| CTRI Number |
CTRI/2025/07/090498 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of Myofascial release technique versus Foam Rolling when combined with Scapular Muscle Strengthening and Conventional physiotherapy protocol on pain and muscle strength on patients with chronic non-specific neck pain-4 week intervention study |
|
Scientific Title of Study
|
Effectiveness of Myofascial Release (MFR) versus Foam Rolling combined with Scapular Muscle Strengthening and Conventional physiotherapy exercises on pain and muscle strength in individuals with chronic non-specific neck pain- A 4-week 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 |
Mayuri Sunil Sawant |
| Designation |
MPT First year Musculoskeletalsciences |
| Affiliation |
DVVPFs College of Physiotherapy, Ahilyanagar |
| Address |
Department of musculoskeletal physiotherapy basement
Dr.Vithalrao
Vikhe Patil college of physiotherapy,Ahmadnagar
MAHARASHTRA 414111
India.
Department of musculoskeletal physiotherapy basement
Dr.Vithalrao
Vikhe Patil college of physiotherapy,Ahmadnagar
MAHARASHTRA 414111
India.
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8104821335 |
| Fax |
|
| Email |
mssawant1929@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deepak Anap |
| Designation |
Professor and HOD Musculoskeletalsciences |
| Affiliation |
DVVPFs College of Physiotherapy, Ahilyanagar |
| Address |
Department of musculoskeletal physiotherapy basement
Dr.Vithalrao
Vikhe Patil college of physiotherapy,Ahmadnagar
MAHARASHTRA 414111
India.
Department of musculoskeletal physiotherapy basement
Dr.Vithalrao
Vikhe Patil college of physiotherapy,Ahmadnagar
MAHARASHTRA 414111
India.
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890200972 |
| Fax |
|
| Email |
deepak.anap@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayuri Sunil Sawant |
| Designation |
MPT First year Musculoskeletalsciences |
| Affiliation |
DVVPFs College of Physiotherapy, Ahilyanagar |
| Address |
Department of musculoskeletal physiotherapy basement
Dr.Vithalrao
Vikhe Patil college of physiotherapy,Ahmadnagar
MAHARASHTRA 414111
India.
Department of musculoskeletal physiotherapy basement
Dr.Vithalrao
Vikhe Patil college of physiotherapy,Ahmadnagar
MAHARASHTRA 414111
India.
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8104821335 |
| Fax |
|
| Email |
mssawant1929@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy, Ahmadnagar |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy, Ahmadnagar |
| Address |
Department of musculoskeletal physiotherapy basement
Dr.Vithalrao
Vikhe Patil college of physiotherapy,Ahmadnagar
MAHARASHTRA 414111
India. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Mayuri Sunil Sawant |
DVVPFs College of Physiotherapy, Ahmadnagar |
Department of musculoskeletal physiotherapy basement.
Dr.Vithalrao Vikhe Patil college of physiotherapy Ahmadnagar
MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA |
08104821335
mssawant1929@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFs College of Physiotherapy, Ahmadnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy exercises |
1) Cervical active range of motion exercises
A) Neck flexion/extension
B) Neck side flexion.
C) Neck rotations.
2) Cervical isometric strengthening exercises
A) Cervical flexion.
B) Cervical extension.
C) Cervical side bending.
D) Cervical rotation.
3) Self-stretching
A) Upper trapezius.
B) Levator scapulae.
4) Strengthening exercises
A) Middle trapezius.
B) Lower trapezius.
5) Contrast bath for 15 mins
|
| Intervention |
Group B Foam rolling with scapular muscle strengthening. |
1-For neck decompress, the patient was lying in a supine position with knees bent. The foam roller was placed behind the neck one inch below the hairline. The patient was instructed to tip his/her nose toward the ceiling and apply gentle pressure on the roller and this pressure was maintained throughout this movement. Further instructions were- “inhale slowly, and on exhalation slowly nod your chin down. Inhale as you hold this position and on exhalation lift your chin slightly and return your nose toward the ceiling”. This process was repeated 4 times. Then the roller was removed to allow for recovery. The cycle was repeated thrice.
