High Intensity Laser and Exercises in Knee OA

NCT ID: NCT04751253

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-02
• Study Completion Date: 2022-01-01

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.

Detailed Description

Adding HILT to the traditional physical therapy program may reduce pain and improve the functional status of the affected joints. This may provide clinicians with an understanding of the different treatment modalities that may improve the quality of life of patients suffering from chronic knee OA. Which may benefit a wide range of individuals affected by this chronic and widespread disease all over the world.

Although little is known about the efficacy or mechanism of action of what has been termed ''high-intensity laser therapy'' using Nd: YAG lasers it has become commercially available in veterinary practice and is being marketed for the treatment of musculoskeletal disease. clinical research specific to Nd: YAG high-intensity laser therapy is required, as it is being used with little supporting evidence.

As there was no evidence about the best protocol for the treatment of knee OA as each study was using different doses, different sites of application, different number of phases, frequency of sessions, and the interval between sessions that make it difficult to have the best results. Specifically, the dosage range in literature was ranged from 1250 to 3000 J as total energy transmitted during one treatment session. The current study is an attempt to answer the question of which dosage of the energy of high-intensity LASER is more effective on pain and functional activities in patients with chronic knee OA at the third degree of osteoarthritis as determined by (Kellgren/Lawrence grading system) as it was recommended that LASER is an ideal treatment for subjects in the later stages of OA .

Conditions

Chronic Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1500 J + exercises

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

Group Type: ACTIVE_COMPARATOR

High Intensity Laser Therapy

Intervention Type: DEVICE

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

3000 J + exercises

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

Group Type: ACTIVE_COMPARATOR

High Intensity Laser Therapy

Intervention Type: DEVICE

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

exercises + sham LASER

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

Group Type: SHAM_COMPARATOR

High Intensity Laser Therapy

Intervention Type: DEVICE

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

Interventions

High Intensity Laser Therapy

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957).

2. Aged between 50- 70 years

3. Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees.

4. Body mass index (BMI) ≤30 kg/m2.

5. Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

6. 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

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mona Mohamed Ibrahim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mona M ibrahim, professor

Role: CONTACT

mona.ibrahiem@cu.edu.eg

+201002992613

Other Identifiers

HILT and Knee OA

Identifier Type: -

Identifier Source: org_study_id