| CTRI Number |
CTRI/2024/11/076240 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| 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
|
Immediate effect of Myofascial stretch dry needling on pain, ROM, disability and pressure pain threshold in Piriformis Syndrome. |
|
Scientific Title of Study
|
Immediate effect of myofascial stretch dry needling versus traditional dry needling in subjects with myofascial trigger points in piriformis syndrome- A randomized control 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 |
Dr Varun Kalia |
| Designation |
Assisstant professor |
| Affiliation |
Lovely Professional University, Phagwara |
| Address |
Lovely Professional University, Jalandhar, Punjab 144001
Jalandhar
PUNJAB
144001
India |
| Phone |
8360374990 |
| Fax |
|
| Email |
varun.26576@lpu.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramandeep Kaur |
| Designation |
Student |
| Affiliation |
Lovely Professional University, phagwara |
| Address |
Lovely Professional University, Jalandhar, Punjab 144001
Jalandhar
PUNJAB
143112
India |
| Phone |
7529883007 |
| Fax |
|
| Email |
ramandeepkaurbatth8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Kalia |
| Designation |
Assisstant professor |
| Affiliation |
Lovely Professional University,Phagwara |
| Address |
Lovely Professional University, Jalandhar, Punjab 144001
Jalandhar
PUNJAB
144001
India |
| Phone |
8360374990 |
| Fax |
|
| Email |
varun.26576@lpu.co.in |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University,Phagwara, India,144411 |
|
|
Primary Sponsor
|
| Name |
Ramandeep Kaur |
| Address |
Lovely Professional University, Jalandhar, Punjab 144001 |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Varun Kalia |
Lovely Professional University, Jalandhar, Punjab 144001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varun Kalia |
Lovely Professional University |
Uni hospital, Department of Physiotherapy ,block 3 room no.105
Jalandhar
PUNJAB |
8360374990
varun.26576@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUIONAL ETHICS COMMITTEE, LOVELY PROFESSIONAL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myofascial stretch dry needling in Piriformis muscle |
With the patient lying in the prone position, the therapist gently stretch the piriformis muscle of affected side and maintain the stretch during the MSDN procedure. Myofascial trigger points will be detected by using a flat palpation approach with appropriate pressure on the piriformis muscle. followed by the insertion of a solid monofilament sterile needle (Suzhou Tianxie, Suzhou, China), 0.25 mm diameter x 60 mm in length.
Fast in and out movements of dry needling will be performed to target multiple active myofascial trigger points until the production of the first visible local twitch response. The needle will remain in the muscle for 10 minutes, and then a cotton swab will be applied over the entry point once the needle will be removed to maintain the homeostasis. A sharps container will be used to dispose of the needle.
|
| Comparator Agent |
Traditional dry needling in piriformis muscle |
With the patient lying in the prone position, Myofascial trigger points will be detected by using a flat palpation approach with appropriate pressure on the piriformis muscle. followed by the insertion of a solid monofilament sterile needle (Suzhou Tianxie, Suzhou, China), 0.25 mm diameter x 60 mm in length. Fast in and out movements of dry needling will be performed to target multiple active myofascial trigger points until the production of the first visible local twitch response. The needle will remain in the muscle for 10 minutes, and then a cotton swab will be applied over the entry point once the needle will be removed to maintain the homeostasis. A sharps container will be used to dispose of the needle. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who were having pain, disability, based on history and physical examination aged between 17-60 years both male and female having MTrPs in piriformis muscle and showed the reffered pain willing to participate in the present study. |
|
| ExclusionCriteria |
| Details |
The subjects who had taken NsAIDS and muscle relaxant medications within 2 days before study recruitment, received injections in the trigger points to be punctured within 2 months prior study, extreme fear of needles, uncooperative behaviour were eliminated from 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 |
| Visual Analog Scale, Pressure Pain Threshold, Universal Goniometer |
Baseline (per-treatment) assessment and immediate post treatment(0 minute) (as it is a one time study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index |
baseline(per-assessement) & immediate post treatment(0 minute)as it is one time study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Researchers will provide data on request
- For how long will this data be available start date provided 01-09-2026 and end date provided 30-09-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Piriformis syndrome is a neuromuscular disorder that can cause symptoms of buttock pain,numbness radiating to the back of thigh due to irritation to sciatic nerve. Anytime the piriformis muscle becomes inflamed or irritated, it can affect the sciatic nerve and cause pain. Many factors can contribute to the development of piriformis syndrome such as trauma or anatomic anomalies Myofascial trigger points are the most common cause and also hyperthrophy in the piriformis muscle tissue,inflammation,trauma, and anatomic variations of the piriformis muscle or sciatic nerve may cause the development of piriformis syndrome.However in present study,immediate effect of myofascial stretch dry needling versus traditional dry needling in subjects with myofascial trigger points in piriformis syndrome in improving pain and disability. 60 subjects age between 18-70years diagnosed with piriformis syndrome will be selected based on inclusion criteria. All subjects will be assessed using VAS,pressure pain threshold, Oswestry disability index ,goniometer. All participants will be randomly allocated into two groups: Group 1 and Group 2.Group1(myofascial stretch dry needling ) and in group 2(traditional dry needling). Thereafter subjects of group 1(n=30)will undergo myofascial stretch dry needling , whereas group2(n=30) will be treated with traditional dry needling . Subjects receive a single session of DN. The location on piriformis muscle were needled for 1 minute.The intervention will be given for 1 day to all subjects . After treatment, the post intervention asessment will be done using same outcome measures on same day.
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