Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05973708
Other study ID # REC/RCR & AHS/23/0411
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2023
Est. completion date March 10, 2024

Study information

Verified date April 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Iliotibial band syndrome is where a tendon called iliotibial band gets irritated or swollen from rubbing against hip or knee when it gets too tensed. Iliotibial band (ITB) syndrome (ITBS) is the most common cause of lateral knee pain among athletes who are involved in sports that require continuous running or repetitive knee flexion and extension. The incidence ranges from 1.6% to 12% in runners. The aim of the study is to compare the effects of clamshells and frog pump exercises on gluteus medius strengthening and lower extremity function in runners with iliotibial band syndrome.


Description:

This study will be a randomized clinical trial and will be conducted in Pakistan Sports Board Lahore. Non-probability convenient sampling will be used to collect the data. Sample size of 32 subjects with age group between 18-30 years (males) will be taken. Data will be collected from the runners with tight ITB, by using tools LEFS, HOS-SS, and Hand held dynamometer. An informed consent will be taken. A total of 26 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both the Groups will continue the conventional training with Group A will receive clamshell Exercise, and Group B will receive frog pump exercise in their respective training programs. Outcome measures will be measured at baseline and after 2 weeks. Data analysis will be done by SPSS version 25.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date March 10, 2024
Est. primary completion date March 8, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - • Age (18-30yrs) - Gender (Males) - Positive Ober's test - Positive Noble's compression test - Suffering pain from past 3 months - Running approximately 5km/week Exclusion Criteria: - • Osteoporosis - Previous knee trauma/surgery - Patellofemoral joint pain - Popliteus tendinitis - Lateral meniscal injure

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Clamshell Exercise
Clamshell Exercise: The clamshell exercise keeps the hips moving, it strengthens both the gluteus medius AND gluteus maximus. The gluteus medius is the main abductor (movement away from the midline of the body) and external rotator of the hip.
Frog pump exercise
Frog pump exercise: The frog hip thrust mainly targets the gluteal muscles responsible for thigh extension and abduction. The exercise also works the hamstrings on the back of the thighs which helps in hip extension.

Locations

Country Name City State
Pakistan Pakistan Sports Board Lahore

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Baker RL, Souza RB, Fredericson M. Iliotibial band syndrome: soft tissue and biomechanical factors in evaluation and treatment. PM R. 2011 Jun;3(6):550-61. doi: 10.1016/j.pmrj.2011.01.002. — View Citation

Fredericson M, Guillet M, Debenedictis L. Innovative solutions for iliotibial band syndrome. Phys Sportsmed. 2000 Feb;28(2):53-68. doi: 10.3810/psm.2000.02.693. — View Citation

Fredericson M, Wolf C. Iliotibial band syndrome in runners: innovations in treatment. Sports Med. 2005;35(5):451-9. doi: 10.2165/00007256-200535050-00006. — View Citation

Friede MC, Innerhofer G, Fink C, Alegre LM, Csapo R. Conservative treatment of iliotibial band syndrome in runners: Are we targeting the right goals? Phys Ther Sport. 2022 Mar;54:44-52. doi: 10.1016/j.ptsp.2021.12.006. Epub 2021 Dec 27. — View Citation

Khaund R, Flynn SH. Iliotibial band syndrome: a common source of knee pain. Am Fam Physician. 2005 Apr 15;71(8):1545-50. — View Citation

McKay J, Maffulli N, Aicale R, Taunton J. Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study. J Orthop Surg Res. 2020 May 24;15(1):188. doi: 10.1186/s13018-020-01713-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Manual Muscle Testing (MMT) For measuring the strength of Hip muscles, Manual Muscle Testing (MMT) is used.
Manual Muscle Testing (MMT) is a standardised set of assessments that measure muscle strength and function against specific criteria and is commonly used in clinical practice by physiotherapists.
Grading Scale Range: 0 to 5 0 None No visible or palpable contraction
Trace Visible or palpable contraction with no motion
Poor Full ROM gravity eliminated
Fair Full ROM against gravity
Good Full ROM against gravity, moderate resistance
Normal Full ROM against gravity, maximum resistance
upto 6th weeks
Primary Hip Outcome Score (HOS) The hip outcome score (HOS) is a questionnaire used to measure the function of the Hip.
The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4).
upto 6th weeks
Primary Lower Extremity Functional Scale (LEFS) The lower extremity functional scale (LEFS) measures the function and disability of the lower extremity.
LEFS is a well-known and validated instrument for the measurement of lower extremity function. The LEFS was developed in a group of patients with various musculoskeletal disorders.
The LEFS rating scale categories are: (1) "extreme difficulty or unable to perform," (2) "quite a bit of difficulty," (3) "moderate difficulty," (4) "a little bit of difficulty," and (5) "no difficulty." LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.
upto 6th weeks
See also
  Status Clinical Trial Phase
Completed NCT05459623 - Effects of Myofascial Release With and Without EMMETT Technique in Iliotibial Band Syndrome N/A
Not yet recruiting NCT06089005 - Home-based Treatment Using the Sidekick Tool for Pain Relief in Patients With Iliotibial Band Syndrome N/A
Recruiting NCT06131658 - Effects of Functional Motor Control on Pain, Flexibility, Lower Extremity Function With ITBS N/A
Recruiting NCT05915754 - Effects of Posterior Oblique Sling Strengthening Exercises on Pain & Flexibility Among Runners With N/A
Completed NCT05427110 - Shearwave Elastography in the Evaluation of Iliotibial Band Syndrome
Not yet recruiting NCT06410781 - Effect of Radial Extracorporeal Shockwave Therapy on Ultrasonography Changes in Patients With Iliotibial Band Syndrome N/A
Completed NCT04787900 - Reliability and Validity of iPhone Application for OBER N/A
Completed NCT03067545 - Do Simple Running Technique Changes Reduce Pain and Change Injury Causing Mechanics N/A
Completed NCT02296151 - Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners N/A
Completed NCT03293121 - Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners N/A
Recruiting NCT04164316 - The Effects of Kinesio Taping on Biomechanical and Clinical Outcomes in Runners With Iliotibial Band Friction Syndrome N/A
Completed NCT04954703 - Myofascial Release With and Without METS of Gluteus Maximus and Tensor Fascia Lata in ITB Syndrome N/A
Not yet recruiting NCT06269757 - Exercise Program for ITB Syndrome N/A