Iliotibial Band SyndromeNCT05459623
Effects of Myofascial Release With and Without EMMETT Technique in Iliotibial Band Syndrome
A study testing Manual myofascial release and Emmett intervention in people with Iliotibial Band Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The iliotibial (IT) tract or band is a lateral thickening of the fascia lata that is composed of the distal fusion of the muscular fascia of the gluteus maximus and tensor fascia lata muscles. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Manual myofascial release and Emmett intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2019to 28 Jun 2020
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive Ober's Test
- Both males and females
- Age 25 to 45 years
Who cannot join
- TFL (Tensor Fascia Lata) tightness
- Any pathological and traumatic conditions, Fractures and Dislocation,
- Already received few sessions of Manual Therapy treatment
- Taking corticosteroids, analgesic or anti-inflammatory drugs.
- Treatment of lower limb myofascial pain or trigger points at the time of the study • Current or previous symptoms of pathology reported in the lower limbs or pelvis
Trial locations and contacts
1 site in 1 country.
About this study
The iliotibial (IT) tract or band is a lateral thickening of the fascia lata that is composed of the distal fusion of the muscular fascia of the gluteus maximus and tensor fascia lata muscles. The iliotibial tract travels along the lateral side of the thigh and across the knee joint, inserting on the lateral epicondyle of the tibia. A tight IT band has been diagnosed in several problems related to the knee including patellofemoral syndrome and iliotibial band syndrome. Several authors have suggested that tightness in the IT band may contribute to patellofemoral syndrome and knee pain by pulling the patella laterally thereby causing abnormal tracking of the patella in the trochlear groove. Stretching of the iliotibial band is frequently recommended in treatment programs for patients with LBP. Because the iliotibial band attaches to the ilium, tightness of this muscle is thought to cause anterior innominate rotation and lateral pelvic tilt. The Ober test is performed to assess tightness in the iliotibial band.
The term myofascial release encompasses various techniques used to release fascial restrictions. Many forms of bodywork that includes a soft tissue technique exist with Bowen therapy, Emmett technique, deep tissue massage, neuromuscular techniques (NMT), Muscle Energy Techniques (MET) and foam rolling.
This study focusses on effects of myofascial release with Emmett technique. This study will be conducted in a clinical set up (Saba's physical therapy, rehabilitation and sports injury clinic in Gulberg 3) and will take 6 months. Study will be conducted on 22 subjects involving 11 subjects in each group. Group A will be given myofascial release only and group B will be given myofascial release with Emmett technique. Total duration of study will be three weeks and assessment will be done before treatment and after every week. Numeric pain rating scale, goniometer and vertical jump test are used for assessing pain, flexibility and power respectively.
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Manual myofascial release, Emmett intervention
- Medical subject headings
- Iliotibial Band Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual myofascial releaseOther
Also called Group A
will receive Manual myofascial release to iliotibial band by having the subject to lie in the side lying position on the unaffected side. The upper leg to be tested was rested on the table with hip and knee flexion. Then the therapist applied a few kilograms of force weight along the iliotibial band course proximally to distally. The therapist will repeat this for 6 minutes.
Emmett interventionOther
Also called Group B
will receive manual myofascial release and the Emmett intervention with the subject sitting upright on a 45cm wooden chair; light, constant pressure via the middle finger (at a perpendicular angle to the skin) will be applied at both points, three times for 10-20s with 5-10s breaks between. A light sweeping action over the sensory area that will treated will be performed once, using the back of the fingers. The rationale for this is that the light brushing action "disperses the sensory awareness to move without being too heavy or specific enough to create muscular response." The sequence performed on one side will then repeated on the opposite leg. In Ross Emmett's teachings of the technique he insists on treatment of both sides when focusing on the lower body (for balance). Once both sides will be completed, the subject will be instructed to walk around the room for a minute.
| Study group | Role | What they receive |
|---|---|---|
| Manual myofascial release | Active comparator | Manual myofascial release as conventional treatment Receives: Other: Manual myofascial release |
| Emmett intervention | Experimental | Emmett intervention and myofascial release Receives: Other: Emmett intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 2 months
Range of Motion
Standard Goniometer was used to measure how far you can move or stretch a part of your body, such as a joint or a muscle specifically hip joint
Measured: 2 months
Vertical Jump test
The Vertical Jump test is designed to measure an applicants lower body strength in . The test is conducted using a vertical jump test gauge. Height was measured in inches or cm The mechanical work performed to accomplish a vertical jump can be determined by using the jump height distance that was measured (using Work = Force x Distance where Force = Mass x Acceleration).
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start15 Sep 2019
- Primary completion20 Mar 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459623
- Sponsor's protocol ID
- REC/RCR/20/1066 Faiza Altaf
- Status last verified
- Jul 2022
- First submitted
- 3 May 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fairclough J, Hayashi K, Toumi H, Lyons K, Bydder G, Phillips N, Best TM, Benjamin M. The functional anatomy of the iliotibial band during flexion and extension of the knee: implications for understanding iliotibial band syndrome. J Anat. 2006 Mar;208(3):309-16. doi: 10.1111/j.1469-7580.2006.00531.x.
PubMed 16533314Hudson Z, Darthuy E. Iliotibial band tightness and patellofemoral pain syndrome: a case-control study. Man Ther. 2009 Apr;14(2):147-51. doi: 10.1016/j.math.2007.12.009. Epub 2008 Mar 3.
PubMed 18313972Reese NB, Bandy WD. Use of an inclinometer to measure flexibility of the iliotibial band using the Ober test and the modified Ober test: differences in magnitude and reliability of measurements. J Orthop Sports Phys Ther. 2003 Jun;33(6):326-30. doi: 10.2519/jospt.2003.33.6.326.
PubMed 12839207Lavine R. Iliotibial band friction syndrome. Curr Rev Musculoskelet Med. 2010 Jul 20;3(1-4):18-22. doi: 10.1007/s12178-010-9061-8.
PubMed 21063495Okamoto T, Masuhara M, Ikuta K. Acute effects of self-myofascial release using a foam roller on arterial function. J Strength Cond Res. 2014 Jan;28(1):69-73. doi: 10.1519/JSC.0b013e31829480f5.
PubMed 23575360Bevilaqua-Grossi D, Monteiro-Pedro V, Sousa G, Silva Z, Bérzin F. Contribution to the anatomical study of the oblique portion of the vastus lateralis muscle. Braz J Morphol Sci. 2004;21(1):47-52.
Ercole B, Antonio S, Julie Ann D, Stecco C. How much time is required to modify a fascial fibrosis? J Bodyw Mov Ther. 2010 Oct;14(4):318-25. doi: 10.1016/j.jbmt.2010.04.006. Epub 2010 May 20.
PubMed 20850038
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Release With and Without EMMETT Technique in Iliotibial Band Syndrome
- ClinicalTrials.gov ID
- NCT05459623
- Acronym / sponsor ID
- REC/RCR/20/1066 Faiza Altaf
- Conditions
- Iliotibial Band Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 15 Jul 2022 (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 iliotibial (IT) tract or band is a lateral thickening of the fascia lata that is composed of the distal fusion of the muscular fascia of the gluteus maximus and tensor fascia lata muscles. The iliotibial tract travels along the lateral side of the thigh and across the knee joint, inserting on the lateral epicondyle of the tibia. A tight IT band has been diagnosed in several problems related to the knee including patellofemoral syndrome and iliotibial band syndrome. Several authors have suggested that tightness in the IT band may contribute to patellofemoral syndrome and knee pain by pulling the patella laterally thereby causing abnormal tracking of the patella in the trochlear groove. Stretching of the iliotibial band is frequently recommended in treatment programs for patients with LBP. Because the iliotibial band attaches to the ilium, tightness of this muscle is thought to cause anterior innominate rotation and lateral pelvic tilt. The Ober test is performed to assess tightness in the iliotibial band.
The term myofascial release encompasses various techniques used to release fascial restrictions. Many forms of bodywork that includes a soft tissue technique exist with Bowen therapy, Emmett technique, deep tissue massage, neuromuscular techniques (NMT), Muscle Energy Techniques (MET) and foam rolling.
This study focusses on effects of myofascial release with Emmett technique. This study will be conducted in a clinical set up (Saba's physical therapy, rehabilitation and sports injury clinic in Gulberg 3) and will take 6 months. Study will be conducted on 22 subjects involving 11 subjects in each group. Group A will be given myofascial release only and group B will be given myofascial release with Emmett technique. Total duration of study will be three weeks and assessment will be done before treatment and after every week. Numeric pain rating scale, goniometer and vertical jump test are used for assessing pain, flexibility and power respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual myofascial release | Active comparator | Other: Manual myofascial releaseManual myofascial release as conventional treatment |
| Emmett intervention | Experimental | Other: Emmett interventionEmmett intervention and myofascial release |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Positive Ober's Test
- Both males and females
- Age 25 to 45 years
Key exclusion criteria (5 listed)
- TFL (Tensor Fascia Lata) tightness
- Any pathological and traumatic conditions, Fractures and Dislocation,
- Already received few sessions of Manual Therapy treatment
- Taking corticosteroids, analgesic or anti-inflammatory drugs.
- Treatment of lower limb myofascial pain or trigger points at the time of the study • Current or previous symptoms of pathology reported in the lower limbs or pelvis
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 |
|---|---|---|
| Manual myofascial releaseAlso: Group Awill receive Manual myofascial release to iliotibial band by having the subject to lie in the side lying position on the unaffected side. The upper leg to be tested was rested on the table with hip and knee flexion. Then the therapist applied a few kilograms of force weight along the iliotibial band course proximally to distally. The therapist will repeat this for 6 minutes. | Other | Manual myofascial release |
| Emmett interventionAlso: Group Bwill receive manual myofascial release and the Emmett intervention with the subject sitting upright on a 45cm wooden chair; light, constant pressure via the middle finger (at a perpendicular angle to the skin) will be applied at both points, three times for 10-20s with 5-10s breaks between. A light sweeping action over the sensory area that will treated will be performed once, using the back of the fingers. The rationale for this is that the light brushing action "disperses the sensory awareness to move without being too heavy or specific enough to create muscular response." The sequence performed on one side will then repeated on the opposite leg. In Ross Emmett's teachings of the technique he insists on treatment of both sides when focusing on the lower body (for balance). Once both sides will be completed, the subject will be instructed to walk around the room for a minute. | Other | Emmett intervention |
Primary outcome
Numeric Pain Rating Scale
Time frame: 2 months
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Range of Motion
Time frame: 2 months
Standard Goniometer was used to measure how far you can move or stretch a part of your body, such as a joint or a muscle specifically hip joint
Vertical Jump test
Time frame: 2 Months
The Vertical Jump test is designed to measure an applicants lower body strength in . The test is conducted using a vertical jump test gauge. Height was measured in inches or cm The mechanical work performed to accomplish a vertical jump can be determined by using the jump height distance that was measured (using Work = Force x Distance where Force = Mass x Acceleration).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Background: PubMed 16533314Fairclough J, Hayashi K, Toumi H, Lyons K, Bydder G, Phillips N, Best TM, Benjamin M. The functional anatomy of the iliotibial band during flexion and extension of the knee: implications for understanding iliotibial band syndrome. J Anat. 2006 Mar;208(3):309-16. doi: 10.1111/j.1469-7580.2006.00531.x.
- Background: PubMed 18313972Hudson Z, Darthuy E. Iliotibial band tightness and patellofemoral pain syndrome: a case-control study. Man Ther. 2009 Apr;14(2):147-51. doi: 10.1016/j.math.2007.12.009. Epub 2008 Mar 3.
- Background: PubMed 12839207Reese NB, Bandy WD. Use of an inclinometer to measure flexibility of the iliotibial band using the Ober test and the modified Ober test: differences in magnitude and reliability of measurements. J Orthop Sports Phys Ther. 2003 Jun;33(6):326-30. doi: 10.2519/jospt.2003.33.6.326.
- Background: PubMed 21063495Lavine R. Iliotibial band friction syndrome. Curr Rev Musculoskelet Med. 2010 Jul 20;3(1-4):18-22. doi: 10.1007/s12178-010-9061-8.
- Background: PubMed 23575360Okamoto T, Masuhara M, Ikuta K. Acute effects of self-myofascial release using a foam roller on arterial function. J Strength Cond Res. 2014 Jan;28(1):69-73. doi: 10.1519/JSC.0b013e31829480f5.
- BackgroundBevilaqua-Grossi D, Monteiro-Pedro V, Sousa G, Silva Z, Bérzin F. Contribution to the anatomical study of the oblique portion of the vastus lateralis muscle. Braz J Morphol Sci. 2004;21(1):47-52.
- Background: PubMed 20850038Ercole B, Antonio S, Julie Ann D, Stecco C. How much time is required to modify a fascial fibrosis? J Bodyw Mov Ther. 2010 Oct;14(4):318-25. doi: 10.1016/j.jbmt.2010.04.006. Epub 2010 May 20.
- 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.
Rabiya Noor, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual myofascial release and Emmett intervention in people with Iliotibial Band Syndrome, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 2 months). 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 NCT05459623, which also lists 7 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 15 Jul 2022.