Comparing two physiotherapy interventions for Low Back Disorders in India: A Randomized Controlled Trial

Phase 3

• Conditions: Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system

• Registration Number: CTRI/2024/08/072259
• Lead Sponsor: Dr Kavitha Raja

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. A primary complaint of either:

a. low back pain, defined as pain between the inferior costal margin and the

inferior gluteal fold with or without referral into the leg(s),

or

b. referred leg pain, defined as predominately unilateral posterior leg pain

extending below the knee, or anterior thigh pain, with or without back pain (disc

herniation with associated radiculopathy subgroup only)

2. Duration of the current episode of primary complaint lasting for greater than 3

months (chronic stage of the injury)

3. Aged between 18 and 65 (inclusive)

4. Fluency in English, Kannada or Hindi languages sufficient to complete questionnaires and to enable understanding of the intervention

5. Agreeing to refrain from other interventions wherever possible for the 10-week

treatment period of the trial, aside from consultations with medical practitioners,

medication, and any exercises already being undertaken.

Exclusion Criteria

1. Active cancer under current treatment

2. Signs of cauda equina syndrome based on bladder or bowel disturbance and/or

imaging

3. Current pregnancy, or childbirth within the last 6 months

4. Spinal injections within the last 6 weeks, as we wish to study treatment effects

independent of the effects of injections

5. Any history of lumbar spine surgery

6. A pain intensity score of less than 2/10 on a 0-10 numerical rating scale due to low

severity

7. Minimal activity limitation, evidenced by a baseline ability to walk, sit, and stand for

one hour or more and no sleep disturbance at night, as we wish to exclude people with

low severity

8. Already received more than 5 sessions of physiotherapy with any of the treating

physiotherapists before enrolment, as these therapists are likely to use many

components of the trial treatment protocol on their usual client caseload

9. Inability to walk safely, such as severe foot drop causing regular tripping, as the

interventions in the trial include walking for most participants

10. Planned absence of more than one week during the treatment period (such as

overseas holidays)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Oswestry Disability Index V2.1 with sex life ? question replaced <br/ ><br>by a work/housework ? question <br/ ><br>Timepoint: 0, 5, 10, 26 and 52 weeks