NCT07089459

Brief Summary

This clinical research study is comparing two non-surgical treatments-Low-Level Laser Therapy (LLLT) and Short Wave Diathermy (SWD)-to see which is more effective for people with a partial tear of the anterior cruciate ligament (ACL) in the knee. The ACL is a key ligament that helps keep the knee stable during movement. When partially torn, it can cause pain, weakness, and difficulty with walking or physical activities. LLLT, also called photobiomodulation, is a painless, light-based therapy that helps reduce swelling, relieve pain, and promote healing. SWD is a type of deep heat therapy commonly used in physiotherapy to improve circulation and tissue repair. This study will include 72 patients between 20 and 40 years old who have been diagnosed with a partial ACL tear through MRI. All participants will receive standard physiotherapy exercises and SWD, while half will also receive LLLT. The study aims to find out if adding LLLT can: Reduce knee pain Improve knee muscle strength Help patients perform daily activities more easily Each participant will be monitored for 6 weeks, with check-ins at the start, the 3rd week, and the 6th week. Pain levels, muscle strength, and knee function will be measured using reliable assessment tools. The results of this study may help guide better treatment options for people with ACL injuries who want to avoid surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

July 20, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

Functional DisabilityKnee PainLow-Level Laser TherapyMuscle StrengthPhotobiomodulationShort wave therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Functional Disability Assessed by KOOS

    The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to evaluate functional disability in participants with partial ACL tears. KOOS is a validated, 42-item questionnaire assessing five subscales: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Higher scores indicate better knee function and less disability. The score will be compared between groups over time to determine the effectiveness of LLLT in improving knee function.

    Baseline, 3rd week, and 6th week

Secondary Outcomes (2)

  • Change in Pain Intensity Assessed by McGill Pain Questionnaire

    Baseline, 3rd week, and 6th week

  • Change in Knee Muscle Strength Measured by Handheld Dynamometer

    Baseline, 3rd week, and 6th week

Study Arms (2)

Low-Level Laser Therapy

EXPERIMENTAL

Participants in this arm will receive Low-Level Laser Therapy (LLLT) along with standard physiotherapy exercises and shortwave diathermy. LLLT will be administered 2-3 times per week for 6 weeks using an 830 nm wavelength, 150 mW power output, and 5 W/cm² power density. Standard exercises include heel slides, partial knee bends, quad sets, and step-ups. Shortwave diathermy will be delivered at 27.12 MHz frequency, 20-30 minutes per session. The intervention aims to improve pain, strength, and functional disability in patients with partial ACL tears.

Device: Low-Level Laser Therapy (LLLT)

Shortwave therapy

ACTIVE COMPARATOR

Participants in this arm will receive standard physiotherapy combined with shortwave diathermy (SWD), without the addition of Low-Level Laser Therapy (LLLT). The physiotherapy protocol includes supervised exercises such as heel slides, partial knee bends, quadriceps sets, and step-ups. SWD will be administered 2-3 times using a 27.12 MHz frequency for 20-30 minutes per session. This arm serves as the control group to evaluate the added clinical value of LLLT in the conservative management of partial ACL tears.

Behavioral: Shortwave therapy

Interventions

Low-Level Laser Therapy (LLLT) will be administered using an 830 nm wavelength and 150 mW power output with 5 W/cm² power density. The laser probe will be applied 2-3 times per week for 6 weeks over the affected knee. Treatment is performed using a direct skin contact method with 3-4 minutes of exposure per point around the knee joint. The goal is to reduce inflammation, enhance collagen synthesis, and support ligament healing in patients with partial anterior cruciate ligament (ACL) tears. This intervention is provided in addition to standard physiotherapy and shortwave diathermy.

Low-Level Laser Therapy

Participants in this group will receive standard physiotherapy exercises combined with shortwave diathermy (SWD), without the application of Low-Level Laser Therapy (LLLT). The exercise protocol includes heel slides, supported partial knee bends, quadriceps sets, and step-ups, performed in 2 sets of 10 repetitions with 3-5 second rest intervals. SWD will be delivered 2-3 times, using a 27.12 MHz frequency for 20-30 minutes per session, targeting pain relief and enhanced soft tissue healing. This group functions as an active comparator to assess the additional therapeutic value of LLLT used in the intervention group.

Shortwave therapy

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain in knee lasting more than 15 days (Masiero et al., 2020)
  • Unilateral partial ACL tear diagnosed with positive lachman test and negative pivot shift test (+ve pivot shift leads to complete tear) with or without other ligament tear (Song et al., 2024)
  • No other osteoarticular or soft tissue lesion (Masiero et al., 2020)

You may not qualify if:

  • Patients with tumors or other serious diseases (Song et al., 2024)
  • History of deep vein thrombosis or vascular pathology in any lower limb (Song et al., 2024)
  • Rheumatoid arthritis or other signifcant co-morbidities (Masiero et al., 2020)
  • Intraarticular injections into the knee in the preceding 6 months (Song et al., 2024)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

Location

Related Publications (1)

  • Masiero S, Pignataro A, Piran G, Duso M, Mimche P, Ermani M, Del Felice A. Short-wave diathermy in the clinical management of musculoskeletal disorders: a pilot observational study. Int J Biometeorol. 2020 Jun;64(6):981-988. doi: 10.1007/s00484-019-01806-x. Epub 2019 Nov 20.

    PMID: 31748973BACKGROUND

MeSH Terms

Conditions

Lacerations

Interventions

Low-Level Light TherapyShort-Wave Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyDiathermyHyperthermia, InducedRadiofrequency Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

July 20, 2025

First Posted

July 28, 2025

Study Start

October 15, 2024

Primary Completion

June 19, 2025

Study Completion

July 15, 2025

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations