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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).

Spine-care needs and perceived barriers to accessing and implementing a model of spine-care for mechanical spine pain in rural community of Raigad district, Maharashtra: A mixed-method study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/053096
Enrollment
1000
Registered
2023-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: M999- Biomechanical lesion, unspecified

Interventions

Intervention1: Supervised Intervention with context-specific and culturally-adapted Treatment model for mechanical spine pain: An evidence-based and culturally-adapted treatment model will be develope

Sponsors

MGM Institute of Health Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1. Cognitive delay, 2. Neurological disorders eg. acute stroke, paraplegia, quadriplegia and 3. Acute trauma.

Design outcomes

Primary

MeasureTime frame
1. Chart Review 2. Community Survey 3. Semi-structured Interviews 4. Focus Groups 5. Visual analogue scale (VAS) 6. Wong-Baker Faces Scale 7. WHODAS 2.0 (World Health Organization Disability Assessment 2.0) 8. Patient Specific Functional Scale (PSFS) 9. Marathi version of EURO QoL 5D 5L (EQ-5DL) 10. Marathi version Neck Disability Index (NDI) 11. Marathi version of Oswestry Disability Index (ODI) 12. Marathi version of MGM Ground Level Activity Exposure Questionnaire-Brief (MGMGLAEQ) 13.Rural Indian Activity Limitation Questionnaire (RIALQ) 14. Acceptability of Intervention Measure (AIM) 15. Appropriateness Measure (IAM) 16. Feasibility of Intervention Measure (FIM) Timepoint: Baseline (pre-implementation); end of year 2 (post-implementation—

Secondary

MeasureTime frame
Fidelity and Context Monitoring Log, Administrative Data (Implementation Status Report)Timepoint: once every month for the entire duration of the project—

Countries

India

Contacts

Public ContactDr Rajani Mullerpatan

MGM Institute of Health Sciences School of Physiotherapy

rajani.kanade@gmail.com

Outcome results

None listed

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