| CTRI Number |
CTRI/2024/07/071505 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Kinesiotaping, myofacial release and stretching in footbal players with Iliotibial band syndrome.
|
|
Scientific Title of Study
|
Assessing the efficacy of Kinesio taping and Myofascial Release Technique along with stretching in College Football Players with Iliotibial Band Syndrome. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof (Dr) Abdur Raheem khan |
| Designation |
Professor & Head, Department of Physiotherapy |
| Affiliation |
Integral University Lucknow |
| Address |
Deaprtment of Physiotherapy, Block G, Integral University, kursi road, Lucknow
Uttar Pradesh
Pin 226026
Deaprtment of Physiotherapy, Block G, Integral University,kursi road , Lucknow, uttar Pradesh
Pin code 226026
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
09616739965 |
| Fax |
|
| Email |
abdurraheem@iul.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof (Dr) Abdur Raheem khan |
| Designation |
Professor & Head, Department of Physiotherapy |
| Affiliation |
Integral University Lucknow |
| Address |
Deaprtment of Physiotherapy, Block G, Integral University, kursi road, Lucknow
Uttar Pradesh
Pin 226026
Deaprtment of Physiotherapy, Block G, Integral University,kursi road , Lucknow, uttar Pradesh
Pin code 226026
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
09616739965 |
| Fax |
|
| Email |
abdurraheem@iul.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof (Dr) Abdur Raheem khan |
| Designation |
Professor & Head, Department of Physiotherapy |
| Affiliation |
Integral University Lucknow |
| Address |
Deaprtment of Physiotherapy, Block G, Integral University, kursi road, Lucknow
Uttar Pradesh
Pin 226026
Deaprtment of Physiotherapy, Block G, Integral University,kursi road , Lucknow, uttar Pradesh
Pin code 226026
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
09616739965 |
| Fax |
|
| Email |
abdurraheem@iul.ac.in |
|
|
Source of Monetary or Material Support
|
| Integral Hospital and Research Centre, Integral University, Kursi Road, Lucknow, Uttar Pradesh 226026 |
|
|
Primary Sponsor
|
| Name |
Dr Namrata suri |
| Address |
Deaprtment of Physiotherapy, Block G,Integral University, kursi road,Lucknow, Uttar Pradesh
Pin 226026 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sezal PT |
Integral University kursi road Lucknow Uttar Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr sezal |
Integral Hospital and Research Centre |
Deaprtment of Physiotherapy, Block G, Integral University kursi road Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH |
07972460714
sezalrahman007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, integral University Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
myofacial release technique along with stretching |
Group B: was given Myofacial release technique (MFR) along with bicep femoris and tensor facia latae stretching.
The participants of group B received Myofacial release technique with stretching, To perform the MFR on IT band, the patient lied supine line with the treatment leg on superior side and the hip and knee of the same side slightly flexed to aid the relaxation [29]. The adduction was then gained by positioning and gravity, it put the muscle in elongated position [30]. The longitudinal strokes were applied by the therapist thumb by placing it over the taut band and moderate pressure unpainful for patient was applied and this was continued for 3 minutes. After it the IT band of the patient was stretched. Intervention will be given and data will be collected every 7 days for 3 weeks. 4th week will be the follow up. Total duration of intervention will be 3 weeks and each session will be of 45 minutes. |
| Intervention |
Kinesiotaping, myofacial release technique (MFR) and stretching |
Effect of Kinesiotaping and stretching of bicep femoris and tensor facia latae in iliotibial band syndrome.
Effect of Myofacial release technique and stretching of bicep femoris and tensor facia latae in Iliotibial band syndrome.
Effect of Stretching of bicep femoris and tensor facia latae in Iliotibial band syndrome. Intervention will be given and data will be collected every 7 days for 3 weeks. 4th week will be the follow up. Total duration of intervention will be 3 weeks and each session will be of 45 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
College students
Both male and females
Pain duration 2-3 days
Participants of age group 18-26years with a diagnosis of iliotibial band syndrome |
|
| ExclusionCriteria |
| Details |
Participants with flat foot, knock knee and limb length discrepancy
Participants with any soft tissue injury around knee joint |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Point numeric pain scale
|
1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lower extremity functional scale LEFs |
1 month |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
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
|
NULL HYPOTHESIS (H0): Kinesiotaping along with stretching have no significant effect in the management of Iliotibial band syndrome. Myofacial release technique along with stretching have no significant effect in the management of Iliotibial band syndrome. Streching of bicep femoris and tensor facia latae will have no significant effect in the management of Iliotibil band syndrome. ALTERNATE HYPOTHESIS (H1): Kinesiotaping along with stretching may have significant effect in the management of Iliotibial band syndrome. Myofacial release technique along with stretching may have significant effect in the management of Iliotibial band syndrome. Stretching of bicep femoris and tensor facia latae may have significant effect in the management of Iliotibial band syndrome. |