Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis

NCT ID: NCT05510648

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-25
• Study Completion Date: 2022-11-25

Brief Summary

The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on range of motion, pain, quality of life, muscle strength and femoral cartilage thickness in patients with knee osteoarthritis.

Detailed Description

Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study.

Conditions

Knee Osteoarthritis; Laser Therapy; Muscle Strength

Study Design

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

Study Groups

High-intensity laser therapy

A total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The hotpack, which is used as a superficial heater, is applied to the knee area for 30 minutes, wrapped in two layers of towels. As analgesic current, conventional TENS is applied to the knee area for 30 minutes with 4 electrodes at 80 Hz frequency, 200 ms current duration. Flow intensity is adjusted according to the patient's tolerance, and the current intensity is increased as the patient's sense of current decreased in the following periods. HILT is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks.

Group Type: ACTIVE_COMPARATOR

high-intensity laser therapy

Intervention Type: OTHER

A total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The patients in the HILT group will be treated with a BTL 6000 brand device (Figure 5) for 3 sessions of high-intensity laser with a power of 10.0 w in the first week, energy density of 12 j/cm², every 25 cm² for 2 minutes in analgesic mode, and 5 sessions in the following 2 weeks. While 6 sessions of .0 w power, energy density of 120 j/cm², each 25 cm² for 10 minutes, will be applied in biostimulant mode for 6 sessions for three weeks, is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks.

sham high-intensity laser therapy

Intervention Type: OTHER

Hotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions.

Sham high-intensity laser therapy

Hotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions.

Group Type: SHAM_COMPARATOR

high-intensity laser therapy

Intervention Type: OTHER

A total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The patients in the HILT group will be treated with a BTL 6000 brand device (Figure 5) for 3 sessions of high-intensity laser with a power of 10.0 w in the first week, energy density of 12 j/cm², every 25 cm² for 2 minutes in analgesic mode, and 5 sessions in the following 2 weeks. While 6 sessions of .0 w power, energy density of 120 j/cm², each 25 cm² for 10 minutes, will be applied in biostimulant mode for 6 sessions for three weeks, is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks.

sham high-intensity laser therapy

Intervention Type: OTHER

Hotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions.

Interventions

high-intensity laser therapy

A total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The patients in the HILT group will be treated with a BTL 6000 brand device (Figure 5) for 3 sessions of high-intensity laser with a power of 10.0 w in the first week, energy density of 12 j/cm², every 25 cm² for 2 minutes in analgesic mode, and 5 sessions in the following 2 weeks. While 6 sessions of .0 w power, energy density of 120 j/cm², each 25 cm² for 10 minutes, will be applied in biostimulant mode for 6 sessions for three weeks, is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks.

Intervention Type: OTHER

sham high-intensity laser therapy

Hotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1-40-70 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more

Exclusion Criteria

1. History of surgery or traumatic injury

2. Inflammatory arthritis

3. History of cancer, bleeding diathesis and psychiatric disease

4. Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events)

5. Hip and ankle problems

6. Participating in another physical therapy program in the last 3 months

7. History of intra-articular injections in the last 6 months

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Banu Ordahan

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

BANU ORDAHAN

Role: PRINCIPAL_INVESTIGATOR

Meram Medical School, Necmettin Erbakan University, Konya, Turkey

Central Contacts

BANU ORDAHAN

Role: CONTACT

banuordahan@gmail.com

5058741256

Other Identifiers

BANU ORDAHAN

Identifier Type: -

Identifier Source: org_study_id