<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/NCT02235207</url>
  </required_header>
  <id_info>
    <org_study_id>R14030</org_study_id>
    <nct_id>NCT02235207</nct_id>
  </id_info>
  <brief_title>Effectiveness of Fustra-Exercise Program in Neck and Low Back Pain</brief_title>
  <acronym>FUSTRA</acronym>
  <official_title>Effectiveness of Fustra-Exercise Program on Pain, Physical Fitness and Quality of Life in Female and Male Office Workers Suffering From Recurrent Neck and Low Back Pain - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UKK Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fustra International Oy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UKK Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the effectiveness of Fustra® exercise program in&#xD;
      relieving recurrent pain in the neck or/and back, and thus improve quality of life in female&#xD;
      and male office workers. The hypothesis is that neuromuscular exercise will improve control&#xD;
      of posture and movement, neck shoulder and trunk flexibility, trunk muscular endurance and&#xD;
      leg strength, and thus decrease intensity of pain by 30% compared to non-exercise group. In&#xD;
      addition, financial feasibility of the exercise program and effects of training on quality of&#xD;
      life and perceived work ability are studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neck and low back pain (LBP) are the two major reasons for visiting a physician and they&#xD;
      cause significant sickness absence from work. Neuromuscular exercise of at least moderate&#xD;
      intensity is the only mode of therapeutic exercise, which has been shown to be effective in&#xD;
      relieving pain and disability in recurrent or chronic neck and LBP.&#xD;
&#xD;
      This study examines the effects of a standardized exercise program Fustra20 Neck &amp; Back&#xD;
      applied individually by educated exercise leaders in about 30 private sports clubs located in&#xD;
      different parts of Finland. The target is to have 5-6 participants in each club. Recruitment&#xD;
      began with advertisements in two national level newspapers. Interested individuals were asked&#xD;
      to contact UKK Institute (UKKI) by phone or e-mail. In addition, the website of UKKI and the&#xD;
      sports clubs are used to reach people more locally. Structured telephone interview is&#xD;
      conducted to screen the eligible participants. Two researchers select the participants&#xD;
      according to eligibility criteria.&#xD;
&#xD;
      Accepted participants are invited to the study by personal e-mail including the detailed&#xD;
      announcement of the study and approval papers to be signed in. The tester of each sport club,&#xD;
      responsible for conducting the fitness measurements (baseline, 3 months, 12 months) will&#xD;
      receive text message from UKKI including names and phone numbers of accepted study&#xD;
      participants. After that UKKI sends similar type of text message to each Fustra exercise&#xD;
      leaders including only those participants that were randomly allocated to exercise group.&#xD;
&#xD;
      The exercise group will participate in individually guided, graded exercise twice a week for&#xD;
      20 times. Each session lasts one hour. Fustra exercise leaders have a personal diary for each&#xD;
      participant, where they make notes on compliance and contents of each exercise session. After&#xD;
      20 sessions participants are encouraged to continue exercising at home with a help of an&#xD;
      individual home exercise plan including diary of compliance.&#xD;
&#xD;
      Participants allocated to control group are asked to continue their usual physical activity&#xD;
      and exercise habits. After the final measurements at 12-month they have a possibility to&#xD;
      participate to Fustra20 Neck &amp; Back exercise for five times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the intensity of pain in the neck or/and low back</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Visual analog scale (line 0-100) filled in electronically (Webrobol) for past 4 weeks assessed separately for neck and low back pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the intensity of pain in the neck or/and low back</measure>
    <time_frame>Baselilne, 3 months</time_frame>
    <description>Visual analog scale (line 0-100) for past 4 weeks filled in electronically (Webrobol) assessed separately for neck and low back pain and</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in musculoskeletal fitness index</measure>
    <time_frame>Baselilne, 3 months</time_frame>
    <description>Fitness index is computed based on age and sex specific norm-reference values of 5 standardized tests assessing balance, shoulder neck mobility, trunk flexibility, ability to stabilize trunk and lower extremity endurance strength.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in the quality of life</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>RAND 36 with six subscales</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in objectively measured physical activity and sedentary behaviour</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Accelerometer assessment for 7 days with simultaneous diary recordings on specific exercise</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in fear avoidance beliefs</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Fear Avoidance Questionnaire (FABQ) filled in electronically</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Neck Pain</condition>
  <condition>Low Back Pain, Recurrent</condition>
  <arm_group>
    <arm_group_label>Neuromuscular exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The exercise group will participate in Fustra20 Neck &amp; Back neuromuscular exercise program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants are encouraged to continue there usual physical activity and exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neuromuscular exercise</intervention_name>
    <description>Fustra20 Neck &amp; Back is individually guided, graded neuromuscular exercise program which is conducted twice a week for 20 times. Each session lasts one hour. After 20 sessions participants are encouraged to continue exercising at home with a help of an individual home exercise plan including diary of compliance.&#xD;
The main targets are to&#xD;
improve movement control in different posture and movements of the neck and back&#xD;
improve flexibility with active functional movements&#xD;
improve pelvic, spine and shoulder-neck stability using co-contraction of several muscle groups, and thus enhancing gross movement of the whole kinetic chain&#xD;
improve muscular endurance of shoulder neck area, trunk, pelvis and lower extremities</description>
    <arm_group_label>Neuromuscular exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 30-50 years&#xD;
&#xD;
          -  sedentary &quot;office&quot; worker sitting at least 6 hours per day&#xD;
&#xD;
          -  rating of neck pain or low back pain in the past four weeks is at least 3 in 10 point&#xD;
             scale (1-10)&#xD;
&#xD;
          -  number of pain episodes (neck/back) in the past year is at least 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic pain (neck/back) defined as continuous pain over 1 year&#xD;
&#xD;
          -  serious former neck injury (fracture, surgery, whiplash, protruded disc)&#xD;
&#xD;
          -  serious former back injury (fracture, surgery, protruded disc)&#xD;
&#xD;
          -  engaged in neuromuscular exercise 3 times a week or more&#xD;
&#xD;
          -  engaged in competitive sports&#xD;
&#xD;
          -  pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaana H Suni, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UKK Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UKK Institute for Health Promotion Research</name>
      <address>
        <city>Tampere</city>
        <state>Pirkanmaa</state>
        <zip>33500</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>March 10, 2016</last_update_submitted>
  <last_update_submitted_qc>March 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UKK Institute</investigator_affiliation>
    <investigator_full_name>Jaana Suni</investigator_full_name>
    <investigator_title>Research and develompment manager</investigator_title>
  </responsible_party>
  <keyword>sedentary work</keyword>
  <keyword>musculoskeletal pain</keyword>
  <keyword>neuromuscular exercise</keyword>
  <keyword>physical fitness</keyword>
  <keyword>quality of life</keyword>
  <keyword>work ability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02235207
org study id: R14030
nct id: NCT02235207
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to investigate the effectiveness of Fustra® exercise program in
      relieving recurrent pain in the neck or/and back, and thus improve quality of life in female
      and male office workers. The hypothesis is that neuromuscular exercise will improve control
      of posture and movement, neck shoulder and trunk flexibility, trunk muscular endurance and
      leg strength, and thus decrease intensity of pain by 30% compared to non-exercise group. In
      addition, financial feasibility of the exercise program and effects of training on quality of
      life and perceived work ability are studied.
Neck and low back pain (LBP) are the two major reasons for visiting a physician and they
      cause significant sickness absence from work. Neuromuscular exercise of at least moderate
      intensity is the only mode of therapeutic exercise, which has been shown to be effective in
      relieving pain and disability in recurrent or chronic neck and LBP.

      This study examines the effects of a standardized exercise program Fustra20 Neck & Back
      applied individually by educated exercise leaders in about 30 private sports clubs located in
      different parts of Finland. The target is to have 5-6 participants in each club. Recruitment
      began with advertisements in two national level newspapers. Interested individuals were asked
      to contact UKK Institute (UKKI) by phone or e-mail. In addition, the website of UKKI and the
      sports clubs are used to reach people more locally. Structured telephone interview is
      conducted to screen the eligible participants. Two researchers select the participants
      according to eligibility criteria.

      Accepted participants are invited to the study by personal e-mail including the detailed
      announcement of the study and approval papers to be signed in. The tester of each sport club,
      responsible for conducting the fitness measurements (baseline, 3 months, 12 months) will
      receive text message from UKKI including names and phone numbers of accepted study
      participants. After that UKKI sends similar type of text message to each Fustra exercise
      leaders including only those participants that were randomly allocated to exercise group.

      The exercise group will participate in individually guided, graded exercise twice a week for
      20 times. Each session lasts one hour. Fustra exercise leaders have a personal diary for each
      participant, where they make notes on compliance and contents of each exercise session. After
      20 sessions participants are encouraged to continue exercising at home with a help of an
      individual home exercise plan including diary of compliance.

      Participants allocated to control group are asked to continue their usual physical activity
      and exercise habits. After the final measurements at 12-month they have a possibility to
      participate to Fustra20 Neck & Back exercise for five times.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in the intensity of pain in the neck or/and low back
time frame: Baseline, 12 months
description: Visual analog scale (line 0-100) filled in electronically (Webrobol) for past 4 weeks assessed separately for neck and low back pain
measure: Change in the intensity of pain in the neck or/and low back
time frame: Baselilne, 3 months
description: Visual analog scale (line 0-100) for past 4 weeks filled in electronically (Webrobol) assessed separately for neck and low back pain and
measure: Change in musculoskeletal fitness index
time frame: Baselilne, 3 months
description: Fitness index is computed based on age and sex specific norm-reference values of 5 standardized tests assessing balance, shoulder neck mobility, trunk flexibility, ability to stabilize trunk and lower extremity endurance strength.
measure: Change in the quality of life
time frame: Baseline, 12 months
description: RAND 36 with six subscales
measure: Changes in objectively measured physical activity and sedentary behaviour
time frame: Baseline, 12 months
description: Accelerometer assessment for 7 days with simultaneous diary recordings on specific exercise
measure: Changes in fear avoidance beliefs
time frame: Baseline, 12 months
description: Fear Avoidance Questionnaire (FABQ) filled in electronically
arm group label: Neuromuscular exercise
arm group type: Experimental
description: The exercise group will participate in Fustra20 Neck & Back neuromuscular exercise program.
arm group label: Control group
arm group type: No Intervention
description: Participants are encouraged to continue there usual physical activity and exercise
intervention type: Behavioral
intervention name: Neuromuscular exercise
description: Fustra20 Neck & Back is individually guided, graded neuromuscular exercise program which is conducted twice a week for 20 times. Each session lasts one hour. After 20 sessions participants are encouraged to continue exercising at home with a help of an individual home exercise plan including diary of compliance.
The main targets are to
improve movement control in different posture and movements of the neck and back
improve flexibility with active functional movements
improve pelvic, spine and shoulder-neck stability using co-contraction of several muscle groups, and thus enhancing gross movement of the whole kinetic chain
improve muscular endurance of shoulder neck area, trunk, pelvis and lower extremities
arm group label: Neuromuscular exercise
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jaana H Suni, PhD
role: Principal Investigator
affiliation: UKK Institute
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: UKK Institute
investigator full name: Jaana Suni
investigator title: Research and develompment manager
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Neck Pain
sharing ipd: No