Knee OsteoarthritisNCT05169606
Effect of Tissue Flossing, AIS, PNF on Hamstring Among Knee OA Patients
A study testing Tissue Flossing, Active Isolated Stretch and Proprioceptive Neuromuscular Facilitation in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
Tissue flossing has been known to produce results such as pain relief and improved range of motion, this technique might yield positive results in knee OA patients as well. These effects can further be compared with existing treatment method for treatment of hamstring such as Active isolated stretch and Proprioceptive… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Tissue Flossing, Active Isolated Stretch and Proprioceptive Neuromuscular Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2021to 20 Jan 2022
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade 1 and Grade 2 osteoarthritis patients
- Tight Hamstrings (pain in passive Straight Leg Raise <70 degrees)
- Willing to participate
Who cannot join
- Patients who have latex allergy
- Hypertension (i.e., resting systolic 130-159 mm Hg and diastolic 85-99 mm Hg)
- Venous thrombotic disease
- Heart diseases
- Respiratory diseases apparent neurological, dermatitis, or neurological problems in their legs
- Patients who do not give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tissue Flossing, Active Isolated Stretch, Proprioceptive Neuromuscular Facilitation on Hamstring Among Knee Osteoarthritis Patients
Tissue flossing has been known to produce results such as pain relief and improved range of motion, this technique might yield positive results in knee OA patients as well. These effects can further be compared with existing treatment method for treatment of hamstring such as Active isolated stretch and Proprioceptive Neuromuscular facilitation. This study will be among the first to carry out the technique of flossing in knee OA patients.
Read the detailed description
Arthritis is a broad term that encompasses a large number of diseases that affects one or more joints of the body. Amongst all other forms, Osteoarthritis (OA) is the most prevalent. Osteoarthritis is widespread throughout the world. It is one of the top leading causes of disability on a global scale. Previously this disease was thought to simply be due to biomechanical disturbances causing 'wear and tear' thus giving the characteristic feature of articular destruction leading to stiffness, inflammation and loss of mobility of joints over a long period of time. Due to recent advances in this area of study, evidence has revealed that OA has a collection of a much more complex multifactorial process composed of inflammatory and metabolic factors.
Typical clinical symptoms found in patients with Osteoarthritis include severe joint pain, stiffness, and significantly reduced mobility, which leads to decreased productivity and quality of life among the patients . Osteoarthritis can develop in any joint of the human body but the most frequently affected are the knees, hips, hands, facet joints and feet. This disease not only has an impact on the patient but in addition it also gives rise to an increased socioeconomic burden on the society. In 2005, it was estimated that over 26 million people in the USA had some form of OA. An estimated 30.8 million adults in the United States and 300 million individuals worldwide are living with OA. The severity of the Osteoarthritis can be categorized according Kellgren-Lawrence Grading System for Osteoarthritis.
Osteoarthritis frequently affects the weight bearing joints of the body. Knee OA has a high prevalence and is a disabling joint disease. The OA of the knee joint almost accounts for more than 80% of the disease's total burden and it affects no less than 19% of American adults aged 45 years and older. The knee joint Osteoarthritis is not only more important for its high prevalence rate in comparison to other types of OA but also for its presentation at earlier age groups. The incidence of knee OA increases by age and further increases with longer lifetime. The prevalence is found to be higher in females as compared to males. Participation in sports, injury to the joint, high BMI, and genetic susceptibility are also some factors that predispose individuals to the development of Knee osteoarthritis. Previous knee trauma increases the risk of knee OA 3.86 times. Overall an estimate of 80% of patients with knee OA suffer from some form of movement restriction, while 20% are unable to perform basic daily activities; indeed, 11% of sufferers require personal care. Amongst the cardinal symptoms of OA, pain is the biggest concern, and motor disability and impaired proprioception are important secondary factors.
Proprioceptive neuromuscular facilitation (PNF) technique has already been found to have beneficial effects in improving hamstring flexibility and reducing pain in the knee joint of knee OA patients. Active isolated stretch is also found to be effective to increase flexibility and improve ROM.
Tissue flossing is a relatively new technique to be introduced in the world of research. Tissue flossing is a new method that aims to improve range of motion (ROM), reduce pain, prevent injury, or enhance recovery. Since its arrival the technique has been researched upon mainly on the athletic population. Tissue flossing is a technique that requires wrapping of a thick rubber band around a joint or muscle concomitantly performing ROM tasks for 1-3 minutes. The results include increase in range of motion and a decrease in pain of the effected muscles. The phenomenon behind getting results through this technique is hypothesized to be blood reperfusion to an occluded area via tissue flossing augments exercise performance mechanisms such as growth hormone, catecholamine responses, muscle force contractility and the efficiency of excitation-contraction coupling in the muscles. In addition, tissue flossing may influence fascia tightness via the fascial mechanoreceptors, therefore reducing muscle activity, resulting in a greater ROM. Nevertheless, the underlying mechanism for tissue flossing, these mechanisms remain speculative.
