Evaluation of the Effects of High Intensity Laser Therapy and Exercise in Hand Thumb Osteoarthritis

NCT ID: NCT07112742

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-08-01

Brief Summary

One of the standard treatment methods in individuals with thumb osteoarthritis (OA) is exercise. Combination therapy options involving these exercises can be applied to patients. It has been demonstrated that high-intensity laser therapy is effective in terms of pain and function in patients with thumb OA.

The aim of this study is to investigate the effects of an exercise program combined with high-intensity laser therapy on pain, function, and muscle strength in patients with first carpometacarpal (CMC) joint osteoarthritis.

Detailed Description

First carpometacarpal (CMC) joint osteoarthritis (OA) is a common degenerative disease of the hand that causes severe pain, stiffness, weakness, and increased functional loss. It is based on joint degeneration involving articular surface deterioration, osteophyte formation, and ligamentous laxity. It is a prevalent condition in the aging population and can significantly affect hand function. The disease affects approximately 7% of men and 15% of women over the age of 50. First CMC joint OA can lead to pain and deformity at the base of the thumb, resulting in limitations in activities of daily living. Consequently, in the chronic stages of the disease, patients may experience decreased neuromuscular control of the joint, subluxation of the thumb, and adduction contracture.

The primary goals in the treatment of first CMC joint OA are to reduce pain and stiffness by improving hand function and functional capacity. Accordingly, patients are often referred to rehabilitation programs that include occupational and physical therapy interventions. High-quality studies on the conservative management of first CMC joint OA are limited. The current literature suggests that orthotic applications and intra-articular hyaluronate or steroid injections provide only partial therapeutic effects. Exercise therapy combined with patient education has been reported to be effective in the management of hand OA. Recent reviews indicate that therapeutic exercises combined with manual therapy and orthotic use may be effective in reducing pain and improving function in the short term in first CMC joint OA.

Laser therapy is a non-invasive treatment method that, through its photobiomodulation effect on cells and tissues, helps increase the rate of healing and supports tissue repair, while also reducing inflammation and alleviating pain. Although low-level laser therapy has been studied in individuals with first CMC joint OA and shown to be effective on grip strength, it has not been found to be more effective than placebo in terms of pain reduction. In another study, high-intensity laser therapy applied alone to the first CMC joint showed short-term effects on pain, but its effectiveness decreased in follow-up assessments. A study on knee osteoarthritis demonstrated that an exercise program combined with high-intensity laser therapy was more beneficial.

The hypothesis of this study is that combining high-intensity laser therapy with exercise therapy will be more effective in reducing pain over the long term in patients with first CMC joint OA.

Exercise programs have no known side effects. Possible side effects of laser therapy include erythema, hypoesthesia, hyperesthesia, petechiae, and thermal hypersensitivity. Detailed descriptions of the exercise protocol, high-intensity laser therapy protocol, and references are provided in the research protocols.

Conditions

Thumb Osteoarthritis; Hand Osteoarthritis

Study Design

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

Study Groups

High-Intensity Laser Therapy and Exercise

High-intensity laser therapy will be applied to the painful and affected joint of the participants. A Class IV high-intensity laser device will be used. The parameters to be applied have been determined based on the relevant guidelines: average power 3 W, in analgesic mode, wavelength of 1064 nm, frequency of 2 Hz, energy dose of 75 J per session, spot size of 5 cm², and treatment will be administered three times per week for a total of 4 weeks. The total treatment duration will be 160 seconds. A standard exercise program including range of motion, stretching, and strengthening exercises will be administered to the participant during the treatment sessions. Strengthening exercises will be performed using a therapy ball to improve grip and pinch strength.

Group Type: EXPERIMENTAL

High-Intensity Laser Therapy and Exercise

Intervention Type: DEVICE

High-intensity laser therapy will be applied to the painful and affected joint of the participants. A Class IV high-intensity laser device will be used. The parameters to be applied have been determined based on the relevant guidelines: average power 3 W, in analgesic mode, wavelength of 1064 nm, frequency of 2 Hz, energy dose of 75 J per session, spot size of 5 cm², and treatment will be administered three times per week for a total of 4 weeks. The total treatment duration will be 160 seconds. A standard exercise program including range of motion, stretching, and strengthening exercises will be administered to the participant during the treatment sessions. Strengthening exercises will be performed using a therapy ball to improve grip and pinch strength.

High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With Exercise

Participants will receive high-intensity laser therapy at an ineffective dose to the painful and affected joint. The same device as in the intervention group will be used. Due to the absence of a placebo mode in the laser device used in hospital, the lowest possible parameters will be applied to simulate an ineffective dose. For the ineffective dose, the device parameters will be set as follows: average power 0.5 W, in analgesic mode, wavelength of 1064 nm, frequency of 1 Hz, energy dose of 12 J per session, spot size of 5 cm², and treatment will be administered three times per week for a total of 4 weeks. The treatment duration will be the same as that of the intervention group. A standard exercise program including range of motion, stretching, and strengthening exercises will be administered to the participant during the treatment sessions. Strengthening exercises will be performed using a therapy ball to improve grip and pinch strength.

Group Type: ACTIVE_COMPARATOR

High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With Exercise

Intervention Type: DEVICE

Participants will receive high-intensity laser therapy at an ineffective dose to the painful and affected joint. Due to the absence of a placebo mode in the laser device used in hospital, the lowest possible parameters will be applied to simulate an ineffective dose. For the ineffective dose, the device parameters will be set as follows: average power 0.5 W, in analgesic mode, wavelength of 1064 nm, frequency of 1 Hz, energy dose of 12 J per session, spot size of 5 cm², and treatment will be administered three times per week for a total of 4 weeks. The treatment duration will be the same as that of the intervention group. A standard exercise program including range of motion, stretching, and strengthening exercises will be administered to the participant during the treatment sessions. Strengthening exercises will be performed using a therapy ball to improve grip and pinch strength.

Interventions

High-Intensity Laser Therapy and Exercise

High-intensity laser therapy will be applied to the painful and affected joint of the participants. A Class IV high-intensity laser device will be used. The parameters to be applied have been determined based on the relevant guidelines: average power 3 W, in analgesic mode, wavelength of 1064 nm, frequency of 2 Hz, energy dose of 75 J per session, spot size of 5 cm², and treatment will be administered three times per week for a total of 4 weeks. The total treatment duration will be 160 seconds. A standard exercise program including range of motion, stretching, and strengthening exercises will be administered to the participant during the treatment sessions. Strengthening exercises will be performed using a therapy ball to improve grip and pinch strength.

Intervention Type: DEVICE

High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With Exercise

Participants will receive high-intensity laser therapy at an ineffective dose to the painful and affected joint. Due to the absence of a placebo mode in the laser device used in hospital, the lowest possible parameters will be applied to simulate an ineffective dose. For the ineffective dose, the device parameters will be set as follows: average power 0.5 W, in analgesic mode, wavelength of 1064 nm, frequency of 1 Hz, energy dose of 12 J per session, spot size of 5 cm², and treatment will be administered three times per week for a total of 4 weeks. The treatment duration will be the same as that of the intervention group. A standard exercise program including range of motion, stretching, and strengthening exercises will be administered to the participant during the treatment sessions. Strengthening exercises will be performed using a therapy ball to improve grip and pinch strength.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with stage I, II, or III carpometacarpal joint osteoarthritis in their dominant hand based on radiographic findings according to the Eaton-Littler-Burton classification system
• Patients experiencing pain equal to or greater than 4 on the Visual Analog Scale during activities of daily living
• Patients who agree to complete the provided clinical evaluation scales to assess treatment efficacy and who can sign the informed consent form

Exclusion Criteria

• Patients with a history of neurological diseases affecting the upper extremity
• Patients with a history of rheumatological diseases
• Patients who have received any treatment for hand problems (including intra-articular joint injections) within the last six months
• Patients with severe hand and wrist injuries (such as fractures)
• Patients with a surgical history related to the thumb
• Patients diagnosed with hand or finger tenosynovitis, Dupuytren's disease, or Carpal Tunnel Syndrome
• Patients with conditions contraindicating laser therapy (cardiac pacemaker, cancer, pregnancy, uncontrolled diabetes mellitus, uncontrolled hypertension)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Gizem Cengiz

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erciyes University

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2025/210

Identifier Type: -

Identifier Source: org_study_id