Iliotibial Band SyndromeNCT04954703
Myofascial Release With and Without METS of Gluteus Maximus and Tensor Fascia Lata in ITB Syndrome
A study testing Muscle energy technique of gluteus maximus and tensor fascia lata and Myofascial release of iliotibial band syndrome in people with Iliotibial Band Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
This Study Will Be Conducted to Evaluate the Effects Of myofascial release of IT band with or without muscle energy technique of gluteus maximus and tensor fascia Lata with iliotibial band syndrome. Data Will Be Collected from Haider memorial hospital in Vehari. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Muscle energy technique of gluteus maximus and tensor fascia lata and Myofascial release of iliotibial band syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2021to 10 Aug 2021
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient having pain on lateral side of knee with positive ober's test
Who cannot join
- medically unstable patients
- others causes of lateral knee pain like meniscus and ligaments tear
- trauma causes
- other pathological condition of knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Myofascial Release of IT Band With or Without Muscle Energy Technique of Gluteus Maximus and Tensor Fascia Lata With Iliotibial Band Syndrome.
This Study Will Be Conducted to Evaluate the Effects Of myofascial release of IT band with or without muscle energy technique of gluteus maximus and tensor fascia Lata with iliotibial band syndrome. Data Will Be Collected from Haider memorial hospital in Vehari. Study will include 24 patients of both genders with pain on lateral side of pain confirmed by positive ober test. Treatment group patient will receive myofascial release and muscle energy technique of gluteus maximus \& tensor fascia Lata muscle to relieve pain of IT band syndrome while control group will only receive myofascial release treatment. All 24 patients will be stable during the study period. Study will be conducted based on 06 month time period after approval of synopsis. Patients will be studied and fill out questionnaire. All possible patients with iliotibial tract syndrome will be taken using consecutive sampling. Informed consent will be taken from all recruited patients. The results of this study will help to manage the pain of iliotibial tract \& will be a randomized controlled trial
Read the detailed description
The iliotibial tract is a dense fibrous connective tissue thickening of the fascia Lata on lateral side of the thigh. The ITB is attached proximally at the greater trochanter of femur with fascial involvement of the tensor fascia Lata and the gluteus maximus and gluteus Medius muscles to lateral condyle of tibia. The most common injury of lateral knee is iliotibial band syndrome(ITBS). ITBS is an overuse injury results from repetitive friction of the iliotibial band (ITB) over the lateral femoral epicondyle, biomechanical studies explained that a maximal zone of impingement is at approximately 30° of knee flexion. Prevalence of ITBS accounts for 15% to 24% in all overuse injuries in non-experimental investigations. Epidemiologic studies demonstrates ITBS as the most common cause of lateral knee symptoms with a reported incidence ranging from 1.6% to 12%.
ITBS is an overuse injury from repetitive movements cause friction, irritation, and pain when moving the knee joint. Prospective research demonstrate that the greater internal rotation at the knee joint and increased adduction angles of the hip joint play important role in the etiology of ITBS and that the strain rate in the iliotibial bands is greater in persons with repetitive movements of knee joints compared to other persons.
Presentation of Iliotibial band syndrome is increased knee internal rotation, decreased rear foot eversion, tibial internal rotation and hip adduction angles at heel strike with maximum internal rotation at the knee and decreased total abduction and adduction range of motion at the hip during stance phase during stance. It also exhibits greater invertor moments at their feet, decreased abduction and flexion at their hip joint and to reach maximum hip flexion angles earlier than healthy individuals. female gender may be a predisposing factor of iliotibial band syndrome. Iliotibial band friction syndrome is an overuse injury mostly seen in long distance runners, cyclists, and military personnel with estimated incidence of 1.6%-52% .ITB length is measured by Ober's test and modified Ober's test, with hip adduction angle that is monitored by using a fluid goniometer.
