Laser Acupuncture on Pain, Range of Motion and Function in Patients With Patellofemoral Pain Syndrome

NCT ID: NCT06610981

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-05-01

Brief Summary

Patellofemoral pain syndrome (PFPS) is among the most prevalent forms of knee discomfort. The main complaint is typically anterior knee pain, which gets worse while jumping, bending knee, going up or down stairs, or sitting for long periods of time with bent knee. Teens and early adulthood are commonly affected by patellofemoral pain syndrome, with a higher frequency in females. In healthy general populations, the prevalence of patellofemoral pain syndrome is 22.7%, and in teens, it is 28.9%.

Detailed Description

The treatment goals of patellofemoral pain syndrome are to reduce pain, increase muscle strength, increase flexibility, and correct the patellar movement tract. Conservative methods should be used before invasive methods when treating PFPS. One of the ways that people with PFPS may benefit from improved knee function and long-term pain reduction is by strengthening their quadriceps muscles, which primarily reduce force in the patellofemoral joint. Conservative methods described in the literature include the following: modifying activities; electrophysical modalities like biofeedback; therapeutic ultrasound; neuromuscular electrical stimulation; thermotherapy; interferential current; transcutaneous electrical nerve stimulation (TENS); knee braces; strengthening the hamstring, anterior tibialis, and gluteal muscles; stretching for iliotibial band and lateral retinaculum.

Conditions

Patellofemoral Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (Laser acupuncture group)

Participants will receive Laser acupuncture with energy of 4 J per point for 80 s, with a total dosage of 24 J in each session, 2 times /week for 4 weeks. Additionally, traditional physical therapy program will be conducted to participants in the study group.

Group Type: EXPERIMENTAL

Laser acupuncture

Intervention Type: DEVICE

Laser acupuncture will be used in this study with energy of 4 J per point for 80 s, with a total dosage of 24 J in each session, 2 times /week for 4 weeks

traditional physical therapy

Intervention Type: OTHER

exercise program consisted of stretching for hamstring, gastrocnemius and iliotibial band, and strengthening exercises, which include isometric quadriceps exercises, straight leg raising, lateral straight leg raise, isometric hip adduction and squat to 30° knee flexion, 2 times /week for 4 weeks

Group B (Sham-laser acupuncture group)

Participants will receive the same intervention while the device turned off, in addition to the exercise program consisted of stretching for hamstring, gastrocnemius and iliotibial band, and strengthening exercises, which include isometric quadriceps exercises, straight leg raising, lateral straight leg raise, isometric hip adduction and squat to 30° knee flexion, 2 times /week for 4 weeks.

Group Type: SHAM_COMPARATOR

traditional physical therapy

Intervention Type: OTHER

exercise program consisted of stretching for hamstring, gastrocnemius and iliotibial band, and strengthening exercises, which include isometric quadriceps exercises, straight leg raising, lateral straight leg raise, isometric hip adduction and squat to 30° knee flexion, 2 times /week for 4 weeks

Sham laser acupuncture

Intervention Type: DEVICE

Participants will receive laser acupuncture while the device is turned off.

Interventions

Laser acupuncture

Laser acupuncture will be used in this study with energy of 4 J per point for 80 s, with a total dosage of 24 J in each session, 2 times /week for 4 weeks

Intervention Type: DEVICE

traditional physical therapy

exercise program consisted of stretching for hamstring, gastrocnemius and iliotibial band, and strengthening exercises, which include isometric quadriceps exercises, straight leg raising, lateral straight leg raise, isometric hip adduction and squat to 30° knee flexion, 2 times /week for 4 weeks

Intervention Type: OTHER

Sham laser acupuncture

Participants will receive laser acupuncture while the device is turned off.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with patellofemoral pain syndrome (positive Clarkes sign and Waldron test)
• Age from 18 to 25 years
• Patients suffering from pain which aggravated by prolonged sitting, stair climbing, running, squatting, kneeling, hopping\jumping, overuse activities and relieved by rest for at least 3 months
• Visual analog scale (VAS) greater than 3 points in daily activity
• The ability to participate in the study and follow the treatment schedule.

Exclusion Criteria

• Physiotherapy in the last 12 months
• Intra-articular injection in the last 3 months
• Other knee disorders such as: (osteoarthritis, previous knee surgery, history of knee arthroplasty, or traumatic injury related joint deformity)
• BMI greater than or equal 30
• Pregnancy
• Pacemaker insertion
• Photosensitivity
• History of using oral analgesic or NSAIDs in the previous 4 weeks,
• History of malignancy, psychiatric disorder, mental retardation, neurologic dysfunction, diabetes mellitus, or uncontrolled hypertension.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Morgan Allam

Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeinab Ali Hamada, PhD

Role: STUDY_DIRECTOR

Assisstant professor of physical therapy for surgery, Faculty of physical therapy

Locations

Faculty of Physical Therapy

Giza, Giza Governorate, Egypt

Countries

Egypt

References

Allam NM, Alsirhani H, Alruwaili MB, Dosh DM, Alruwaili HM, Almazyad WH, Toson RA, Elimy DA, El-Sherbiny M, Ibrahim AM, Ebrahim HA, Nosseir N, Eladl MA, Ali ZA. Effect of laser acupuncture on pain, range of motion, and function in patellofemoral pain syndrome: a randomised controlled trial. Front Med (Lausanne). 2025 Jul 15;12:1613197. doi: 10.3389/fmed.2025.1613197. eCollection 2025.

Reference Type: DERIVED

PMID: 40735438 (View on PubMed)

Other Identifiers

IRB Approval No. 2024-82

Identifier Type: -

Identifier Source: org_study_id