- Conditions
- Knee Osteoarthritis
- Being tested
- Tissue Flossing, Active Isolated Stretch, Proprioceptive Neuromuscular Facilitation
- Keywords
- Tissue Flossing, Active Isolated Stretch, Proprioceptive Neuromuscular Facilitation, Knee Osteoarthritis, Pain, Range of motion
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue FlossingOther
Tissue flossing is a technique that requires wrapping of a thick rubber band around a joint or muscle concomitantly performing ROM tasks for 1-3 minutes. The results include increase in range of motion and a decrease in pain of the effected muscles. The phenomenon behind getting results through this technique is hypothesized to be blood reperfusion to an occluded area via tissue flossing augments exercise performance mechanisms such as growth hormone, catecholamine responses, muscle force contractility and the efficiency of excitation-contraction coupling in the muscles. In addition, tissue flossing may influence fascia tightness via the fascial mechanoreceptors, therefore reducing muscle activity, resulting in a greater ROM. Nevertheless, the underlying mechanism for tissue flossing, these mechanisms remain speculative.
Active Isolated StretchOther
AIS is a specific stretching program developed by Aaron Mattes. This technique is based on these four basic principles:
Isolate the muscle to be stretched. Repeat the stretch eight to 10 times. Hold each stretch for no more than two seconds. Exhale on the stretch; inhale on the release.
Proprioceptive Neuromuscular FacilitationOther
Proprioceptive neuromuscular facilitation (PNF) technique has already been found to have beneficial effects in improving hamstring flexibility and reducing pain in the knee joint of knee OA patients
| Study group | Role | What they receive |
|---|---|---|
| Tissue Flossing | Experimental | Tissue flossing is a technique that requires wrapping of a thick rubber band around a joint or muscle concomitantly performing ROM tasks for 1-3 minutes. The results include increase in range of motion and a decrease in pain of the effected muscles. The phenomenon behind getting results through this technique is hypothesized to be blood reperfusion to an occluded area via tissue flossing augments exercise performance mechanisms such as growth hormone, catecholamine responses, muscle force contractility and the efficiency of excitation-contraction coupling in the muscles. In addition, tissue flossing may influence fascia tightness via the fascial mechanoreceptors, therefore reducing muscle activity, resulting in a greater ROM. Nevertheless, the underlying mechanism for tissue flossing, these mechanisms remain speculative. Receives: Other: Tissue Flossing; Other: Active Isolated Stretch; Other: Proprioceptive Neuromuscular Facilitation |
| Active Isolated Stretch | Experimental | Active Isolated Stretch is a specific stretching program developed by Aaron Mattes over 30 years ago. Active isolated stretch is also found to be effective to increase flexibility and improve ROM. Receives: Other: Tissue Flossing; Other: Active Isolated Stretch; Other: Proprioceptive Neuromuscular Facilitation |
| Proprioceptive Neuromuscular Facilitation | Experimental | Proprioceptive neuromuscular facilitation (PNF) technique has already been found to have beneficial effects in improving hamstring flexibility and reducing pain in the knee joint of knee OA patients. Receives: Other: Tissue Flossing; Other: Active Isolated Stretch; Other: Proprioceptive Neuromuscular Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Straight Leg Raise for Flexibility
The leg is raised straight raise test when performed when the subject is placed supine, the therapist grasps the ankle and lifts the leg straight up, while stabilises the same anterior superior iliac spine. If the leg cannot be raised beyond 80degrees the hamstrings is considered tight.
Measured: for four weeks
Passive Knee Extension Test for Flexibility
The patient is positioned in supine with the hip of the tested leg in 90 degrees of flexion.The contralateral leg stays flat on the examination table. The clinician extends the knee until reaching the maximal tolerable stretch of the hamstring muscle as indicated by the patient with the ipsilateral hip remaining in 90 of flexion. The knee angle is then measured with a goniometer.
Measured: For four weeks
Secondary outcomes (2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The test-retest reliability of the WOMAC varies for the different subscales.
