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RecruitingNCT06172231Updated Dec 15, 2023

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

An interventional study of Instrument Assisted Soft tissue mobilization and Conventional therapy in Knee Arthrofibrosis, sponsored by Foundation University Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Sep 2023, registered Dec 2023).
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Knee Arthrofibrosis

Keywords

  • Knee, Arthrofibrosis,IASTM Instrument Assisted Soft Tissue Mobilization,range of motion
03

In context

Lead sponsor

Foundation University Islamabad is the lead sponsor of 238 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • 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

  • 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: Instrument Assisted Soft tissue mobilization · Procedure: Conventional therapy

Interventions

  • ProcedureInstrument 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.

  • ProcedureConventional 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 weeks

  2. 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)

    Time frame: 4 weeks

  3. 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

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Foundation University College of Physical Therapy
    Rawalpindi, Punjab 46000, Pakistan
    • Furqan Hassan, MS-OMPT,PHD* · Contact · 03334056768
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06172231
Lead sponsor
Foundation University Islamabad
Responsible party
Sponsor
First posted
Dec 15, 2023
Start date
Sep 4, 2023
Primary completion
Jan 1, 2024 (estimated)
Completion
Feb 1, 2024 (estimated)
Last update
Dec 15, 2023

Study contacts

Asma Malik, MS-MSKPT*
Contact
dr.asmamalik014@gmail.com
03025184561

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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