| CTRI Number |
CTRI/2020/03/023821 [Registered on: 06/03/2020] Trial Registered Prospectively |
| Last Modified On: |
11/06/2021 |
| 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
|
cervical stabilization exercises or scapular stabilization exercises: which is effective in chronic neck pain? |
|
Scientific Title of Study
|
Effects of cervical and scapular stabilization exercises in chronic mechanical 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 |
Sapna Dhiman |
| Designation |
Assistant Professor,Physiotherapy |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room no-610,6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University,Pushp Vihar,sector-III,New Delhi
South
DELHI
110017
India |
| Phone |
8588055147 |
| Fax |
|
| Email |
sapnadhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Kumar Sahu |
| Designation |
Physiotherapist |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no- 17, 6th floor,
Neurosciences Centre, AIIMS
South
DELHI
110029
India |
| Phone |
8384065426 |
| Fax |
|
| Email |
pksahu9938@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sapna Dhiman |
| Designation |
Assistant Professor,Physiotherapy |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room no-610,6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University,Pushp Vihar,sector-III,New Delhi
South
DELHI
110017
India |
| Phone |
8588055147 |
| Fax |
|
| Email |
sapnadhi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sapna Dhiman |
| Address |
Room no-610,6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University,Pushp Vihar,sector-III,New Delhi
|
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Sapna Dhiman |
Physiotherapy OPD |
Room no-610,6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University,Pushp Vihar,sector-III,New Delhi
South
DELHI |
8588055147
sapnadhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Delhi Pharmaceutical Sciences and Research University, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional exercises |
In this group, conventional treatment such as manual therapy to thoracic spine, flexibility exercises of neck will be done |
| Intervention |
Conventional exercises and cervical stabilization exercises |
In this group, conventional treatment such as manual therapy to thoracic spine, flexibility exercises of neck will be done. Along with the conventional exercises supervised cervical stabilization exercises in sitting and supine lying will be carried out. |
| Intervention |
Conventional exercises and Scapular stabilization exercises |
In this group, conventional treatment such as manual therapy to thoracic spine, flexibility exercises of neck will be done. Along with the conventional exercises supervised scapular stabilization exercises by therabands will be carried out. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Duration of pain ≥ 3 months
2. Mechanical neck pain is characterized as pain in neck with or without referral pain up to shoulder region.
3. Non-specific neck pain(absence of any specific diagnosis)
|
|
| ExclusionCriteria |
| Details |
1.Patients with tumour or malignancy.
2.Pregnant and lactating women.
3.Features of radiculopathy
4.Any known neurological, cardiovascular and psychiatric abnormalities
5. Any other specific causes of neck pain (spondylolisthesis, spondylolysis, ankylosing spondylitis)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Intensity of pain in VAS
2. Neck disability index
3. Core muscle activity by pressure biofeedback unit |
1. At baseline
2. At 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Global rate of change(GROC) |
1. At baseline
2. At 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2020 |
| Date of Study Completion (India) |
20/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this randomized controlled clinical trial, all participants with chronic non-specific neck pain will be randomly allocated in to three groups. In all the groups conventional exercises will be part of exercises program. However, in group "A" along with conventional exercises scapular stabilization exercises and in group "B" along with conventional exercises scapular stabilization exercises will be done. Group "C" will receive only conventional exercises. Outcome measures such as intensity of pain, disability, cervical Core muscle function and global rate of change will be evaluated at baseline at at 6 weeks of intervention. Data will be compared to find the effect of scapular stabilization and cervical stabilization exercises in chronic mechanical neck pain. |