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Efficacy of Homoeopathy and Physiotherapy in Chronic Low Back Pain Due to Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02207998
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Dr J. Pellow, University of Johannesburg

Brief 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 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) .


Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Homeopathic complex and physiotherapy Drug: Placebo and physiotherapy Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of the Homoeopathic Complex and Physiotherapy in the Treatment of Chronic Low Back Pain Due to Osteoarthritis
Study Start Date : July 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Homeopathic complex and physiotherapy

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.

Drug: Homeopathic complex and physiotherapy
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 Comparator: Placebo and physiotherapy

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 .

Drug: Placebo and physiotherapy
Unmedicated lactose tablets. Physiotherapy: lower back classic massage, lumber joint manipulation and the application of a hot pack




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. visual analogue pain scale (VAS) [ Time Frame: 6 weeks ]
    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.


Other Outcome Measures:
  1. range of motion (ROM) [ Time Frame: 6 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207998


Locations
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South Africa
University of Johannesburg
Johannesburg, Gauteng, South Africa, 2028
Sponsors and Collaborators
University of Johannesburg
Investigators
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Study Director: Tebogo Tsele-Tebakang, M.Tech Hom University of Johannesburg
Study Director: Elizabeth M Solomon, D.Tech Hom University of Johannesburg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr J. Pellow, Dr, University of Johannesburg
ClinicalTrials.gov Identifier: NCT02207998    
Other Study ID Numbers: Morris 201005532
AEC49-01-2013 ( Other Identifier: UJohannesburg )
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr J. Pellow, University of Johannesburg:
osteoarthritis, physiotherapy, homeopathy, complex
Additional relevant MeSH terms:
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Osteoarthritis
Back Pain
Low Back Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations