| CTRI Number |
CTRI/2024/12/078779 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| 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
|
physiotherapy treatment for low back pain in cricketers |
|
Scientific Title of Study
|
Effect of myofascial release technique of the quadratus lumborum muscle combined with core stabilization exercises in cricketers with low back 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 |
Nidhi Joshi |
| Designation |
Post Graduate Scholar |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8077546241 |
| Fax |
|
| Email |
nidhijoshi7719@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anu Bansal |
| Designation |
Assistant Professor Grade 3 |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anu Bansal |
| Designation |
Assistant Professor Grade 3 |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy
Amity Institute of Health Allied Sciences, Amity University F1 LGF sector 125 Noida
Uttar Pradesh, India
201313 |
|
|
Primary Sponsor
|
| Name |
Nidhi Joshi |
| Address |
Department of Physiotherapy
Amity Institute of Health Allied Sciences, Amity University F1 LGF sector 125 Noida
Uttar Pradesh
201313 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Anu Bansal |
Department of Physiotherapy
Amity Institute of Health Allied Sciences, Amity University F1 LGF sector 125 Noida
Uttar Pradesh
201313 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Joshi |
Department of Physiotherapy Amity Institute of Health Allied Sciences |
Department of Physiotherapy
F1 LGF sector 125
Gautam Buddha Nagar
UTTAR PRADESH |
08077546241
nidhijoshi7719@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar PPradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Core stabilization exercises along with conventional treatment |
core stabilization exercises will be done for 10 repetitions with 5 secs hold, 3 sets,3 times per week. Conventional treatment includes hot pack for 10 mins,TENS for 10 mins and cold pack for 5-10 mins. This Intervention will be for 4 weeks |
| Intervention |
Myofascial release technique with core stabilization exercises along with conventional treatment |
Myofascial release technique will be given for 7 mins for quadratus lumborum muscle and core stabilization exercises will be done for 10 repetitions with 5 secs hold, 3 sets. Conventional treatment includes hot pack for 10 mins,TENS for 10 mins and cold pack for 5-10 mins. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
- Active participation in cricket for at least 1year
- Cricketers with LBP associated with Quadratus Lumborum (QL) muscle involvement
- poor core stability in cricketers- grade 3 [Sahrmann core stability test (SCST)]
- Patient who can hold side plank position for less than 5 secs only
- pain in QL on side bending
- tenderness along QL
- grade 3 strength of QL muscle (pelvis elevation test)
- lateral flexion ROM limited contralateral side
- lateral pelvic tilt on the contralateral side
|
|
| ExclusionCriteria |
| Details |
- Anyone who denied consent
- History of recent trauma/ injury
- Players with low back pain (LBP) but have some other cause
- History of any systemic illness
- Acute or chronic lower limb injuries
- neurological disorders
- a history of neck trauma
- existing hamstring injury or surgery
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity, Functional Disability, Range of motion, core endurance testing |
Baseline,4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
15/01/2025 |
| 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="5"
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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nidhijoshi7719@gmail.com].
- For how long will this data be available start date provided 15-01-2025 and end date provided 15-05-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
AIM: To determine the efficacy of myofascial release technique (MRT) of the quadratus lumborum muscle combined with core stabilization in cricketers with low back pain OBJECTIVES: - To assess the effect of myofascial release technique of quadratus lumborum muscle combined with e core stabilization among cricketers with low back pain
- To assess the effect of myofascial release technique of quadratus lumborum muscle combined with core stabilization on disability among cricketers with low back pain
- To assess the effect of Myofascial release technique of quadratus lumborum muscle combined with core stabilization on lumbar range of motion among cricketers with low back pain
- To assess the effect of Myofascial release technique of quadratus lumborum muscle combined with core stabilization on core stability endurance among cricketers with low back pain
- To assess the effect of Myofascial release technique of quadratus lumborum muscle combined with core stabilization on Quadratus lumborum muscle endurance among cricketers with low back pain
|