CTRI Number |
CTRI/2025/06/088910 [Registered on: 16/06/2025] Trial Registered Prospectively |
Last Modified On: |
14/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparing Foam Rolling and Muscle Energy Technique to Reduce Neck Pain and Improve Movement and Daily Activity of Life |
Scientific Title of Study
|
Effectiveness of Foam Rolling and Muscle Energy Technique on Pain, Range of Motion, Functional Disability and Quality of Life in Patients with Mechanical Neck Pain : A Single Blinded Randomized Controlled Trial |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Pratiksha Sayam |
Designation |
Post Graduate Student |
Affiliation |
Datta Meghe College Of Physiotherapy Nagpur |
Address |
Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road Nagpur.
Nagpur MAHARASHTRA 441110 India |
Phone |
7219100806 |
Fax |
|
Email |
poojasayam00@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Swapna Jawade |
Designation |
Assosicate Professor |
Affiliation |
Datta Meghe College Of Physiotherapy Nagpur |
Address |
Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road Nagpur.
Nagpur MAHARASHTRA 441110 India |
Phone |
9860677955 |
Fax |
|
Email |
drswapnasj@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Swapna Jawade |
Designation |
Assosicate Professor |
Affiliation |
Datta Meghe College Of Physiotherapy Nagpur |
Address |
Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road Nagpur.
MAHARASHTRA 441110 India |
Phone |
9860677955 |
Fax |
|
Email |
drswapnasj@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Datta Meghe College Of Physiotherpy Nagpur |
Address |
Department of Musculoskeletal Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road Nagpur 441110
Nagpur
MAHARASHTRA
441110
India |
Type of Sponsor |
Research institution and hospital |
|
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 Pratiksha Sayam |
Shalinitai Meghe Hospital and Research Center ,Nagpur. |
Department-Musculoskeletal Department.
Datta Meghe College of Physiotherapy,Wanadongri Hingna Road Nagpur-441110.
OPD ROOM no.1 Nagpur MAHARASHTRA |
07219100806
poojasayam00@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Nagar Yuvak Sanstha, Datta Meghe college of Physiotherapy,Nagpur. |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Foam rolling |
Patient Position- supine
Intensity-3 repetitions
Frequency-Once a day
Conventional-15 min
Total Duration- 30 minute |
Comparator Agent |
Muscle Energy Technique |
Patient position- sitting
Frequency -once a day
Intensity - 5 repetitions
Conventional- 15 min
Total Duration-30 min
|
|
Inclusion Criteria
|
Age From |
19.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Both |
Details |
Patients are willing to participate.
Experiencing mechanical neck pain for 3 months.
Neck pain on NPRS between 4 to 8.
NDI more than 40 percentage
|
|
ExclusionCriteria |
Details |
A history of cervical spine injuries or fractures.
Cervical radiculopathy symptoms.
A history of degenerative musculoskeletal disorders, such as osteoporosis, spondylosis, spondylolisthesis, and prolapsed intervertebral disc.
Patients with acute neck pain.
Patients with history of surgery of the cervical spine during the previous 12 months
Subjects were excluded if they have neck pain associated with headaches or facial pain and malignancy, infections, inflammatory disorders.
Subjects were excluded with neurological conditions.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Numerical pain rating scale
Neck disability index
Goniometer
SF36 |
Pre treatment day 1 and post treatment after 4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
11/07/2025 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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 - NO
|
Brief Summary
|
Neck pain is a prevalent cause of long-term impairment globally, accounting for around 30% of cases each year. Women are more affected than men, and middle-aged people are more likely to experience . Mechanical neck pain (MNP) can cause pain, limited range of motion, and reduced function. It is frequently caused by muscular spasms or problems with the facet joints Alternative therapies including Myofascial Release (MFR) and Muscle Energy Techniques (MET) have been studied recently. MET, a manual therapy, has been shown to be successful in increasing range of motion and reducing pain by contracting muscles against resistance to increase mobility and decrease muscle tension. MFR has also demonstrated advantages in reducing pain and enhancing function in MNP patients by applying concentrated force to target fascial limitations. Another promising technique is foam rolling, which is a type of self-myofascial release. By using a foam roller to apply pressure to muscular tissues, it helps to increase flexibility and lessen muscle tightness. Although foam rolling has demonstrated advantages in enhancing short-term range of motion, nothing is known about how well it works to relieve mechanical neck discomfort. The purpose of this study is to examine the effects of foam rolling and MET on MNP patients’ pain, range of motion, functional disability, and quality of life using a variety of end measures, such as disability indices and pain scales. Over the course of four weeks, both groups will also receive traditional exercise regimens. |