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Clinical Trials/CTRI/2024/08/072259
CTRI/2024/08/072259
Not yet recruiting
Phase 3

Individualized physiotherapy versus usual care(STOPS trial) for Low Back Disorders in India: A Randomized Clinical Trial - NI

Dr Kavitha Raja0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: M958- Other specified acquired deformities of musculoskeletal system

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system
Sponsor
Dr Kavitha Raja
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Dr Kavitha Raja

Eligibility Criteria

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),
  • •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

Exclusion Criteria

  • •1\. Active cancer under current treatment
  • •2\. Signs of cauda equina syndrome based on bladder or bowel disturbance and/or
  • •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
  • •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

Outcomes

Primary Outcomes

Not specified

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