Measured: For four weeks
Numeric pain rating scale for pain
Numeric pain rating scale is used to capture the patient's level of pain. Patients will be asked to indicate the intensity of current, best, and worst levels of pain over the past 24 hours using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start30 Jun 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169606
- Sponsor's protocol ID
- REC/01068 Mohammad Jawwad
- Status last verified
- Feb 2022
- First submitted
- 13 Dec 2021
- Last updated
- 2 Feb 2022
- 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 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tissue Flossing, Active Isolated Stretch, Proprioceptive Neuromuscular Facilitation on Hamstring Among Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT05169606
- Acronym / sponsor ID
- REC/01068 Mohammad Jawwad
- Conditions
- Knee Osteoarthritis
- Keywords
- Tissue Flossing, Active Isolated Stretch, Proprioceptive Neuromuscular Facilitation, Knee Osteoarthritis, Pain, Range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 27 Dec 2021 (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.
Tissue flossing has been known to produce results such as pain relief and improved range of motion, this technique might yield positive results in knee OA patients as well. These effects can further be compared with existing treatment method for treatment of hamstring such as Active isolated stretch and Proprioceptive Neuromuscular facilitation. This study will be among the first to carry out the technique of flossing in knee OA patients.
Detailed description
Arthritis is a broad term that encompasses a large number of diseases that affects one or more joints of the body. Amongst all other forms, Osteoarthritis (OA) is the most prevalent. Osteoarthritis is widespread throughout the world. It is one of the top leading causes of disability on a global scale. Previously this disease was thought to simply be due to biomechanical disturbances causing 'wear and tear' thus giving the characteristic feature of articular destruction leading to stiffness, inflammation and loss of mobility of joints over a long period of time. Due to recent advances in this area of study, evidence has revealed that OA has a collection of a much more complex multifactorial process composed of inflammatory and metabolic factors.
Typical clinical symptoms found in patients with Osteoarthritis include severe joint pain, stiffness, and significantly reduced mobility, which leads to decreased productivity and quality of life among the patients . Osteoarthritis can develop in any joint of the human body but the most frequently affected are the knees, hips, hands, facet joints and feet. This disease not only has an impact on the patient but in addition it also gives rise to an increased socioeconomic burden on the society. In 2005, it was estimated that over 26 million people in the USA had some form of OA. An estimated 30.8 million adults in the United States and 300 million individuals worldwide are living with OA. The severity of the Osteoarthritis can be categorized according Kellgren-Lawrence Grading System for Osteoarthritis.
Osteoarthritis frequently affects the weight bearing joints of the body. Knee OA has a high prevalence and is a disabling joint disease. The OA of the knee joint almost accounts for more than 80% of the disease's total burden and it affects no less than 19% of American adults aged 45 years and older. The knee joint Osteoarthritis is not only more important for its high prevalence rate in comparison to other types of OA but also for its presentation at earlier age groups. The incidence of knee OA increases by age and further increases with longer lifetime. The prevalence is found to be higher in females as compared to males. Participation in sports, injury to the joint, high BMI, and genetic susceptibility are also some factors that predispose individuals to the development of Knee osteoarthritis. Previous knee trauma increases the risk of knee OA 3.86 times. Overall an estimate of 80% of patients with knee OA suffer from some form of movement restriction, while 20% are unable to perform basic daily activities; indeed, 11% of sufferers require personal care. Amongst the cardinal symptoms of OA, pain is the biggest concern, and motor disability and impaired proprioception are important secondary factors.
Proprioceptive neuromuscular facilitation (PNF) technique has already been found to have beneficial effects in improving hamstring flexibility and reducing pain in the knee joint of knee OA patients. Active isolated stretch is also found to be effective to increase flexibility and improve ROM.
