| CTRI Number |
CTRI/2025/07/090961 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Mechanical Neck Pain Using a Novel Treatment Approach |
|
Scientific Title of Study
|
Effectiveness of Function Induced Biomechanical Correction Therapy for the Management of Mechanical 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 |
Sadia Nowshin |
| Designation |
Undergraduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
Jashore, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
8801782698598 |
| Fax |
|
| Email |
sadianowshinsimthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Feroz Kabir |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
Jashore-7408, Bangladesh
7408
Other |
| Phone |
8801765932545 |
| Fax |
|
| Email |
feroz@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Feroz Kabir |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801765932545 |
| Fax |
|
| Email |
feroz@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room No: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bela Health and Education Foundation BHEF |
House-05, Road-01, Sector-06,Uttara, Dhaka-1230, Dhaka |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raju Ahmed |
BRB Hoispitals Ltd. |
Room No: 534, Physiotherapy Unit,77/A Panthopath, Dhaka-1215, Bangladesh
|
8801718877376
rajuahmed14@yahoo.com |
| Dr Md Kabir Hossain |
Dr MR Khan Medical Center |
Room No: 301, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology Jashore-7408, Bangladesh
|
8801778315139
kabir2002pt@gmail.com |
| Dr Sonjit Kumar |
SP Hospitals Ltd. |
Room No: 301, Physiotherapy Unit, Ring Road, Dhaka-1207, Bangladesh
|
8801793557825
sphddhaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy & Rehabilitation, Jashore University of Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Control Group:
Conventional Physiotherapy will be given in 12 sessions, each lasting 30–40 minutes, twice a week for 6 weeks. It includes
1.Warm up
2. Conventional exercises therapy for neck
3. Electrotherapy such as TENS
4. Cool Down |
| Intervention |
Function Induced Biomechanical Correction Therapy with conventional physiotherapy |
Experimental Group:
This will be 30-40 minutes session given twice a week for 6 weeks. All sessions will be delivered under the supervision of the therapist. It includes
1. Warm Up
2. Function Induced Biomechanical Correction Therapy
3. Conventional physiotherapy
4. Cool Down |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having clinically diagnosed with
mechanical neck pain (duration should be 1 week or more than 1 week and less than 3 months)
2. Male and female between age group of 18
to 50 years
3. VAS score greater than 3
4. Willing to refrain from using pain medication during the study period
5. Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Myelopathy, cervical spinal stenosis or any neurological symptoms
2. Previous neck and upper limb surgery
3. History of recent cervical fractures
4. Frequent migraine
5. Carcinoma
6. Pregnancy or breastfeeding women |
|
|
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 |
| Pain Severity by using Visual Analog Scale (VAS), Pain Sensitivity by using Pressure Pain Threshold(PPT) |
Baseline and after 6 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cervical Range of Motion (CROM)by using digital inclinometer, functional ability by using Neck Disability Index (NDI) and Patient-Specific Functional Scale (PSFS)
|
Baseline and after 6 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="0"
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)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [feroz@just.edu.bd].
- For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background and Objective
Mechanical neck pain refers to the pain
in the cervical region that occurs without trauma, symptoms of structural
pathology, or neurological symptomatology, but instead is caused by poor
posture, anxiety, depression, neck strain, and activities such as sports or
occupations. Neck pain has been a major public health burden
and a common musculoskeletal disorder for many years.
Existing treatment protocols primarily
rely on conventional physiotherapy; however, in clinical practice, experts
frequently mention the efficacy of Function Induced Biomechanical Correction
Therapy for spinal pain, particularly
for mechanical neck pain. This study aims to evaluate the effectiveness of
Function Induced Biomechanical Correction Therapy in reducing pain and
improving function in patient with mechanical neck pain.
Methodology
This double-blinded two-arm
randomized controlled trial will be conducted by enrolling patients aged 18–50 years with diagnosed mechanical neck pain. Participants will be recruited from the
Department of Physiotherapy and Rehabilitation, Jashore University of Science
and Technology (JUST), Jashore, Bangladesh, BRB Hoispitals Ltd., Dhaka,
Bangladesh, SP Hospitals Ltd., Dhaka Bangladesh and DPRC Hospitals Ltd., Dhaka,
Bangladesh and randomly assigned to two groups in a 1:1 ratio to receive either
Function Induced Biomechanical Correction Therapy along with
conventional physiotherapy or conventional physiotherapy only like exercise
therapy and electrotherapy. Both groups will receive 12
sessions, each lasting 30–40 minutes, twice a week for 6 weeks. Primary
outcomes include subjective pain severity, measured using the Visual Analogue
Scale (VAS), and pain sensitivity assessed by Pressure Pain Threshold.
Secondary outcomes, such as Range of Motion and functional ability, will be
evaluated using a digital inclinometer, the Neck Disability Index (NDI), and
the Patient-Specific Functional Scale (PSFS). |