- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293195
Adjunctive Effects of Heat vs Contrast Therapy With Otago Exercises on Patellofemoral Pain Syndrome (PFPS OEP CT HT)
Adjunctive Effects of Heat Versus Contrast Therapy With Otago Exercises on Pain, Swelling, Range of Motion and Functional Limitations in Patients With Patellofemoral Pain Syndrome
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 57000
- Ghurki Trust Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants having age group between 18 and 40 years with anterior, retropatellar, or peripatellar pain with at least severity of 3/10 on the numerical pain rating scale.
Participants who have reported anterior knee pain for at least three months during at least two of the following activities: seating for prolonged periods of time; ascending and descending stairs; squatting; running and jumping, or have had experienced crepitus (popping, or crackling) while walking or running, pain on palpation, insidious pain lasting at least two months.
Positive patellar compression and Grind tests.
Clinical evidence of lateral patellar tracking, given its established role in patellofemoral joint dysfunction.
Pain produced by at least two of the following four tests: (i) isometric muscle contraction with a mild bent knee, (ii) patellofemoral joint line palpation, (iii) compression of patella against the femur and (iv) active resisted knee extension were enrolled in the study.
Exclusion Criteria:
Pain lasting less than three months, previous knee operations, meniscal lesions, patellar instability (subluxation/dislocation), clinical evidence of tendinopathy or ligamentous injury, fractures or dislocations involving the pelvis, spinal surgical history, osteoporosis, pregnancy, neurological diseases or radiological findings of chondromalacia beyond grade 2 on MRI, ultrasound, or X-ray.
Recent participation in lower-limb rehabilitation or structured training within six weeks, or prior diagnoses of rheumatoid arthritis, gout, or other rheumatic knee disorders.
Use of NSAIDs in the preceding four weeks, prior history of cancer, infection, psychiatric conditions, cognitive impairment, autoimmune pathology, or neurological dysfunction likely to interfere with walking ability.
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: Experimental Group: Heat therapy with Otago exercises
Heat Therapy:
Otago Exercise Program:
Routine Physical Therapy (Medial Patellar Mobilization):
|
Heat therapy is a non-surgical technique being recognized for its application in knee pain management.
HT enhances blood flow, alleviates pain, and aids tissue repair.
It have been effective in knee osteoarthritis but have yet to be fully explored for the treatment of PFPS.
Other Names:
Contrast therapy (CT), a commonly used thermal treatment, is gaining attention as a non-invasive option for managing knee pain.
By alternating between heat and cold, CT helps stimulate circulation, reduce swelling, and ease joint stiffness.
While it has shown benefits in other knee conditions, its potential role in treating patellofemoral pain syndrome (PFPS) is still not well established.
|
|
Active Comparator: Active Experimental Group: Contrast therapy with Otago exercises
Contrast Therapy:
Otago Exercise Program:
Routine Physical Therapy (Medial Patellar Mobilization):
|
Heat therapy is a non-surgical technique being recognized for its application in knee pain management.
HT enhances blood flow, alleviates pain, and aids tissue repair.
It have been effective in knee osteoarthritis but have yet to be fully explored for the treatment of PFPS.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Swelling
Time Frame: 4 Weeks
|
Measured by a tape (Girth measurement)
|
4 Weeks
|
|
Range Of Motion
Time Frame: 4 Weeks
|
Measured by a universal goniometer.
|
4 Weeks
|
|
Pain Intensity
Time Frame: 4 Weeks
|
Assessed by using the NPRS scale.
0-4 scored as No pain to mild pain 5-7 scored as Moderate pain 8-10 scored as Severe pain
|
4 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional limtations
Time Frame: 4 Weeks
|
The Oxford Knee Score (OKS), knee pain severity and functional capacity using a scoring system from 0 (most severe impairment) to 48 (full function and no pain).
|
4 Weeks
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCPT/DPT/ERB/31
- U1111-1332-0257 (Registry Identifier: WHO- Universal Trial Number)
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
- CSR
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.
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