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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06439251
Other study ID # REC-UOL-546-10-2023
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 18, 2023
Est. completion date October 2024

Study information

Verified date May 2024
Source University of Lahore
Contact Zunaira Saeed, Masters
Phone +923024728701
Email zunairasaeed444@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women. the effectiveness of Mulligan technique with or without diclofenac phonophoresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome is known little. This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises will be administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) will be assessed by a blinded assessor at baseline and study completion.


Description:

Background: The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women without any structural changes such as increased Q-angle or significant pathological changes in articular cartilage. Objective: To evaluate the effectiveness of Mulligan technique with or without diclofenac phonopheresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome. Methodology: This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises were administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) were assessed by a blinded assessor at baseline and study completion.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date October 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - • Patients of age range 20-45 years and both genders (Rehman, 2021 #171) - Unilateral anterior knee pain persisting for over two months, referred by orthopedic (Rehman, 2021 #171) - Pain scoring rate on numeric pain rating scale (NPRS) >3 during at least two activities (Rehman, 2021 #171) - Patients with positive Clarke's test/ Patellar grind test (Rehman, 2021 #171) - Pain while going up and down stairs, when sitting with knees flexed and with squatting, kneeling or returning from squat. (Powers, 2017 #172) Exclusion Criteria: - • Patients with other knee pathologies; meniscus tears, bursitis, patellar tendon injury, ligamentous injury - Degenerative joint disorders; knee osteoarthritis, rheumatoid arthritis etc. - Patellofemoral dislocation and / or frequent subluxation. - Patients having undergone lower extremity surgery - Those taking any pain medications

Study Design


Intervention

Combination Product:
Group 1
The treatment included TENS therapy, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques. Participants in Group A also received Phonophoresis as an experimental technique.
Group 2
The treatment included routine physiotherapy with TENS, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques.

Locations

Country Name City State
Pakistan Lahore General Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). 4 weeks
Primary KOOS-PF Scale KOOS-PF is a subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that specifically measures symptoms and function related to patellofemoral pain and osteoarthritis. It was developed to provide a more detailed assessment in this specific knee condition. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. This direction, 100 indicating no problems. 4 weeks
Primary Universal Goniometer It has a scale for the measurement of the angle. The scale can extend from 0 to 180 degrees for half-circle models or 0 to 360 degrees for full-circle models. 4 weeks
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