NCT06233955

Brief Summary

Background: Osteoarthritis is a common cause of chronic pain and disability in elderly people. Objective: To evaluate the efficacy of low-level laser therapy (LLLT) in combination with Maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis. Design: Pre-test post-test randomized control trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable knee-osteoarthritis

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

January 23, 2024

Last Update Submit

January 30, 2024

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Visual analogue scale

    Is a bidirectional 10 cm straight line with two labels, that is, "no pain" and "worst possible pain", located at either end of the line. Patients were instructed to draw a vertical mark on the line indicating their pain level where zero mean no pain and 10 means worst imaginable pain

    Four weeks

  • Pressure Algometer

    is a handheld pressure algometer that responds linearly to force application between 0 and 5 Kg and it has a 1-cm2 round rubber tip.

    Four weeks

  • Knee digital goniometry

    Baseline digital absolute + axis TM goniometer was used which consisted of one movable arm and one fixed arm and fulcrum

    Four weeks

Secondary Outcomes (1)

  • Knee injury and osteoarthritis outcome score short form

    Four weeks

Study Arms (3)

Group A

EXPERIMENTAL

Group A received LLLT and Maitland mobilization technique along with conventional physical therapy,

Device: Low Level laser therapyOther: Maitland mobilization technique

Group B

EXPERIMENTAL

received LLLT and conventional physical therapy

Device: Low Level laser therapy

Group C

EXPERIMENTAL

received Maitland mobilization and conventional physical therapy.

Other: Maitland mobilization technique

Interventions

Low Level laser therapyDEVICE

is a non-invasive light source treatment that generates a single wavelength of light. It emits no heat, sound, or vibration. It is also called photobiology or bio-stimulation

Also known as: LLLT
Group AGroup B
Maitland mobilization techniqueOTHER

is a process of examination; assessment and treatment of musculoskeletal disorders by manipulative physiotherapy where a chain of oscillatory joint mobilization grades based on the pathological limit of tissue are used

Group AGroup C

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with proven bilateral Knee OA with age range 50- 65 years according to the American College of Rheumatology criteria.
  • Only patients with X-ray stages II and III osteoarthritis selected according to Kellgren \& Lawrence classification system.
  • BMI equal to or less than 30 . 4- Patients with Knee pain lasted at least 6 months with intensity at least 3 on VAS scale in activities such as going up-and downstairs, sitting and squatting.
  • Patients with normal mental state. 6- Patients who are not participating in physical therapy in the recent 3 months.

You may not qualify if:

  • Patient with history of gout, infection, tumour, autoimmune diseases, trauma or other causes of knee pain or knee deformities.
  • Patient with neurologic dysfunction, or with history of chronic disease that may affect the study.
  • Patient with history of knee intra-articular injection in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Cairo university

Cairo, Dokki, 02, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

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

Study Record Dates

First Submitted

January 23, 2024

First Posted

January 31, 2024

Study Start

July 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

EG(1)