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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Pakistan1 site
  • Alees Medical centre

    Islamabad, Punjab Province, 44150

Other trials in Pakistan

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.

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 groups in NCT05169606
Study groupRoleWhat they receive
Tissue FlossingExperimentalTissue 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 StretchExperimentalActive 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 FacilitationExperimentalProprioceptive 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.

  1. 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

  2. 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)
  1. 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

  2. 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.

  1. First posted27 Dec 2021
  2. Study start30 Jun 2021
  3. Primary completion20 Jan 2022
  4. Study completion20 Jan 2022

Resources

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)
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

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.

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