Knee OsteoarthristisNCT07181421
Impact of Tissue Flossing and Therapeutic Exercises in Patient With Knee Osteoarthritis
A study testing Tissue flossing with Therapeutic exercises and Therapeutic Exercises in people with Knee Osteoarthristis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Knee osteoarthritis (OA) is a common degenerative joint disease that primarily affects individuals aged 40 years and older, and results in painful symptoms along with limited range of motion (ROM) and muscle weakness(1). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Tissue flossing with Therapeutic exercises and Therapeutic Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Sep 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-70 years with diagnosed knee OA (Grades 1 and 2). Unilateral knee OA or if bilateral OA is present, only the more symptomatic knee (Grade 1 or 2) Willingness to comply with the intervention protocol. Both Genders
Who cannot join
- Higher grade 3 and 4 knee OA. Recent knee surgeries Soft tissue injury of lower limb less than six months prior to the study Neurological or cardiovascular conditions contraindicating exercise Ongoing participation in another knee Rehabilitation program Latex allergy or Skin diseases varicose veins and Thrombosis Diabetic Neuropathy Fractures and open wounds.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Foundation University Islamabad
Islamabad, Punjab Province, 46000
Muhammad Furqan Hassan, MS-MSKPT, +923334056768, furqan.hassan@fui.edu.pk
About this study
Knee osteoarthritis (OA) is a common degenerative joint disease that primarily affects individuals aged 40 years and older, and results in painful symptoms along with limited range of motion (ROM) and muscle weakness(1). Therapeutic exercise covers a range of targeted physical activities that directly aim to improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One of the main aims of exercise is to improve muscle strength, given that weakness is common in knee OA. Exercise, especially isometric ROM exercises and step-ups as therapeutic exercise, are very important in OA patients, because they not only maintain the activity of the joint but also treat the pain and strengthen the joint (2).Use of tissue flossing, in which an elastic band is wrapped around muscles and joints to enhance blood flow and reduce pain(3).It has been on the rise as an adjunct to rehabilitation, but its efficacy when combined with therapeutic exercise is not well-known. The objective of this non-blinded randomized controlled trial is to compare the effects of tissue flossing combined with therapeutic exercises versus therapeutic exercises alone on pain, ROM, and muscle strength in patients with knee OA. The study will be conducted over a period of 4 weeks, with two sessions per week at Sheikh Khalifa Bin Zayed Hospital, Quetta. Initially, participants aged 40-70 years with diagnosed Grade 1,2and 3 knee OA will be screened for eligibility based on inclusion and exclusion criteria. Eligible participants will be informed about the study objectives and procedures, and written informed consent will be obtained. Participants will then be randomly allocated into two groups using the envelope method for group randomization. Baseline assessment will include knee ROM measurement, muscle strength assessment using Manual Muscle Testing (MMT), pain evaluation using the Numeric Pain Rating Scale (NPRS), Group A will receive tissue flossing in addition to therapeutic exercises, while Group B will receive only therapeutic exercises. All outcome measures will be reassessed after 4 weeks of intervention to evaluate the effects of the intervention. Data will be entered and analyzed using SPSS v.22.
Read the detailed description
Knee Osteoarthritis (OA) is a chronic degenerative joint disorder characterized by the breakdown of articular cartilage, synovial inflammation, and structural changes in subchondral bone, leading to pain, stiffness, and functional limitations (1). Knee OA, the most prevalent form of OA, significantly affects mobility and quality of life, especially in individuals with sedentary lifestyles or obesity. According to the Global Burden of Disease (GBD) report, knee OA accounts for a substantial proportion of disability-adjusted life years (DALYs), with high body mass index (BMI) identified as a major risk factor. By 2050, an estimated 642 million individuals are expected to suffer from knee OA, highlighting the urgent need for effective therapeutic interventions(4).Non pharmacological approaches, particularly therapeutic exercises, remain central to knee OA management.
Even a few degrees of extension or flexion loss can affect function and cause pain. The opposite, normal knee must be examined to establish a baseline for normal ROM. In patients with knee OA, most nonoperative rehabilitation programs concentrate on increasing strength, which is difficult to achieve when any ROM loss is present. The Shelbourne Knee Center ROM-based rehabilitation program emphasizes normalizing knee extension, followed by improving flexion and then strength. This ROM-based rehabilitation program has been effective for improving ROM, pain, symptoms, and function in patients with OA, and 76% were prevented from undergoing TKA surgery(5).
