NCT04751253

Brief Summary

The purpose of the study is to compare the effect of different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Status
unknown

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

First Submitted

Initial submission to the registry

January 31, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

February 2, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

January 31, 2021

Last Update Submit

February 10, 2021

Conditions

Keywords

kneeosteoarthritisHILTexercisepainfunction

Outcome Measures

Primary Outcomes (2)

  • visual analogue scale

    pain intensity

    8 weeks

  • The functional disability assessment

    The Western Ontario and McMaster Universities Osteoarthritis Index

    8 weeks

Study Arms (3)

1500 J + exercises

ACTIVE COMPARATOR

consist of 17 patients, they will receive the application of HILT with intensity 1500 J plus exercises.

Device: High Intensity Laser Therapy

3000 J + exercises

ACTIVE COMPARATOR

consist of 17 patients, they will receive the application of HILT with intensity 3000 J plus exercises.

Device: High Intensity Laser Therapy

exercises + sham LASER

SHAM COMPARATOR

consist of 17 patients, they will apply exercises plus sham LASER.

Device: High Intensity Laser Therapy

Interventions

different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.

1500 J + exercises3000 J + exercisesexercises + sham LASER

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957).
  • Aged between 50- 70 years
  • Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees.
  • Body mass index (BMI) ≤30 kg/m2.
  • Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
  • All subjects who will participate in this study will read, sign and date an informed consent form which required by ethical committee of faculty of physical therapy, Cairo university

You may not qualify if:

  • Patients will be excluded if they have the following conditions:
  • History of joint replacement.
  • Symptoms or signs suggestive of another cause of knee pain.
  • Rheumatoid arthritis.
  • Steroid injection or knee surgery (previous six months).
  • acute inflammation around knee joint.
  • Underlying disease such as malignancy.
  • Infection or systemic disease of musculoskeletal system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoarthritisMotor ActivityPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mona M ibrahim, professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 12, 2021

Study Start

February 2, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

February 12, 2021

Record last verified: 2021-02