NCT06428136

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

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 20, 2024

Last Update Submit

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)

EXPERIMENTAL
Diagnostic Test: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)

Conservative Treatment (CT)

OTHER
Other: Conservative Treatment (CT)

Interventions

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

Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)

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

Conservative Treatment (CT)

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Distal Myopathies

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics

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

Locations