| CTRI Number |
CTRI/2023/09/057639 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
10/09/2023 |
| 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
|
A study to compare effect of needles and manual muscle release technique on upper trapezius (neck muscle) spasm in subjects with neck pain |
|
Scientific Title of Study
|
A comparative study on effect of Dry needling with Active release technique on pain,neck range of motion,pain pressure threshold on myofascial trigger points in upper trapezius muscle in subjects with 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 |
Ankita Ajay Dude |
| Designation |
Post graduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12,Thube Park,Shivajinagar,Pune-411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9834617187 |
| Fax |
|
| Email |
ankitadude13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venu Mohan PT |
| Designation |
Associate Proffesor MSK deparrment |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12,Thube Park,Shivajinagar,Pune-411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venu Mohan PT |
| Designation |
Associate Proffesor MSK deparrment |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12,Thube Park,Shivajinagar,Pune-411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopeadics and Rehabilitation college of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopeadics and Rehabilitation college of Physiotherapy |
| Address |
Sancheti Institute for Orthopeadics and Rehabilitation college of Physiotherapy,11/12,Thube park,Shivajinagar,Pune-33 |
| 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 |
| DrAnkita Dude |
Sancheti Institute for Orthopeadics and Rehabilitation college of Physiotherapy |
Department of musculoskeletal physiotherapy,1st floor,11/12 Thube Park Shivajinagar,Pune 411005
Pune
MAHARASHTRA |
9834617187
ankitadude13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active release technique |
Active release technique will be given on myofascial trigger points in upper trapezius by trapping trigger points under the pulp of finger and pressure will be applied on trigger point.
With this constant pressure applied by therapist,patient will be actively moving neck in side flexion and then neutral.15 repititions will be performed,along with conventional exercises taken by therapist.Total duration of intervention is 10 minutes.Intervention will be performed for 3 days in a week for 1 week. |
| Intervention |
Dry needling |
Dry needling will be done on myofascial trigger points in upper trapezius muscle.25 mm needle will be inserted with patient in prone position and will be placed for 10 mins.Along with dry needling conventional exercises will also be taken by therapist.Total time for intervetion is 20 minutes.Interventions will be performed 3 days in a week,for 1 week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Pain on VAS 4-8
subjects with neck pain
subjects fulfilling simmons criteria |
|
| ExclusionCriteria |
| Details |
Cervical spine surgery
Cervical myelopathy or radiculopathy diagnosed by primary care physician
Acute muscle trauma
Shoulder surgery
Contraindications of dry needling such as bruising, pneumothorax, internal tissue damage, bleeding
Systemic/local infection
Phobia of needle
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
Pre-On day 0
Post-After 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neck Range of motion
Pain pressure threshold |
Pre-On day 0
Post-After 1 week |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/09/2023 |
| 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="0"
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
|
| The aim of the current study is to compare the effect of dry needling and active release technique on pain , neck ROM, pain pressure threshold on myofascial trigger points in upper trapezius muscle in subjects with neck pain.Primary hypothesis of study is there is a no comparable effect of dry needling and active release technique on pain,neck range of motion and pain pressure threshold on myofascial trigger points in upper trapezius in subjects with neck pain. Group A will recieve Dry needling and Group B will recieve Active Release Technique both groups will recieve conventional exercises for neck.Intervention duration is 1 week.
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