training group led by a physiotherapist once a week with a special training
           program tailored to elderly women with osteoporosis and back pain.

        3. Control group. Power calculation Primary endpoints in the treatment study are a change
           in experienced back pain, measured with VAS scale and Borg CR-10.

      With a sample size of 99 subjects, I e 33 women in each arm analyzed by ANOVA, 88% power at
      the alpha 5% level is able to detect if there is a difference between the groups. With a
      possible anticipated drop-out of about 10% of the participants during the study, the
      investigators have decided to include 36 women in each group, I e a total of 108 women.

      Recruitment

        1. Participation is offered to women aged ≥ 60 years from the Primos project.

        2. Recruitment through an invitation of women aged ≥ 60 years who participated in
           osteoporosis school in the last five years at Rehab City Kungsholmen.

        3. Recruitment through advertisements in daily newspapers and ads in appropriate web forums
           (eg website for the National Association of Osteoporotic ROP) Flow chart Baseline

      1. Clinical examination of the back, assessment of spinal curvature and of muscle strength of
      the back extensors, measurement of weight and height, assessment of health related quality of
      life with SF-36 [16, 17], Qualeffo-41 [18, 19, 20] and EQ-5D [21]. Manual balance test.
      Evaluation of hand grip strength with JAMAR dynamometer.

      Assessment of physical performance and perceived pain using questionnaires, VAS scales and
      Borg CR-10. Examination with spirometry and PEF. Assessment of previous falls during the last
      year and other risk factors for osteoporotic fractures. Use of drugs and analgesics.

      2. Referral to X-ray of the thoracic and lumbar spine for assessment of the occurrence of
      vertebral fractures. 3. Blood sample of 20 ml venous blood for analysis of substance P and
      CGRP (Calcitonin Gene Related Peptide) and IL-6 (Interleukin-6). Storage of samples: frozen
      in -70gr freezer until analyzes at a special research laboratory where one of the co-worker
      in the study is responsible for the analyzes.

      Collaboration with the same radiological clinic at Karolinska University Hospital Solna for
      all X-ray examinations.

      Follow-up after 1 month Pain drawing, pain measured by VAS-scale and Borg CR-10. For the
      spinal orthotic group adjustment of the spinal orthotic. Report of falls during last month.
      Use of drugs and analgesics.

      Visit 2 after 3 months Clinical examination: functional assessment of the back, muscle
      strength of the back extensors, hand grip strength with JAMAR, pain drawing, manual balance
      test, back pain measured by VAS scale and Borg CR-10, EQ-5D, SF-36, Qualeffo-41. Adjustment
      of spinal orthotic. Spirometry. Weight and height. Report of falls since visit 1. Use of
      drugs and analgesics.

      Visit 3 after 6 months Clinical examination: Functional assessment of the back. Manual
      balance test, muscle strength of the back extensors, grip strength with JAMAR, pain drawing,
      back pain measured by VAS-scale and Borg CR-10, EQ-5D, SF-36, Qualeffo-41. Spirometry. Weight
      and height. Assessment of spinal curvature. Report of falls since 3 month visit. Use of drugs
      and analgesics. Blood sample for substance P, IL-6 and CGRP analysis (Calcitonin Gene Related
      Peptide).

      Qualitative group interviews in the Spinomed groups, using a semi-structured interview guide
      will be performed after the participants have completed their participation in the RCT.

      Follow-up 12 months after study start Women in the group treated with the spinal orthotic
      Spinomed may continue to use the orthotic on their own initiative between 2 hours to a
      maximum of 4 hours per day, but without follow-up until after six months. Follow-up with
      reporting falls in a logbook once a week.

