Knee Osteoarthritis (OA)NCT07710209
Instrument-Assisted Soft Tissue Mobilization as an Adjunct to Therapeutic Exercises in Individuals With Knee Osteoarthritis
A study testing IATSM and Therapeutic Exercise in people with Knee Osteoarthritis (OA), run by Foundation of Medical Research and Laboratories, Pakistan at 1 site in Pakistan.
Trial summary
To determine the efficacy of IASTM as an adjunct to therapeutic exercises on pain, range of motion, and functional performance in individuals with knee OA. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthritis (OA)
- What is being tested?
- IATSM and Therapeutic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2025to 31 Dec 2025
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: Osteoarthritis, both gender, Age between 40-60 years. -
Exclusion Criteria: Not meeting the inclusion criteria, underwent recent surgery of lower limb.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Instrument-Assisted Soft Tissue Mobilization as an Adjunct to Therapeutic Exercises in Individuals With Knee Osteoarthritis: A Parallel-Group Randomized Controlled Trial
To determine the efficacy of IASTM as an adjunct to therapeutic exercises on pain, range of motion, and functional performance in individuals with knee OA.
Read the detailed description
Background: Knee osteoarthritis (OA) is a leading cause of chronic pain and functional limitation, particularly in older adults, and is associated with soft tissue restrictions, quadriceps weakness, and reduced joint mobility. Therapeutic exercise remains a cornerstone of conservative management, but persistent myofascial restrictions may limit its full benefit. Instrument-Assisted Soft Tissue Mobilization (IASTM) has been proposed as an adjunct technique to address fascial adhesions, improve tissue extensibility, and enhance the outcomes of exercise-based rehabilitation. However, evidence regarding its added value when combined with conventional therapeutic exercise in knee OA remains limited.
Objective: To determine the efficacy of IASTM as an adjunct to therapeutic exercises on pain, range of motion, and functional performance in individuals with knee OA.
Methodology: A parallel-group randomized controlled trial was conducted on 50 participants diagnosed with knee OA (Kellgren-Lawrence grade II-III), randomly allocated into two equal groups (n=25 each) using a computer-generated random sequence with allocation concealment. Group A received IASTM combined with a standardized therapeutic exercise protocol, while Group B received the therapeutic exercise protocol alone. Treatment was administered three times per week for 6 weeks. Outcome measures included the Numeric Pain Rating Scale (NPRS), Knee range of motion (goniometry), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional status, assessed at baseline and post-intervention (6 weeks). Data were analyzed using paired and independent sample t-tests, with significance set at p<0.05.
- Conditions
- Knee Osteoarthritis (OA)
- Being tested
- IATSM, Therapeutic Exercise
- Keywords
- Knee osteoarthritis; Instrument-assisted soft tissue mobilization; Therapeutic exercise; Randomized controlled trial; Functional outcomes
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IATSMBehavioural
IATSM were administered for a duration of 6 weeks
Therapeutic ExerciseBehavioural
Therapeutic Exercise were administered for a duration of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| IASTM Combined with a Standardized Therapeutic Exercise Protocol | Experimental | IASTM Combined with a Standardized Therapeutic Exercise Protocol: Treatment was administered three times per week for 6 weeks Receives: Behavioral: IATSM |
| Therapeutic Exercise Protocol | Experimental | Therapeutic Exercise Protocol: Treatment was administered three times per week for 6 weeks Receives: Behavioral: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
The value were taken at base line and after 6 weeks of intervention
Measured: 6 weeks
Knee range of motion (goniometry)
The value were taken at base line and after 6 weeks of intervention
Measured: 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The value were taken at base line and after 6 weeks of intervention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Feb 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (OA)Studies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation of Medical Research and Laboratories, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malika Hassan, Study director, fmr.labs@medicalresearchforum.net
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710209
- Sponsor's protocol ID
- FMRL_03_26
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 17 Jul 2026
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Instrument-Assisted Soft Tissue Mobilization as an Adjunct to Therapeutic Exercises in Individuals With Knee Osteoarthritis: A Parallel-Group Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07710209
- Acronym / sponsor ID
- FMRL_03_26
- Conditions
- Knee Osteoarthritis (OA)
- Keywords
- Knee osteoarthritis; Instrument-assisted soft tissue mobilization; Therapeutic exercise; Randomized controlled trial; Functional outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Foundation of Medical Research and Laboratories, PakistanUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Jul 2026 (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.
To determine the efficacy of IASTM as an adjunct to therapeutic exercises on pain, range of motion, and functional performance in individuals with knee OA.
Detailed description
Background: Knee osteoarthritis (OA) is a leading cause of chronic pain and functional limitation, particularly in older adults, and is associated with soft tissue restrictions, quadriceps weakness, and reduced joint mobility. Therapeutic exercise remains a cornerstone of conservative management, but persistent myofascial restrictions may limit its full benefit. Instrument-Assisted Soft Tissue Mobilization (IASTM) has been proposed as an adjunct technique to address fascial adhesions, improve tissue extensibility, and enhance the outcomes of exercise-based rehabilitation. However, evidence regarding its added value when combined with conventional therapeutic exercise in knee OA remains limited.
Objective: To determine the efficacy of IASTM as an adjunct to therapeutic exercises on pain, range of motion, and functional performance in individuals with knee OA.
Methodology: A parallel-group randomized controlled trial was conducted on 50 participants diagnosed with knee OA (Kellgren-Lawrence grade II-III), randomly allocated into two equal groups (n=25 each) using a computer-generated random sequence with allocation concealment. Group A received IASTM combined with a standardized therapeutic exercise protocol, while Group B received the therapeutic exercise protocol alone. Treatment was administered three times per week for 6 weeks. Outcome measures included the Numeric Pain Rating Scale (NPRS), Knee range of motion (goniometry), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional status, assessed at baseline and post-intervention (6 weeks). Data were analyzed using paired and independent sample t-tests, with significance set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IASTM Combined with a Standardized Therapeutic Exercise Protocol | Experimental | Behavioral: IATSMIASTM Combined with a Standardized Therapeutic Exercise Protocol: Treatment was administered three times per week for 6 weeks |
| Therapeutic Exercise Protocol | Experimental | Behavioral: Therapeutic ExerciseTherapeutic Exercise Protocol: Treatment was administered three times per week for 6 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| IATSMIATSM were administered for a duration of 6 weeks | Behavioural | IASTM Combined with a Standardized Therapeutic Exercise Protocol |
| Therapeutic ExerciseTherapeutic Exercise were administered for a duration of 6 weeks | Behavioural | Therapeutic Exercise Protocol |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 6 weeks
The value were taken at base line and after 6 weeks of intervention
Knee range of motion (goniometry)
Time frame: 6 weeks
The value were taken at base line and after 6 weeks of intervention
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 weeks
The value were taken at base line and after 6 weeks of intervention
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 Jul 2026.
- 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.
Malika Hassan study director
fmr.labs@medicalresearchforum.net
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IATSM and Therapeutic Exercise in people with Knee Osteoarthritis (OA), run by Foundation of Medical Research and Laboratories, Pakistan 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?
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 Jul 2026. 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?
Numeric Pain Rating Scale (NPRS) (time frame: 6 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 Jul 2026.