| CTRI Number |
CTRI/2024/02/063250 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Find out the difference between effect of MET on different neck muscles |
|
Scientific Title of Study
|
EFFECT OF MUSCLE ENERGY TECHNIQUE ON SUBOCCIPITAL MUSCLE VERSUS UPPER TRAPEZIUS ALONG WITH LEVATOR SCAPULAE MUSCLE IN PATIENTS WITH NON-SPECIFIC NECK PAIN: A COMPARATIVE 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 |
Dr Shikha |
| Designation |
Assistant Professor |
| Affiliation |
Saket College of Physiotherapy |
| Address |
Room no. 66, Saket college of Physiotherapy, Chandimandir, Panchkula, Haryana
Panchkula
HARYANA
134107
India |
| Phone |
7419114943 |
| Fax |
|
| Email |
dr.shikha.ins@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha |
| Designation |
Assistant Professor |
| Affiliation |
Saket College of Physiotherapy |
| Address |
Room no. 66, Saket college of Physiotherapy, Chandimandir, Panchkula, Haryana
Panchkula
HARYANA
134107
India |
| Phone |
7419114943 |
| Fax |
|
| Email |
dr.shikha.ins@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumit |
| Designation |
Student |
| Affiliation |
Saket College of Physiotherapy |
| Address |
Room no- 55 College Rehabilitation Center, Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana
Panchkula
HARYANA
134107
India |
| Phone |
8708063441 |
| Fax |
|
| Email |
sumitsam093@gmail.com |
|
|
Source of Monetary or Material Support
|
| I will myself bear the other cost required. Room no 55 College rehabilitation centre Saket college of physiotherapy chandi mandir Panchkula |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Shikha |
Saket College of Physiotherapy |
1. Room no- 55 College Rehabilitation Centre, Saket College of Physiotherapy.
2. Room no -33Mother Teresa Saket College of physiotherapy sector-1 Panchkula
2. Department of Physiotherapy, Civil Hospital, Sector-6.
Panchkula
HARYANA |
8708063441
sumitsam093@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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 |
| Intervention |
Muscle Energy Technique |
Muscle Energy Technique on suboccipital muscle the contraction will be held for 10 seconds followed by 5 second rest period.The muscle will be again taken into the new barrier range and the same above procedure will be repeated 3 times with 10 second contraction followed by 30 second hold. |
| Comparator Agent |
Muscle Energy Technique |
Muscle Energy Technique on upper trapezius the isometric contraction is done for 7-10 seconds and this position
is maintained for 30 second. The muscle will be again taken into the new barrier range and the same above procedure will be repeated 3 to 5 times.
Muscle Energy Technique on levator scapular the isometric contraction is done for 7-10 seconds and this position
is maintained for 30 second. The muscle will be again taken into the new barrier range and the same above procedure will be repeated 3 to 5 times. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Participants with Chronic non-specific neck pain duration more than 3 months.
2) Age group between 20-40 years.
3) Numeric pain rating scale of greater than 5.
4) Mild to moderate disability scores on the neck disability index.
1) Participants with Chronic non-specific neck pain duration more than 3 months.
2) Age group between 20-40 years.
3) Numeric pain rating scale of greater than 5.
4) Mild to moderate disability scores on the neck disability index.
5) Craniovertebral angle less than 51.
|
|
| ExclusionCriteria |
| Details |
1) History of malignancy and infection.
2) Trauma in the region of the neck, shoulder and head (e.g., Whiplash injury).
3) Signs of cerebrovascular insufficiency (e.g., Dizziness, drop attack, cerebrovascular accident and TIA).
4) Chronic disease of locomotor system (e.g., Polyarthritis, muscular disease).
5) Cervical disc prolapse.
6) Peripheral nerve entrapment.
7) Spinal stenosis and fibromyalgia.
8) Previous neck surgery.
9) Spasmodic torticollis, inflammatory rheumatic disease, psychiatric illness.
10) Spinal deformity and cardiovascular accident.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pain on Numeric Pain Rating Scale.
2) Disability on Neck Disability Index.
3) Craniovertebral Angle on Image J Software.
|
1. Baseline data (pre-treatment)
2. post-treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/03/2024 |
| 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
|
In this study we will include the mechanical neck pain patients. We will compare the effect of muscle energy technique on suboccipital muscle versus muscle energy technique on upper trapezius muscle along with levator scapulae muscle. Pre and post measurement of pain on NPRS , Neck Disability on neck disability index, craniovertebral angle on Image J software will be measured. Both the groups will get conventional treatment including neck stabilization exercise and neck dynamic exercise. The data collected will be analyzed statistically using appropriate tests. Result, discussion and conclusion will then be written accordingly. |