NCT05262049

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

February 20, 2022

Last Update Submit

February 20, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • 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

    4th week

  • 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

    4th week

  • 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.

    4th week

Study Arms (3)

intermittent compression-decompression with glides

EXPERIMENTAL

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)

Other: intermittent compression-decompression with glides

Conventional Physical Therapy

EXPERIMENTAL

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)

Other: Conventional Physical Therapy

conventional physical therapy and intermittent compression-decompression with glides

EXPERIMENTAL

Patients 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).

Other: conventional physical therapy and intermittent compression-decompression with glides

Interventions

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)

intermittent compression-decompression with glides
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
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).

conventional physical therapy and intermittent compression-decompression with glides

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chaudhary Medical Center

Haripur, Khyber Pakhtunkhwa, 22620, Pakistan

Location

DHQ Haripur

Haripur, Khyber Pakhtunkhwa, 22620, Pakistan

Location

Yahya Welfare Complex Hospital

Haripur, Khyber Pakhtunkhwa, 22620, Pakistan

Location

Akhtar jahan medical center

Wah, Punjab Province, 47040, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Muhammad Affan Iqbal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 2, 2022

Study Start

October 18, 2020

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(4)