OsteoarthritisPhase 2NCT02207998
Efficacy of Homoeopathy and Physiotherapy in Chronic Low Back Pain Due to Osteoarthritis
A Phase 2 study testing Homeopathic complex and physiotherapy in people with Osteoarthritis, run by University of Johannesburg at 1 site in South Africa.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Homeopathic complex and physiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must present with symptomatic chronic lower back pain due to OA for more than 3 months and having been diagnosed by a health care practitioner with OA;
- They must have symptoms of OA such as pain and decreased range of motion, on subjective and physical examination and
- Participants must be receiving physiotherapy treatment from a specific and identified physiotherapist
Who cannot join
- Participants who are receiving any other forms of therapy other than physical therapy (massage and thermotherapy), for example osteopathy, acupuncture, ultrasound or electrotherapy as part of physiotherapy treatment;
- Those presenting with acute lower back pain (with duration of only 3 months or less) and those suffering from chronic lower back pain as a result of disc herniation, compression fracture, lumbar spinal stenosis or spondylolisthesis.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2028
About this study
Official title: The Efficacy of the Homoeopathic Complex and Physiotherapy in the Treatment of Chronic Low Back Pain Due to Osteoarthritis
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) .
Read the detailed description
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
- Conditions
- Osteoarthritis
- Being tested
- Homeopathic complex and physiotherapy, Placebo and physiotherapy
- Keywords
- osteoarthritis, physiotherapy, homeopathy, complex
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeopathic complex and physiotherapyDrug
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.
Placebo and physiotherapyDrug
Unmedicated lactose tablets. Physiotherapy: lower back classic massage, lumber joint manipulation and the application of a hot pack
| Study group | Role | What they receive |
|---|---|---|
| Homeopathic complex and physiotherapy | Experimental | 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. Receives: Drug: Homeopathic complex and physiotherapy |
| Placebo and physiotherapy | Placebo comparator | 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 . Receives: Drug: Placebo and physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Low Back Pain Disability Questionnaire
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.
Measured: 6 weeks
Secondary outcomes (1)
visual analogue pain scale (VAS)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- Tebogo Tsele-Tebakang, M.Tech Hom, Study director, University of JohannesburgElizabeth M Solomon, D.Tech Hom, Study director, University of Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207998
- Sponsor's protocol ID
- Morris 201005532
- Other IDs
- AEC49-01-2013
- Status last verified
- May 2016
- First submitted
- 31 Jul 2014
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Morris M, Pellow J, Solomon EM, Tsele-Tebakang T. Physiotherapy and a Homeopathic Complex for Chronic Low-back Pain Due to Osteoarthritis: A Randomized, Controlled Pilot Study. Altern Ther Health Med. 2016 Jan-Feb;22(1):48-56.
PubMed 26773321
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Homoeopathic Complex and Physiotherapy in the Treatment of Chronic Low Back Pain Due to Osteoarthritis
- ClinicalTrials.gov ID
- NCT02207998
- Acronym / sponsor ID
- Morris 201005532
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, physiotherapy, homeopathy, complex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homeopathic complex and physiotherapy | Experimental | Drug: Homeopathic complex and physiotherapyHomeopathic 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. |
| Placebo and physiotherapy | Placebo comparator | Drug: Placebo and physiotherapyPlacebo 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 . |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must present with symptomatic chronic lower back pain due to OA for more than 3 months and having been diagnosed by a health care practitioner with OA;
- They must have symptoms of OA such as pain and decreased range of motion, on subjective and physical examination and
- Participants must be receiving physiotherapy treatment from a specific and identified physiotherapist
Key exclusion criteria (2 listed)
- Participants who are receiving any other forms of therapy other than physical therapy (massage and thermotherapy), for example osteopathy, acupuncture, ultrasound or electrotherapy as part of physiotherapy treatment;
- Those presenting with acute lower back pain (with duration of only 3 months or less) and those suffering from chronic lower back pain as a result of disc herniation, compression fracture, lumbar spinal stenosis or spondylolisthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeopathic complex and physiotherapyHomoeopathic 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. | Drug | Homeopathic complex and physiotherapy |
| Placebo and physiotherapyUnmedicated lactose tablets. Physiotherapy: lower back classic massage, lumber joint manipulation and the application of a hot pack | Drug | Placebo and physiotherapy |
Primary outcome
Oswestry Low Back Pain Disability Questionnaire
Time frame: 6 weeks
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.
1 secondary outcome
visual analogue pain scale (VAS)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Derived from this study: PubMed 26773321Morris M, Pellow J, Solomon EM, Tsele-Tebakang T. Physiotherapy and a Homeopathic Complex for Chronic Low-back Pain Due to Osteoarthritis: A Randomized, Controlled Pilot Study. Altern Ther Health Med. 2016 Jan-Feb;22(1):48-56.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tebogo Tsele-Tebakang, M.Tech Hom study director
University of Johannesburg
Elizabeth M Solomon, D.Tech Hom study director
University of Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Homeopathic complex and physiotherapy in people with Osteoarthritis, run by University of Johannesburg at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Low Back Pain Disability Questionnaire (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02207998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.