Manual therapy is first choice in treatment of ITBS consists of soft tissue release and medial patella mobilizations for relieve of pain and lengthening the ITB. Myofascial release with use of foam roller as a myofascial release tool is used to break up soft-tissue adhesions in the ITB . Studies also showed that myofascial release is beneficial for relieving lateral knee pain. With progression of patient performing the stretching regimen without pain, strengthening is also added to the rehabilitation program. Physical Interventions such static stretching, strengthening, manual therapy and neuromuscular re-education and muscle energy techniques are performed for treatment of ITBS. Active Release Technique and Myofascial Release Technique are also effective in patients with musculoskeletal pain but researches revealed that Myofascial Release Technique demonstrated has better outcomes than Active Release Technique in the management of Chronic pain.
The increased tone of gluteus maximus can be corrected with active pump techniques, combining of soft tissue mobilization with muscle energy techniques. Isometric of hip abduction and adduction strengthening also performed for relieve and gain range of motion in ITBS. MET is a treatment technique includes a willful constriction of a subject's muscle in a controlled bearing, against a counterforce that is given by the specialist. MET is utilized to diminish the pain, extend the tight muscles and belts, decrease muscle tone, enhances nearby flow, strengthen the feeble musculature, and mobilizes the joint restrictions. MET increase the extensibility of muscles and spinal range of motion, treating patients with reduced mobility. Muscle energy techniques involve post isometric relaxation and post facilitation stretching techniques. METS of specific muscles are used for improvement the efficacy of neurodynamic and lymphatic system
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Muscle energy technique of gluteus maximus and tensor fascia lata, Myofascial release of iliotibial band syndrome
- Keywords
- ITB syndrome, Muscle energy technique (METS), Myofascial release
- 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.
Muscle energy technique of gluteus maximus and tensor fascia lataOther
it is used for lengthening of hypertonic muscles for relief of pain and range of motion.Position of patient is supine lying and therapist is at side of table .The patient leg is fully adducted to stretch IT band and then patient attempts to abduct the leg against resistance contracting the muscles being stretched at approximately 25% of maximum effort for 10 seconds. They then relax and the therapist lengthen it.
Myofascial release of iliotibial band syndromeOther
Myofascial release of IT band Syndrome. Therapist fingers track up and down your ITB with fingertips to find the most tender spots and use a tennis ball to apply small, circular, light release in those places.
| Study group | Role | What they receive |
|---|---|---|
| Muscle energy technique of gluteus maximus and tensor fascia lata | Experimental | INTERVENTIONAL GROUP (muscle energy technique of gluteus maximus and tensor fascia lata) Receives: Other: Muscle energy technique of gluteus maximus and tensor fascia lata |
| Myofascial release of iliotibial band | Active comparator | CONTROL GROUP(Myofascial release of iliotibial band) Receives: Other: Myofascial release of iliotibial band syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale
It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 3 weeks
Secondary outcomes (1)
lower extremity functional scale
lower extremity functional scale score = sum (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability. The Minimal Detectable Change (MDC) is 9 scale points. The Minimal clinically Important Difference (MCID) is 9 scale points
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start10 Jan 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sana ullah, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954703
- Sponsor's protocol ID
- REC/Lhr/21/0104/Aqsa
- Status last verified
- Aug 2021
- First submitted
- 6 Jul 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khaund R, Flynn SH. Iliotibial band syndrome: a common source of knee pain. Am Fam Physician. 2005 Apr 15;71(8):1545-50.
PubMed 15864895Holzer M, Padberg F. Intermittent theta burst stimulation (iTBS) ameliorates therapy-resistant depression: a case series. Brain Stimul. 2010 Jul;3(3):181-3. doi: 10.1016/j.brs.2009.10.004. Epub 2009 Nov 1. No abstract available.
PubMed 20633448De Maeseneer M, Boulet C, Willekens I, Lenchik L, De Mey J, Cattrysse E, Shahabpour M. Segond fracture: involvement of the iliotibial band, anterolateral ligament, and anterior arm of the biceps femoris in knee trauma. Skeletal Radiol. 2015 Mar;44(3):413-21. doi: 10.1007/s00256-014-2044-x. Epub 2014 Dec 4.
PubMed 25468067Subotnick SI. Limb length discrepancies of the lower extremity (the short leg syndrome). J Orthop Sports Phys Ther. 1981;3(1):11-6. doi: 10.2519/jospt.1981.3.1.11.
