| CTRI Number |
CTRI/2023/06/053498 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
02/06/2023 |
| 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
|
The effect of muscle energy technique and respiratory exercise along with therapeutic exercises in neck pain patients |
|
Scientific Title of Study
|
The Effect of Muscle Energy Technique and Respiratory Exercise as an Adjunct to Therapeutic Exercises in Patients with Chronic Neck Pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha |
| Designation |
MPT student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy and rehabilitation, Maharishi Markandeshwar Deemed to be university
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
8571999208 |
| Fax |
|
| Email |
mittalsneha6289@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy and rehabilitation, Maharishi Markandeshwar Deemed to be university
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy and rehabilitation, Maharishi Markandeshwar Deemed to be university
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy, Maharishi Markandeshwar deemed to be university, Ambala |
|
|
Primary Sponsor
|
| Name |
Sneha |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be university, Ambala |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sunita Sharma |
Maharishi Markandeshwar Institute of Physiotherapy, Maharishi Markandeshwar deemed to be university, Ambala |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| sneha |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Orthopaedics OPD
Ambala
HARYANA |
8571999208
mittalsneha6289@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Neck Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muscle Energy Technique
Resistance Exercises
Balloon Breathing |
Muscle Energy Technique will be used for treating patients with Neck Pain.
In Post Isometric Relaxation (PIR) is a technique that involves isometrically contracting hyperactive muscles for a short while, followed by a brief latent period of relaxation to allow for gradual muscular lengthening.
Resistance Exercises plays an important role in the restoration of muscular imbalance. Improvements in functional ability, strength, and endurance with greater muscular activation, as well as better body composition, potency, and quality of life, are among its advantages.
The patient lies back on the bed with a flat pelvic tilt and sets a 3–4–inch ball between his or her knees, which he or she must maintain for the entire training period through the contraction of the internal thigh muscles. holds the balloon in the left hand while holding the right hand over the head. It takes three to four seconds to breathe in via its nose before slowly exhaling into the balloon.
Intervention will be given for 1 hour 5 days a week for 4 weeks
|
| Comparator Agent |
Myofascial Release
Resistance Exercises
Spirometry
Deep breathing |
It eases stiff muscles while enhancing lymphatic drainage and blood flow. Moreover, it changes the connective tissues viscoelasticity and corrects the alignment of muscles.
Resistance Exercises plays an important role in the restoration of muscular imbalance. Improvements in functional ability, strength, and endurance with greater muscular activation, as well as better body composition, potency, and quality of life, are among its advantages.
A physiological test called spirometry examines the amount of air that a person inhales or exhales over the course of a given amount of time. Spirometry can measure volume or flow as the main signals.
Deep breathing exercises are frequently used as interventions, either on their own or in conjunction with other non-pharmacological therapies like hypnosis, relaxation, and meditation. Intervention will be given for 40 minutes 5 days a week for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-40 years
2. Non-Specific Neck Pain lasting at least
more than 3 months
3. Visual Analogue Scale (VAS) more than 6
4. Mechanical and Radiating Pain
5. Forehead posture
|
|
| ExclusionCriteria |
| Details |
• Any metal implant in Neck and Back
• Vascular diseases and neurological condition
• Skin disorders such as dermatitis
• Chemical allergies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Neck Disability Index |
Baseline, 2nd week and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dyspnoea Scale
SF-12 |
Baseline, 2nd week & 4th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
26/06/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Group A will receive 40 minute session of exercises which include 10 minutes of Muscle Energy Technique along with resistance exercise of 20 minutes and 10 minutes of Balloon Breathing And Group B will receive 40 minute session of exercises which include 10 minutes of Myofascial Release along with resistance exercise of 20 minutes, Spirometry and deep breathing for 10 minutes. Both the interventions are given for 5 days a week for 4 weeks. |