2-For base of skull shear, the patient was lying on the right side with the base of the skull behind the right ear lying on the foam roller. The knees were kept bent and the right arm extended out to relax the shoulders. The patient was instructed to take a deep breath while creating small circular motions of the head in either direction 5-6 times.
Then after a pause, the left knee was opened towards the ceiling so that the patient was lying on the right half of the back. The roller was still under the base of the skull, an inch or so away from the right ear closer to the centre of the base of the skull. The patient was again told to take a deep breath and repeat the circular motion of the head.
The same procedure was repeated with the patient lying on the left side. Then the patient was instructed to lie on the back with knees bent with the centre of the base of skull on the roller with chin lifted slightly. While maintaining consistent pressure, the patient was instructed to inhale deeply and carry out 5-6 figure of eight motions of the head while exhaling.
3-For rotator cuff muscle the foam roller was on the back of the armpit with the arm in the same starting position as the latissimus inhibition. The subject rolled over the foam roll until an area of restriction was felt and held that position on the foam roll for 2 minutes while he or she actively internally and externally rotated his or her humerus with the elbow stabilized on the floor. At the completion of the myofascial intervention, resting scapular measurements were taken immediately.
4-For Pectoralis Major and Minor -The subject lied on his or her stomach with the foam roller placed underneath the pectoralis region over the chest and armpit area. The subject rolled over the foam roll until an area of restriction was felt, and held that position on the foam roller for 2 minutes.
5-For Trapezius muscle- To foam roll the trapezius muscle, the subject lies supine with the foam roller placed underneath their back inferior to the scapulae. Using a flexion-extension motion, the subject rolled the foam roller to above the trapezius muscle before returning it to its initial position.
|
| Intervention |
Group-A MFR along with scapular muscle strengthening. |
Group A- MFR
Mfr -The patient will be in sitting position, trigger point will be assessed by using algometer. Muscles assessed will be – Upper-trapezius, Rhomboids major and rhomboids minor, levator scapulae, supraspinatus and infraspinatus also subscapularis muscle.
Technique used will be- Direct MFR.
Patients position will be according to the muscle to which MFR will be given
For- upper trapezius, rhomboid major and minor, levator scapulae infraspinatus, supraspinatus and serratus anterior the patient will be positioned in sitting.
Subscapularis supine position with shoulder abducted and also pectoralis major
Middle trapezius side-lying position.
Muscle strengthening exs.
1-Scapular Retraction (Shoulder Blade Squeezes)
2-External Rotation
3-Shoulder Diagonals
4-Horizontal Rows.
5-Shoulder Extension
6-Angel Wings
7-Active: Push ups
8-Shoulder shrugs
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Neck pain more than 3 months of duration.
2.Age group 20-50 years
3.Neck pain intensity on visual analogue scale (VAS) more than 3.
|
|
| ExclusionCriteria |
| Details |
1.Signs of serious pathology (e.g., malignancy, inflammatory disorders, Infections).
2. History of trauma or fracture in cervical spine.
3.Signs of cervical radiculopathy or myelopathy.
4. Alternative treatment for neck pain or shoulder 6 months prior to the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain, pain pressure threshold, strength, neck disability index |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/08/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This study aims to find out the effectiveness of myofascial release versus foam rolling combined with scapular muscle strengthening and conventional physiotherapy exercises on pain and muscle strength in individuals with chronic non-specific neck pain A-4 weeks single blinded randomized controlled trail. 40subjects 20 in each group will be recruited based on inclusion and exclusion criteria. There will be 2 groups MFR along with scapluar muscle strengthening and foam rolling with scapular muscle strengthening. Conventional treatment will be given to both groups. Outcome measures are pain, pain pressure threshold, muscle strength and neck disability index. Pre intervention outcome measure will be taken. Intervention will be given for 4 weeks and post treatment outcome measures will be taken. follow up will be taken after 4 weeks. analysis and result will be
calculated. |