Iliotibial Band SyndromeNCT06131658
Effects of Functional Motor Control on Pain, Flexibility, Lower Extremity Function With ITBS
A study testing convectional excercise in people with Iliotibial Band Syndrome and Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by non-probability convenient random sampling technique. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Iliotibial Band Syndrome, Pain, Flexibility
- What is being tested?
- convectional excercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2023to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female athlete within 19-40 years,
- running a minimum average of 15 running kilometers,
- Runners with one sided iliotibial band syndrome for at least 3 months were included,
- Pain along IT band at either Gerdy's tubercle or the lateral femoral epicondyle during running,
- positive stiffness with Ober's test, and
- reporting pain during Noble's compression test.
Who cannot join
- Individuals with a history of previous knee trauma of past 6 months,
- Individuals with a history of previous knee surgery of past 6 months,
- Other knee abnormalities including patellofemoral joint pain,
- popliteus tendinitis,
- lateral meniscal injury,
- Degenerative joint disease, and
- lateral collateral ligament sprain to the affected side.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jawad Club
Faisalābad, Punjab Province, 37700
hamza ali, MBA, +92-3020160361, hamza.azeem2018@gmail.com
Maham Athar, DPT, 03356600213 ext. Athar, mahamathar666@gmail.com
About this study
Official title: Effects of Functional Motor Control Exercise on Pain, Flexibility, Lower Extremity Function Among Runners With Iliotibial Band Syndrome
The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by non-probability convenient random sampling technique. Subjects in group A will receive functional motor control exercises. Group B will receive conventional exercises.
Read the detailed description
The objective of this study is to determine the effects of functional motor control exercises on pain, flexibility and lower limb functional. It will be randomized controlled trial (RCT) research design at Pakistan sports board through non probability convenience sampling technique on 72 runners' athletes which will be allocated using random sampling through computerized generated number into Group A and Group B, 36 athletes will be in each group. Group A (interventional) will be given conventional training with functional motor exercise and Group B (control) will be given conventional training. There will be 3 sessions in a week for 6 weeks. The baseline scoring will be on 1st day, follow up will be taken at 6th week. Assessment will be made by Numeric pain rating scale, Lower extremity functional scale (LEFS), Single leg mini squat, Y balance. Data will be analyzed during SPSS software version 26. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two group
- Conditions
- Iliotibial Band Syndrome, Pain, Flexibility
- Being tested
- Functional motor control excercise, convectional excercise
- Keywords
- motor control function excercise, lower extermity function, Iliotibial Band Syndrome
- Medical subject headings
- Iliotibial Band Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional motor control excerciseOther
This include functional motor control thrice a week for six weeks
convectional excerciseOther
This include convectional exercise thrice a week for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Functional motor control excercise | Experimental | Functional motor control exercise Includes side plank with clamshell, Side plank with hip abduction, Side-lying hip abduction, Lateral monster walk, Hip hikes, Single leg squat, TKE with T-band-hip abduction All exercises done with 2 sets of 10 reps with 3 sessions per week for 6 weeks Receives: Other: Functional motor control excercise |
| conventional exercise | Experimental | The conventional exercise included 4 stages of self-myofascial techniques, strengthening, and integration techniques. In the first phase, individuals did fascial release exercises using foam rolls, focusing on tensor fascia latae, iliotibial band, and hip adductor muscles, and tennis balls for the quadratus lumborum. The exercises were performed at high-intensity maximum pain tolerance for 30 seconds or low-intensity minimum pain tolerance for 90 seconds. Receives: Other: convectional excercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
pain will be assess by Numeric pain rating scale with minimum score 0 to maximum score 10
Measured: pre and 6 weeks post interventional
flexibility
flexibility will be assess by Y balance
Measured: pre and 6 weeks post interventional
lower extremity function
lower extremity function will be assess by lower limb extremity scale with score 0 to 80
Measured: pre and 6 weeks post interventional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start20 Oct 2023
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iliotibial Band SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maham Athar, DPT, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131658
- Sponsor's protocol ID
- REC/RCR&AHS/23/0429
- Status last verified
- Jun 2024
- First submitted
- 9 Nov 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McKean KA, Manson NA, Stanish WD. Musculoskeletal injury in the masters runners. Clin J Sport Med. 2006 Mar;16(2):149-54. doi: 10.1097/00042752-200603000-00011.
PubMed 16603885Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running injuries. Br J Sports Med. 2002 Apr;36(2):95-101. doi: 10.1136/bjsm.36.2.95.
PubMed 11916889Fredericson M, Cookingham CL, Chaudhari AM, Dowdell BC, Oestreicher N, Sahrmann SA. Hip abductor weakness in distance runners with iliotibial band syndrome. Clin J Sport Med. 2000 Jul;10(3):169-75. doi: 10.1097/00042752-200007000-00004.
PubMed 10959926Baker RL, Fredericson M. Iliotibial Band Syndrome in Runners: Biomechanical Implications and Exercise Interventions. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):53-77. doi: 10.1016/j.pmr.2015.08.001.
PubMed 26616177Noehren B, Davis I, Hamill J. ASB clinical biomechanics award winner 2006 prospective study of the biomechanical factors associated with iliotibial band syndrome. Clin Biomech (Bristol). 2007 Nov;22(9):951-6. doi: 10.1016/j.clinbiomech.2007.07.001. Epub 2007 Aug 28.
PubMed 17728030
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Motor Control Exercise on Pain, Flexibility, Lower Extremity Function Among Runners With Iliotibial Band Syndrome
- ClinicalTrials.gov ID
- NCT06131658
- Acronym / sponsor ID
- REC/RCR&AHS/23/0429
- Conditions
- Iliotibial Band Syndrome, Pain, Flexibility
- Keywords
- motor control function excercise, lower extermity function, Iliotibial Band Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by non-probability convenient random sampling technique. Subjects in group A will receive functional motor control exercises. Group B will receive conventional exercises.
Detailed description
The objective of this study is to determine the effects of functional motor control exercises on pain, flexibility and lower limb functional. It will be randomized controlled trial (RCT) research design at Pakistan sports board through non probability convenience sampling technique on 72 runners' athletes which will be allocated using random sampling through computerized generated number into Group A and Group B, 36 athletes will be in each group. Group A (interventional) will be given conventional training with functional motor exercise and Group B (control) will be given conventional training. There will be 3 sessions in a week for 6 weeks. The baseline scoring will be on 1st day, follow up will be taken at 6th week. Assessment will be made by Numeric pain rating scale, Lower extremity functional scale (LEFS), Single leg mini squat, Y balance. Data will be analyzed during SPSS software version 26. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two group
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Functional motor control excercise | Experimental | Other: Functional motor control excerciseFunctional motor control exercise Includes side plank with clamshell, Side plank with hip abduction, Side-lying hip abduction, Lateral monster walk, Hip hikes, Single leg squat, TKE with T-band-hip abduction All exercises done with 2 sets of 10 reps with 3 sessions per week for 6 weeks |
| conventional exercise | Experimental | Other: convectional excerciseThe conventional exercise included 4 stages of self-myofascial techniques, strengthening, and integration techniques. In the first phase, individuals did fascial release exercises using foam rolls, focusing on tensor fascia latae, iliotibial band, and hip adductor muscles, and tennis balls for the quadratus lumborum. The exercises were performed at high-intensity maximum pain tolerance for 30 seconds or low-intensity minimum pain tolerance for 90 seconds. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male and female athlete within 19-40 years,
- running a minimum average of 15 running kilometers,
- Runners with one sided iliotibial band syndrome for at least 3 months were included,
- Pain along IT band at either Gerdy's tubercle or the lateral femoral epicondyle during running,
- positive stiffness with Ober's test, and
Key exclusion criteria (7 listed)
- Individuals with a history of previous knee trauma of past 6 months,
- Individuals with a history of previous knee surgery of past 6 months,
- Other knee abnormalities including patellofemoral joint pain,
- popliteus tendinitis,
- lateral meniscal injury,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional motor control excerciseThis include functional motor control thrice a week for six weeks | Other | Functional motor control excercise |
| convectional excerciseThis include convectional exercise thrice a week for six weeks | Other | conventional exercise |
Primary outcome
Numeric pain rating scale
Time frame: pre and 6 weeks post interventional
pain will be assess by Numeric pain rating scale with minimum score 0 to maximum score 10
flexibility
Time frame: pre and 6 weeks post interventional
flexibility will be assess by Y balance
lower extremity function
Time frame: pre and 6 weeks post interventional
lower extremity function will be assess by lower limb extremity scale with score 0 to 80
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 16603885McKean KA, Manson NA, Stanish WD. Musculoskeletal injury in the masters runners. Clin J Sport Med. 2006 Mar;16(2):149-54. doi: 10.1097/00042752-200603000-00011.
- Background: PubMed 11916889Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running injuries. Br J Sports Med. 2002 Apr;36(2):95-101. doi: 10.1136/bjsm.36.2.95.
- Background: PubMed 10959926Fredericson M, Cookingham CL, Chaudhari AM, Dowdell BC, Oestreicher N, Sahrmann SA. Hip abductor weakness in distance runners with iliotibial band syndrome. Clin J Sport Med. 2000 Jul;10(3):169-75. doi: 10.1097/00042752-200007000-00004.
- Background: PubMed 26616177Baker RL, Fredericson M. Iliotibial Band Syndrome in Runners: Biomechanical Implications and Exercise Interventions. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):53-77. doi: 10.1016/j.pmr.2015.08.001.
- Background: PubMed 17728030Noehren B, Davis I, Hamill J. ASB clinical biomechanics award winner 2006 prospective study of the biomechanical factors associated with iliotibial band syndrome. Clin Biomech (Bristol). 2007 Nov;22(9):951-6. doi: 10.1016/j.clinbiomech.2007.07.001. Epub 2007 Aug 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maham Athar, DPT principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing convectional excercise in people with Iliotibial Band Syndrome and Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amna Shahid, MS-DPT (+92 334 4512823, amna.shahid@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: pre and 6 weeks post interventional). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06131658, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.