An Open labelled double arm non-randomised phase II clinical trial to compare the efficacy of VARMA MANIPULATION with KARUNKURINJI KUDINEER (INTERNAL)and ETTI PATTAI ENNAI (EXTERNAL) in the treatment of KOARAI VATHAM
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Assessment of change from baseline in QUEBEC BACK PAIN DISABILITY SCALE at day of between Group I and Group II for varma manipulation and internal and external medicine
Study Overview
Brief Summary
LUMBAR SPONDYLOSIS is the term given to theoccurrence of degenerative disc disease and osteoarthritic change in the lumbarspine. Within the literature, lumbar spondylosis encompasses numerous associated pathologiesincluding spinal stenosis, degenerative spondylolisthesis, osteoarthritis andmany others.spondylosis is not aclinical diagnosis but instead a descriptiveterm utilized to designate spinal problems. Thelumbar spine carries most of the body’s weight. therefore degenerative changesaffect its structure causes pain with activity such as walking and standing,lifting objects or after a long period of rest. The manipulation of varma pointsfor treating diseases is called varma therapy. According to varma textthe signs and symptoms of koarai vatham mentioned in vatha noi nithanamcan be correlated with lumbarspondylosis (Ref. Vaadha Noi Nidhanam – 800(42/800). This study is to evaluate the therapeutic efficacy of VarmaManipulation and clinical efficacy of karunkurinji kudineer (Internal) and ulunthennai (External).on koaraivatham (lumbar spondylosis). The manipulation of varma pointsfor treating diseases is called varma therapy. According to varma textthe signs and symptoms of koarai vatham mentioned in vatha noi nithanamcan be correlated with lumbarspondylosis (Ref. Vaadha Noi Nidhanam – 800(42/800). This study is to evaluate the therapeutic efficacy of VarmaManipulation and clinical efficacy of karunkurinji kudineer (Internal) and ulunthennai (External).on koaraivatham (lumbar spondylosis).
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients having symptoms of Pain in the lumbar region, Radiating pain to buttocks and lower limbs ,stiffness present in lumbar region, Exacerbation of pain on movements, Pain increased on forward bending, Tingling sensation.(Numbness) Patients who are willing to give radiological investigation and provide blood for lab investigation.
- •Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can option out of the trial of his/her own conscious discretion.
Exclusion Criteria
- •Auto immune diseases like Rheumatoid arthiritis, SLE, Psoriasis, Mixed connective tissue disorder.
- •Spina bifida Pregnancy and lactation Osteo myelitis Renal Disease Tuberculosis in spine Patient with any other serious illness.
Outcomes
Primary Outcomes
Assessment of change from baseline in QUEBEC BACK PAIN DISABILITY SCALE at day of between Group I and Group II for varma manipulation and internal and external medicine
Time Frame: Group I Intermittent varma manipulation within 48 days | 1st sitting 50 percentage of symptoms will reduce | 2nd sitting 80 percentage of symptoms will reduce | Group II After giving internal and external medine for 12 days with varma manipulation 50 percentage of primary symptoms will reduce | within 48 days 80 percentage of symptoms will reduce
Secondary Outcomes
- Assessment of OSWESTRY LOWBACK PAIN DISABILITY QUESTIONNAIRE.(Assessment of safety parameters)