Clinical trial NCT02207998: Efficacy of Homoeopathy and Physiotherapy in Chronic Low Back Pain Due to Osteoarthritis
Official title: The Efficacy of the Homoeopathic Complex and Physiotherapy in the Treatment of Chronic Low Back Pain Due to Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: osteoarthritis, physiotherapy, homeopathy, complex
Lead sponsor: University of Johannesburg
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) .

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

Eligibility 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.

Primary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 6 weeks
Secondary outcomes:
measure: visual analogue pain scale (VAS)
timeFrame: 6 weeks
Other outcomes:
measure: range of motion (ROM)
timeFrame: 6 weeks
Locations:
city: Johannesburg
country: South Africa
facility: University of Johannesburg
state: Gauteng
Study officials:
affiliation: University of Johannesburg
name: Tebogo Tsele-Tebakang, M.Tech Hom
role: STUDY_DIRECTOR
affiliation: University of Johannesburg
name: Elizabeth M Solomon, D.Tech Hom
role: STUDY_DIRECTOR
References:
citation: 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.