<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/NCT02207998</url>
  </required_header>
  <id_info>
    <org_study_id>Morris 201005532</org_study_id>
    <secondary_id>AEC49-01-2013</secondary_id>
    <nct_id>NCT02207998</nct_id>
  </id_info>
  <brief_title>Efficacy of Homoeopathy and Physiotherapy in Chronic Low Back Pain Due to Osteoarthritis</brief_title>
  <official_title>The Efficacy of the Homoeopathic Complex and Physiotherapy in the Treatment of Chronic Low Back Pain Due to Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Johannesburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Johannesburg</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteoarthritis (OA) is a chronic arthropathy characterised by disruption and possible loss of&#xD;
      joint cartilage along with other joint changes. OA symptoms include progressively developing&#xD;
      joint pain provoked or elicited by activity, joint stiffness that lasts for less than 30&#xD;
      minutes on waking and after activity, and occasional joint swelling. It is a common specific&#xD;
      mechanical cause of chronic low back pain. Conventional treatment for OA includes&#xD;
      physiotherapy treatment and drugs such as paracetamol, non-steroidal anti-Inflammatory drugs&#xD;
      (NSAIDs), intra-articular injection of corticosteroids and surgery, however these may have&#xD;
      possible side effects. Arnica montana, Bryonia alba, Rhus toxicodendron, Causticum, Kalmia&#xD;
      latifolia and Calcarea fluoride are homoeopathic remedies indicated and used in the treatment&#xD;
      of OA, however, there is no evidence of studies conducted on a complex made up of these&#xD;
      remedies.&#xD;
&#xD;
      The aim of the study is to investigate the efficacy of the homoeopathic complex (Arnica&#xD;
      montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH&#xD;
      and Calcarea fluoride 6CH) and physiotherapy in the treatment of chronic low back pain due to&#xD;
      osteoarthritis, using the Oswestry Low Back Pain Disability Questionnaire, range of motion&#xD;
      (ROM) measurement using the attraction tape and the visual analogue pain scale (VAS) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a six week, double-blinded, placebo-controlled study, involving thirty&#xD;
      participants, males and females, aged 45-75 years receiving physiotherapy treatment for OA of&#xD;
      the lumbar spine at a specific and identified physiotherapist's private practice. A poster&#xD;
      advert , placed in the physiotherapist's private practice, with permission , will be used to&#xD;
      recruit participants. Individuals who respond to the poster advert will be provided with&#xD;
      information pertaining to the study and will be requested to sign a consent form . A&#xD;
      screening examination forming part of the inclusion criteria will be conducted by the&#xD;
      researcher. Participants meeting the inclusion criteria will be randomly allocated to a&#xD;
      treatment or control group; both groups will receive a standard physiotherapy treatment once&#xD;
      every two weeks from the physiotherapist. Treatment will consist of lower back classic&#xD;
      massage, lumbar joint manipulation, the application of a hot pack and each treatment session&#xD;
      will last for 30 minutes. In addition to physiotherapy treatment, participants will be&#xD;
      allocated, either a placebo or the homoeopathic complex, with instruction to take two&#xD;
      tablets, dissolved under the tongue 20 minutes away from meals, twice daily, starting from&#xD;
      day one. This will comprise of 168 tablets, 56 tablets will be issued forth nightly to assess&#xD;
      participant's compliance in taking their medicine.&#xD;
&#xD;
      Four consultations will take place at the physiotherapist's private practise. At the first&#xD;
      consultation after having divided participants into the treatment and control group,&#xD;
      participants will complete the Oswestry Low Back Pain Disability Questionnaire with the&#xD;
      researcher's assistance. The researcher will assess the lumbar spine's ROM using the&#xD;
      attraction tape measurement. Participants will be provided with 1 copy of the VAS pain scale&#xD;
      with spaces to rate their pain every evening for 14 days and 56 tablets. During the second&#xD;
      and third consultation, copies of the VAS pain scale will be collected as well as medication&#xD;
      containers, to assess participant's compliance in taking their medication. A subjective and&#xD;
      physical examination will be conducted, the Oswestry Low Back Pain Disability Questionnaire&#xD;
      will be completed and ROM for the lumbar spine will be measured. Participants will receive&#xD;
      tablets and copies of the VAS pain scale. On the forth consultation the researcher will&#xD;
      conduct the last subjective and physical examination, complete the last Oswestry Low Back&#xD;
      Pain Disability Questionnaire and conduct the last ROM measurement using the attraction tape&#xD;
      measurement. The last copies of the VAS pain scale and medication containers will be&#xD;
      collected.&#xD;
&#xD;
      A subjective and physical examination, Oswestry Low Back Pain Disability Questionnaire, the&#xD;
      retraction tape measurement for ROM and the VAS pain scale will be used to collect data and&#xD;
      analysed statistically using the Wilcoxon signed test or t-test within groups and t-test&#xD;
      (parametric) or Mann-Whitney U (non-parametric) on between groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Low Back Pain Disability Questionnaire</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Oswestry Low Back Pain Disability Questionnaire is a standard and validated Questionnaire used in many studies conducted on low back pain. It measures the intensity of pain, how personal care may be affected by pain, how activities such as lifting, walking, standing, sitting and sleeping may be affected by pain. Each section is scored on a six-point scale (0-5) with 0 representing no limitation and 5 representing a maximal limitation. The total score is 50 which is doubled and interpreted as a percentage of the patient-perceived disability (the higher the score, the greater the disability). This will be completed at week 0, and at the end of weeks 2, 4 and 6.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual analogue pain scale (VAS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The VAS for pain is also an established and validated tool that is used in determining the subjective level of pain in an individual. It can be used to assess how pain changes with treatment. It will be completed once daily from week 0 to week 6.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>range of motion (ROM)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Range of motion is assessed using the attraction tape measurement (a standard validated approach) which involves the use of a tape measure, placed directly over the lumbar spine while the patient bends as far as they can. A 0-cm mark is represented by the spinal intersection of a horizontal line drawn between the left and right posterior superior iliac spines. From this point, a second mark is placed 10 cm superior (flexion reference) and a third mark 5 cm inferior (extension reference). Lumbar flexion and extension is measured using this method and it demonstrates test reliability and can differentiate normal from those with &quot;significantly limiting low back pain&quot;. ROM will be assessed every two weeks, from week 0 to week 6.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Homeopathic complex and physiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Homeopathic complex and physiotherapy: (Arnica montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH and Calcarea fluoride 6CH) will comprise of 168 tablets; 56 tablets will be issued forth nightly to assess participant's compliance in taking their medicine. Participants will be given instruction to take two tablets, dissolved under the tongue 20 minutes away from meals, twice daily, starting from day one.&#xD;
Physiotherapy treatment will consist of lower back classic massage, lumber joint manipulation and the application of a hot pack. Treatment sessions will last for 30 minutes, once every two weeks at the same physiotherapy practice from the same specific and identified physiotherapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo and physiotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo and Physiotherapy: Placebo will comprise of 168 unmedicated lactose tablets; 56 tablets will be issued forth nightly to assess participant's compliance in taking their medicine. Participants will be given instruction to take two tablets, dissolved under the tongue 20 minutes away from meals, twice daily, starting from day one.&#xD;
Physiotherapy treatment will consist of lower back classic massage, lumber joint manipulation and the application of a hot pack. Treatment sessions will last for 30 minutes, once every two weeks at the same physiotherapy practice from the same specific and identified physiotherapist .</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Homeopathic complex and physiotherapy</intervention_name>
    <description>Homoeopathic complex (Arnica montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH and Calcarea fluoride 6CH) will comprise of medicated lactose tablets.</description>
    <arm_group_label>Homeopathic complex and physiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo and physiotherapy</intervention_name>
    <description>Unmedicated lactose tablets. Physiotherapy: lower back classic massage, lumber joint manipulation and the application of a hot pack</description>
    <arm_group_label>Placebo and physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must present with symptomatic chronic lower back pain due to OA for more than 3 months&#xD;
             and having been diagnosed by a health care practitioner with OA;&#xD;
&#xD;
          -  They must have symptoms of OA such as pain and decreased range of motion, on&#xD;
             subjective and physical examination and&#xD;
&#xD;
          -  Participants must be receiving physiotherapy treatment from a specific and identified&#xD;
             physiotherapist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are receiving any other forms of therapy other than physical therapy&#xD;
             (massage and thermotherapy), for example osteopathy, acupuncture, ultrasound or&#xD;
             electrotherapy as part of physiotherapy treatment;&#xD;
&#xD;
          -  Those presenting with acute lower back pain (with duration of only 3 months or less)&#xD;
             and those suffering from chronic lower back pain as a result of disc herniation,&#xD;
             compression fracture, lumbar spinal stenosis or spondylolisthesis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tebogo Tsele-Tebakang, M.Tech Hom</last_name>
    <role>Study Director</role>
    <affiliation>University of Johannesburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth M Solomon, D.Tech Hom</last_name>
    <role>Study Director</role>
    <affiliation>University of Johannesburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Johannesburg</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2028</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>May 18, 2016</last_update_submitted>
  <last_update_submitted_qc>May 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Johannesburg</investigator_affiliation>
    <investigator_full_name>Dr J. Pellow</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>osteoarthritis, physiotherapy, homeopathy, complex</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back 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/NCT02207998
org study id: Morris 201005532
secondary id: AEC49-01-2013
nct id: NCT02207998
lead sponsor: 
has dmc: Yes
Osteoarthritis (OA) is a chronic arthropathy characterised by disruption and possible loss of
      joint cartilage along with other joint changes. OA symptoms include progressively developing
      joint pain provoked or elicited by activity, joint stiffness that lasts for less than 30
      minutes on waking and after activity, and occasional joint swelling. It is a common specific
      mechanical cause of chronic low back pain. Conventional treatment for OA includes
      physiotherapy treatment and drugs such as paracetamol, non-steroidal anti-Inflammatory drugs
      (NSAIDs), intra-articular injection of corticosteroids and surgery, however these may have
      possible side effects. Arnica montana, Bryonia alba, Rhus toxicodendron, Causticum, Kalmia
      latifolia and Calcarea fluoride are homoeopathic remedies indicated and used in the treatment
      of OA, however, there is no evidence of studies conducted on a complex made up of these
      remedies.

      The aim of the study is to investigate the efficacy of the homoeopathic complex (Arnica
      montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH
      and Calcarea fluoride 6CH) and physiotherapy in the treatment of chronic low back pain due to
      osteoarthritis, using the Oswestry Low Back Pain Disability Questionnaire, range of motion
      (ROM) measurement using the attraction tape and the visual analogue pain scale (VAS) .
This study is a six week, double-blinded, placebo-controlled study, involving thirty
      participants, males and females, aged 45-75 years receiving physiotherapy treatment for OA of
      the lumbar spine at a specific and identified physiotherapist's private practice. A poster
      advert , placed in the physiotherapist's private practice, with permission , will be used to
      recruit participants. Individuals who respond to the poster advert will be provided with
      information pertaining to the study and will be requested to sign a consent form . A
      screening examination forming part of the inclusion criteria will be conducted by the
      researcher. Participants meeting the inclusion criteria will be randomly allocated to a
      treatment or control group; both groups will receive a standard physiotherapy treatment once
      every two weeks from the physiotherapist. Treatment will consist of lower back classic
      massage, lumbar joint manipulation, the application of a hot pack and each treatment session
      will last for 30 minutes. In addition to physiotherapy treatment, participants will be
      allocated, either a placebo or the homoeopathic complex, with instruction to take two
      tablets, dissolved under the tongue 20 minutes away from meals, twice daily, starting from
      day one. This will comprise of 168 tablets, 56 tablets will be issued forth nightly to assess
      participant's compliance in taking their medicine.

      Four consultations will take place at the physiotherapist's private practise. At the first
      consultation after having divided participants into the treatment and control group,
      participants will complete the Oswestry Low Back Pain Disability Questionnaire with the
      researcher's assistance. The researcher will assess the lumbar spine's ROM using the
      attraction tape measurement. Participants will be provided with 1 copy of the VAS pain scale
      with spaces to rate their pain every evening for 14 days and 56 tablets. During the second
      and third consultation, copies of the VAS pain scale will be collected as well as medication
      containers, to assess participant's compliance in taking their medication. A subjective and
      physical examination will be conducted, the Oswestry Low Back Pain Disability Questionnaire
      will be completed and ROM for the lumbar spine will be measured. Participants will receive
      tablets and copies of the VAS pain scale. On the forth consultation the researcher will
      conduct the last subjective and physical examination, complete the last Oswestry Low Back
      Pain Disability Questionnaire and conduct the last ROM measurement using the attraction tape
      measurement. The last copies of the VAS pain scale and medication containers will be
      collected.

      A subjective and physical examination, Oswestry Low Back Pain Disability Questionnaire, the
      retraction tape measurement for ROM and the VAS pain scale will be used to collect data and
      analysed statistically using the Wilcoxon signed test or t-test within groups and t-test
      (parametric) or Mann-Whitney U (non-parametric) on between groups
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Oswestry Low Back Pain Disability Questionnaire
time frame: 6 weeks
description: The Oswestry Low Back Pain Disability Questionnaire is a standard and validated Questionnaire used in many studies conducted on low back pain. It measures the intensity of pain, how personal care may be affected by pain, how activities such as lifting, walking, standing, sitting and sleeping may be affected by pain. Each section is scored on a six-point scale (0-5) with 0 representing no limitation and 5 representing a maximal limitation. The total score is 50 which is doubled and interpreted as a percentage of the patient-perceived disability (the higher the score, the greater the disability). This will be completed at week 0, and at the end of weeks 2, 4 and 6.
measure: visual analogue pain scale (VAS)
time frame: 6 weeks
description: The VAS for pain is also an established and validated tool that is used in determining the subjective level of pain in an individual. It can be used to assess how pain changes with treatment. It will be completed once daily from week 0 to week 6.
measure: range of motion (ROM)
time frame: 6 weeks
description: Range of motion is assessed using the attraction tape measurement (a standard validated approach) which involves the use of a tape measure, placed directly over the lumbar spine while the patient bends as far as they can. A 0-cm mark is represented by the spinal intersection of a horizontal line drawn between the left and right posterior superior iliac spines. From this point, a second mark is placed 10 cm superior (flexion reference) and a third mark 5 cm inferior (extension reference). Lumbar flexion and extension is measured using this method and it demonstrates test reliability and can differentiate normal from those with "significantly limiting low back pain". ROM will be assessed every two weeks, from week 0 to week 6.
arm group label: Homeopathic complex and physiotherapy
arm group type: Experimental
description: Homeopathic complex and physiotherapy: (Arnica montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH and Calcarea fluoride 6CH) will comprise of 168 tablets; 56 tablets will be issued forth nightly to assess participant's compliance in taking their medicine. Participants will be given instruction to take two tablets, dissolved under the tongue 20 minutes away from meals, twice daily, starting from day one.
Physiotherapy treatment will consist of lower back classic massage, lumber joint manipulation and the application of a hot pack. Treatment sessions will last for 30 minutes, once every two weeks at the same physiotherapy practice from the same specific and identified physiotherapist.
arm group label: Placebo and physiotherapy
arm group type: Placebo Comparator
description: Placebo and Physiotherapy: Placebo will comprise of 168 unmedicated lactose tablets; 56 tablets will be issued forth nightly to assess participant's compliance in taking their medicine. Participants will be given instruction to take two tablets, dissolved under the tongue 20 minutes away from meals, twice daily, starting from day one.
Physiotherapy treatment will consist of lower back classic massage, lumber joint manipulation and the application of a hot pack. Treatment sessions will last for 30 minutes, once every two weeks at the same physiotherapy practice from the same specific and identified physiotherapist .
intervention type: Drug
intervention name: Homeopathic complex and physiotherapy
description: Homoeopathic complex (Arnica montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH and Calcarea fluoride 6CH) will comprise of medicated lactose tablets.
arm group label: Homeopathic complex and physiotherapy
intervention type: Drug
intervention name: Placebo and physiotherapy
description: Unmedicated lactose tablets. Physiotherapy: lower back classic massage, lumber joint manipulation and the application of a hot pack
arm group label: Placebo and physiotherapy
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tebogo Tsele-Tebakang, M.Tech Hom
role: Study Director
affiliation: University of Johannesburg
last name: Elizabeth M Solomon, D.Tech Hom
role: Study Director
affiliation: University of Johannesburg
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of Johannesburg
investigator full name: Dr J. Pellow
investigator title: Dr
mesh term: Osteoarthritis
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No