      Women in the equipment training group receive a home exercise program they can continue at
      home, but without follow-up until after six months Visit 4 six months after end of treatment
      Clinical examination: Functional assessment of the back, manual balance test, muscle strength
      of the back extensors, hand grip strength with JAMAR, pain drawing, back pain measured with
      VAS scale and Borg CR-10. EQ-5D, Qualeffo-41, SF-36, Spirometry, Weight and height. Falls
      frequency. Assessment of spinal curvature. Use of drugs and analgesics.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Back pain
time frame: Baseline and six months
description: Measured with Visual Analogue Scale
measure: Back muscle extensor strength
time frame: Baseline and six months
description: Measured with DigiMax in newton, women press their back against a pad for 6 seconds, three times.
measure: Borg CR-10
time frame: Baseline and six months
description: Back pain measured by Borg CR-10
measure: Kyphosis
time frame: Baseline and six months
description: Measured by flexicurve ruler
measure: Substance P
time frame: Baseline and six months
description: Biochemical markers
measure: CGRP Calcitonin Gene Related Peptide
time frame: Baseline and six months
description: Biochemical markers
measure: IL-6 Interleukin
time frame: Baseline and six months
description: Biochemical markers
measure: Lung function
time frame: Baseline and six months
description: Spirometry
measure: Balance
time frame: Baseline and six months
description: Manual balance test
measure: Gait speed
time frame: Baseline and six months
description: Women walk 2x15 meter as fast as possible
measure: SF-36
time frame: Baseline and six months
description: Health related quality of life
measure: QUALEFFO-41
time frame: Baseline and six months
description: Health related quality of life
measure: EQ-5D
time frame: Baseline and six months
description: Health related quality of life
measure: Hand grip strength
time frame: Baseline and six months
description: Measured by JAMAR Manometer
measure: Height
time frame: Baseline and six months
description: Measured by stadiometer in cm
measure: Log book
time frame: Baseline and six months
description: Back pain measured by log book
measure: Paindrawing
time frame: Baseline and six months
description: Back pain measured by paindrawing
measure: Falls
time frame: Baseline and six months
description: Self reported falls
arm group label: Spinal orthosis group
arm group type: Active Comparator
description: Women wearing the spinal orthosis Spinomed for 6 months at least 2 hours a day.
arm group label: Equipment training group
arm group type: Active Comparator
description: Women training once a week in an equipment training group led by a physiotherapist for six months.
arm group label: Control
arm group type: No Intervention
description: Women in the control group get no intervention for six months.
intervention type: Device
intervention name: Spinal orthosis Spinomed
arm group label: Spinal orthosis group
intervention type: Other
intervention name: Equipment training
arm group label: Equipment training group
criteria: 
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Eeva Helena S Salminen, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
facility: 
country: Sweden
citation: Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Report of a WHO Study Group. World Health Organ Tech Rep Ser. 1994;843:1-129. No abstract available.
PMID: 7941614
citation: Cauley JA, Hochberg MC, Lui LY, Palermo L, Ensrud KE, Hillier TA, Nevitt MC, Cummings SR. Long-term risk of incident vertebral fractures. JAMA. 2007 Dec 19;298(23):2761-7. doi: 10.1001/jama.298.23.2761.
PMID: 18165669
citation: Delmas PD, van de Langerijt L, Watts NB, Eastell R, Genant H, Grauer A, Cahall DL; IMPACT Study Group. Underdiagnosis of vertebral fractures is a worldwide problem: the IMPACT study. J Bone Miner Res. 2005 Apr;20(4):557-63. doi: 10.1359/JBMR.041214. Epub 2004 Dec 6.
PMID: 15765173
citation: Kanis JA, Johnell O, Oden A, Borgstrom F, Zethraeus N, De Laet C, Jonsson B. The risk and burden of vertebral fractures in Sweden. Osteoporos Int. 2004 Jan;15(1):20-6. doi: 10.1007/s00198-003-1463-7. Epub 2003 Oct 31.
PMID: 14593450
citation: Kasukawa Y, Miyakoshi N, Hongo M, Ishikawa Y, Noguchi H, Kamo K, Sasaki H, Murata K, Shimada Y. Relationships between falls, spinal curvature, spinal mobility and back extensor strength in elderly people. J Bone Miner Metab. 2010;28(1):82-7. doi: 10.1007/s00774-009-0107-1. Epub 2009 Aug 19.
PMID: 19690799
citation: Hallberg I, Bachrach-Lindstrom M, Hammerby S, Toss G, Ek AC. Health-related quality of life after vertebral or hip fracture: a seven-year follow-up study. BMC Musculoskelet Disord. 2009 Nov 3;10:135. doi: 10.1186/1471-2474-10-135.
PMID: 19886998
citation: Papaioannou A, Kennedy CC, Ioannidis G, Brown JP, Pathak A, Hanley DA, Josse RG, Sebaldt RJ, Olszynski WP, Tenenhouse A, Murray TM, Petrie A, Goldsmith CH, Adachi JD. Determinants of health-related quality of life in women with vertebral fractures. Osteoporos Int. 2006;17(3):355-63. doi: 10.1007/s00198-005-2020-3. Epub 2005 Dec 9.
PMID: 16341623
citation: Strom O, Borgstrom F, Zethraeus N, Johnell O, Lidgren L, Ponzer S, Svensson O, Abdon P, Ornstein E, Ceder L, Thorngren KG, Sernbo I, Jonsson B. Long-term cost and effect on quality of life of osteoporosis-related fractures in Sweden. Acta Orthop. 2008 Apr;79(2):269-80. doi: 10.1080/17453670710015094.
PMID: 18484255
citation: Francis RM, Aspray TJ, Hide G, Sutcliffe AM, Wilkinson P. Back pain in osteoporotic vertebral fractures. Osteoporos Int. 2008 Jul;19(7):895-903. doi: 10.1007/s00198-007-0530-x. Epub 2007 Dec 11.
PMID: 18071648
citation: Pfeifer M, Begerow B, Minne HW. Effects of a new spinal orthosis on posture, trunk strength, and quality of life in women with postmenopausal osteoporosis: a randomized trial. Am J Phys Med Rehabil. 2004 Mar;83(3):177-86. doi: 10.1097/01.phm.0000113403.16617.93.
PMID: 15043351
citation: Pfeifer M, Kohlwey L, Begerow B, Minne HW. Effects of two newly developed spinal orthoses on trunk muscle strength, posture, and quality-of-life in women with postmenopausal osteoporosis: a randomized trial. Am J Phys Med Rehabil. 2011 Oct;90(10):805-15. doi: 10.1097/PHM.0b013e31821f6df3.
PMID: 21681065
citation: Salminen H, Saaf M, Ringertz H, Strender LE. Bone mineral density measurement in the calcaneus with DXL: comparison with hip and spine measurements in a cross-sectional study of an elderly female population. Osteoporos Int. 2005 May;16(5):541-51. doi: 10.1007/s00198-004-1719-x. Epub 2004 Sep 21.
PMID: 15448984
citation: Salminen H, Saaf M, Johansson SE, Ringertz H, Strender LE. Nutritional status, as determined by the Mini-Nutritional Assessment, and osteoporosis: a cross-sectional study of an elderly female population. Eur J Clin Nutr. 2006 Apr;60(4):486-93. doi: 10.1038/sj.ejcn.1602341.
PMID: 16391579
citation: Salminen H, Saaf M, Ringertz H, Strender LE. The role of IGF-I and IGFBP-1 status and secondary hyperparathyroidism in relation to osteoporosis in elderly Swedish women. Osteoporos Int. 2008 Feb;19(2):201-9. doi: 10.1007/s00198-007-0463-4. Epub 2007 Sep 14.
PMID: 17874030
citation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PMID: 1593914
citation: Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA, Kellingray S, Leplege A, Liberman UA, McCloskey E, Minne H, Reeve J, Reginster JY, Scholz M, Todd C, de Vernejoul MC, Wiklund I. Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Working Party for Quality of Life of the European Foundation for Osteoporosis. Osteoporos Int. 1999;10(2):150-60. doi: 10.1007/s001980050210.
PMID: 10501796
citation: Lips P, van Schoor NM. Quality of life in patients with osteoporosis. Osteoporos Int. 2005 May;16(5):447-55. doi: 10.1007/s00198-004-1762-7. Epub 2004 Dec 18.
PMID: 15609073
citation: Lips P, Agnusdei D, Caulin F, Cooper C, Johnell O, Kanis J, Liberman U, Minne H, Reeve J, Reginster JY, de Vernejoul MC, Wiklund I. The development of a European questionnaire for quality of life in patients with vertebral osteoporosis. Scand J Rheumatol Suppl. 1996;103:84-5; discussion 86-8. doi: 10.3109/03009749609103757.
PMID: 8966496
citation: Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
PMID: 10158943
citation: Sullivan M, Karlsson J, Ware JE Jr. The Swedish SF-36 Health Survey--I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med. 1995 Nov;41(10):1349-58. doi: 10.1016/0277-9536(95)00125-q.
PMID: 8560302
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Helena Salminen
investigator title: PI
mesh term: Osteoporosis
mesh term: Back Pain
mesh term: Spinal Fractures
sharing ipd: No
ipd description: Individual participant data is available only for the research group and available for other researchers only after new ethical review and in collaboration