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Knee OsteoarthritisNCT05262049

Comparison of Intermittent Compression-decompression With Glides for Knee Osteoarthritis

A study testing intermittent compression-decompression with glides, Conventional Physical Therapy and conventional physical therapy and intermittent compression-decompression with glides in people with Knee Osteoarthritis, run by Riphah International University at 4 sites 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

the aim of this study is to compare the effects of intermittent compression decompression with glides with conventional physical therapy in patients having knee osteoarthritis. there are three groups in which patient will be allocated randomly. Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Knee Osteoarthritis
What is being tested?
intermittent compression-decompression with glides, Conventional Physical Therapy and conventional physical therapy and intermittent compression-decompression with glides
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesPakistan
Study dates
18 Oct 2020to 30 Dec 2021
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects diagnose with osteoarthritis of knee joint
  • Age: above 40, below70 years
  • Both gender (male and female) included
  • Subjects with unilateral or bilateral involvement of knee
  • Patients who will be able to comprehend commands.

Who cannot join

  • Subject who undergone any lower limb surgery
  • Subject with inflammatory joint disease of lower limb neurological disorder (motor or sensory loss).
  • Intra-articular corticosteroids or hyaluronic injection during past six months.
  • Subject giving history of hypersensitive skin, allergy or any other skin conditions
  • Subjects with any deformity like genu varum/ genu valgum

Trial locations and contacts

4 sites in 1 country.

Pakistan4 sites
  • Chaudhary Medical Center

    Haripur, Khyber Pakhtunkhwa, 22620

  • DHQ Haripur

    Haripur, Khyber Pakhtunkhwa, 22620

  • Yahya Welfare Complex Hospital

    Haripur, Khyber Pakhtunkhwa, 22620

  • Akhtar jahan medical center

    Wah, Punjab Province, 47040

Other trials in Pakistan

About this study

Official title: Comparison of Intermittent Compression-decompression With Glides and Conventional Physical Therapy Protocol for Knee Osteoarthritis

the aim of this study is to compare the effects of intermittent compression decompression with glides with conventional physical therapy in patients having knee osteoarthritis. there are three groups in which patient will be allocated randomly. group A will receive treatment technique intermittent compression decompression with glides only while group B will be treated with conventional physical therapy protocol whereas group c patients will receive combination of intermittent compression decompression with glides along with conventional physical therapy protocol. Pre and post treatment data will be collected by using questionnaires WOMAC and KOOS. treatment will be given 3 times a week for 4 weeks.

Read the detailed description

Most prevalent musculoskeletal age-related disorder worldwide is Osteoarthritis whose prevalence is supposed to rise in elderly population as it ages. knee pain is common issue contributing to OA in older population increasing with the increase of risk factor obesity and as population ages. People with Knee OA experience reduced movement, frequent chronic pain along with strength and balance compromising and face limitations in daily activities. Radio graphs of patients with knee OA show changes in lateral and medical tibiofemoral joints along with patellofemoral joint. Currently, 40% people aged above 75 years are affected with knee OA. In US, 28% adults older than 45 years of age and 37% older than 65 years of age are affected with knee OA. Knee osteoarthritis is a major age-related health problem and is leading cause of pain and disability in people.

Radiographic evidence of osteoarthritis is present in the majority of people over age 65; 80% of those over 75, Approximately 11% of those over 65 have symptomatic osteoarthritis of the knee Current guidelines recommend nonpharmacologic methods, such as physical therapy, as first-line options in the management of OA. Currently there is no medically effective treatment available. NSAIDS and acetaminophens are widely used to treat this but sometimes they fail to relieve symptoms leading to more adverse effects. Physical therapy is considered as an essential element in alleviating pain and improving physical functioning, but the data is limited. Exercise has showed improvement is walking speed, strength, functions self-efficacy along with pain alleviation during activities and enables to reduce limitation of daily. It is an urgent need to identify new effective treatment and techniques for patients with Knee OA as it is urgent health and clinical priority. Physiotherapy interventions commonly prescribed for the knee OA management includes electrotherapy along with knee isometric exercises but these are not as effective as in OA cartilage damages to as extent along with limited blood flow and reduced metabolic activity. These interventions are not enough to promote healing response of cartilage. Is supposed to promote osteoblastic activity, thus improving symptoms along with delaying the degeneration process Intermittent compression and decompression with glides has significant results in improving symptoms associated with knee OA along with betterment of quality of life. This technique is believed to delay and prevent surgical interventions as well as is cost effective treatment for patients suffering from knee OA.

Mobilization of knee joint includes the mobilization of tibiofemoral joint. This includes anterior and posterior glides with compression and decompression. Mobilization is a passive procedure performed to improve pain, increase range of motion and increase functional capability of patient, because optimal stimulus for the regeneration of the joint cartilage is intermittent compression and decompression with gliding. Manual physical therapy has also been reported to inhibit and modulate pain, induce a controlled inflammatory response that initiates healing and influences processing of pain, and alter acute inflammation in response to exercise. These could all contribute to decreased pain from muscle contract ion, improving tolerance for exercise. Joint mobilizations also modulate proprioceptive input to joint structures, prime the joint and surrounding muscles for optimal response to strengthening programs, improve muscle control and reaction times. Intermittent compression and decompression along with gliding of articular cartilage during moderate exercise activities allows synovial fluid to nourish the joint and remove waste products. This movement can also lead to thickening and increased resilience in the cartilage. Exercise also leads to increased muscle and ligamentous strength that provides stability to the joint.

Damaged articular cartilage has less healing capacity due to its low metabolic activity and limited blood circulation which permit limited response to injury. This cartilage lesion is sometime very progressive. Therefore, its early intervention is aimed to limit this progressive lesion to articular cartilage which is may be critical for decreasing the disability and chronic pain associated with osteoarthritis .Compressive forces applied on the knee joint pushes the fluid out of cartilage and during decompression it is reabsorbed, this phenomenon helps in the regeneration of cartilage by means of supplying nutrients and oxygen. Physical therapy interventions included are electrotherapy along with knee isometric exercises for management of osteoarthritis. But these interventions are not so effective and do not help in regeneration of the cartilage. Intermittent compression and decompression with glide helps to activate osteoblastic activity and improve the symptoms of osteoarthritis thus delaying the process of degeneration. The study is concerned with finding the effects of intermittent compression and decompression with glides for the knee osteoarthritis .Treatment technique in this research will substantially help to improve all the important outcomes as per literature evident .i.e. pain, disability, range of motion in patients with knee osteoarthritis. It will add innovative intervention to existing literature which will be helpful in improving quality of life in patients with knee OA.

Being tested
intermittent compression-decompression with glides, Conventional Physical Therapy, conventional physical therapy and intermittent compression-decompression with glides
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intermittent compression-decompression with glidesOther

    Patients in this group will be given only intermittent compression and decompression with glides. Traction (decompression applied at knee joint with anteroposterior glide followed by compression for about 6 minutes (30 glides, 10 seconds compression and vice versa), for the duration of 4 weeks (3 days a week, alternate days)

  • Conventional Physical TherapyOther

    In this group conventional therapy will be given according to below mentioned protocol for 4 weeks (3 days a week, alternate days).

    • Hot pack /TENS for 10 minutes
    • Stretching: Hamstring(10x) and calf (10x)
    • Strengthening of periarticular muscles especially the quadriceps (straight leg raising, pillow squeeze-isometric and dynamic)
  • conventional physical therapy and intermittent compression-decompression with glidesOther

    Patients in this group will receive the combination of conventional physical therapy and intermittent compression and decompression with glides, for 4 weeks (3 days a week, alternate days).

Study groups in NCT05262049
Study groupRoleWhat they receive
intermittent compression-decompression with glidesExperimentalPatients in this group will be given only intermittent compression and decompression with glides. Traction (decompression applied at knee joint with anteroposterior glide followed by compression for about 6 minutes (30 glides, 10 seconds compression and vice versa), for the duration of 4 weeks (3 days a week, alternate days)
Receives: Other: intermittent compression-decompression with glides
Conventional Physical TherapyExperimentalIn this group conventional therapy will be given according to below mentioned protocol for 4 weeks (3 days a week, alternate days). * Hot pack /TENS for 10 minutes * Stretching: Hamstring(10x) and calf (10x) * Strengthening of periarticular muscles especially the quadriceps (straight leg raising, pillow squeeze-isometric and dynamic)
Receives: Other: Conventional Physical Therapy
conventional physical therapy and intermittent compression-decompression with glidesExperimentalPatients in this group will receive the combination of conventional physical therapy andintermittent compression and decompression with glides, for 4 weeks (3 days a week, alternate days).
Receives: Other: conventional physical therapy and intermittent compression-decompression with glides

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Rating Scale (NPRS)

    changes from baseline numeric pain rating scale, The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") were taken

    Measured: 4th week

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    changes from baseline, The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life were taken

    Measured: 4th week

  3. Western Ontario And McMaster Osteoarthritis Index (WOMAC)

    changes from baseline Western Ontario And McMaster Osteoarthritis Index (WOMAC) were taken. The WOMAC consists of 24 items: 5 pain, 2 stiffness, and 17 physical function items. It produces three subscale scores (pain, stiffness, and physical function) and a total score.

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start18 Oct 2020
  3. Primary completion1 Dec 2021
  4. Study completion30 Dec 2021

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262049
Sponsor's protocol ID
Riphah/RCRS/REC/00862
Status last verified
Feb 2022
First submitted
20 Feb 2022
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
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 intermittent compression-decompression with glides, Conventional Physical Therapy and conventional physical therapy and intermittent compression-decompression with glides in people with Knee Osteoarthritis, run by Riphah International University at 4 sites 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 5 inclusion and 5 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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: 4th week). 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 2 Mar 2022.

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