Tissue flossing is a relatively new technique to be introduced in the world of research. Tissue flossing is a new method that aims to improve range of motion (ROM), reduce pain, prevent injury, or enhance recovery. Since its arrival the technique has been researched upon mainly on the athletic population. Tissue flossing is a technique that requires wrapping of a thick rubber band around a joint or muscle concomitantly performing ROM tasks for 1-3 minutes. The results include increase in range of motion and a decrease in pain of the effected muscles. The phenomenon behind getting results through this technique is hypothesized to be blood reperfusion to an occluded area via tissue flossing augments exercise performance mechanisms such as growth hormone, catecholamine responses, muscle force contractility and the efficiency of excitation-contraction coupling in the muscles. In addition, tissue flossing may influence fascia tightness via the fascial mechanoreceptors, therefore reducing muscle activity, resulting in a greater ROM. Nevertheless, the underlying mechanism for tissue flossing, these mechanisms remain speculative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tissue Flossing | Experimental | Other: Tissue Flossing, Other: Active Isolated Stretch, Other: Proprioceptive Neuromuscular FacilitationTissue flossing is a technique that requires wrapping of a thick rubber band around a joint or muscle concomitantly performing ROM tasks for 1-3 minutes. The results include increase in range of motion and a decrease in pain of the effected muscles. The phenomenon behind getting results through this technique is hypothesized to be blood reperfusion to an occluded area via tissue flossing augments exercise performance mechanisms such as growth hormone, catecholamine responses, muscle force contractility and the efficiency of excitation-contraction coupling in the muscles. In addition, tissue flossing may influence fascia tightness via the fascial mechanoreceptors, therefore reducing muscle activity, resulting in a greater ROM. Nevertheless, the underlying mechanism for tissue flossing, these mechanisms remain speculative. |
| Active Isolated Stretch | Experimental | Other: Tissue Flossing, Other: Active Isolated Stretch, Other: Proprioceptive Neuromuscular FacilitationActive Isolated Stretch is a specific stretching program developed by Aaron Mattes over 30 years ago. Active isolated stretch is also found to be effective to increase flexibility and improve ROM. |
| Proprioceptive Neuromuscular Facilitation | Experimental | Other: Tissue Flossing, Other: Active Isolated Stretch, Other: Proprioceptive Neuromuscular FacilitationProprioceptive neuromuscular facilitation (PNF) technique has already been found to have beneficial effects in improving hamstring flexibility and reducing pain in the knee joint of knee OA patients. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Grade 1 and Grade 2 osteoarthritis patients
- Tight Hamstrings (pain in passive Straight Leg Raise <70 degrees)
- Willing to participate
Key exclusion criteria (6 listed)
- Patients who have latex allergy
- Hypertension (i.e., resting systolic 130-159 mm Hg and diastolic 85-99 mm Hg)
- Venous thrombotic disease
- Heart diseases
- Respiratory diseases apparent neurological, dermatitis, or neurological problems in their legs
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 FlossingTissue flossing is a technique that requires wrapping of a thick rubber band around a joint or muscle concomitantly performing ROM tasks for 1-3 minutes. The results include increase in range of motion and a decrease in pain of the effected muscles. The phenomenon behind getting results through this technique is hypothesized to be blood reperfusion to an occluded area via tissue flossing augments exercise performance mechanisms such as growth hormone, catecholamine responses, muscle force contractility and the efficiency of excitation-contraction coupling in the muscles. In addition, tissue flossing may influence fascia tightness via the fascial mechanoreceptors, therefore reducing muscle activity, resulting in a greater ROM. Nevertheless, the underlying mechanism for tissue flossing, these mechanisms remain speculative. | Other | Active Isolated Stretch, Proprioceptive Neuromuscular Facilitation, Tissue Flossing |
| Active Isolated StretchAIS is a specific stretching program developed by Aaron Mattes. This technique is based on these four basic principles: Isolate the muscle to be stretched. Repeat the stretch eight to 10 times. Hold each stretch for no more than two seconds. Exhale on the stretch; inhale on the release. | Other | Active Isolated Stretch, Proprioceptive Neuromuscular Facilitation, Tissue Flossing |
| Proprioceptive Neuromuscular FacilitationProprioceptive neuromuscular facilitation (PNF) technique has already been found to have beneficial effects in improving hamstring flexibility and reducing pain in the knee joint of knee OA patients | Other | Active Isolated Stretch, Proprioceptive Neuromuscular Facilitation, Tissue Flossing |
Primary outcome
Straight Leg Raise for Flexibility
Time frame: for four weeks
The leg is raised straight raise test when performed when the subject is placed supine, the therapist grasps the ankle and lifts the leg straight up, while stabilises the same anterior superior iliac spine. If the leg cannot be raised beyond 80degrees the hamstrings is considered tight.
Passive Knee Extension Test for Flexibility
Time frame: For four weeks
The patient is positioned in supine with the hip of the tested leg in 90 degrees of flexion.The contralateral leg stays flat on the examination table. The clinician extends the knee until reaching the maximal tolerable stretch of the hamstring muscle as indicated by the patient with the ipsilateral hip remaining in 90 of flexion. The knee angle is then measured with a goniometer.
2 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: For four weeks
Numeric pain rating scale for pain
Time frame: for four weeks
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 2 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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, MSOMPT 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 Tissue Flossing, Active Isolated Stretch and Proprioceptive Neuromuscular Facilitation 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 3 inclusion and 6 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 2 Feb 2022. 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?
Straight Leg Raise for Flexibility (time frame: for four weeks). The study lists 2 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 2 Feb 2022.