PubMed 18810144Fredericson M, Wolf C. Iliotibial band syndrome in runners: innovations in treatment. Sports Med. 2005;35(5):451-9. doi: 10.2165/00007256-200535050-00006.
PubMed 15896092
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Release of IT Band With or Without Muscle Energy Technique of Gluteus Maximus and Tensor Fascia Lata With Iliotibial Band Syndrome.
- ClinicalTrials.gov ID
- NCT04954703
- Acronym / sponsor ID
- REC/Lhr/21/0104/Aqsa
- Conditions
- Iliotibial Band Syndrome
- Keywords
- ITB syndrome, Muscle energy technique (METS), Myofascial release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 8 Jul 2021 (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.
This Study Will Be Conducted to Evaluate the Effects Of myofascial release of IT band with or without muscle energy technique of gluteus maximus and tensor fascia Lata with iliotibial band syndrome. Data Will Be Collected from Haider memorial hospital in Vehari. Study will include 24 patients of both genders with pain on lateral side of pain confirmed by positive ober test. Treatment group patient will receive myofascial release and muscle energy technique of gluteus maximus \& tensor fascia Lata muscle to relieve pain of IT band syndrome while control group will only receive myofascial release treatment. All 24 patients will be stable during the study period. Study will be conducted based on 06 month time period after approval of synopsis. Patients will be studied and fill out questionnaire. All possible patients with iliotibial tract syndrome will be taken using consecutive sampling. Informed consent will be taken from all recruited patients. The results of this study will help to manage the pain of iliotibial tract \& will be a randomized controlled trial
Detailed description
The iliotibial tract is a dense fibrous connective tissue thickening of the fascia Lata on lateral side of the thigh. The ITB is attached proximally at the greater trochanter of femur with fascial involvement of the tensor fascia Lata and the gluteus maximus and gluteus Medius muscles to lateral condyle of tibia. The most common injury of lateral knee is iliotibial band syndrome(ITBS). ITBS is an overuse injury results from repetitive friction of the iliotibial band (ITB) over the lateral femoral epicondyle, biomechanical studies explained that a maximal zone of impingement is at approximately 30° of knee flexion. Prevalence of ITBS accounts for 15% to 24% in all overuse injuries in non-experimental investigations. Epidemiologic studies demonstrates ITBS as the most common cause of lateral knee symptoms with a reported incidence ranging from 1.6% to 12%.
ITBS is an overuse injury from repetitive movements cause friction, irritation, and pain when moving the knee joint. Prospective research demonstrate that the greater internal rotation at the knee joint and increased adduction angles of the hip joint play important role in the etiology of ITBS and that the strain rate in the iliotibial bands is greater in persons with repetitive movements of knee joints compared to other persons.
Presentation of Iliotibial band syndrome is increased knee internal rotation, decreased rear foot eversion, tibial internal rotation and hip adduction angles at heel strike with maximum internal rotation at the knee and decreased total abduction and adduction range of motion at the hip during stance phase during stance. It also exhibits greater invertor moments at their feet, decreased abduction and flexion at their hip joint and to reach maximum hip flexion angles earlier than healthy individuals. female gender may be a predisposing factor of iliotibial band syndrome. Iliotibial band friction syndrome is an overuse injury mostly seen in long distance runners, cyclists, and military personnel with estimated incidence of 1.6%-52% .ITB length is measured by Ober's test and modified Ober's test, with hip adduction angle that is monitored by using a fluid goniometer.
Manual therapy is first choice in treatment of ITBS consists of soft tissue release and medial patella mobilizations for relieve of pain and lengthening the ITB. Myofascial release with use of foam roller as a myofascial release tool is used to break up soft-tissue adhesions in the ITB . Studies also showed that myofascial release is beneficial for relieving lateral knee pain. With progression of patient performing the stretching regimen without pain, strengthening is also added to the rehabilitation program. Physical Interventions such static stretching, strengthening, manual therapy and neuromuscular re-education and muscle energy techniques are performed for treatment of ITBS. Active Release Technique and Myofascial Release Technique are also effective in patients with musculoskeletal pain but researches revealed that Myofascial Release Technique demonstrated has better outcomes than Active Release Technique in the management of Chronic pain.
The increased tone of gluteus maximus can be corrected with active pump techniques, combining of soft tissue mobilization with muscle energy techniques. Isometric of hip abduction and adduction strengthening also performed for relieve and gain range of motion in ITBS. MET is a treatment technique includes a willful constriction of a subject's muscle in a controlled bearing, against a counterforce that is given by the specialist. MET is utilized to diminish the pain, extend the tight muscles and belts, decrease muscle tone, enhances nearby flow, strengthen the feeble musculature, and mobilizes the joint restrictions. MET increase the extensibility of muscles and spinal range of motion, treating patients with reduced mobility. Muscle energy techniques involve post isometric relaxation and post facilitation stretching techniques. METS of specific muscles are used for improvement the efficacy of neurodynamic and lymphatic system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle energy technique of gluteus maximus and tensor fascia lata | Experimental | Other: Muscle energy technique of gluteus maximus and tensor fascia lataINTERVENTIONAL GROUP (muscle energy technique of gluteus maximus and tensor fascia lata) |
| Myofascial release of iliotibial band | Active comparator | Other: Myofascial release of iliotibial band syndromeCONTROL GROUP(Myofascial release of iliotibial band) |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patient having pain on lateral side of knee with positive ober's test
Key exclusion criteria (4 listed)
- medically unstable patients
- others causes of lateral knee pain like meniscus and ligaments tear
- trauma causes
- other pathological condition of knee
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 |
|---|---|---|
| Muscle energy technique of gluteus maximus and tensor fascia latait is used for lengthening of hypertonic muscles for relief of pain and range of motion.Position of patient is supine lying and therapist is at side of table .The patient leg is fully adducted to stretch IT band and then patient attempts to abduct the leg against resistance contracting the muscles being stretched at approximately 25% of maximum effort for 10 seconds. They then relax and the therapist lengthen it. | Other | Muscle energy technique of gluteus maximus and tensor fascia lata |
| Myofascial release of iliotibial band syndromeMyofascial release of IT band Syndrome. Therapist fingers track up and down your ITB with fingertips to find the most tender spots and use a tennis ball to apply small, circular, light release in those places. | Other | Myofascial release of iliotibial band |
Primary outcome
Numerical pain rating scale
Time frame: 3 weeks
It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
1 secondary outcome
lower extremity functional scale
Time frame: 3 weeks
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 30 Aug 2021.
- Background: PubMed 15864895Khaund R, Flynn SH. Iliotibial band syndrome: a common source of knee pain. Am Fam Physician. 2005 Apr 15;71(8):1545-50.
- Background: PubMed 20633448Holzer M, Padberg F. Intermittent theta burst stimulation (iTBS) ameliorates therapy-resistant depression: a case series. Brain Stimul. 2010 Jul;3(3):181-3. doi: 10.1016/j.brs.2009.10.004. Epub 2009 Nov 1. No abstract available.
- Background: PubMed 25468067De Maeseneer M, Boulet C, Willekens I, Lenchik L, De Mey J, Cattrysse E, Shahabpour M. Segond fracture: involvement of the iliotibial band, anterolateral ligament, and anterior arm of the biceps femoris in knee trauma. Skeletal Radiol. 2015 Mar;44(3):413-21. doi: 10.1007/s00256-014-2044-x. Epub 2014 Dec 4.
- Background: PubMed 18810144Subotnick SI. Limb length discrepancies of the lower extremity (the short leg syndrome). J Orthop Sports Phys Ther. 1981;3(1):11-6. doi: 10.2519/jospt.1981.3.1.11.
- Background: PubMed 15896092Fredericson M, Wolf C. Iliotibial band syndrome in runners: innovations in treatment. Sports Med. 2005;35(5):451-9. doi: 10.2165/00007256-200535050-00006.
- 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.
Muhammad Sana ullah 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 Muscle energy technique of gluteus maximus and tensor fascia lata and Myofascial release of iliotibial band syndrome 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 1 inclusion and 4 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 30 Aug 2021. 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?
Numerical pain rating scale (time frame: 3 weeks). 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 NCT04954703, 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 30 Aug 2021.