NCT05084014

Brief Summary

This is a randomized controlled trial, 44 participants selected based on inclusion criteria from physical therapy department of Surriya Azeem Surgical Hospital, Pattoki. Participants randomly recruited into two groups, 22 in deep stripping group receiving deep stripping with conventional physical therapy and 22 in kneading group receiving kneading with conventional physical therapy. Pain, range of motion and functional mobility are the primary outcomes measured by numeric pain rating scale, universal goniometer and lower extremity functional scale. Data collected at the baseline, at the 6th session, and the 12th session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 3, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
2.3 years until next milestone

Study Start

First participant enrolled

February 11, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

May 20, 2025

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 3, 2021

Last Update Submit

May 14, 2025

Conditions

Keywords

Non-inflammatory diseaseDegenerative joint diseaseOsteoarthritisknee jointsoft tissue mobilizationdeep longitudinal strippingkneading

Outcome Measures

Primary Outcomes (3)

  • Change from the baseline in Numeric pain rating scale at 2nd and 4th week

    It is the simplest and most commonly used numeric scale in which the individual rates the pain from 0 (no pain) to 10 (worst pain) 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain

    Baseline, 2nd week, 4th week

  • Change from baseline in Universal Goniometer at 2nd and 4th week

    the range of motion (flexion and extension) measured by using Universal Goniometer. For the range of motion, Universal Goniometer was used. It is an instrument made up of plastic material; it has a moveable arm, stationary arm and a fulcrum. The range of motion of the knee joint in extension and flexion was measured. The normal knee flexion range is 0⁰-130⁰ and the extension range is 130⁰-0⁰.

    Baseline, 2nd week, 4th week

  • Change from baseline in Lower Extremity Functional Scale at 2nd and 4th week

    For functional mobility Lower Extremity Functional Scale is used. This questionnaire contains 20 questions about the ability of a person to carry out his/her daily routine tasks. Every question has 5 options 0 = Extreme difficulty or unable to perform an activity 1. = Quite a bit of difficulty 2. = Moderate difficulty 3. = a little bit of difficulty 4. = no difficulty. The participant's score was interpreted at the end by adding all the scores of 20 questions, categorizing them into very high function, moderate function, mild function and very low function

    Baseline, 2nd week, 4th week

Study Arms (2)

Deep Stripping

EXPERIMENTAL

This group will receive deep stripping technique with conventional physical therapy.

Other: Deep Stripping

Kneading

EXPERIMENTAL

This group will receive deep kneading with conventional physical therapy.

Other: Kneading

Interventions

The deep longitudinal stripping can be applied on adhesions and knots in muscles. The lengthening stokes are parallel to muscle fiber and applied in an oblique direction with the help of the thumbs of hands/ elbow/ knuckles

Deep Stripping

kneading lifts the muscle in circular movements with the help of the hands. It lifted, rolled, and squeezed muscle

Kneading

Eligibility Criteria

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

You may qualify if:

  • Chronic osteoarthritis (more than 3 months) with pain in one knee joint (unilateral)
  • A prior medical diagnosis having radiographic evidence of grade 2 and 3 of Kellgren and Lawrence criteria for knee osteoarthritis by an orthopedic.
  • Pain intensity level more than 3 points of the numeric pain rating scale.

You may not qualify if:

  • Any acute inflammation, contracture, or surgery affecting the knee joint.
  • Any cognitive problem.
  • Participants taking non-steroid anti-inflammatory drugs, intra-articular injection, or physical therapy within the last three months for the knee joint.
  • Participants having a lumbar spine and/or any other lower limb impairment and/or surgery affecting knee joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.Mubeen Javed

Pattoki, Punjab Province, 55300, Pakistan

Location

Related Publications (6)

  • GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

    PMID: 30496104BACKGROUND
  • Peters AE, Akhtar R, Comerford EJ, Bates KT. The effect of ageing and osteoarthritis on the mechanical properties of cartilage and bone in the human knee joint. Sci Rep. 2018 Apr 12;8(1):5931. doi: 10.1038/s41598-018-24258-6.

    PMID: 29651151BACKGROUND
  • Ilas DC, Churchman SM, McGonagle D, Jones E. Targeting subchondral bone mesenchymal stem cell activities for intrinsic joint repair in osteoarthritis. Future Sci OA. 2017 Sep 6;3(4):FSO228. doi: 10.4155/fsoa-2017-0055. eCollection 2017 Nov.

    PMID: 29134116BACKGROUND
  • Karaborklu Argut S, Celik D, Kilicoglu OI. The Combination of Exercise and Manual Therapy Versus Exercise Alone in Total Knee Arthroplasty Rehabilitation: A Randomized Controlled Clinical Trial. PM R. 2021 Oct;13(10):1069-1078. doi: 10.1002/pmrj.12542. Epub 2021 Feb 3.

    PMID: 33352007BACKGROUND
  • Ferreira RM, Torres RT, Duarte JA, Goncalves RS. Non-Pharmacological and Non-Surgical Interventions for Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Acta Reumatol Port. 2019 Jul 29;44(3):173-217.

    PMID: 31356585BACKGROUND
  • Perlman A, Fogerite SG, Glass O, Bechard E, Ali A, Njike VY, Pieper C, Dmitrieva NO, Luciano A, Rosenberger L, Keever T, Milak C, Finkelstein EA, Mahon G, Campanile G, Cotter A, Katz DL. Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial. J Gen Intern Med. 2019 Mar;34(3):379-386. doi: 10.1007/s11606-018-4763-5. Epub 2018 Dec 12.

    PMID: 30543021BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeJoint DiseasesOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ayesha Javed, MSPT-MSK

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In this study, the outcome assessor will be blinded. He will just take the data regarding pain, functional mobility and measure the range of motion of the knee joint at the baseline, mid of the treatment and at the end of the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In this study there are two groups, one receiving deep longitudinal stripping technique with conventional physical therapy and the second group receiving kneading technique with conventional physical therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2021

First Posted

October 19, 2021

Study Start

February 11, 2024

Primary Completion

October 11, 2024

Study Completion

October 11, 2024

Last Updated

May 20, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations