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

May 10, 2025 updated by: Nesma Morgan Allam, Cairo University

Impact of Laser Acupuncture on Pain, Range of Motion and Function in Patients With Patellofemoral Pain Syndrome: A Randomized Sham-Controlled Trial

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%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Giza, Egypt, 12111
        • Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: 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
Other: 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
Sham Comparator: 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.
Other: 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
Device: Sham laser acupuncture
Participants will receive laser acupuncture while the device is turned off.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual analogue scale
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Range of motion for knee flexion
Time Frame: 4 weeks
A universal goniometer was used to assess knee flexion while the subject was lying prone. It is an accurate and trustworthy measuring device. It was assessed while resting prone and with the knee extended. While keeping the other foot in touch with the plinth, the patient was instructed to bring the heel of the leg being tested as near to the buttock as feasible. With one arm aligned with the lateral malleolus and the other with the greater trochanter, the fulcrum of the goniometry is situated on the lateral epicondyle of the examined knee. A range of motion of knee flexion ranged from 0-135°. The higher the range, the better the results.
4 weeks
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.
4 weeks
Range of motion for knee extension
Time Frame: 4 weeks
The dominant limbs hip and knee were bent to a 90-degree angle for the first assessment, while the foot was kept in a relaxed position. Knee extension, as demonstrated by Norkin &White with the universal goniometer. The normal ROM for knee extension is 135- 0º. Each person's knee extension range of motion was assessed three times, and the computations employed the arithmetic mean of the three measures. The lower the range, the better the results.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Zeinab Ali Hamada, PhD, Assisstant professor of physical therapy for surgery, Faculty of physical therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB Approval No. 2024-82

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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