| CTRI Number |
CTRI/2023/07/054594 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
30/06/2023 |
| 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
|
Effect of Scapular Stabilization exercises and Bruegger’s Relief exercise in patients with Neck Pain |
|
Scientific Title of Study
|
Efficacy of Scapular Stabilization exercises and Bruegger’s Relief exercise on Pain, Functional Disability and Forward Head Posture in patients with Chronic Nonspecific Neck Pain |
| 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 Sujata Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Health Science Hisar |
| Address |
Room no. 101 Department of Physiotherapy Guru Jambheshwar University of Health Science and Technology,
Hisar-Delhi Bypass Road
Hisar
HARYANA
125001
India |
| Phone |
9416918688 |
| Fax |
|
| Email |
sujatasharmaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Health Science Hisar |
| Address |
Room no. 101 Department of Physiotherapy Guru Jambheshwar University of Health Science and Technology,
Hisar-Delhi Bypass Road
Hisar
HARYANA
125001
India |
| Phone |
9416918688 |
| Fax |
|
| Email |
sujatasharmaphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogita Jhandai |
| Designation |
Masters in physiotherapy |
| Affiliation |
Guru Jambheshwar University of Health Science Hisar |
| Address |
Guru Jambheshwar University of Health Science and Technology,
Hisar-Delhi Bypass Road
Hisar
HARYANA
125001
India |
| Phone |
8708129262 |
| Fax |
|
| Email |
yogitajhandai06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yogita Jhandai (MPT) Department of Physiotherapy Guru Jambheshwar University of Science and Technology New Delhi-Sirsa Highway Hisar-125001 Haryana |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
New Delhi-Sirsa Highway, Hisar-125001 Haryana, India |
| Type of Sponsor |
Other [Government University] |
|
|
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 Sujata Sharma |
Guru Jambheshwar University of Health Science and Technology, Hisar-Delhi Bypass Road |
Room no. 6, Department of Physiotherapy
Hisar
HARYANA |
9416918688
sujatasharmaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (Guru Jambheshwar University of Health Science and Technology) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Brueggers Relief Exercise |
In a high sitting position an elastic resistance band is tied on each hand of the participant leaving the palms open then instructed to abduct and extend their thumbs and fingers, followed by wrist extension and forearm supination and also tell to perform shoulder external rotation, elbow extension, shoulder abduction, and extension, as well as scapular retraction with their chin tucked in (6-10 minutes); Conventional exercises include cervical isometric exercises (6-8 minutes); stretching exercises for upper trapezius 2 minute); levator scapulae (2 minute); and pectoralis muscle (2 minute) and ergonomic advices for 12 sessions carried out for 4 consecutive weeks. |
| Intervention |
Scapular Stabilization Exercises |
SSE consists of 5 stages (16-20 minutes);
Conventional exercises include cervical isometric exercises (6-8 minutes); stretching exercises for upper trapezius 2 minute); levator scapulae (2 minute); and pectoralis muscle (2 minute) and ergonomic advices for 12 sessions carried out for 4 consecutive weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 18-45 years.
Nonspecific neck pain for more than three months.
Both males and females were included.
|
|
| ExclusionCriteria |
| Details |
History of neck pain due to any specific cervical spine pathological cause.
History of inflammatory joint disorders, infectious, metabolic, and malignant diseases.
Patients diagnosed with epilepsy.
Any history of previous spinal surgeries of the cervical spine.
Presence of any open wound on the neck.
Pregnant and lactating women.
Un-cooperative patients and not willing to participate in the study.
|
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Neck Disability
Cranioverteral Angle |
All outcome measured before the start of intervention i.e. at baseline & after the completion of treatment i.e. at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
09/07/2023 |
| 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="0"
Months="3"
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
|
A randomized clinical trial on population with chronic nonspecific neck pain. Neck pain is affecting around 71-75.1 % of general population and it is rising as a result of sedentary lifestyles and unhealthy working environments. Different types of intervention heat therapy, medication, deep neck flexor stabilizing exercises, manual therapy, electrotherapy, non-surgical procedure and physiotherapy for management of chronic nonspecific neck pain. Surgical intervention results in complications and researches don’t show any firm results. Manual therapy can be an effective method in treating chronic nonspecific neck pain. So this study was planned to evaluate the efficacy of Scapular stabilization exercises and Bruegger’s relief exercise on pain, functional disability and forward head posture in patients with chronic nonspecific neck pain. Subjects will be screened for chronic nonspecific neck pain using inclusion criteria. Informed consent will be taken for participation in study. Participants will be allocated in two groups. Treatment protocol for group A - scapular stabilization exercises for 30 minutes and conventional exercises include cervical isometric exercises, stretching exercise of trapezius, levator scapulae and pectoralis minor and ergonomic advices. Treatment protocol for group B - bruegger’s relief exercise and conventional exercises. Treatment will be given for 4 weeks with 3 sessions in a week. Data would be recorded at day 1 then at completion of treatment of 4 weeks using VAS, NDI and CVA for pain, disability and forward head posture respectively. |