Home » Trials » SLCTR/2024/005
Effectiveness of Supervised Telerehabilitation Program versus Standard Physiotherapy Treatment Program on Pain and Disability in Patients with Chronic Non-specific Neck Pain; A Randomized controlled trial
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SLCTR Registration Number
SLCTR/2024/005
Date of Registration
The date of last modification
Mar 15, 2024
Scientific Title of Trial
Effectiveness of Supervised Telerehabilitation Program versus Standard Physiotherapy Treatment Program on Pain and Disability in Patients with Chronic Non-specific Neck Pain; A Randomized controlled trial
Public Title of Trial
A Randomized controlled trial on effectiveness of supervised telerehabilitation program versus standard physiotherapy treatment program on reducing pain and disability; and barriers to attending rehabilitation among Patients with Chronic Non-specific Neck Pain attending a selected clinic in Sri Lanka.
Disease or Health Condition(s) Studied
Chronic non-specific neck pain
Scientific Acronym
CNSNP_RCT
Public Acronym
CNSNP-Study
Brief title
Comparing Telerehabilitation and Standard Physiotherapy for Chronic Neck Pain: A Randomized Controlled Trial
Universal Trial Number
U1111-1302-0292
Any other number(s) assigned to the trial and issuing authority
ERC/2023/072 ERC Rajarata
What is the research question being addressed?
Is telerehabilitation effective compared to standard institutional rehabilitation in reducing pain, disability, and barriers to attendance among patients with chronic non-specific neck pain?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Department of Physiotherapy (DPM), Teaching Hospital Anuradhapura. Method of randomization: Simple Randomization. Participants will be allocated to each group with computer generated random sequence. Intervention: Telerehabilitation sessions for 4 days a week with distant supervision through videos and reminders of sessions for the intervention group include: o 15 min hot pack application o 15 minutes self-administered deep-pressure tissue massage o 15 minutes of cold therapy o Neck stabilization exercise program for 2-3 minutes o A leaflet will be shared to patients through selected digital media to introduce good posture during activities of daily living.
Control: Standard physiotherapy care comprises of weekly visits to the Department of Physiotherapy (DPM) for: o Weekly Infrared therapy for 15 min followed by a home exercise and care program with hot pack application for 15 minutes. o 15 minutes of self-administered deep-pressure tissue massage followed by cold therapy for 15 minutes. o Neck stabilization exercise program for 20-30 min for 3 days a week. The patients will not follow the home exercise program on the day of physical visits to DPM. A leaflet displayed in the DPM will be used to introduce good posture during activities of daily living.
Inclusion criteria
• Male/ Female • 18 -65 years • Chronic Non-Specific Neck Pain (CNSP) diagnosis confirmed by a consultant and from physiotherapy assessment. • Pain for more than 3 months. • Pain score of 5 or more on a VAS (Visual Analogue Scale) during activity or at rest. • Smartphone literacy or patients who can get help in smartphone communication.
Exclusion criteria
• Patients with neurological neck pain, mental impairment, known previous injuries in the cervical region, fractures in the shoulder joint, scapular, clavicular, and cervical regions. • Patients who present with red flag signs at the time of physical assessment.
Primary outcome(s)
|
1.
Pain with Visual Analogue Scale for pain. |
[ Baseline, at the end of the fifth week of treatment ] |
|
2.
Level of Disability with Neck Disability Index (a standard instrument for measuring self-rated disability due to neck pain). Components include: pain intensity, personal care, lifting, reading, headaches, work, driving, sleeping and recreation |
[ Baseline, at the end of the fifth week of treatment ] |
Secondary outcome(s)
|
1.
Barriers to accessing telerehabilitation versus standard care through a pretested interviewer administered questionnaire. |
[ Baseline, at the end of the fifth week of treatment ] |
Target number/sample size
150 (75 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2024-02-18
Anticipated end date
2024-05-31
Date of first enrollment
2024-03-13
Date of study completion
Recruitment status
Recruiting
Funding source
Self-funded
Regulatory approvals
Status
Approved
Date of Approval
2023-12-19
Approval number
ERC/2023/72
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine and Allied Health sciences, Rajarata University of Sri Lanka |
| Institutional Address: | Ethics Review Committee, Faculty of Health Sciences, Rajarata University, Saliyapura, Sri Lanka |
| Telephone: | +94 (0)25 2053633, |
| Email: | erc@med.rjt.ac.lk |
Contact person for Scientific Queries/Principal Investigator
RNC Jayanath
Physiotherapist
Department of Physiotherapy, Teaching Hospital Anuradhapura
0703536991
chathu.rncj@gmail.com
Contact Person for Public Queries
Dr. ACM Fahim
Senior Research Fellow and Director
SACTRC, Faculty of Medicine, University of Peradeniya
0814479822
fahim.cader@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
