NCT07584603

Brief Summary

This clinical trial will evaluate the effects of High-Intensity Laser Therapy (HILT) on femoral cartilage thickness and other clinical outcomes in people with knee osteoarthritis. Participants aged 40 to 60 years with grade II or III knee osteoarthritis will be randomly assigned to receive either HILT plus conventional physiotherapy or conventional physiotherapy alone. Both groups will receive 12 treatment sessions on alternate days for 4 weeks. The study will assess changes in cartilage thickness using ultrasound, as well as improvements in pain, knee movement, muscle strength, and daily function. Findings from this research may help improve physiotherapy treatment strategies for patients with knee osteoarthritis.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

November 17, 2025

Last Update Submit

May 7, 2026

Conditions

Keywords

High Intensity Laser TherapyKnee OsteoarthritisFemoral Cartilage ThicknessHigh Level Laser TherapyOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Femoral Cartilage Thickness

    Mean change in femoral cartilage thickness (mm) measured by high-frequency musculoskeletal ultrasound at three standardized sites - medial femoral condyle, intercondylar notch, and lateral femoral condyle. The measurement will be performed using a 7-12 MHz linear probe following standardized scanning protocol

    Baseline, Week 4

Secondary Outcomes (5)

  • Pain Intensity

    Baseline, Week 2, Week 4

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Baseline, Week 2, Week 4

  • Knee Range of Motion (ROM)

    Baseline, Week 2, Week 4

  • One-Leg Stance Test

    Baseline, Week 2, Week 4

  • Quadriceps Muscle Strength

    Baseline, Week 2, Week 4

Study Arms (2)

High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy

EXPERIMENTAL

Participants in this group will receive High-Intensity Laser Therapy (HILT) using a Class IV laser (1064 nm wavelength) applied at eight standardized knee points according to WALT guidelines, along with conventional physiotherapy including hot moist pack, joint mobilization, and strengthening exercises. Treatment will be given on alternate days for 4 weeks (12 sessions total).

Device: High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

Participants in this group will receive only conventional physiotherapy, including hot moist pack, patellofemoral and tibiofemoral joint mobilization, and a structured exercise program for quadriceps and hamstrings. Treatment will be given on alternate days for 4 weeks (12 sessions total).

Other: Conventional Physiotherapy

Interventions

Conventional physiotherapy includes hot moist pack application, manual joint mobilization, stretching, and strengthening exercises for quadriceps and hamstrings. Sessions will be held on alternate days for 4 weeks (12 sessions total).

Conventional Physiotherapy

HILT will be administered using a Class IV laser applied perpendicularly at eight standardized knee points. Both analgesic and biostimulation modes will be used.. Sessions will be conducted on alternate days for 4 weeks (12 sessions total).

High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female participants aged 40-60 years.
  • Diagnosed with knee osteoarthritis (Kellgren-Lawrence grade II or III).
  • Knee pain for at least 3 months.
  • Visual Analogue Scale (VAS) score ≥ 3.
  • Willing to provide written informed consent and comply with treatment and follow-up schedule.

You may not qualify if:

  • History of knee surgery or traumatic knee injury.
  • Inflammatory arthritis (e.g., gout, psoriatic arthritis).
  • History of cancer or psychiatric illness.
  • Cognitive disorders (e.g., Parkinson's disease, Alzheimer's disease).
  • Severe comorbidities limiting exercise (e.g., severe COPD, heart failure, cerebrovascular event).
  • Hip or ankle joint disability.
  • Intra-articular knee injection within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Aesthetics and Rejuvenation Center

Lahore, Punjab Province, 55000, Pakistan

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Iqra Waseem, Ph.D Scholar

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is a single-blind study. The outcome assessor will be blinded to group allocation, while the participants and treating physiotherapist will be aware of the intervention assigned
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into two parallel groups: one receiving High-Intensity Laser Therapy (HILT) plus conventional physiotherapy, and the other receiving conventional physiotherapy alone. Each group will receive 12 treatment sessions on alternate days for 4 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

May 13, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

May 10, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations