UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055882 |
|---|---|
| Receipt number | R000063863 |
| Scientific Title | Targeted Interventions for Iliotibial Band Syndrome: A Comparative Study on the Efficacy of Foam Rolling and Stretching Combined with Strengthening Exercises Versus Strengthening Alone Among Athletes |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2024/10/19 00:27:54 |
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Basic information
Public title
Evaluating Treatment Efficacy for Iliotibial Band Syndrome: A Comparison of Combined Foam Rolling and Stretching with Strengthening Exercises Versus Strengthening Alone in Athletes
Acronym
ETIBS
Scientific Title
Targeted Interventions for Iliotibial Band Syndrome: A Comparative Study on the Efficacy of Foam Rolling and Stretching Combined with Strengthening Exercises Versus Strengthening Alone Among Athletes
Scientific Title:Acronym
CIFRS Study
Region
| Asia(except Japan) |
Condition
Condition
Iliotibial Band Syndrome (ITBS)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and compare the effectiveness of two intervention strategies for reducing pain and improving functional outcomes in athletes with ITBS: (1) a combined approach involving foam rolling, stretching, and strengthening exercises; and (2) strengthening exercises alone. This study aims to determine which approach yields better results in alleviating symptoms and enhancing rehabilitation outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain Intensity:
Lower Extremity Function:
Hip Abductor Strength:
Iliotibial Band Flexibility:
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Athletes receiving the combined treatment of foam rolling and stretching exercises along with strengthening exercises for Iliotibial Band Syndrome.
Interventions/Control_2
Group 2 (Control Arm):
Athletes receiving only strengthening exercises for Iliotibial Band Syndrome.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Localized Pain:
Participants must exhibit localized pain over the lateral epicondyle of the knee.
Pain Exacerbation:
Pain must be exacerbated by downhill running, indicating a functional limitation related to the condition.
Reproducible Pain:
Participants must demonstrate reproducible pain during the Noble compression test, confirming the diagnosis of ITBS.
Knee Flexion Discomfort:
Significant discomfort must be reported at approximately 30 degrees of knee flexion, which is characteristic of ITBS.
ITB Tightness:
Positive results on the modified Thomas and Ober tests must indicate iliotibial band (ITB) tightness, supporting the diagnosis.
Key exclusion criteria
Other Knee Pathologies:
Participants exhibiting symptoms of other knee conditions that may confound the results (e.g., patellar tendinopathy, meniscus injuries) will be excluded.
History of Knee Surgery or Trauma:
Any participant with a history of knee surgery or trauma on the affected side will be excluded to eliminate potential complications from previous injuries.
Current Treatment for ITBS:
Individuals currently undergoing treatment with iliotibial band stretching or foam rolling for iliotibial band friction syndrome (ITBFS) will be excluded to prevent interference with the study interventions.
Voluntary Withdrawal:
Participants who voluntarily withdraw from the study at any point will be excluded from the analysis.
Session Attendance:
Any participant missing more than two consecutive sessions or a total of over five training sessions will be excluded to ensure consistent participation in the intervention protocol.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport scinces
Zip code
3619995161
Address
Shahrud, Semnan Province
TEL
+982332392202
Ay.naderi@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport scinces
Zip code
3619995161
Address
Shahrud, Semnan Province
TEL
+982332392204
Homepage URL
ay.naderi@shahroodut.ac.ir
Sponsor or person
Institute
Shahrood University of Technology
Institute
Department
Personal name
Funding Source
Organization
Shahrood University of Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shahrood University of Technology
Address
Shahrud, Semnan Province
Tel
+982332392204
ay.naderi@shahroodut.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063863
