Effects of Instrument Assisted Soft Tissue Mobilization in Addition to Conventional Physiotherapy in Knee Arthrofibrosis

Arthrofibrosis is the abnormal proliferation of fibrous tissue within a joint and around the joint that leads to loss of motion, pain, muscle weakness, swelling, functional limitation. Study conducted to determine additional effects of IASTM along with conventional physiotherapy as compared to conventional physiotherapy alone on Range of motion, functional limitation and pain in knee arthrofibrosis.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthrofibrosis
• Intervention / Treatment: Procedure: Conventional therapy; Procedure: Instrument Assisted Soft tissue mobilization

Detailed Description

Arthrofibrosis is common condition after surgeries, most of the arthrofibrosis literature addresses arthrofibrosis after arthroplasty or ligamentous reconstruction, and it is replete with manipulation under anesthesia or with arthroscopic interventions or both. Study will be conducted over period of 1 year at fauji foundation hospital.Ethical approval from ERC foundation university medical college. Participants recruited and written inform consent, following which they will be required to complete a self-reported demographic form. The data will be entered and analyzed on SPSS 22. IASTM is simple and effective intervention to improve Rom and functional limitation in patients with knee arthrofibrosis

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asma Malik, MS-MSKPT*; Phone Number: 03025184561; Email: dr.asmamalik014@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Foundation University College of Physical Therapy
      • Contact: Furqan Hassan, MS-OMPT,PHD*; Phone Number: 03334056768

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• post Total knee replacement patients
• Extension lag >10
• Flexion deficit >25
• Age 18_60
• both male and female
• Numeric pain rating scale between 3-5

Exclusion Criteria:

• skin allergy
• Diabetic patient
• Any vascular disease
• Prolonged use of Corticosteroids
• Any infective or active inflammatory condition
• Fracture or dislocation
• Lower extremity functional scale score above 71.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A ( Conventional physiotherapy); 5 min moist Hot pack ,Patellar joint mobilizations and Tibiofemoral ,Maitland grades III and IV (5 oscillations in first week) ,PROMs of knee joint ( 5 reps) ,Quad sets ( 5 reps with 5 sec hold)Progression: 5 repetition of each exercise would be add in every week ,Frequency: 4 sessions in 4-week period Duration: 15_ 35 min each session.	Procedure: Conventional therapy; 5 min moist Hot pack ,Patellar joint mobilizations and Tibiofemoral ,Maitland grades III and IV (5 oscillations in first week) ,PROMs of knee joint ( 5 reps) ,Quad sets ( 5 reps with 5 sec hold)Progression: 5 repetition of each exercise would be add in every week ,Frequency: 4 sessions in 4-week period Duration: 15_ 35 min each session.
Experimental: Group B ( IASTM along with conventional physiotherapy)); rst conventional Physiotherapy same as group A thenIASTM protocol.The treatment processes consist of Four phases: warm up (heat), Graston Technique®, passive stretching and cryotherapy.6_10 long strokes on Hamstring and Rectus femoris by using G1 instrument .Brief bouts (30 - 60 s) of deeper and more specific.Frequency: 4 sessions in 4-week period.Duration: 15_35 min each session.	Procedure: Conventional therapy; 5 min moist Hot pack ,Patellar joint mobilizations and Tibiofemoral ,Maitland grades III and IV (5 oscillations in first week) ,PROMs of knee joint ( 5 reps) ,Quad sets ( 5 reps with 5 sec hold)Progression: 5 repetition of each exercise would be add in every week ,Frequency: 4 sessions in 4-week period Duration: 15_ 35 min each session.; Procedure: Instrument Assisted Soft tissue mobilization; The treatment processes consist of Four phases: warm up (heat), Graston Technique®, passive stretching and cryotherapy.6_10 long strokes on Hamstring and Rectus femoris by using G1 instrument .Brief bouts (30 - 60 s) of deeper and more specific. Frequency: 4 sessions in 4-week period. Duration: 15_35 min each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Extremity Functional Scale	The Lower Extremity Functional Scale (LEFS), developed by the North American Orthopaedic Rehabilitation Research Network, consists of 20 items. Each item is scored from 0 (extreme difficulty/unable to perform activity) to 4 (no difficulty), for a total maximum score of 80 points, which indicates a high functional level. The LEFS scores demonstrated excellent test-retest reliability (intraclass correlation coefficients ranging between 0.85 and 0.99	4 weeks
Knee range of motion	Goniometer use to check range of motion of knee joint.For range of motion, intertester reliability (r = .98; ICC = .99) and validity (r = .97-.98; ICC = .98-.99)	4 weeks
pain intensity	The Numeric pain rating scale is an 11 point scale comprising a number from 0 through 10, 0 indicates no pain and 10 indicates worst imaginable pain	4 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Knee, Arthrofibrosis,IASTM Instrument Assisted Soft Tissue Mobilization,range of motion
• Other Study ID Numbers: FUI/CTR/2023/25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No