| CTRI Number |
CTRI/2024/03/064250 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of physical techniques in neck pain |
|
Scientific Title of Study
|
Efficacy of Gua Sha Technique along with LWD in the treatment of neck pain - A 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 |
Vanshika |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
0 |
| Fax |
|
| Email |
vanshis0011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Gera |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
0 |
| Fax |
|
| Email |
charugera321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Gera |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
0 |
| Fax |
|
| Email |
charugera321@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vanshika BPT Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
| Type of Sponsor |
Other [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 |
| Vanshika |
Room no 5 OPD department of physiotherapy |
Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA |
7494976627
vanshis0011@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 |
Gua Sha with LWD and hotpack |
Gua Sha along with LWD and hot pack will be given to the patients for 3 weeks on alternate days. |
| Comparator Agent |
LWD with hot pack |
LWD with hotpack will be given to the patients for 3 weeks on alternate days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Neck pain with headaches
Patients with muscle spasm and tenderness over neck and scapular area
|
|
| ExclusionCriteria |
| Details |
1. Any neurological disorder
2. Any cardiovascular disorder
3. Recent surgical patients
4. Uncooperative patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Craniovertebral angle
VAS
Neck Disability Index |
The outcome measures will be assessed for two times which is at the baseline and after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life
|
The outcome measure will be assessed for two times which is at the baseline and after 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Paper communicated |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neck pain is the most common condition among adult population with prevalence ranges from 5.9% to 38.7%. The yearly prevalence rate of neck pain varies from 8.8%to 11.6%. Females are more affected with this condition as of males. The most common causes of neck pain include sedentary lifestyle, excessive computer use and abnormal posture for prolong duration. This affects the person’s life physically, psychologically, socially and economically. Hence, this condition needs to be treated. Various treatment options available for neck pain such as conservative, physiotherapy and surgical treatment. Physiotherapy treatment include various like stretching and strengthening exercises. Other methods of physiotherapy includes acupuncture, massage therapy, exercises, traction, soft cervical collars, spinal manipulation and electrotherapy which includes TENS, IFT, Ultrasonic therapy, Shortwave Diathermy, Longwave Diathermy. Manual therapy and physiotherapy modalities can be effective method in the treatment of neck pain. Evidence suggests that GuaSha technique can be used for the treatment of neck pain. Hence, the rationale of the present study is to evaluate the efficacy of Gua Sha along with Long wave diathermy in patients suffering from neck pain. |