| CTRI Number |
CTRI/2025/02/080009 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Immediate effect of chest movement exercise versus muscle technique on neck pain and flexibility in people with neck pain - A study. |
|
Scientific Title of Study
|
Immediate effect of Thoracic Mobility Exercise v/s Muscle Energy Technique on neck pain and cervical range of motion in patients with Non Specific Neck Pain- An Experimental Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Durga Jat |
| Designation |
Masters in Musculoskeletal Physiotherapy student |
| Affiliation |
K. J. Somaiya College of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy OPD number 4 and 5, K. J. Somaiya College of Physiotherapy, Ayurvihar, Eastern Express Highway, Sion, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9029127127 |
| Fax |
|
| Email |
durga.jat@somaiya.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupali Shevalkar |
| Designation |
Associate professor |
| Affiliation |
K. J. Somaiya College of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy OPD number 4 and 5, K. J. Somaiya College of Physiotherapy, Ayurvihar, Eastern Express Highway, Sion, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8898737701 |
| Fax |
|
| Email |
rupali.salvi@somaiya.edu |
|
Details of Contact Person
Public Query
|
| Name |
Durga Jat |
| Designation |
Masters in Musculoskeletal Physiotherapy student |
| Affiliation |
K. J. Somaiya College of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy OPD number 4 and 5, K. J. Somaiya College of Physiotherapy, Ayurvihar, Eastern Express Highway, Sion, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9029127127 |
| Fax |
|
| Email |
durga.jat@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| K.J.Somaiya College of Physiotherapy, Ayurvihar, Eastern Express Highway, Sion, Mumbai, Maharashtra, India 400022 |
|
|
Primary Sponsor
|
| Name |
K. J. Somaiya College of Physiotherapy |
| Address |
K.J.Somaiya College of Physiotherapy, Ayurvihar, Eastern Express
Highway, Sion, Mumbai, Maharashtra,400022
|
| 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 Durga Jat |
K. J. Somaiya College of Physiotherapy |
Musculoskeletal Physiotherapy OPD number 4 and 5, K. J. Somaiya College of Physiotherapy, Ayurvihar, Eastern Express Highway, Sion, Mumbai, Maharashtra, 400022, India
Mumbai
MAHARASHTRA |
9029127127
durga.jat@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF K J SOMAIYA COLLEGE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Muscle Energy Technique |
Muscle Energy Technique will include Post-Isometric Relaxation for upper trapezius and levator scapulae. The procedure will be repeated 5 times. It will be performed bilaterally. For Post-Isometric Relaxation for upper trapezius, patient will be in supine position. Therapist will stand at the head end and place one hand on the patient’s shoulder and the other hand will cup the ipsilateral mastoid process. The patient’s head will be placed in flexion, contralateral side flexion and slight ipsilateral rotation. The patient will be instructed to move the head back to the table and at the same time shrug the stabilized shoulder with 50% of maximum isometric contraction, against the therapist’s resistance. The isometric contraction will be held for 10 seconds followed by relaxation and gentle stretch for 10 seconds. For Post-Isometric Relaxation for levator scapulae , patient will be in supine position. Therapist will stand at the head end and place one hand on the patient’s shoulder and with the other hand support the patient’s head. The patient’s head will be placed in flexion and contralateral side flexion and rotation. The patient will be instructed to move the head back to the table and at the same time shrug the shoulder with 50 % of maximum isometric contraction, against the therapist’s resistance. The isometric contraction will be held for 10 seconds followed by relaxation and gentle stretch for 10 seconds. This is a one time study. Post treatment assessment will be done immediately after administering the procedure.
|
| Intervention |
Thoracic Mobility Exercise |
Each exercise will be performed for 15 repetitions with 10 second hold for 2 sets. The exercises include: 1)Thoracic spine extension: In crook lying position, both hands are interlocked behind the head and the back is placed on a foam roller with the feet positioned flat on the floor. The knee is maintained at 90° to perform the extension exercise on the foam roller. 2)Thoracic spine extension: The patient is in kneeling position and the hands are locked with the elbows on a chair placed in front of the patient. After kneeling, the hip is moved toward the heels to extend the thoracic spine. 3)Thoracic spine flexion: In a quadruped position, the thoracic spine is flexed by moving backward until the hip touches the heels. 4)Thoracic spine rotation: The rotation exercise is conducted with patients lying on their side with the head supported on a small foam roller and turned to one side. The elbows are straight and the palms are held together. The leg facing the ceiling is bent to the level of the stomach. Then the arm facing the ceiling is moved backward in a large arc to rotate the thoracic spine. The procedure is performed bilaterally. 5)Thoracic spine rotation: In a quadruped position, the hand in the direction of rotation is placed behind the neck and the elbow of the opposite arm is placed on the floor. Then the torso is slowly rotated toward the ceiling. The procedure is performed bilaterally. 6)Thoracic spine lateral flexion: Both hands are locked behind the neck with the participant seated on a chair with back support and the torso is then flexed laterally. The procedure is performed bilaterally. This is a one time study. Post treatment assessment will be done immediately after administering the procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with Non Specific Neck pain having NPRS score of 3-7
2) Patients having sub-acute neck pain
3) Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1) Any pathological condition affecting the cervical or thoracic spine
2) Diagnosed cervical or thoracic spinal disc herniation
3) Diagnosed cervical or thoracic spinal stenosis
4) Orthopedic diseases of the shoulder
5) Neurological symptoms in the upper limbs
6) Patients with history of cervical spine, thoracic spine or shoulder surgery.
7) Patients not able to perform thoracic mobility exercises due to any reason
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numerical Pain Rating Scale (NPRS) for neck pain intensity
2. Cervical flexion, extension, lateral flexion and rotation range of motion using Universal Goniometer |
Pre-intervention: Baseline assessment
Post-intervention: Immediately after first session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
08/02/2025 |
| 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="6"
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
|
Approval is obtained from the Institutional ethics
committee. Participants will be screened according to the inclusion and
exclusion criteria and a written informed consent will be obtained in the
language best understood by them. The subjects will be randomly allocated to
group A or group B by using the SNOSE method. Pre-treatment
assesment will be done using Numerical Pain Rating Scale for neck pain and
Universal Goniometer for cervical range of motion including cervical flexion,
extension, right and left lateral flexion, right and left rotation. Group A
will receive Thoracic mobility exercises including thoracic flexion, extension,
bilateral side flexion and bilateral rotation. Group B will receive Muscle
Energy Technique for bilateral upper trapezius and levator scapulae. Both
groups will also receive standard physiotherapy protocol. Immediate post
treatment assessment of neck pain using
Numerical Pain Rating Scale and cervical range of motion using universal
goniometer will be done and the values will be noted. The values obtained will
be statistically analyzed and the results will be generated. Normality of
numerical data will be checked using Shapiro Wilk test. If data passes
normality, intra-group analysis will be done using Paired t test and
inter-group analysis will be done using Unpaired t test. If the data does not
pass normality, intra-group analysis will be done using Wilcoxon signed rank
test and inter-group analysis will be done using Mann Whitney test. Keeping
alpha error at 5% and Beta error at 20 %, power at 80%, p<0.05 will be
considered statistically significant. Statistical Analysis will be done and
results will be obtained. |