Exercise, particularly isometric range of motion (ROM) exercises and step-ups, plays a crucial role in managing osteoarthritis (OA). These exercises help maintain joint activity, alleviate pain, and strengthen the joint. For instance, a study published in Cures demonstrated that isometric strengthening exercises significantly reduced pain intensity and improved functional ability in patients with knee osteoarthritis(6). The meta-analysis finding indicates that isometric exercise is an effective physical therapy for treating KOA. It significantly reduces pain, improves physical function, and enhances muscle strength in KOA patients making it a valuable therapeutic option(7). Progressive resistance training, where the resistance is progressively increased to maintain relative intensity, can lead to significant improvements in older adults with knee OA by ameliorating sarcopenic changes and by improving the strength and function of the surrounding connective tissue, which is often damaged by the disease.(21)(22) However, despite their proven benefits, a significant proportion of patients continue to experience pain and functional limitations, necessitating the exploration of complementary interventions to optimize outcomes. Tissue flossing, a technique introduced by Dr. Kelly Starrett in 2014, has emerged as a novel adjunct therapy. Tissue flossing was first proposed by Starrett and Cordoza (2015), who suggested that flossing can increase the range of motion and/or performance (strength ), speed up recovery, and decrease pain caused by various disease or injuries. This intervention involves the application of elastic bands with controlled compression around the joint or muscle, followed by functional movements. Konrad., et al. in 2021 states that the mechanism of tissue flossing is hypothesized to enhance blood flow, reduce fascial adhesions, promote lymphatic drainage, and improve joint mobility (8). Pavlu D., et al. in 2021 indicate that tissue flossing is effective in reducing pain, improving range of motion (ROM), and enhancing functional capacity (9). A study by Driller.,et al. in 2017 states Flossing involves the mechanism of the ischemic preconditioning afterwards the reperfusion of the blood into the flossed area could be associated with subsequent increases in growth hormone, catecholamine responses, increased muscle force and contractility and increased efficiency of excitation-contraction coupling in the muscles (10). The mechanisms behind tissue flossing can also be described as facial shearing where the compression together with movement alter the relationship with the fascia and the neuromuscular system(8). The choice of Kallgren-Lawrence Grades 1,2 and 3 for my study is supported by literature that indicates their physical therapy suitability. Tuna et al. (2022) reported that physical therapy with exercises benefited pain relief at all grades of peripheral knee osteoarthritis (OA).In addition, the majority of radiological OA patients are likely to have KL Grade II and III ranging from 12% to 17% (12). This grade is at a moderate disease severity level, which is great for studying the impacts of tissue flossing. These early stages of the disease are more common and easier to treat, therefore it is beneficial to prioritize these grades to maximize function. A systematic review showed that the effects of floss band could lead to noticeable improvement in the general population and patients. (8). This study aims to evaluate the combined effects of tissue flossing and therapeutic exercises on pain relief, ROM, and muscle strength in patients with knee OA. By addressing gaps in the current literature, the findings of this study may provide innovative and clinically relevant strategies for managing knee OA, thereby improving patient outcomes and quality of life.
- Conditions
- Knee Osteoarthristis
- Being tested
- Tissue flossing with Therapeutic exercises, Therapeutic Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue flossing with Therapeutic exercisesProcedure or surgery
Isometric Knee Extension - Standing Hamstring Curl - Wall Squats - Leg Press Against Wall. The Red TheraBand from Thera Tool (2m * 5cm * 1.3mm) will be used. The band will be wrapped starting from the tibial tuberosity and extending to 5 cm above the femoral epicondyle. Care will be taken to ensure that the patella remains uncovered.
- The band will be wrapped with 50% tension and 50% overlap.
- Flossing Duration: The floss band will be kept on for 2 minutes, and during this time, the patient will perform the exercises mentioned above. The number of repetitions for each exercise will depend on the patient's tolerance level, with a reference of 10 repetitions per exercise (based on similar tissue flossing protocols, though adapted for knee OA patients).
Therapeutic ExercisesProcedure or surgery
Isometric Knee Extension - Standing Hamstring Curl - Wall Squats - Leg Press Against Wall.
| Study group | Role | What they receive |
|---|---|---|
| Tissue Flossing and Therapeutic Exercises | Experimental | Detailed of tissue flossing and therapeutic exercises.: The floss band will be kept on for 2 minutes, and during this time, the patient will perform the exercises with progression. After each 2-minute flossing session, the patient will rest for 2 minutes. Receives: Procedure: Tissue flossing with Therapeutic exercises |
| Therapeutic Exercises only | Active comparator | Isometric Knee Extension - Standing Hamstring Curl - Wall Squats - Leg Press Against Wall Receives: Procedure: Therapeutic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain
Numeric pain rating scale will be used to measure knee pain
Measured: 4 weeks
Knee Range of Motion
Goniometer willl be used to measure knee range of motion
Measured: 4 weeks
Knee Muscle Strength
Manual Muscle Testing will be used for knee muscle strength
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 posted18 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181421
- Sponsor's protocol ID
- FUI/CTR/2025/05
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tissue Flossing and Therapeutic Exercises in Patient With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07181421
- Acronym / sponsor ID
- FUI/CTR/2025/05
- Conditions
- Knee Osteoarthristis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 Sep 2025 (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.
Knee osteoarthritis (OA) is a common degenerative joint disease that primarily affects individuals aged 40 years and older, and results in painful symptoms along with limited range of motion (ROM) and muscle weakness(1). Therapeutic exercise covers a range of targeted physical activities that directly aim to improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One of the main aims of exercise is to improve muscle strength, given that weakness is common in knee OA. Exercise, especially isometric ROM exercises and step-ups as therapeutic exercise, are very important in OA patients, because they not only maintain the activity of the joint but also treat the pain and strengthen the joint (2).Use of tissue flossing, in which an elastic band is wrapped around muscles and joints to enhance blood flow and reduce pain(3).It has been on the rise as an adjunct to rehabilitation, but its efficacy when combined with therapeutic exercise is not well-known. The objective of this non-blinded randomized controlled trial is to compare the effects of tissue flossing combined with therapeutic exercises versus therapeutic exercises alone on pain, ROM, and muscle strength in patients with knee OA. The study will be conducted over a period of 4 weeks, with two sessions per week at Sheikh Khalifa Bin Zayed Hospital, Quetta. Initially, participants aged 40-70 years with diagnosed Grade 1,2and 3 knee OA will be screened for eligibility based on inclusion and exclusion criteria. Eligible participants will be informed about the study objectives and procedures, and written informed consent will be obtained. Participants will then be randomly allocated into two groups using the envelope method for group randomization. Baseline assessment will include knee ROM measurement, muscle strength assessment using Manual Muscle Testing (MMT), pain evaluation using the Numeric Pain Rating Scale (NPRS), Group A will receive tissue flossing in addition to therapeutic exercises, while Group B will receive only therapeutic exercises. All outcome measures will be reassessed after 4 weeks of intervention to evaluate the effects of the intervention. Data will be entered and analyzed using SPSS v.22.
Detailed description
Knee Osteoarthritis (OA) is a chronic degenerative joint disorder characterized by the breakdown of articular cartilage, synovial inflammation, and structural changes in subchondral bone, leading to pain, stiffness, and functional limitations (1). Knee OA, the most prevalent form of OA, significantly affects mobility and quality of life, especially in individuals with sedentary lifestyles or obesity. According to the Global Burden of Disease (GBD) report, knee OA accounts for a substantial proportion of disability-adjusted life years (DALYs), with high body mass index (BMI) identified as a major risk factor. By 2050, an estimated 642 million individuals are expected to suffer from knee OA, highlighting the urgent need for effective therapeutic interventions(4).Non pharmacological approaches, particularly therapeutic exercises, remain central to knee OA management.
Even a few degrees of extension or flexion loss can affect function and cause pain. The opposite, normal knee must be examined to establish a baseline for normal ROM. In patients with knee OA, most nonoperative rehabilitation programs concentrate on increasing strength, which is difficult to achieve when any ROM loss is present. The Shelbourne Knee Center ROM-based rehabilitation program emphasizes normalizing knee extension, followed by improving flexion and then strength. This ROM-based rehabilitation program has been effective for improving ROM, pain, symptoms, and function in patients with OA, and 76% were prevented from undergoing TKA surgery(5).
Exercise, particularly isometric range of motion (ROM) exercises and step-ups, plays a crucial role in managing osteoarthritis (OA). These exercises help maintain joint activity, alleviate pain, and strengthen the joint. For instance, a study published in Cures demonstrated that isometric strengthening exercises significantly reduced pain intensity and improved functional ability in patients with knee osteoarthritis(6). The meta-analysis finding indicates that isometric exercise is an effective physical therapy for treating KOA. It significantly reduces pain, improves physical function, and enhances muscle strength in KOA patients making it a valuable therapeutic option(7). Progressive resistance training, where the resistance is progressively increased to maintain relative intensity, can lead to significant improvements in older adults with knee OA by ameliorating sarcopenic changes and by improving the strength and function of the surrounding connective tissue, which is often damaged by the disease.(21)(22) However, despite their proven benefits, a significant proportion of patients continue to experience pain and functional limitations, necessitating the exploration of complementary interventions to optimize outcomes. Tissue flossing, a technique introduced by Dr. Kelly Starrett in 2014, has emerged as a novel adjunct therapy. Tissue flossing was first proposed by Starrett and Cordoza (2015), who suggested that flossing can increase the range of motion and/or performance (strength ), speed up recovery, and decrease pain caused by various disease or injuries. This intervention involves the application of elastic bands with controlled compression around the joint or muscle, followed by functional movements. Konrad., et al. in 2021 states that the mechanism of tissue flossing is hypothesized to enhance blood flow, reduce fascial adhesions, promote lymphatic drainage, and improve joint mobility (8). Pavlu D., et al. in 2021 indicate that tissue flossing is effective in reducing pain, improving range of motion (ROM), and enhancing functional capacity (9). A study by Driller.,et al. in 2017 states Flossing involves the mechanism of the ischemic preconditioning afterwards the reperfusion of the blood into the flossed area could be associated with subsequent increases in growth hormone, catecholamine responses, increased muscle force and contractility and increased efficiency of excitation-contraction coupling in the muscles (10). The mechanisms behind tissue flossing can also be described as facial shearing where the compression together with movement alter the relationship with the fascia and the neuromuscular system(8). The choice of Kallgren-Lawrence Grades 1,2 and 3 for my study is supported by literature that indicates their physical therapy suitability. Tuna et al. (2022) reported that physical therapy with exercises benefited pain relief at all grades of peripheral knee osteoarthritis (OA).In addition, the majority of radiological OA patients are likely to have KL Grade II and III ranging from 12% to 17% (12). This grade is at a moderate disease severity level, which is great for studying the impacts of tissue flossing. These early stages of the disease are more common and easier to treat, therefore it is beneficial to prioritize these grades to maximize function. A systematic review showed that the effects of floss band could lead to noticeable improvement in the general population and patients. (8). This study aims to evaluate the combined effects of tissue flossing and therapeutic exercises on pain relief, ROM, and muscle strength in patients with knee OA. By addressing gaps in the current literature, the findings of this study may provide innovative and clinically relevant strategies for managing knee OA, thereby improving patient outcomes and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue Flossing and Therapeutic Exercises | Experimental | Procedure: Tissue flossing with Therapeutic exercisesDetailed of tissue flossing and therapeutic exercises.: The floss band will be kept on for 2 minutes, and during this time, the patient will perform the exercises with progression. After each 2-minute flossing session, the patient will rest for 2 minutes. |
| Therapeutic Exercises only | Active comparator | Procedure: Therapeutic ExercisesIsometric Knee Extension - Standing Hamstring Curl - Wall Squats - Leg Press Against Wall |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 40-70 years with diagnosed knee OA (Grades 1 and 2). Unilateral knee OA or if bilateral OA is present, only the more symptomatic knee (Grade 1 or 2) Willingness to comply with the intervention protocol. Both Genders
Key exclusion criteria (1 listed)
- Higher grade 3 and 4 knee OA. Recent knee surgeries Soft tissue injury of lower limb less than six months prior to the study Neurological or cardiovascular conditions contraindicating exercise Ongoing participation in another knee Rehabilitation program Latex allergy or Skin diseases varicose veins and Thrombosis Diabetic Neuropathy Fractures and open wounds.
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 |
|---|---|---|
| Tissue flossing with Therapeutic exercisesIsometric Knee Extension - Standing Hamstring Curl - Wall Squats - Leg Press Against Wall. The Red TheraBand from Thera Tool (2m * 5cm * 1.3mm) will be used. The band will be wrapped starting from the tibial tuberosity and extending to 5 cm above the femoral epicondyle. Care will be taken to ensure that the patella remains uncovered. * The band will be wrapped with 50% tension and 50% overlap. * Flossing Duration: The floss band will be kept on for 2 minutes, and during this time, the patient will perform the exercises mentioned above. The number of repetitions for each exercise will depend on the patient's tolerance level, with a reference of 10 repetitions per exercise (based on similar tissue flossing protocols, though adapted for knee OA patients). | Procedure or surgery | Tissue Flossing and Therapeutic Exercises |
| Therapeutic ExercisesIsometric Knee Extension - Standing Hamstring Curl - Wall Squats - Leg Press Against Wall. | Procedure or surgery | Therapeutic Exercises only |
Primary outcome
Knee Pain
Time frame: 4 weeks
Numeric pain rating scale will be used to measure knee pain
Knee Range of Motion
Time frame: 4 weeks
Goniometer willl be used to measure knee range of motion
Knee Muscle Strength
Time frame: 4 weeks
Manual Muscle Testing will be used for knee muscle strength
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue flossing with Therapeutic exercises and Therapeutic Exercises in people with Knee Osteoarthristis, run by Foundation University Islamabad 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 18 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noor ul Aqsa, DPT (+923312413859, noorulaqsa2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain (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 18 Sep 2025.