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NCT Number: NCT07655258

High-Intensity Laser Acupuncture for Treating Patellofemoral Pain Syndrome

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%.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patellofemoral pain syndrome (PFPS) is a common cause of anterior knee pain that limits activities such as stair climbing, squatting, running, and prolonged sitting, leading to reduced function and participation (Crossley et al., 2016; Gaitonde et al., 2019). Exercise therapy is considered a key conservative treatment, especially combined hip and knee exercises, but additional non-invasive modalities may help improve pain relief and recovery (Collins et al., 2018). Laser acupuncture provides non-invasive stimulation of acupuncture points and may offer analgesic and functional benefits without needle insertion. Recent studies suggest that laser acupuncture and high-intensity laser therapy may improve pain and function in patients with PFPS (Ozlu et al., 2024). Therefore, this study aims to evaluate the effect of high-intensity laser acupuncture on pain, knee function, and patient satisfaction in patients with PFPS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

high-intensity laser acupuncture and Exercise therapy program

Device

The experimental group will receive high-intensity lasers and the treatment will be applied at over six points (ST34, ST 35, GB34, EX-LE4, SP9, and SP10) Exercise therapy 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, 3 times /week for 4 weeks

Other names: high-power laser acupuncture

Sham laser acupuncture

Other

Sham laser acupuncture and exercise therapy Program. Exercise therapy 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, 3 times /week for 4 weeks

Primary outcomes

  1. Pain Intensity

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Function of knee joint

    Time frame: 4 weeks

    A scale known as Kujala patellofemoral score will be used for assessment of the function of the patellofemoral pain syndrome. The scores of this rating system vary from 100 (a normal, painless, totally functional knee) to 0 (severe pain and dysfunction in the knee). Haddad et al. conducted research on the validity and reliability of the Arabic version of the scale. The greater the scores, the better the results.

  2. patient Satisfaction

    Time frame: 4 weeks

    The satisfaction VAS will be used to measure patient satisfaction. The patient will be by placing an indicator at 0 to100 milliliters line. Zero usually represents 'no satisfaction at all' whereas the upper limit represents 'the best satisfaction ever'.

Study contacts

Contact information is provided by the study sponsor or research team.

Doaa A Elimy, lecturer

CONTACT

[email protected]

00201066474654

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

High-Intensity Laser Acupuncture for Treating Patellofemoral Pain Syndrome: Impact on Pain, Function, and Patient Satisfaction

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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