- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07361770
Comparative Effect of Instrument Assisted Soft Tissue Mobilization and Cross Fiber Massage in Patients With Total Knee Replacement.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Arif Memorial Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both male and female of Age 40-60
- Radiological diagnosis
- Advanced degenerative OA knee, undergoing a primary TKR
- Pain intensity >3
Exclusion Criteria:
- Rheumatoid Arthritis patients
- Septic Arthritis and other inflammatory arthritis patients
- Secondary or traumatic O.A
- Congenital bony deformities
- Flexion contracture, patellar dislocation
- Fracture or pervious osteotomy
- Neurological dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Instrument Assisted Soft Tissue Mobilization
The Graston Technique of Soft-Tissue Therapy (GT), also known as instrument-assisted soft tissue mobilization (IASTM), is used by chiropractors, physicians, and therapists to manage pain and range-of-motion limitations caused by scar tissue and musculoskeletal injuries.
The GT treats tissue injuries and pain by separating scar tissue and producing heat, which increases blood flow to the areas affected by pain or trauma.
|
Each treatment session was of 15-20 minutes for all muscles, with the help of IASTM device assisted by friction-free oil or gel.
The general principle is a six-step technique comprising examination, warm-up, IASTM, stretching, strengthening and icing.
Data was collected by an independent assessor at baseline and after 4 weeks
|
|
Active Comparator: Cross Fibre Massage
Deep tissue massage is a type of massage that focuses on the muscular tissue's most profound levels.
In tight regions, therapists utilize a combination of gentle strokes and deep pressure with their fingers, palms, and forearms.
Either following or by going over the muscle fibers.
It is used for back pain Reduce high blood pressure, Relieve pain and stiffness Speed up the healing of muscle strains and sprains Chronic constipation.
|
The massage is deep and must be applied transversely to the specific tissue involved unlike the superficial massage given in the longitudinal direction parallel to the vessels which enhances circulation and return of fluid. The therapist's fingers and patient's skin must move as one, otherwise moving subcutaneous fascia against muscle or ligament could lead to blister formation or subcutaneous bruising. Data was collected by an independent assessor at baseline and after 4 weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline and 4th week
|
Visual Analogue Scale (VAS) is a widely used tool to measure pain intensity.
The visual analog scale (VAS) for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
It was used to assess pain.
|
Baseline and 4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range Of Motion
Time Frame: Baseline and 4th week
|
An inclinometer app is a tool that helps measure and track changes in joint mobility, flexibility, and range of motion.
It provide objective, reliable degree measurements of knee range of motion and joint position sense error.
These measurements are then compared against established normal ranges or the patient's own previous results to track progress.
|
Baseline and 4th week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Funtion
Time Frame: Baseline and 4th week
|
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee.
It is a questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life.
|
Baseline and 4th week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB/2024/168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Total Knee Replacement
-
Central DuPage HospitalTerminatedTotal Knee Replacement | Replacement, Total Knee | Arthroplasty, Knee ReplacementUnited States
-
Ottawa Hospital Research InstituteThe Ottawa Hospital Academic Medical AssociationCompletedTotal Hip Replacement | Total Knee ReplacementCanada
-
Concentra AI, incRecruitingTotal Hip Replacement | Total Knee ReplacementUnited States
-
National University Hospital, SingaporeActive, not recruitingKnee Replacement, Total | Knee Replacement SurgerySingapore
-
University of North Carolina, Chapel HillNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedKnee Arthroplasty, Total | Knee Replacement, TotalUnited States
-
Istanbul UniversityCompleted
-
Singapore General HospitalCompletedTotal Knee Arthroplasty | Total Knee ReplacementSingapore
-
Istanbul UniversityCompletedTotal Knee Arthroplasty | Total Knee ReplacementTurkey
-
Mayo ClinicStryker OrthopaedicsCompletedArthroplasty, Replacement, Knee | Total Knee ReplacementUnited States
-
ElsanRecruitingKnee Replacement Arthroplasty | Knee Replacement, Total | Knee OsteoarthristisFrance
Clinical Trials on Instrument-assisted soft tissue mobilization
-
Kirsehir Ahi Evran UniversitesiCompletedMyofascial Pain | Instrument Assisted Soft Tissue MobilizationTurkey
-
Beth MarschnerMinot State UniversityCompleted
-
Beth MarschnerMinot State UniversityCompleted
-
Saglik Bilimleri UniversitesiHarran UniversityRecruitingMusculoskeletal Pain | Musculoskeletal Disorder | Soreness, MuscleTurkey
-
University of PrimorskaCompleted
-
Karabuk UniversityThe Scientific and Technological Research Council of TurkeyCompletedMyofascial PainTurkey
-
Tokat Gaziosmanpasa UniversityCompleted
-
KTO Karatay UniversityCompleted
-
Youngstown State UniversityCompleted
-
Eastern Mediterranean UniversityCompletedChronic Low-back PainCyprus