NCT06610981

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 13, 2025

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 17, 2024

Last Update Submit

May 10, 2025

Conditions

Keywords

laser acuouncturefunctionpainrange of motion

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    The visual analogue scale represents the pain range that a patient thinks they might experience. The line is typically 10 centimetres long, with or without markings at each centimetre serves as a representation of the range. The worst pain the patient could possibly envision is represented by one end, while; no pain; is represented by the other. The patient marks the scale by drawing a line on it to indicate the amount of discomfort they are experiencing from 0-10. Higher scores represent worse pain.

    4 weeks

Secondary Outcomes (3)

  • Range of motion for knee flexion

    4 weeks

  • Function of knee joint

    4 weeks

  • Range of motion for knee extension

    4 weeks

Study Arms (2)

Group A (Laser acupuncture group)

EXPERIMENTAL

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.

Device: Laser acupunctureOther: traditional physical therapy

Group B (Sham-laser acupuncture group)

SHAM COMPARATOR

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.

Other: traditional physical therapyDevice: Sham laser acupuncture

Interventions

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

Group A (Laser acupuncture group)

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 A (Laser acupuncture group)Group B (Sham-laser acupuncture group)

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

Group B (Sham-laser acupuncture group)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, Giza Governorate, 12111, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Patellofemoral Pain SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zeinab Ali Hamada, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 24, 2024

Study Start

October 1, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

May 13, 2025

Record last verified: 2024-09

Locations