NCT05973708

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

June 27, 2023

Last Update Submit

April 29, 2024

Conditions

Iliotibial Band Syndrome

Keywords

gluteus mediuspainiliotibial band syndromestrength

Outcome Measures

Primary Outcomes (3)

  • 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 1. Trace Visible or palpable contraction with no motion 2. Poor Full ROM gravity eliminated 3. Fair Full ROM against gravity 4. Good Full ROM against gravity, moderate resistance 5. Normal Full ROM against gravity, maximum resistance

    upto 6th weeks

  • 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

  • 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

Study Arms (2)

Group A: Clamshell Exercise

ACTIVE COMPARATOR

Group B will be given frog pumps exercises in their regular training program. These exercises are given as: * In (0-2) week ,2 sets 10 repetitions * In (2-4)week, 3 sets of 10 repetitions * In (4-6)week, 3 sets of 15 repetitions

Other: Clamshell Exercise

Group B: Frog Pump Exercise

ACTIVE COMPARATOR

Group B will be given frog pumps exercises in their regular training program. These exercises are given as: * In (0-2) week ,2 sets 10 repetitions * In (2-4)week, 3 sets of 10 repetitions * In (4-6)week, 3 sets of 15 repetitions

Other: Frog pump exercise

Interventions

Clamshell ExerciseOTHER

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.

Group A: Clamshell Exercise
Frog pump exerciseOTHER

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.

Group B: Frog Pump Exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age (18-30yrs)
  • Gender (Males)
  • Positive Ober's test
  • Positive Noble's compression test
  • Suffering pain from past 3 months
  • Running approximately 5km/week

You may not qualify if:

  • Osteoporosis
  • Previous knee trauma/surgery
  • Patellofemoral joint pain
  • Popliteus tendinitis
  • Lateral meniscal injure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Sports Board

Lahore, 54000, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 35007886BACKGROUND

  • 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.

    PMID: 21665168BACKGROUND

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

    PMID: 15864895BACKGROUND

  • 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.

    PMID: 20086621BACKGROUND

  • 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.

    PMID: 32448384BACKGROUND

  • 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.

    PMID: 15896092BACKGROUND

MeSH Terms

Conditions

Iliotibial Band SyndromePain

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesCumulative Trauma DisordersSprains and StrainsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Samrood Akram, Mphil

    Riphah International University,Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

August 3, 2023

Study Start

October 5, 2023

Primary Completion

March 8, 2024

Study Completion

March 10, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)