- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06131658
Effects of Functional Motor Control on Pain, Flexibility, Lower Extremity Function With ITBS
December 26, 2023 updated by: Riphah International University
Effects of Functional Motor Control Exercise on Pain, Flexibility, Lower Extremity Function Among Runners With Iliotibial Band Syndrome
The study is randomized and single-blinded.
Ethical approval is taken from ethical committee of Riphah International University, Lahore.
Participants who meet the inclusion criteria will be enrolled and allocated in group A & B through sealed envelope method by non-probability convenient random sampling technique.
Subjects in group A will receive functional motor control exercises.
Group B will receive conventional exercises.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to determine the effects of functional motor control exercises on pain, flexibility and lower limb functional.
It will be randomized controlled trial (RCT) research design at Pakistan sports board through non probability convenience sampling technique on 18 runners' athletes which will be allocated using random sampling through computerized generated number into Group A and Group B, 9 athletes will be in each group.
Group A (interventional) will be given conventional training with functional motor exercise and Group B (control) will be given conventional training.
There will be 3 sessions in a week for 6 weeks.
The baseline scoring will be on 1st day, follow up will be taken at 6th week.
Assessment will be made by Numeric pain rating scale, Lower extremity functional scale (LEFS), Single leg mini squat, Y balance.
Data will be analyzed during SPSS software version 26.
After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two group
Study Type
Interventional
Enrollment (Estimated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amna Shahid, MS-DPT
- Phone Number: +92 334 4512823
- Email: amna.shahid@riphah.edu.pk
Study Locations
-
-
Punjab
-
Faisalābad, Punjab, Pakistan, 37700
- Recruiting
- Jawad Club
-
Contact:
- hamza ali, MBA
- Phone Number: +92-3020160361
- Email: hamza.azeem2018@gmail.com
-
Contact:
- Maham Athar, DPT
- Phone Number: Athar 03356600213
- Email: mahamathar666@gmail.com
-
Principal Investigator:
- Maham Athar, DPT
-
Sub-Investigator:
- amna shahid, MS-DPT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- male and female athlete within 19-40 years,
- running a minimum average of 15 running kilometers,
- Runners with one sided iliotibial band syndrome for at least 3 months were included,
- Pain along IT band at either Gerdy's tubercle or the lateral femoral epicondyle during running,
- positive stiffness with Ober's test, and
- reporting pain during Noble's compression test.
Exclusion Criteria:
- Individuals with a history of previous knee trauma of past 6 months,
- Individuals with a history of previous knee surgery of past 6 months,
- Other knee abnormalities including patellofemoral joint pain,
- popliteus tendinitis,
- lateral meniscal injury,
- Degenerative joint disease, and
- lateral collateral ligament sprain to the affected side.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Functional motor control excercise
Functional motor control exercise Includes side plank with clamshell, Side plank with hip abduction, Side-lying hip abduction, Lateral monster walk, Hip hikes, Single leg squat, TKE with T-band-hip abduction All exercises done with 2 sets of 10 reps with 3 sessions per week for 6 weeks
|
This include functional motor control thrice a week for six weeks
|
Experimental: conventional exercise
The conventional exercise included 4 stages of self-myofascial techniques, strengthening, and integration techniques.
In the first phase, individuals did fascial release exercises using foam rolls, focusing on tensor fascia latae, iliotibial band, and hip adductor muscles, and tennis balls for the quadratus lumborum.
The exercises were performed at high-intensity maximum pain tolerance for 30 seconds or low-intensity minimum pain tolerance for 90 seconds.
|
This include convectional exercise thrice a week for six weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain rating scale
Time Frame: pre and 6 weeks post interventional
|
pain will be assess by Numeric pain rating scale with minimum score 0 to maximum score 10
|
pre and 6 weeks post interventional
|
flexibility
Time Frame: pre and 6 weeks post interventional
|
flexibility will be assess by Y balance
|
pre and 6 weeks post interventional
|
lower extremity function
Time Frame: pre and 6 weeks post interventional
|
lower extremity function will be assess by lower limb extremity scale with score 0 to 80
|
pre and 6 weeks post interventional
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: maham Athar, DPT, Investigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running injuries. Br J Sports Med. 2002 Apr;36(2):95-101. doi: 10.1136/bjsm.36.2.95.
- Baker RL, Fredericson M. Iliotibial Band Syndrome in Runners: Biomechanical Implications and Exercise Interventions. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):53-77. doi: 10.1016/j.pmr.2015.08.001.
- McKean KA, Manson NA, Stanish WD. Musculoskeletal injury in the masters runners. Clin J Sport Med. 2006 Mar;16(2):149-54. doi: 10.1097/00042752-200603000-00011.
- Fredericson M, Cookingham CL, Chaudhari AM, Dowdell BC, Oestreicher N, Sahrmann SA. Hip abductor weakness in distance runners with iliotibial band syndrome. Clin J Sport Med. 2000 Jul;10(3):169-75. doi: 10.1097/00042752-200007000-00004.
- Noehren B, Davis I, Hamill J. ASB clinical biomechanics award winner 2006 prospective study of the biomechanical factors associated with iliotibial band syndrome. Clin Biomech (Bristol, Avon). 2007 Nov;22(9):951-6. doi: 10.1016/j.clinbiomech.2007.07.001. Epub 2007 Aug 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2023
Primary Completion (Estimated)
February 20, 2024
Study Completion (Estimated)
February 20, 2024
Study Registration Dates
First Submitted
November 9, 2023
First Submitted That Met QC Criteria
November 9, 2023
First Posted (Actual)
November 14, 2023
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 26, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0429
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Functional motor control excercise
-
Centro Universitário Augusto MottaRio de Janeiro State Research Supporting Foundation (FAPERJ)CompletedPain | Back Pain | Low Back Pain | Neuromuscular Manifestations | Signs and SymptomsBrazil
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedPain | Fatigue | Chronic Fatigue Syndrome | Myalgic EncephalomyelitisNorway
-
Baylor Research InstituteRecruiting
-
Riphah International UniversityCompletedSpinal Cord InjuryPakistan
-
Hacettepe UniversityCompleted
-
Ankara Yildirim Beyazıt UniversityCompletedParkinson Disease | Muscle Strength | Mobility | Balance | Non-motor SymptomsTurkey
-
Riphah International UniversityCompletedPostural ControlPakistan
-
National Yang Ming UniversityNot yet recruitingShoulder Impingement SyndromeTaiwan
-
Duke UniversityRecruiting
-
Universidad Rey Juan CarlosCompleted