NCT05459623

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

May 3, 2021

Last Update Submit

July 14, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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").

    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

    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).

    2 Months

Study Arms (2)

Manual myofascial release

ACTIVE COMPARATOR

Manual myofascial release as conventional treatment

Other: Manual myofascial release

Emmett intervention

EXPERIMENTAL

Emmett intervention and myofascial release

Other: Emmett intervention

Interventions

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.

Also known as: Group A
Manual myofascial release

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.

Also known as: Group B
Emmett intervention

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive Ober's Test
  • Both males and females
  • Age 25 to 45 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah IU

Lahore, 54000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 16533314BACKGROUND
  • Hudson 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.

    PMID: 18313972BACKGROUND
  • Reese 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.

    PMID: 12839207BACKGROUND
  • Lavine R. Iliotibial band friction syndrome. Curr Rev Musculoskelet Med. 2010 Jul 20;3(1-4):18-22. doi: 10.1007/s12178-010-9061-8.

    PMID: 21063495BACKGROUND
  • Okamoto 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.

    PMID: 23575360BACKGROUND
  • Bevilaqua-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
  • 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.

    PMID: 20850038BACKGROUND

MeSH Terms

Conditions

Iliotibial Band Syndrome

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesCumulative Trauma DisordersSprains and Strains

Study Officials

  • Rabiya Noor, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

July 15, 2022

Study Start

September 15, 2019

Primary Completion

March 20, 2020

Study Completion

June 28, 2020

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations