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Effects of Deep Stripping Versus Kneading on Pain, Range of Motion and Function in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Deep Stripping
Kneading
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Non-inflammatory disease, Degenerative joint disease, Osteoarthritis, knee joint, soft tissue mobilization, deep longitudinal stripping, kneading

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • M.Mubeen Javed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Deep Stripping

Kneading

Arm Description

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

This group will receive deep kneading with conventional physical therapy.

Outcomes

Primary Outcome Measures

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
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.
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 = Quite a bit of difficulty = Moderate difficulty = a little bit of difficulty = 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

Secondary Outcome Measures

Full Information

First Posted
October 3, 2021
Last Updated
October 15, 2021
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05084014
Brief Title
Effects of Deep Stripping Versus Kneading on Pain, Range of Motion and Function in Knee Osteoarthritis
Official Title
Effects of Deep Stripping Technique Versus Kneading Technique on Pain, Range of Motion and Function in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
In this randomized controlled trial, 44 individuals with knee osteoarthritis (II-III grade of Kellgren-Lawrence scale) pre-diagnosed by an orthopedic, were assessed for eligibility from the physical therapy department of Surriya Azeem Surgical Hospital, Pattoki. Participants with any other musculoskeletal disorder, cognitive problem and receiving any treatment within the past three months were excluded from the study. The participants were randomly recruited into two groups with 22 participants in each group. Group A received deep stripping along with conventional physiotherapy and group B received kneading along with conventional physiotherapy. Both the deep stripping and kneading technique applied on the quadriceps muscle group, hamstring muscle group and around the knee joint. Data collected by a blinded assessor at the baseline, at the 6th session, and the 12th session. Outcome measures were pain (measured by Numeric Pain Rating Scale), range of motion (measured by Universal Goniometer), and functional mobility (assessed by Lower Extremity Functional Scale). After collecting the data, normality of the data will be entered and analyzed in Statistical Package for the Social Sciences and than the statistical test will be applied to compare the within group analysis and between group analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Non-inflammatory disease, Degenerative joint disease, Osteoarthritis, knee joint, soft tissue mobilization, deep longitudinal stripping, kneading

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep Stripping
Arm Type
Experimental
Arm Description
This group will receive deep stripping technique with conventional physical therapy.
Arm Title
Kneading
Arm Type
Experimental
Arm Description
This group will receive deep kneading with conventional physical therapy.
Intervention Type
Other
Intervention Name(s)
Deep Stripping
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Kneading
Intervention Description
kneading lifts the muscle in circular movements with the help of the hands. It lifted, rolled, and squeezed muscle
Primary Outcome Measure Information:
Title
Change from the baseline in Numeric pain rating scale at 2nd and 4th week
Description
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
Time Frame
Baseline, 2nd week, 4th week
Title
Change from baseline in Universal Goniometer at 2nd and 4th week
Description
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.
Time Frame
Baseline, 2nd week, 4th week
Title
Change from baseline in Lower Extremity Functional Scale at 2nd and 4th week
Description
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 = Quite a bit of difficulty = Moderate difficulty = a little bit of difficulty = 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
Time Frame
Baseline, 2nd week, 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Javed, MSPT-MSK
Organizational Affiliation
The University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
M.Mubeen Javed
City
Pattoki
State/Province
Punjab
ZIP/Postal Code
55300
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30496104
Citation
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. Erratum In: Lancet. 2019 Jun 22;393(10190):e44.
Results Reference
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PubMed Identifier
29651151
Citation
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.
Results Reference
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PubMed Identifier
29134116
Citation
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.
Results Reference
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PubMed Identifier
33352007
Citation
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.
Results Reference
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PubMed Identifier
31356585
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Effects of Deep Stripping Versus Kneading on Pain, Range of Motion and Function in Knee Osteoarthritis

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