| CTRI Number |
CTRI/2023/10/059298 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
27/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of different techniques in neck Pain. |
|
Scientific Title of Study
|
Efficacy of Instrument Assisted Soft Tissue Mobilization, Thoracic Manipulation and Pressure Biofeedback in Mechanical Neck Pain |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amandeep Singh |
| Designation |
Research scholar |
| Affiliation |
Department of Physiotherapy |
| Address |
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology
Hisar-125001, Haryana (India)
Hisar
HARYANA
125001
India |
| Phone |
9467877678 |
| Fax |
|
| Email |
mutrejaaman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabnam Joshi |
| Designation |
Professor |
| Affiliation |
Department of Physiotherapy |
| Address |
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology
Hisar-125001 Haryana (India)
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shabnam Joshi |
| Designation |
Professor |
| Affiliation |
Department of Physiotherapy |
| Address |
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology
Hisar-125001 Haryana (India)
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amandeep Singh Research Scholar Department of Physiotherapy
Guru Jambheshwar University of Science and Technology
Hisar-125001, Haryana (India) |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology |
| Address |
New Delhi-Sirsa Highway Hisar-125001, Haryana (India |
| Type of Sponsor |
Other [Government] |
|
|
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 |
| Amandeep Singh |
Guru Jambheshwar University of Science and Technology Hisar |
Room No:109, Research Lab,
Department of Physiotherapy
Hisar-125001, Haryana (India)
Hisar
HARYANA |
9467877678
mutrejaaman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Department of Physiotherapy GJUST Hisar Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening interventions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Treatment protocol in group A will include IASTM, thoracic manipulation and
strengthening exercises utilizing pressure biofeedback.
IASTM will be given for 3 days a week for a duration of 4 weeks |
| Intervention |
Group B |
Treatment protocol in group B will include IASTM and strengthening exercises
utilizing pressure biofeedback. Pressure biofeedback will be given for 3 days a week for a duration of 4 weeks. |
| Intervention |
Group C |
Treatment protocol in group C will include thoracic manipulation and strengthening
exercises utilizing pressure biofeedback. Thoracic manipulation will be given once a week for a duration of 4 weeks |
| Comparator Agent |
Group D |
Treatment protocol in group D will include strengthening exercises utilizing pressure
biofeedback. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with mechanical neck pain greater than three months
2. Participants with pain in the area of neck and/or neck-shoulder with neck pain which could be provoked by sustained neck postures or by cervical movements, or by manual palpation of cervical muscles
3. Age group between 20-50 years
4. Both males and females
5. Presence of active upper trapezius trigger points
|
|
| ExclusionCriteria |
| Details |
1. History of whiplash injury
2. History of Cervical-surgery
3. History of Cervical myelopathy or radiculopathy
4. Fibromyalgia, Fractures, post-traumatic neck pain, cancer, severe osteoporosis, infectious or inflammatory conditions, vertigo, headache and congenital malformations
5. Conditions in which Manual therapy is contraindicated
6. Pregnancy
7. Participants using any painkillers
8. Non cooperative patients/participants not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Pain
• Deep neck flexor Endurance
• Neck disability
• Cervical range of motion
|
The outcome measures will be evaluated at the baseline, at 4
th week (at the end of treatment
protocol) and follow up at 6
th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nill |
nill |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/11/2023 |
| 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="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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 [muttrejaaman@gmail.com].
- For how long will this data be available start date provided 06-11-2023 and end date provided 06-06-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nill
|
|
Brief Summary
|
Mechanical neck pain (NP) is defined as the pain in the area of neck and/or neck-shoulder with neck pain that could be provoked by mechanical characteristics including sustained neck postures, or by cervical movements, or by manual palpation of cervical muscle. There are studies that have individually explored the role of IASTM, thoracic manipulation and pressure biofeedback and have found them to be effective in decreasing neck pain, improving neck ROM, neck functions, life quality, and muscle endurance in mechanical neck pain However, till date no study has explored the combined effectiveness of IASTM, thoracic manipulation and pressure biofeedback in mechanical neck pain. Therefore, the current study will be done to explore the combined effectiveness of IASTM, thoracic manipulation and pressure biofeedback in mechanical neck pain. |