Efficacy of Homoeopathy and Physiotherapy in Chronic Low Back Pain Due to Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

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
    

Intervention name(s): Homeopathic complex and physiotherapy; Placebo and physiotherapy
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Unmedicated lactose tablets. Physiotherapy: lower back classic massage, lumber joint manipulation and the application of a hot pack
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: osteoarthritis, physiotherapy, homeopathy, complex