| CTRI Number |
CTRI/2017/03/007990 [Registered on: 02/03/2017] Trial Registered Prospectively |
| Last Modified On: |
26/04/2018 |
| 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
|
Comparison of immediate effect of exercise and joint mobilization in patients with neck pain |
|
Scientific Title of Study
|
Comparison of Immediate effect of active cranio-cervical flexion exercise and Mulligan mobilization on pain,cervical range of motion and cranio-cervical flexion test performance in patients with 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 |
Ashwini Suresh Shelke |
| Designation |
Post Graduate Student |
| Affiliation |
School of Allied health sciences ,Manipal university |
| Address |
Department of Physiotherapy ,
School of Allied health sciences
Manipal university
Manipal
District -Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9657777909 |
| Fax |
|
| Email |
ashwinishelke999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ganesh Balthillaya |
| Designation |
Assistant Professor- Senior Grade |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences,
Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
Ganesh.bm@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr YVRaghava Neelapala |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied health sciences, Manipal University |
| Address |
Department of Physiotherapy,
School of allied health sciences,
Manipal university
Udupi
KARNATAKA
576104
India |
| Phone |
9482773219 |
| Fax |
|
| Email |
yv.raghava@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Allied Health Sciences, Manipal university, Manipal - 576104
District - Udupi
State - Karnataka
Country - India |
|
|
Primary Sponsor
|
| Name |
Ashwini Suresh Shelke |
| Address |
Department Of Physiotherapy
School of Allied Health Sciences
Manipal University |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ashwini Suresh Shelke |
Department of Physiotherapy |
Department of Physiotherapy
School of Allied Health Sciences
Kasturba Hospital
Manipal University
Manipal
Udupi
KARNATAKA |
9071589664
ashwinishelke999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient with Mechanical Neck Pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active Cranio-cervical flexion exercise |
Exercise of neck muscles focusing on mainly activation of deep neck flexors which helps in improving endurance and muscle control. The patient has to do gentle nodding movement along with holds for this exercise |
| Comparator Agent |
mulligan joint mobilization |
Facet joint mobilization will be performed following principles of mulligan approach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with Mechanical Neck Pain
2 Duration of pain less than 3 weeks
3 The pain intensity on numerical pain rating scale more than 3 |
|
| ExclusionCriteria |
| Details |
1 cervical radiculopathy
2 vertebrobasilar insufficiency
3 tumors
4 metabolic bone disease
5 anticoagulant therapy
6 cervical myelopathy
7 major respiratory cardiovascular or neurological disorders
8 pregnancy
9 spinal surgery
10 recent history of fall trauma or fracture to cervical spine
11 cervical instability
12 patient undergoing any physiotherapy treatment for the pain |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale |
Numerical Pain Rating Scale will be taken from the subjects before giving the intervention and immediately after the intervention is given. The Scale will be taken twice |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cervical range of motion |
Cervical Range of motion using CROM device will be assessed twice during the study. Once before giving the intervention and second immediately after the intervention |
| Cranio-cervical flexion test performance |
testing of cranio-cervical flexion test performance 5 levels using the Pressure biofeedback unit will be assessed twice during the study. Once before giving the intervention and second immediately after the intervention is given |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/04/2017 |
| Date of Study Completion (India) |
12/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/12/2017 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to compare the effectiveness between mulligan mobilization technique and active cranio-cervical flexion exercise on pain response cervical range of motion and cranio-cervical flexion test performance in patients with mechanical neck pain. The result of the study will be useful to find out an effective treatment technique for an immediate pain relief that can be incorporated in the treatment regime. |