Knee OsteoarthritisNCT06109038
Effects of ITB Myofascial Release on Symptoms Associated With Knee OA.
A study testing Conventional PT + ITB release with graston technique and Conventional PT in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Conventional PT + ITB release with graston technique and Conventional PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 1 Feb 2024
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee OA Grade 2 and Grade 3 according to kellgren and Lawrence grading scale
- Positive Ober's test
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Conventional PT + ITB release with graston technique, Conventional PT
- Keywords
- knee OA, ITB tightness, Graston technique
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PT + ITB release with graston techniqueOther
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 PTOther
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).
| Study group | Role | What they receive |
|---|---|---|
| : 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). Receives: 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). Receives: Other: Conventional PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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),
Measured: 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
Measured: 4 WEEKS
Goniometer
It is an instrument that measures the available range of motion at a joint.
Measured: 4 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria khalid, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109038
- Sponsor's protocol ID
- Nida Anwar / REC-01686
- Status last verified
- Dec 2024
- First submitted
- 25 Oct 2023
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ITB Myofascial Release on Symptoms Associated With Knee OA.
- ClinicalTrials.gov ID
- NCT06109038
- Acronym / sponsor ID
- Nida Anwar / REC-01686
- Conditions
- Knee Osteoarthritis
- Keywords
- knee OA, ITB tightness, Graston technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 31 Oct 2023 (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 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| : Conventional PT + ITB release with graston technique | Experimental | Other: Conventional PT + ITB release with graston techniqueAn 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). |
| Conventional PT | Other | Other: Conventional PTConventional 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). |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- knee OA Grade 2 and Grade 3 according to kellgren and Lawrence grading scale
- Positive Ober's test
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Conventional PT + ITB release with graston techniqueAn 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 + ITB release with graston technique |
| Conventional PTConventional 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 |
Primary outcome
WOMAC questionnaire
Time frame: 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
Time frame: 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
Time frame: 4 WEEKS
It is an instrument that measures the available range of motion at a joint.
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 17 Dec 2024.
- 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.
Maria khalid, MS-OMPT 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 Conventional PT + ITB release with graston technique and Conventional PT in people with Knee Osteoarthritis, 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 2 inclusion and 8 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 17 Dec 2024. 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?
WOMAC questionnaire (time frame: 4 WEEKS). 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?
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 17 Dec 2024.