| CTRI Number |
CTRI/2024/11/076320 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| 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
|
A Study of Myofascial Stretch Dry Needling (MSDN) versus Conventional Dry Needling as intervention in Badminton Players with Lateral Epicondylitis. |
|
Scientific Title of Study
|
Efficacy of Myofascial Stretch Dry Needling (MSDN) in badminton sport players with Lateral Epicondylitis - 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 |
Dr Priyanka Rajput |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy,
Block 4, Room no 213
Lovely Professional University, Jalandhar-Delhi, Grand Trunk Rd, Phagwara, Punjab 144001.
Jalandhar
PUNJAB
144411
India |
| Phone |
9149585365 |
| Fax |
|
| Email |
priyankarajput@outlook.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Rajput |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University, Jalandhar-Delhi, Grand Trunk Rd, Phagwara, Punjab 144001.
Kupwara
PUNJAB
144411
India |
| Phone |
9149585365 |
| Fax |
|
| Email |
priyankarajput@outlook.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Rajput |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Block 4- Room no 213, department of physiotherapy, Lovely school of allied medical science, LPU
PUNJAB
144411
India |
| Phone |
9149585365 |
| Fax |
|
| Email |
priyankarajput@outlook.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hirock Biswas |
| Address |
Lovely Professional University, 144411 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| Hirock Biswas |
Lovely Professional University |
Block 3, Room no 105, Lovely Professional University
Jalandhar
PUNJAB |
9123717749
dr.hirockbiswaspt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University (IEC-LPU) |
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 |
The subject will be asked to sit down in the comfortable position. All baseline measurements will be taken by the therapist before treatment. Flat palpation with appropriate pressure for MTrPs in the ECRB muscle will be done by the examiner. In the next step, the therapist will gently stretch the ECRB muscle. The needle (0.25× 25 mm) will be inserted after locating the MTrPs in the affected muscle, for ten minutes. The needle will be removed after 10 minutes, and the hemostasis will be maintained.
the intervention will be given for 6 alternative days , total for 12 days |
| Comparator Agent |
Traditional Dry Needling |
The subject will be asked to sit down in the comfortable position. All baseline measurements will be taken by the therapist before treatment. In the next step, the ECRB muscle will be in the neutral position and then the flat palpation with appropriate pressure for MTrPs in the ECRB muscle was done by the examiner. The needle (0.25× 25 mm) will be inserted after locating the MTrPs in the affected muscle, for ten minutes. The needle will be removed after 10 minutes, and the hemostasis will be maintained.
the intervention will be given for 6 alternative days , total for 12 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Pain lasting between 6 months and a year
2. Pain in the lateral epicondyle during forced (resisted) wrist extension.
3. Presence of MTrPs in ECRB muscle.
4. Decrease in handgrip strength.
5. Tenderness to palpation along the common extensor origin. |
|
| ExclusionCriteria |
| Details |
1. Any injections within 6 months prior to the intervention.
2. The presence of active infection around the affected elbow.
3. Systemic disorders (rheumatoid arthritis, diabetes, immunodeficiency, and coagulopathy).
4. Acute and severe elbow trauma.
5. Any elbow surgery in the past 6 months.
6. The presence of cervical radiculopathy
7. Needle phobia.
8. Patients with posterior interosseous nerve compression.
9. Taking NSAIDs or muscle relaxants for the past 5 days. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Visual Analogue Scale (VAS)
2. Patient Rated Tennis Elbow Evaluation Scale (PRTEE)
3. Pain Pressure Threshold (PPT) |
3 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Hand Held Dynamometer |
3 times |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Total number of 60 Subjects will be
selected according to the inclusion and exclusion criteria and consent will be
taken from all the selected subjects before the commencement of study. Then, all the baseline measurements will
be taken by the therapist before treatment. Then we will take the
pre-intervention assessment for pain by using visual analogue scale and
disability by PRTEE scale, Grip Strength by Hand-held Dynamometer and PPT of
MTrPs by pressure algometer for the ECRB muscle.
The subject will be allocated into
two groups using a simple randomization process. After
that the therapist
will gently stretch the ECRB muscle. The needle will be
inserted after locating the MTrPs. The needle will remain in
the affected muscle for ten
minutes, and then after 10 minutes, the needle will be removed and the
hemostasis
will be maintained. Group
1: Myofascial Stretch Dry Needling Group
Myofascial Stretch Dry Needling
(MSDN) Group [n=30], The subject will be asked to sit down in the comfortable
position. All baseline measurements will be taken by the therapist before
treatment. Flat palpation with appropriate pressure for MTrPs in the ECRB
muscle will be done by the examiner. In the next step, the therapist will
gently stretch the ECRB muscle. The needle (0.25× 25 mm) will be inserted after
locating the MTrPs in the affected muscle, for ten minutes. The needle will be
removed after 10 minutes, and the hemostasis will be maintained. Group
2: Traditional Dry Needling Group
Myofascial Stretch Dry Needling
(MSDN) Group [n=30], The subject will be asked to sit down in the comfortable
position. All baseline measurements will be taken by the therapist before
treatment. In
the next step, the ECRB muscle will be in the neutral position and then the
flat palpation with appropriate pressure for MTrPs in the ECRB muscle was done
by the examiner. The needle (0.25× 25 mm) will be inserted after locating the
MTrPs in the affected muscle, for ten minutes. The needle will be removed after
10 minutes, and the hemostasis will be maintained. Therapeutic sessions will be provided for 6 alternative days and data will be collected 3 times (Before the starting of the session, in between of the ongoing session and after the session is finished )
|