Knee ArthrofibrosisNCT06172231
Effects of Instrument Assisted Soft Tissue Mobilization in Addition to Conventional Physiotherapy in Knee Arthrofibrosis
A study testing Instrument Assisted Soft tissue mobilization and Conventional therapy in people with Knee Arthrofibrosis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Knee Arthrofibrosis
- What is being tested?
- Instrument Assisted Soft tissue mobilization and Conventional therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Sep 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Furqan Hassan, MS-OMPT,PHD*, 03334056768
About this study
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
- Conditions
- Knee Arthrofibrosis
- Being tested
- Instrument Assisted Soft tissue mobilization, Conventional therapy
- Keywords
- Knee, Arthrofibrosis,IASTM Instrument Assisted Soft Tissue Mobilization,range of motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft tissue mobilizationProcedure or surgery
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.
Conventional therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Instrument Assisted Soft tissue mobilization; Procedure: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start4 Sep 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthrofibrosisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both group will be recruited concurrently. Both group will receive treatment.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172231
- Sponsor's protocol ID
- FUI/CTR/2023/25
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument Assisted Soft Tissue Mobilization in Addition to Conventional Physiotherapy in Knee Arthrofibrosis
- ClinicalTrials.gov ID
- NCT06172231
- Acronym / sponsor ID
- FUI/CTR/2023/25
- Conditions
- Knee Arthrofibrosis
- Keywords
- Knee, Arthrofibrosis,IASTM Instrument Assisted Soft Tissue Mobilization,range of motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both group will be recruited concurrently. Both group will receive treatment.
| Arm | Type | Receives |
|---|---|---|
| Group A ( Conventional physiotherapy) | Active comparator | Procedure: Conventional therapy5 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 B ( IASTM along with conventional physiotherapy)) | Experimental | Procedure: Instrument Assisted Soft tissue mobilization, Procedure: Conventional therapyrst 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- post Total knee replacement patients
- Extension lag >10
- Flexion deficit >25
- Age 18_60
- both male and female
Key exclusion criteria (7 listed)
- skin allergy
- Diabetic patient
- Any vascular disease
- Prolonged use of Corticosteroids
- Any infective or active inflammatory condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrument Assisted Soft tissue mobilizationThe 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 or surgery | Group B ( IASTM along with conventional physiotherapy)) |
| Conventional therapy5 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 or surgery | Group A ( Conventional physiotherapy), Group B ( IASTM along with conventional physiotherapy)) |
Primary outcome
Lower Extremity Functional Scale
Time frame: 4 weeks
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
Knee range of motion
Time frame: 4 weeks
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)
pain intensity
Time frame: 4 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft tissue mobilization and Conventional therapy in people with Knee Arthrofibrosis, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asma Malik, MS-MSKPT* (03025184561, dr.asmamalik014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Functional Scale (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.