Low Level Laser Therapy Versus Short Wave Diathermy in Patients With Anterior Cruciate Ligament Tear

NCT ID: NCT07089459

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-07-15

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.

Detailed Description

Background & Rationale:

Partial anterior cruciate ligament (ACL) tears are frequent orthopedic injuries, particularly among young adults involved in sports requiring rapid pivoting or directional changes. These injuries often result in pain, instability, muscular weakness, and functional limitations. While complete ACL tears often necessitate surgical reconstruction, partial tears are typically managed with conservative approaches such as physiotherapy and adjunctive non-invasive therapies.

Low-Level Laser Therapy (LLLT), or photobiomodulation, is a non-thermal modality that promotes tissue healing through light-induced cellular stimulation. It has shown beneficial effects in reducing inflammation and pain across various musculoskeletal conditions. However, there is limited high-quality evidence evaluating its specific effects on partial ACL injuries or how it compares to widely used modalities like Short Wave Diathermy (SWD).

Study Design and Methodology:

This is a single-blinded, randomized controlled trial enrolling 72 participants aged 20-40 years with MRI-confirmed partial ACL tears. Participants are randomly assigned (n=36 each) into two groups:

Group A (LLLT + SWD + Physiotherapy): Receives Low-Level Laser Therapy in addition to standard physiotherapy and short wave diathermy

Group B (SWD + Physiotherapy): Receives standard physiotherapy and short wave diathermy only

LLLT Protocol:

Wavelength: 830 nm

Power Output: 150 mW

Power Density: 5 W/cm²

Frequency: 2-3 sessions per week for 6 weeks

Application Time: 3-4 minutes per treatment site (targeting multiple anatomical points around the knee)

Standard Physiotherapy for Both Groups:

Exercises: Heel slides, partial knee bends, quadriceps sets, step-ups

Repetitions: 2 sets of 10, with 3-5 second rest intervals

Short Wave Diathermy Protocol (Both Groups):

Frequency: 27.12 MHz

Duration: 20-30 minutes per session

Application: 2-3 sessions over baseline phase

Outcome Measures:

Assessments will be conducted at baseline, 3rd week, and 6th week using validated clinical tools:

Pain: McGill Pain Questionnaire

Muscle Strength: Handheld dynamometer (quadriceps/hamstrings)

Functional Disability: KOOS (Knee Injury and Osteoarthritis Outcome Score)

Blinding and Randomization:

Random allocation via computerized random number generation

Single-blinded: Outcome assessors blinded to group assignment

Ethical Approval and Consent:

Approved by the Ethical Review Committee at the University of Lahore

Informed written consent obtained from all participants

Privacy and confidentiality strictly maintained

Expected Impact:

This study aims to provide evidence on whether LLLT offers superior clinical outcomes in pain relief, strength enhancement, and functional recovery compared to SWD in the conservative management of partial ACL injuries. The findings may help refine treatment protocols, promote cost-effective and non-invasive rehabilitation options, and guide physiotherapists in evidence-based practice.

Conditions

Anterior Cruciate Ligament (ACL) Tear

Study Design

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

Study Groups

Low-Level Laser Therapy

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.

Group Type: EXPERIMENTAL

Low-Level Laser Therapy (LLLT)

Intervention Type: DEVICE

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.

Shortwave therapy

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.

Group Type: ACTIVE_COMPARATOR

Shortwave therapy

Intervention Type: BEHAVIORAL

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.

Interventions

Low-Level Laser Therapy (LLLT)

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.

Intervention Type: DEVICE

Shortwave 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Sana Ali

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Lahore Teaching Hospital

Lahore, , Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 31748973 (View on PubMed)

Other Identifiers

REC-UOL-/505/08/24

Identifier Type: -

Identifier Source: org_study_id