NCT06109038

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable knee-osteoarthritis

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

October 1, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

October 25, 2023

Last Update Submit

December 12, 2024

Conditions

Keywords

knee OAITB tightnessGraston technique

Outcome Measures

Primary Outcomes (3)

  • WOMAC questionnaire

    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),

    4 WEEKS

  • Numeric Pain Rating Scale

    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

    4 WEEKS

  • Goniometer

    It is an instrument that measures the available range of motion at a joint.

    4 WEEKS

Study Arms (2)

: Conventional PT + ITB release with graston technique

EXPERIMENTAL

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

Conventional PT

OTHER

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

Interventions

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).

: Conventional PT + ITB release with graston technique

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).

Conventional PT

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Maria khalid, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

October 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations