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

NCT05510648 | Unknown

• 1 other identifier: BANU ORDAHAN
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis; Laser Therapy; Muscle Strength

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3

  Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.

  Baseline and month 3

Secondary Outcomes (5)

• Knee joint range of motion Change from baseline in knee joint on the measuring the range of motion at knee joint at month 3

  Baseline and month 3

• Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3

  Baseline and month 3

• SF-36 quality of life scale Change from baseline in physical and mental functions on SF-36 quality of life scale at month 3

  Baseline and month 3

• Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month 3

  Baseline and month 3

• Isokinetic muscle strength measurement Change from baseline in knee joint on the measuring the isokinetic muscle strength at month 3

  Baseline and month 3

Study Arms (2)

High-intensity laser therapy

ACTIVE COMPARATOR

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.

Other: high-intensity laser therapy; Other: sham high-intensity laser therapy

Sham high-intensity laser therapy

SHAM COMPARATOR

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.

Other: high-intensity laser therapy; Other: sham high-intensity laser therapy

Interventions

high-intensity laser therapy 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.

High-intensity laser therapy; Sham high-intensity laser therapy

sham high-intensity laser therapy 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.

High-intensity laser therapy; Sham high-intensity laser therapy

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of surgery or traumatic injury
• Inflammatory arthritis
• History of cancer, bleeding diathesis and psychiatric disease
• Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events)
• Hip and ankle problems
• Participating in another physical therapy program in the last 3 months
• History of intra-articular injections in the last 6 months

Sponsors & Collaborators

• Necmettin Erbakan University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• BANU ORDAHAN

  Meram Medical School, Necmettin Erbakan University, Konya, Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BANU ORDAHAN

CONTACT

5058741256; banuordahan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: September 25, 2022
• Primary Completion: September 25, 2022
• Study Completion: November 25, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09