treatment of chronic low back pain using magnetic stimulation.
- Conditions
- Health Condition 1: M545- Low back pain
- Registration Number
- CTRI/2023/03/050516
- Lead Sponsor
- Science and Engineering research Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria for CLBP:
Right-handed individuals of either sex, aged 18 to 50 years will included after screening. Chronic low back pain patients visiting the outpatient department of orthopaedics and physical medicine and rehabilitation will be screened for recruitment as per the criteria described by the National Institute of Health pain consortium non-specific pathology.
Inclusion Criteria for Controls:
Healthy pain free right-handed individuals of either sex, aged 18 to 50 years
Exclusion criteria for the participants for both CLBP and controls:
Individuals with presence of any major illness that prevents the participants from adhering to the protocol (psychiatric, neurological, autoimmune, cardiovascular), contraindicated to transcranial magnetic stimulation (metallic implants, intra-cardiac lines, neuro-active drugs, history of seizures, major head trauma in past six months); history of opioid or substance abuse, pregnant and lactating women will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method among study (intervention) group and sham intervention group following assessments will be done to evaluate the outcome <br/ ><br>pain status using visual analogue scale , <br/ ><br>low back functional outcome using disability (MODI) score . <br/ ><br>Autonomic status using composite autonomic symptom score (COMPASS-31) and EWINGS battery of autonomic function tests. <br/ ><br>cognitive status using self administered Gerocognitive scale (SAGE) and event related evoked potentials (p300) <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Time points at specific time at which the outcome will be assessed/estimated <br/ ><br>will be at baseline before intervention, at 4 weeks immediately after intervention and 8 weeks after intervention
- Secondary Outcome Measures
Name Time Method for secondary outcome assessment among the age matched healthy subjects (control group) following evaluation will be done. <br/ ><br> <br/ ><br>pain status using visual analogue scale , <br/ ><br>low back functional outcome using disability (MODI) score . <br/ ><br>Autonomic status using composite autonomic symptom score (COMPASS-31) and EWINGS battery of autonomic function tests. <br/ ><br>cognitive status using self administered Gerocognitive scale (SAGE) and event related evoked potentials (p300) <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: assessment will be done using single point time assessment