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Effects of Posterior Oblique Sling Strengthening Exercises on Pain & Flexibility Among Runners With (ITBS)

Primary Purpose

Iliotibial Band Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hip abductors stretching and strengthening exercises
Posterior oblique sling strengthening exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iliotibial Band Syndrome focused on measuring lateral knee pain, Posterior Oblique Sling, Runner

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female Treadmill runners of age 18 to 35 years. Perform running of average 15 running kilometers per week and Experience of burning lateral knee pain after 2nd-3rd kilometer of running Localized point tenderness over the femoral condyle about 2-4 cm above joint line on palpation Positive Noble's Compression test Positive modified Ober's Test Exclusion Criteria: Short distance runners People with any other medical condition Including myofacial pain syndrome, early degenerative joint disease, lateral collateral ligament pathology, lateral meniscal injuries, tibiofibular joint sprain, popliteal or biceps femoris tendonitis, or referred pain from lumbar spine. All these conditions will be ruled out with carefully history and examination People taking any other form of treatment including corticosteroids, non-steroidal anti-inflammatory drugs or analgesics People with previous history of surgical treatment for ITBS People with neurological deficits or systemic illness

Sites / Locations

  • SHAPES gymnasiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hip abductors stretching and strengthening exercises

Posterior oblique sling strengthening exercises

Arm Description

Patients will get the hip abductor stretching and strengthening exercise treatment for four weeks four times per week and will consist of four sets of 15 repetitions.

Patients will get treatment plan of Hip abductors stretching and strengthening exercises plus a posterior oblique sling strengthening program for four weeks, four times per week and will consist of four sets of 15 repetitions.

Outcomes

Primary Outcome Measures

Numerical Rating Scale-101 Questionnaire:
The patient's perception of their pain intensity level is recorded on a numerical scale from 1 to 100, with 0 being no pain and 100 being the worst pain. The patient indicates by means of a percentage on a 10cm line, when the pain was at its worst and again on another 10cm line when the pain was at its least. The average of these two figures indicates the average pain experienced by the patient as a percentage. NRS-101 questionnaire is regarded as a superior measuring instrument, being extremely easy to administer and score. It can be done either in written or verbal form, or due to its simplicity, there are very low tendencies for incorrect responses from patients.
Modified Ober's test using digital inclinometer
ITB tightness is elicited by this test and will be measured using digital inclinometer.The use of an inclinometer to measure hip adduction using both the Ober test and the modified Ober test appears to be a reliable method for the measurement of ITB flexibility. As described the test is performed as follows: The patient is made to lie laterally recumbent with the affected side uppermost. The affected lower limb was then brought into full extension by the examiner, with some abduction at the hip. In the Ober's test, the knee is flexed at this moment during the test, while in the Modified Ober's test, the knee is left extended. The examiner then slowly releases support of the limb, allowing the limb to fall into adduction past the neutral position. This constitutes a normal or negative test. A tight ITB restricts adduction and prevents the knee from falling past the neutral position. This constitutes a positive test for ITB tightness
Noble's Compression test:
The test is performed as follows: The patient is made to lie supine with the affected knee flexed to 90 degrees. Pressure is placed over the proximal part of the lateral femoral condyle. The knee was then gradually extended, and at 30 to 40 degrees, if the patient complained of a similar pain to that experienced while running, then the test was positive for ITBS
ITB Questionnaire
The effect on participants' running performance will be measured using the ITB Questionnaire. The ITB Questionnaire was designed by the author of the study (Wood, 1997) for the measurement of patient disability specifically for ITBS.
The Daily Exercise Diary
The Daily Exercise Diary will be used to monitor participant compliance and ability to perform the exercises. The Daily Exercise Diary was designed by the author of the study (Wood, 1997) for the measurement of patient disability specifically for ITBS.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
June 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05915754
Brief Title
Effects of Posterior Oblique Sling Strengthening Exercises on Pain & Flexibility Among Runners With
Acronym
ITBS
Official Title
Effects of Posterior Oblique Sling Strengthening Exercises on Pain & Flexibility Among Runners With Iliotibial Band Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
June 25, 2023 (Anticipated)
Study Completion Date
July 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The popularity of recreational running and rate of running related injuries are increasing. Research has shown that iliotibial band syndrome (ITBS) is one of the most common knee injuries among runners alongside plantar fasciitis, meniscal injuries, patellar tendinopathy, and patelleofemoral pain (PFP). ITBS is twice as common in female runners as compared to male long distance runners due to biomechanical variations. Literature supports the use of gluteal strengthening and IT band stretching as an effective treatment for iliotibial band syndrome. Posterior oblique sling is activated during running and its weakness is thought to be the predisposing factor of iliotibial band syndrome among long distance runners. The purpose of this study is to evaluate the effectiveness of posterior oblique sling exercises in decreasing lateral knee pain and improving flexibility of iliotibial band among female runner compared to gluteal strengthening and IT band stretching alone. Data will be collected by using non-probability purposive sampling method. Sample size will be 26. 13 Female runners with average running of 15 kilometers per week and chronic iliotibial band syndrome will be employed in two different study groups A and B randomly. Both groups will get treatment for four weeks four times per week. Control group A will get conventional treatment of hip abductors strengthening and Iliotibial band stretching and Experimental group B will get posterior oblique sling strengthening exercises plus conventional hip abductors strengthening and IT band stretching. Pain and flexibility will be measured before treatment after every week and by the end of the month to note progression. Numeric Pain Rating Scale (NPRS) will be used to rate pain and modified Ober's test using digital inclinometer will be used to rate flexibility of iliotibial band. Statistical analysis will be done using SPSS latest version
Detailed Description
The purpose of this study is to compare the two different treatment protocols for Iliotibial band syndrome and help create an effective treatment option for long distance runners who suffer lateral knee pain due to IT band tightness. The study will be Randomized control trial. Non-probability purposive sampling method will be used.Subjective and objective data of all the participants will be taken by using NPRS, Modified Ober's test using Digital inclinometer, Noble's compression test and ITB Questionnaire. Researcher will take careful history of the participant with proper assessment and examination of the knee. At baseline, weekly and by the end of 4th week of treatment objective and subjective measurements of participants will be taken using NPRS, Modified Ober's test using Digital inclinometer, Noble's Compression test and ITB Questionnaire. All the participants will receive equal treatment of 4 weeks. The Data will be analyzed using SPSS for windows software version 25. Statistical significance P=0.05. After assessing the normality of current data by shapiro wilk test. it will be decided whether parametric or non parametric test will be used within the groups or between 2 groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliotibial Band Syndrome
Keywords
lateral knee pain, Posterior Oblique Sling, Runner

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hip abductors stretching and strengthening exercises
Arm Type
Experimental
Arm Description
Patients will get the hip abductor stretching and strengthening exercise treatment for four weeks four times per week and will consist of four sets of 15 repetitions.
Arm Title
Posterior oblique sling strengthening exercises
Arm Type
Experimental
Arm Description
Patients will get treatment plan of Hip abductors stretching and strengthening exercises plus a posterior oblique sling strengthening program for four weeks, four times per week and will consist of four sets of 15 repetitions.
Intervention Type
Other
Intervention Name(s)
Hip abductors stretching and strengthening exercises
Intervention Description
Treatment consist of four stretches for the ITB including: ITB stretch with trunk side bend, ITB stretch with trunk side bend and upward lateral reach, trunk side bend with downward lateral reach and side lying leg adduction and Strengthening exercise plan involving the gluteal muscle groups. These exercises include clams, side-lying abduction, reverse clams and supine bridge
Intervention Type
Other
Intervention Name(s)
Posterior oblique sling strengthening exercises
Intervention Description
Treatment consists of treatment A plus the intervention program of POSS consisted of four different exercises utilizing activation of the POSS. The intervention program focuses on one specific exercise each week that will progress in difficulty over the 4 weeks. The equipment used in the exercise progression included a blue, latex-free, medium-resistance theraband (TB), and the final exercise of the progression will include the use of a step stool. The TB will be used to increase the activation of the latissimus dorsi while simultaneously performing lower-extremity exercise to increase gluteal muscle involvement. The exercises are to be used in the 4-week progression.
Primary Outcome Measure Information:
Title
Numerical Rating Scale-101 Questionnaire:
Description
The patient's perception of their pain intensity level is recorded on a numerical scale from 1 to 100, with 0 being no pain and 100 being the worst pain. The patient indicates by means of a percentage on a 10cm line, when the pain was at its worst and again on another 10cm line when the pain was at its least. The average of these two figures indicates the average pain experienced by the patient as a percentage. NRS-101 questionnaire is regarded as a superior measuring instrument, being extremely easy to administer and score. It can be done either in written or verbal form, or due to its simplicity, there are very low tendencies for incorrect responses from patients.
Time Frame
4 weeks
Title
Modified Ober's test using digital inclinometer
Description
ITB tightness is elicited by this test and will be measured using digital inclinometer.The use of an inclinometer to measure hip adduction using both the Ober test and the modified Ober test appears to be a reliable method for the measurement of ITB flexibility. As described the test is performed as follows: The patient is made to lie laterally recumbent with the affected side uppermost. The affected lower limb was then brought into full extension by the examiner, with some abduction at the hip. In the Ober's test, the knee is flexed at this moment during the test, while in the Modified Ober's test, the knee is left extended. The examiner then slowly releases support of the limb, allowing the limb to fall into adduction past the neutral position. This constitutes a normal or negative test. A tight ITB restricts adduction and prevents the knee from falling past the neutral position. This constitutes a positive test for ITB tightness
Time Frame
4 weeks
Title
Noble's Compression test:
Description
The test is performed as follows: The patient is made to lie supine with the affected knee flexed to 90 degrees. Pressure is placed over the proximal part of the lateral femoral condyle. The knee was then gradually extended, and at 30 to 40 degrees, if the patient complained of a similar pain to that experienced while running, then the test was positive for ITBS
Time Frame
4 weeks
Title
ITB Questionnaire
Description
The effect on participants' running performance will be measured using the ITB Questionnaire. The ITB Questionnaire was designed by the author of the study (Wood, 1997) for the measurement of patient disability specifically for ITBS.
Time Frame
4 weeks
Title
The Daily Exercise Diary
Description
The Daily Exercise Diary will be used to monitor participant compliance and ability to perform the exercises. The Daily Exercise Diary was designed by the author of the study (Wood, 1997) for the measurement of patient disability specifically for ITBS.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Treadmill runners of age 18 to 35 years. Perform running of average 15 running kilometers per week and Experience of burning lateral knee pain after 2nd-3rd kilometer of running Localized point tenderness over the femoral condyle about 2-4 cm above joint line on palpation Positive Noble's Compression test Positive modified Ober's Test Exclusion Criteria: Short distance runners People with any other medical condition Including myofacial pain syndrome, early degenerative joint disease, lateral collateral ligament pathology, lateral meniscal injuries, tibiofibular joint sprain, popliteal or biceps femoris tendonitis, or referred pain from lumbar spine. All these conditions will be ruled out with carefully history and examination People taking any other form of treatment including corticosteroids, non-steroidal anti-inflammatory drugs or analgesics People with previous history of surgical treatment for ITBS People with neurological deficits or systemic illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Nosheen Manzoor, MS-OMPT
Phone
03236877879
Email
Nosheenmanzoor_444@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Nosheen Manzoor, MS-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SHAPES gymnasium
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Awais Manzoor
Phone
03234446846

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25701012
Citation
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Results Reference
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32566382
Citation
Charles D, Rodgers C. A LITERATURE REVIEW AND CLINICAL COMMENTARY ON THE DEVELOPMENT OF ILIOTIBIAL BAND SYNDROME IN RUNNERS. Int J Sports Phys Ther. 2020 May;15(3):460-470.
Results Reference
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Gordon S. Iliotibial Band Syndrome. Clinical Practice Guidelines. 2018:321.
Results Reference
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PubMed Identifier
15896092
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.
Results Reference
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PubMed Identifier
22994651
Citation
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Results Reference
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Results Reference
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PubMed Identifier
32448384
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.
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Citation
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Rosenthal MD. Clinical testing for extra-articular lateral knee pain. A modification and combination of traditional tests. N Am J Sports Phys Ther. 2008 May;3(2):107-9.
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Effects of Posterior Oblique Sling Strengthening Exercises on Pain & Flexibility Among Runners With

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