Comparative Effects of Clamshell Technique With EMS vs CTin Iliotibial Band Tightness for Pain and Function
1 other identifier
interventional
62
1 country
1
Brief Summary
Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. The current theory is that this condition is likely to be caused by compression of the innervated tissues beneath the iliotibial band (ITB), leading to inflammation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 20, 2024
CompletedFirst Posted
Study publicly available on registry
May 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedMay 24, 2024
May 1, 2024
5 months
May 20, 2024
May 20, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Measured using a numeric pain rating scale (NPRS)
ranging from 0 (no pain) to 10 (worst imaginable pain) assessed at baseline, after intervention, and at 1-month follow-up.
12 Months
Lower Extremity Functional Scale (LEFS)
Measured using the Lower Extremity Functional Scale (LEFS) assessed at baseline, after intervention, and at 1-month follow-up
12 months
ITBT length
Measured using a goniometer at baseline, after intervention, and at 1-month follow-up.
12 months
Range of motion (ROM):
Measured using a goniometer for knee flexion and extension at baseline, after intervention, and at 1-month follow-up."
12 months
Study Arms (2)
Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)
EXPERIMENTALConservative Treatment (CT)
OTHERInterventions
Side-lying clamshells: 3 sets of 10 repetitions per leg, 3 times per week Hip abduction with theraband: 3 sets of 10 repetitions per leg, 3 times per week Bridge with hip abduction: 3 sets of 10 repetitions per leg, 3 times per week Electrical muscle stimulation: Applied to the gluteus medius and minimus muscles for 20 minutes per session, 3 times per week Frequency and intensity adjusted to individual tolerance
Stretching: Iliotibial band stretch: 30-second hold, 3 repetitions per leg, 2 times per day Quadriceps stretch: 30-second hold, 3 repetitions per leg, 2 times per day Hamstring stretch: 30-second hold, 3 repetitions per leg, 2 times per day
Eligibility Criteria
You may qualify if:
- Adults aged 45-65 years old (Jeong et al., 2019)
- Both genders will be included (Jeong et al., 2019)
- Diagnosed with iliotibial band tightness (ITBT) based on clinical examination and positive Noble compression test (Hutchinson et al., 2022)
- Reporting lateral knee pain aggravated by activity (Hutchinson et al., 2022)
You may not qualify if:
- Recent history of knee surgery or other knee injuries (Peterson et al., 2022)
- Presence of other musculoskeletal conditions affecting the knee (Peterson et al., 2022)
- Inflammatory conditions such as rheumatoid arthritis or gout (Peterson et al., 2022)
- Neurological conditions affecting leg function (Peterson et al., 2022)
- Pregnancy (Jeong et al., 2019)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Lahore Teaching Hospital
Lahore, Punjab Province, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 20, 2024
First Posted
May 24, 2024
Study Start
November 1, 2023
Primary Completion
April 1, 2024
Study Completion
September 1, 2024
Last Updated
May 24, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share