Anterior Cruciate Ligament (ACL) TearNCT07089459
Low Level Laser Therapy Versus Short Wave Diathermy in Patients With Anterior Cruciate Ligament Tear
A study testing Low-Level Laser Therapy (LLLT) and Shortwave therapy in people with Anterior Cruciate Ligament (ACL) Tear, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear
- What is being tested?
- Low-Level Laser Therapy (LLLT) and Shortwave therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Low-Level Laser Therapy (LLLT), Shortwave therapy
- Keywords
- Functional Disability, Knee Pain, Low-Level Laser Therapy, Muscle Strength, Photobiomodulation, Short wave therapy
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser Therapy (LLLT)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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Shortwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3rd week, and 6th week
Secondary outcomes (2)
Change in Pain Intensity Assessed by McGill Pain Questionnaire
Pain intensity will be measured using the McGill Pain Questionnaire, a multidimensional tool that assesses sensory, affective, and evaluative aspects of pain through 78 descriptors. The total pain rating index will be calculated based on participant responses. A reduction in the score will indicate decreased pain severity.
Measured: Baseline, 3rd week, and 6th week
Change in Knee Muscle Strength Measured by Handheld Dynamometer
Knee extensor and flexor muscle strength will be assessed using a handheld dynamometer. Participants will perform isometric contractions while force output is measured in Newtons. Improvements in strength values over time will indicate muscular recovery.
Measured: Baseline, 3rd week, and 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Oct 2024
- Primary completion19 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Ali, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089459
- Sponsor's protocol ID
- REC-UOL-/505/08/24
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31748973
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Therapy Versus Short Wave Diathermy in Patients With Anterior Cruciate Ligament Tear
- ClinicalTrials.gov ID
- NCT07089459
- Acronym / sponsor ID
- REC-UOL-/505/08/24
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Keywords
- Functional Disability, Knee Pain, Low-Level Laser Therapy, Muscle Strength, Photobiomodulation, Short wave therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser Therapy | Experimental | Device: Low-Level Laser Therapy (LLLT)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. |
| Shortwave therapy | Active comparator | Behavioral: Shortwave therapyParticipants 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Low-Level Laser Therapy |
| Shortwave therapyParticipants 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. | Behavioural | Shortwave therapy |
Primary outcome
Change in Functional Disability Assessed by KOOS
Time frame: Baseline, 3rd week, and 6th week
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.
2 secondary outcomes
Change in Pain Intensity Assessed by McGill Pain Questionnaire
Time frame: Baseline, 3rd week, and 6th week
Change in Knee Muscle Strength Measured by Handheld Dynamometer
Time frame: Baseline, 3rd week, and 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 31748973Masiero 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.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament (ACL) Tear
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy (LLLT) and Shortwave therapy in people with Anterior Cruciate Ligament (ACL) Tear, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Disability Assessed by KOOS (time frame: Baseline, 3rd week, and 6th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07089459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.