Skip to content

A clinical trial to evaluate the effect of Marma Therapy in radiating low back pain.

A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF MARMA THERAPY IN PAIN MANAGEMENT IN LUMBAR DISC HERNIATION WITH RADICULOPATHY

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040491
Enrollment
90
Registered
2022-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy

Interventions

None listed

Sponsors

Central Council for Research in Ayurvedic Sciences Ministry of Ayush
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants of any gender in the age group 30-60 years. 2. Participants diagnosed with Lumbar Radiculopathy with unilateral radiating pain (either left or right lower limb), due to Intervertebral disc herniation confirmed by MRI (disc herniation between L3 and S1 level; at single or double level) provided no neurologic deficit is evident. 3. Positive straight leg raise test (ipsilateral or contralateral pain in leg, buttock or back at 70 degrees or less of leg elevation and the pain is typically worsened by dorsi-flexion of ankle or neck flexion after slowly lowering the leg until the patient no longer feels pain) 4. Willingness to provide informed consent and adhere to the study protocol for a period of 3 months.

Exclusion criteria

Exclusion criteria: 1. Indication for surgical intervention for disc herniation like severe motor deficit (motor power of lower limbs assessed through Medical Research Council Manual Muscle Testing scale ââ?°Â¤3), severe spinal stenosis; excruciating pain that cannot be managed by conservative treatment, foraminal stenosis, conjoint nerve root, perineural cyst etc. 2. Patients who have received non pharmacological interventions like physiotherapy, traction, manual therapy, etc. for the management of lumbar disc herniation in last 3 months. 3. History of or evidence of any of the following - Osteoporotic lumbar fracture, presence of inflammatory or infective diseases that affect spinal morphology, such as ankylosing spondylitis, Spondylodiscitis or inflammatory spondylitis, spondylolisthesis, Pottââ?¬•s spine, Pyriformis syndrome, sacro-iliitis 4. History of spinal surgery in last 2 years or having epidural fibrosis. 5. Patients with caudaequina syndrome or neurological deficits such as foot drop, limb muscle wasting and bowel/bladder incontinence or Non-ambulatory patients with Monoplegia/ Paraplegia/ Hemiplegia 6. Evidence or history of spinal trauma or Spinal Malignancy 7. Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease, Motor Neuron Disease, Multiple Sclerosis, Stroke or Cognitive Impairment. 8. Major coexisting medical condition such as cancer, chronic obstructive pulmonary disease, cardiovascular disease and severe hepatic and renal dysfunction. 9. Obesity (BMI greater than or equal to 30 kg/m2) 10. Metallic implants like pace makers, hearing aid implants etc. and other contraindications for MRI. 11. Any other condition that as per the investigator, is contraindicated for the intervention in the study.

Design outcomes

Primary

MeasureTime frame
Reduction in the intensity of pain in lumbo-sacral region and legs (radiating pain) perceived by the patients suffering from radiculopathy due to lumbar disc herniation assessed by Visual Analogue ScaleTimepoint: At baseline, every week till 4 weeks, biweekly till 12th week

Secondary

MeasureTime frame
Any change in the dependence on allopathic analgesics assessed through frequency of use of rescue medicines for pain management during the treatment periodTimepoint: On 7th, 15th, 21st, 30th, 45th, 60th and 90th day of the treatment.;Any change in the grade of disc herniation evident in MRI lumbo-sacral spineTimepoint: At baseline and at the end of 12 weeks;Change in neurodynamic evaluation through Straight Leg Raise testTimepoint: At baseline, at the end of 2 weeks, 4 weeks, 8 weeks and 12 weeks;Compliance of patients to marma therapyTimepoint: On 7th, 15th, 21st, 30th day of the treatment;Improvement in functional disability assessed by Oswestry Disability Index Version 2.0 (ODI)Timepoint: At baseline, at the end of 2 weeks, 4 weeks, 8 weeks and 12 weeks;Improvement in Quality of Life assessed through SF36Timepoint: At baseline, at the end of 4 weeks, 8 weeks and 12 weeks;Safety of Marma therapy in patients with lumbar disc herniation assessed through occurrence of treatment emergent adverse events during the study periodTimepoint: On 7th, 15th, 21st, 30th, 45th, 60th and 90th day of the treatment.

Countries

India

Contacts

Public ContactDr Sunil Kumar Joshi

Uttarakhand Ayurved University

mrityunjaymission@gmail.com9897523499

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026