A clinical trial to understand the needs, barriers and facilitators of a rural community with regards to having a novel, sustainable treatment model for neck and back pain (without serious pathology).
- Conditions
- Health Condition 1: M999- Biomechanical lesion, unspecified
- Registration Number
- CTRI/2023/05/053096
- Lead Sponsor
- MGM Institute of Health Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Chart Review: Health care administrative chart review, records of all adult patients presenting to the clinic will be accessed and information will be de-identified. It will be conducted on 50 consecutive charts (or until data saturation)
2)Community Survey: All adults ( >18 years) in randomly selected 2 out of the 5 villages (adopted by MGM Institute of Health Sciences under the Unnat Bharat Abhiyan) will be surveyed.
3)Focus Group: Licensed local care providers (e.g., medical doctors, nurses, physiotherapists), local community health workers (paid or volunteers: ASHA and Anganwadi health workers), and traditional medicine practitioners (Ayurvedic, Homeopathy or Unani practitioners).
4)Semi-Structured Interviews: Community leaders, residents, and Spinal pain patients
5)Intervention: Patients with mechanical spinal pain (neck and back) without serious pathology.
1.Cognitive delay,
2.Neurological disorders eg. acute stroke, paraplegia, quadriplegia and
3.Acute trauma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Chart Review <br/ ><br>2. Community Survey <br/ ><br>3. Semi-structured Interviews 4. Focus Groups <br/ ><br>5. Visual analogue scale (VAS) 6. Wong-Baker Faces Scale <br/ ><br>7. WHODAS 2.0 (World Health Organization Disability Assessment 2.0) <br/ ><br>8. Patient Specific Functional Scale (PSFS) <br/ ><br>9. Marathi version of EURO QoL 5D 5L (EQ-5DL) <br/ ><br>10. Marathi version Neck Disability Index (NDI) <br/ ><br>11. Marathi version of Oswestry Disability Index (ODI) <br/ ><br>12. Marathi version of MGM Ground Level Activity Exposure Questionnaire-Brief (MGMGLAEQ) <br/ ><br>13.Rural Indian Activity Limitation Questionnaire (RIALQ) <br/ ><br>14. Acceptability of Intervention Measure (AIM) <br/ ><br>15. Appropriateness Measure (IAM) <br/ ><br>16. Feasibility of Intervention Measure (FIM) <br/ ><br> <br/ ><br>Timepoint: Baseline (pre-implementation); end of year 2 (post-implementation <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Fidelity and Context Monitoring Log, Administrative Data (Implementation Status Report)Timepoint: once every month for the entire duration of the project