| CTRI Number |
CTRI/2025/07/090776 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study on Neck Muscle Activity and Fatigue During Theraband Exercises in People with Chronic Neck Pain |
|
Scientific Title of Study
|
Analysis of Cervical Muscle Activity and Fatigue in Response to Moderate Intensity Theraband Exercises in Patients with Persistent Neck Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
Room No. B-319, Department of Physiotherapy, School of Allied Health Sciences, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
06006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
Room No. B-319, Department of Physiotherapy, School of Allied Health Sciences, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit,
UTTAR PRADESH
203201
India |
| Phone |
06006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B 316, Department of Physiotherapy, School of Allied Health Sciences,Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
09717161626 |
| Fax |
|
| Email |
jyoti.sharma@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Research & Development Cell, Galgotias University, Plot No 2, Sector 17A, opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India, 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar pradesh, India, 203201 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammad Sidiq |
Room No 217, Ai Block Galgotias University |
Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
6006204628
sidufatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Galgotias University Human Research Ethics Committee (GUHREC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Moderate Intensity TheraBand training |
Participants in the intervention group will perform a structured, moderate-intensity Theraband exercise protocol targeting both deep and superficial cervical muscles. The exercise regimen will include resisted cervical flexion, extension, lateral flexion (left and right), and scapular stabilization exercises using Therabands of standardized moderate resistance based on color-coded levels. Each session will last approximately 30 minutes and will be conducted three times per week for a duration of 6 weeks. All exercises will be supervised by a qualified physiotherapist to ensure correct technique, progression, and safety. Resistance will be adjusted as needed to maintain moderate intensity, and participants will be instructed to report any discomfort. This protocol aims to improve cervical muscle strength, reduce fatigue, and enhance neuromuscular control in individuals with persistent neck pain.
|
| Comparator Agent |
Standard Physiotherapy Care |
Participants in the control group will receive a conventional physiotherapy program consisting of moist heat therapy for 15 minutes applied to the posterior neck to reduce pain and stiffness, followed by cervical isometric exercises in all directions (flexion, extension, lateral flexion, and rotation) with 10 repetitions and 5-second holds. Cervical range of motion (ROM) exercises will also be included to maintain mobility, with 10 slow, pain-free repetitions in each direction. Scapular stabilization exercises such as shoulder shrugs and blade squeezes (10 reps × 2 sets) will be performed to enhance postural support. Additionally, participants will receive education on correct posture and ergonomic modifications for daily activities. A home exercise program comprising basic ROM and isometric exercises will be prescribed for daily practice. The intervention will be administered twice weekly for 6 weeks under the supervision of a licensed physiotherapist, with continuous monitoring of pain and fatigue levels.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with persistent non-specific Neck Pain for more than 3 months duration.
Neck Disability Index score indicating mild to moderate disability
Able to perform basic neck movements without severe restriction.
Willingness to participate and provide informed written consent.Able to understand and follow instructions for exercise protocol and assessments.
|
|
| ExclusionCriteria |
| Details |
History of neck surgery or trauma in the past 6 months.
Specific neck pathology (e.g., cervical radiculopathy, myelopathy, disc herniation, inflammatory arthritis, tumor).
Neurological disorders affecting muscle function (e.g., stroke, multiple sclerosis, Parkinson’s disease).
Pregnancy, due to potential risk during exercise.
Current physiotherapy treatment for neck pain or recent participation in a neck strengthening program (within last 3 months).
Use of muscle relaxants or corticosteroids during the study period.
Systemic illnesses such as uncontrolled diabetes, hypertension, or thyroid disorders affecting fatigue or musculoskeletal function.Cognitive impairments or psychiatric conditions that hinder understanding of instructions or participation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Surface EMG Muscle Activity
Pressure pain threshold
NPRS for pain |
At Baseline, 8 weeks after 26 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fatigue Severity Scale |
At Baseline, 8 weeks after 26 weeks |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/08/2025 |
| Date of Study Completion (India) |
25/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effects of moderate-intensity Theraband exercises on cervical muscle activity and fatigue in individuals with persistent neck pain. Persistent neck pain is a prevalent musculoskeletal disorder associated with reduced cervical muscle function, endurance, and quality of life. The study will include adult participants diagnosed with non-specific neck pain lasting for more than 3 months. Participants will be randomly assigned into two groups: an intervention group receiving a structured, moderate-intensity Theraband exercise program and a control group receiving conventional physiotherapy. The intervention will consist of cervical flexion, extension, lateral flexion, and scapular stabilization exercises using Therabands, performed three times per week for six weeks under physiotherapist supervision. The control group will receive moist heat therapy, cervical isometric exercises, range of motion exercises, and postural training twice a week for six weeks. Primary outcomes include cervical muscle activity assessed via surface electromyography (sEMG) and fatigue levels measured through standardized fatigue scales. Secondary outcomes include pain intensity and functional disability. This study seeks to provide evidence on the efficacy of resistance-based rehabilitation in managing cervical neuromuscular dysfunction, potentially offering a cost-effective, scalable intervention for physiotherapy management of persistent neck pain. |