NCT07829835

Brief Summary

This study is being conducted to compare two commonly used physical therapy treatments, low-level laser therapy (LLLT) and infrared therapy, for people with a Grade II anterior cruciate ligament (ACL) injury of the knee. A Grade II ACL injury is a partial tear of the ACL, which may cause knee pain, reduced movement, weakness, and difficulty performing daily or physical activities. Rehabilitation is an important part of recovery after this type of injury. Physical therapy may help reduce symptoms and improve knee function and confidence during movement. In this randomized controlled trial, participants with a Grade II ACL injury will be assigned to one of two treatment groups. One group will receive low-level laser therapy along with standard physiotherapy, while the other group will receive infrared therapy along with the same standard physiotherapy program. The low-level laser therapy group will receive laser treatment in addition to exercises used in standard physiotherapy. The infrared therapy group will receive infrared treatment in addition to the same standard physiotherapy exercises. The standard physiotherapy program includes knee range-of-motion exercises, knee isometric strengthening exercises, and light aerobic exercises. Treatment will be provided five days per week for four weeks. Participants will be assessed before treatment and again after completion of the four-week rehabilitation program. The main outcomes of the study include pain intensity and psychological readiness to return to activity following an ACL injury. Pain will be assessed using the Numeric Pain Rating Scale (NPRS), while psychological readiness will be assessed using the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale. Magnetic resonance imaging (MRI) findings will also be considered in relation to the ACL injury. The purpose of this study is to determine whether low-level laser therapy or infrared therapy, when combined with standard physiotherapy, provides greater improvement in patients undergoing rehabilitation for Grade II ACL injury. The findings may help physiotherapists and other health care providers select an appropriate adjunct treatment during ACL rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

April 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 15, 2026

Last Update Submit

September 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity measured by the Numeric Pain Rating Scale (NPRS)

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), a 0-10 scale in which 0 represents no pain and 10 represents the worst imaginable pain. NPRS will be assessed at baseline (week 0) and after completion of the 4-week intervention.

    Baseline (week 0) and after 4 weeks of treatment

Secondary Outcomes (1)

  • Change in psychological readiness to return to sport measured by the ACL-RSI

    Baseline (week 0) and after 4 weeks of treatment

Study Arms (2)

LLLT + Physiotherapy

EXPERIMENTAL

Participants assigned to this group received Low-Level Laser Therapy (LLLT) applied to the knee/ACL region, using an 808 nm wavelength and 150 mW power for 10 minutes, in addition to the standardized physiotherapy protocol. The physiotherapy program included knee isometric strengthening, range of motion exercises, proprioception and balance training, light aerobic conditioning, and manual therapy. Treatment was provided for 40 minutes per session, 5 sessions per week, for 4 weeks.

Device: Low-Level Laser Therapy (LLLT)Other: Standard Physiotherapy

IRT + Physiotherapy

ACTIVE COMPARATOR

Participants assigned to this group received Infrared Therapy (IRT) applied to the knee/ACL region using a 100 W infrared lamp for 10 minutes, in addition to the same standardized physiotherapy protocol. The physiotherapy program included knee isometric strengthening, range of motion exercises, proprioception and balance training, light aerobic conditioning, and manual therapy. Treatment was provided for 40 minutes per session, 5 sessions per week, for 4 weeks.

Device: Infrared Therapy (IRT)Other: Standard Physiotherapy

Interventions

low-Level Laser Therapy was applied to the knee/ACL region using an 808 nm wavelength and 150 mW power for 10 minutes per session, 5 sessions per week for 4 weeks. It was administered in addition to the standardized physiotherapy program..

LLLT + Physiotherapy

Infrared therapy was applied to the knee/ACL region using a 100 W infrared lamp for 10 minutes per session, 5 sessions per week for 4 weeks. It was administered in addition to the standardized physiotherapy program..

IRT + Physiotherapy

The standardized physiotherapy program included knee isometric strengthening, range of motion exercises, proprioception and balance training, light aerobic conditioning, and manual therapy. The program was provided in addition to the assigned treatment intervention for 5 sessions per week for 4 weeks.

IRT + PhysiotherapyLLLT + Physiotherapy

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants aged 15-45 years.
  • Male and female participants.
  • Participants with Grade II ACL injury diagnosed through MRI as prescribed by an orthopedic surgeon or orthopedic physician.
  • MRI findings confirming a partial/Grade II ACL injury following orthopedic referral.
  • Positive results from ACL special tests, including the pivot-shift, anterior drawer, and Lachman tests.
  • Participants with MRI findings consistent with a partial or Grade II ACL injury and clinical symptoms suggestive of ACL instability.
  • Athletes participating in football, soccer, cricket, basketball, volleyball, badminton, or running.
  • OPD patients.

You may not qualify if:

  • Fracture of the affected knee or associated lower-limb fracture.
  • Neurological or systemic disorders.
  • Participants who are not medically cleared for conservative physiotherapy rehabilitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Enzee Clinic

Lahore, Punjab Province, Pakistan

Location

M. Ali Medical Center

Lahore, Punjab Province, Pakistan

Location

Lahore Poly Clinic

Lahore, Pakistan

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Dr Rubab Naqvi

    Superior university Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study uses single blinding, in which the outcome assessor is unaware of the treatment group allocation. Participants and care providers are not reported as masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly allocated into two parallel treatment groups. Group A received Low-Level Laser Therapy (LLLT) combined with standardized physiotherapy, while Group B received Infrared Therapy (IRT) combined with the same standardized physiotherapy protocol. Both groups received treatment during the rehabilitation period, and outcomes were assessed using the specified outcome measures.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 21, 2026

Study Start

April 27, 2026

Primary Completion

September 2, 2026

Study Completion

September 3, 2026

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations