NCT06172231

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

December 7, 2023

Last Update Submit

December 14, 2023

Conditions

Knee Arthrofibrosis

Keywords

Knee, Arthrofibrosis,IASTM Instrument Assisted Soft Tissue Mobilization,range of motion

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Group A ( Conventional physiotherapy)

ACTIVE COMPARATOR

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

Group B ( IASTM along with conventional physiotherapy))

EXPERIMENTAL

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: Instrument Assisted Soft tissue mobilizationProcedure: Conventional therapy

Interventions

Instrument Assisted Soft tissue mobilizationPROCEDURE

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.

Group B ( IASTM along with conventional physiotherapy))
Conventional therapyPROCEDURE

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.

Group A ( Conventional physiotherapy)Group B ( IASTM along with conventional physiotherapy))

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Central Study Contacts

Asma Malik, MS-MSKPT*

CONTACT

03025184561dr.asmamalik014@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Both group will be recruited concurrently. Both group will receive treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 15, 2023

Study Start

September 4, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations

PA(1)