Effects of ITB Myofascial Release on Symptoms Associated With Knee OA.

Sponsor

Riphah International University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06109038

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this randomized controlled trial is to determine the effects of ITB myofascial release with graston technique on symptoms associated with knee Osteoarthritis for reducing pain, enhancing knee range of motion and decrease functional disability.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: Conventional PT + ITB release with graston technique Other: Conventional PT	N/A

Detailed Description

Graston technique, Instrument assisted soft tissue mobilization (IASTM) also known as myofascial release technique is a skilled myofascial intervention used for soft-tissue treatment. Graston is a myofascial release tool that decreases adhesions, trigger points and tension in muscles. Graston Technique on Iliotibial Band Syndrome resulted in a decrease in subjective symptoms and an improvement in muscle function.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of ITB Myofascial Release on Symptoms Associated With Knee OA.

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: : Conventional PT + ITB release with graston technique An emollient will be applied to the leg from the lateral joint line along the tibial condyle to just below the iliac crest. The instrument GT-4 will be used for treatment. The tool was used to assess the soft tissue in three locations on the lateral leg: anterior to the ITB, over the ITB, and posterior to the ITB. Brushing and strumming strokes were performed to the tissue utilising the instrument's convex surface. Treatment time with the instrument is 8 -10 mins . Conventional PT including Hot Pack for 5mins. Quadriceps setting exercises, short arc terminal knee extension, straight leg raise, ROM excercises, hamstring curls in prone lying position, quadriceps strengthening in high sitting position, gastrocnemius muscle stretching (10reps × 5sec × 2sets). Maitland mobilization (Grade 1, 2 and 3 for 10 repititions).	Other: Conventional PT + ITB release with graston technique An emollient will be applied to the leg from the lateral joint line along the tibial condyle to just below the iliac crest. The instrument GT-4 will be used for treatment. The tool was used to assess the soft tissue in three locations on the lateral leg: anterior to the ITB, over the ITB, and posterior to the ITB. Brushing and strumming strokes were performed to the tissue utilising the instrument's convex surface. Treatment time with the instrument is 8 -10 mins . Conventional PT including Hot Pack for 5mins. Quadriceps setting exercises, short arc terminal knee extension, straight leg raise, ROM exercises, hamstring curls in prone lying position, quadriceps strengthening in high sitting position, gastrocnemius muscle stretching (10reps × 5sec × 2sets). Maitland mobilization (Grade 1, 2 and 3 for 10 repetitions).
Other: Conventional PT Conventional PT including Hot Pack for 5mins. Quadriceps setting exercises, short arc terminal knee extension, straight leg raise, ROM excercises, hamstring curls in prone lying position, quadriceps strengthening in high sitting position, gastrocnemius muscle stretching (10reps × 5sec × 2sets). Maitland mobilization (Grade 1, 2 and 3 for 10 repititions).	Other: Conventional PT Conventional PT including Hot Pack for 5mins. Quadriceps setting exercises, short arc terminal knee extension, straight leg raise, ROM exercises, hamstring curls in prone lying position, quadriceps strengthening in high sitting position, gastrocnemius muscle stretching (10reps × 5sec × 2sets). Maitland mobilization (Grade 1, 2 and 3 for 10 repetitions).

Arm

Intervention/Treatment

Experimental: : Conventional PT + ITB release with graston technique

An emollient will be applied to the leg from the lateral joint line along the tibial condyle to just below the iliac crest. The instrument GT-4 will be used for treatment. The tool was used to assess the soft tissue in three locations on the lateral leg: anterior to the ITB, over the ITB, and posterior to the ITB. Brushing and strumming strokes were performed to the tissue utilising the instrument's convex surface. Treatment time with the instrument is 8 -10 mins . Conventional PT including Hot Pack for 5mins. Quadriceps setting exercises, short arc terminal knee extension, straight leg raise, ROM excercises, hamstring curls in prone lying position, quadriceps strengthening in high sitting position, gastrocnemius muscle stretching (10reps × 5sec × 2sets). Maitland mobilization (Grade 1, 2 and 3 for 10 repititions).

Other: Conventional PT + ITB release with graston technique

An emollient will be applied to the leg from the lateral joint line along the tibial condyle to just below the iliac crest. The instrument GT-4 will be used for treatment. The tool was used to assess the soft tissue in three locations on the lateral leg: anterior to the ITB, over the ITB, and posterior to the ITB. Brushing and strumming strokes were performed to the tissue utilising the instrument's convex surface. Treatment time with the instrument is 8 -10 mins . Conventional PT including Hot Pack for 5mins. Quadriceps setting exercises, short arc terminal knee extension, straight leg raise, ROM exercises, hamstring curls in prone lying position, quadriceps strengthening in high sitting position, gastrocnemius muscle stretching (10reps × 5sec × 2sets). Maitland mobilization (Grade 1, 2 and 3 for 10 repetitions).

Other: Conventional PT

Conventional PT including Hot Pack for 5mins. Quadriceps setting exercises, short arc terminal knee extension, straight leg raise, ROM excercises, hamstring curls in prone lying position, quadriceps strengthening in high sitting position, gastrocnemius muscle stretching (10reps × 5sec × 2sets). Maitland mobilization (Grade 1, 2 and 3 for 10 repititions).

Other: Conventional PT

Conventional PT including Hot Pack for 5mins. Quadriceps setting exercises, short arc terminal knee extension, straight leg raise, ROM exercises, hamstring curls in prone lying position, quadriceps strengthening in high sitting position, gastrocnemius muscle stretching (10reps × 5sec × 2sets). Maitland mobilization (Grade 1, 2 and 3 for 10 repetitions).

Outcome Measures

Primary Outcome Measures

WOMAC questionnaire [4 WEEKS]
The WOMAC is a reliable , valid, and responsive instrument for evaluating the severity of OA of the knee, with metric properties. The WOMAC measures 5 items for pain (score range 0-20), 2 for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68),
Numeric Pain Rating Scale [4 WEEKS]
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
Goniometer [4 WEEKS]
It is an instrument that measures the available range of motion at a joint.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

knee OA Grade 2 and Grade 3 according to kellgren and Lawrence grading scale
Positive Ober's test

Exclusion Criteria:

Patient with cardiovascular or medical illness.
Patient with any severe trauma or surgery of knee.
Knee deformity
Low back pain with or without radiculopathy.
Neurological illness
Participants having any wound or scar on the site of treatment.
Pregnant female
Participants having co-morbidities such as neoplasm etc.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pakistan General Hospital	Rawalpindi	Punjab	Pakistan	46000

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Maria khalid, MS-OMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT06109038

Other Study ID Numbers:

Nida Anwar / REC-01686

First Posted:

Oct 31, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

knee OA

ITB tightness

Graston technique

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Oct 31, 2023