| CTRI Number |
CTRI/2023/05/053096 [Registered on: 24/05/2023] Trial Registered Prospectively |
| Last Modified On: |
23/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
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). |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sona Kolke |
| Designation |
PhD Scholar |
| Affiliation |
MGM Institute of Health Sciences School of Physiotherapy |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Sector 1 Plot 1 & 2 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
|
| Fax |
|
| Email |
phd_sonasarma@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor and Director |
| Affiliation |
MGM Institute of Health Sciences School of Physiotherapy |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Sector 1 Plot 1 & 2 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
|
| Fax |
|
| Email |
rajani.kanade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor and Director |
| Affiliation |
MGM Institute of Health Sciences School of Physiotherapy |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Sector 1 Plot 1 & 2 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
|
| Fax |
|
| Email |
rajani.kanade@gmail.com |
|
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Source of Monetary or Material Support
|
| MGM Institute of Health Sciences MGM School of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Health Sciences |
| Address |
MGM Institute of Health Sciences Sector 1 Plot 1 & 2 Kamothe Navi Mumbai-410209 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rajani Mullerpatan |
MGM School of Physiotherapy MGM Institute of Health Sciences |
Department of Physiotherapy Intergrated OPD 2nd floor OPD no 55 MGM Institute of Health Sciences MGM Hospital Sector 1 Plot 1 & 2 Kamothe Navi Mumbai 410209. Taluka Panvel
Raigarh
MAHARASHTRA |
9920048476
rajani.kanade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Low back pain |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health promotion |
Will receive education to recognize serious pathology related to spine pain and manage non-serious mechanical spine pain with self-care and low-intensity evidence-based exercises for neck and back pain with basic mobility and strengthening exercises |
| Intervention |
Supervised Intervention with context-specific and culturally-adapted Treatment model for mechanical spine pain |
An evidence-based and culturally-adapted treatment model will be developed and implemented for mechanical neck and back pain of the rural community. The supervised exercises will be tailored to the patients needs. The intervention will include patient evaluation, evidence-based condition-specific exercise training and home exercise program. The exercises will be given twice a week for 12 weeks and will be supervised by the PI. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
1. Cognitive delay,
2. Neurological disorders eg. acute stroke, paraplegia, quadriplegia and
3. Acute trauma.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
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)
|
Baseline (pre-implementation); end of year 2 (post-implementation
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Fidelity and Context Monitoring Log, Administrative Data (Implementation Status Report) |
once every month for the entire duration of the project |
|
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Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This mixed-methods study using a participatory research approach will be conducted in the rural community of two of the five randomly selected villages in the Raigad district of Maharashtra (adopted by MGM Institute of Health Science under the Unnat Bharat Abhiyan). The study will assess the implementation of a context-specific and culturally-adapted treatment model of care for mechanical spine pain. It will involve both qualitative and quantitative study designs and will be conducted amongst 1000 residents in the selected villages and will include all the stakeholders namely the community leaders, residents, and patients with spine pain, along with the local physicians and frontline health (ASHA and Anganwadi) workers. The study will help to assess the existing spine care in the rural community and the needs, along with understanding the facilitators and barriers to adopting an evidence-based treatment model. The treatment will include educating the community and frontline health workers about recognizing serious pathology related to spine pain and managing non-serious mechanical spine pain with self-care and low-intensity exercises. A pilot of the supervised intervention will be done using a randomized clinical trial on patients with mechanical neck or back pain. All the exercises will be evidence-based and culturally adapted to the rural community. The primary and secondary outcome measures will be collected at baseline and the mentioned timelines during and after the intervention. The primary outcome measures are as follows: a) For determining the extent of mechanical spine pain and the existing care in the rural community using a retrospective chart review and community survey, b) For assessing the intent to adopt the treatment model amongst all stakeholders using semi-structured interviews and focus groups and using three implementation outcome measures namely the Acceptability of Intervention Measures (AIM), the Intervention Appropriateness Measure (IAM), and the Feasibility of Intervention Measures (FIM), and c) To study the efficacy of the Intervention using validated and standardized Marathi versions of clinical outcome measures namely- Visual Analogue Scale and Wong-Baker Faces for assessing pain; Patient Specific Functional Scale for function; the World Health Organization Disability Assessment 2.0 (WHODAS 2.0) to measure ability; EURO QoL 5D 5L (EQ 5DL) for measuring health-related quality of life; Neck Disability Index (NDI) and Oswestry Disability Index (ODI) for measuring disability and function related to spine pain; the MGM Ground Level Activity Exposure Questionnaire ( MGMGLAEQ)- Brief and the Rural Indian Activity Limitation Questionnaire (RIALQ) for assessing their activity limitations with respect to ground level activities and rural lifestyle respectively. The secondary outcomes will include administrative data (Implementation Status Report) to keep a log of the activities and communication and the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to document the modifications to Implementation strategies throughout the project. |