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

NCT07112742 | Enrolling By Invitation DMC

• 1 other identifier: 2025/210
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Thumb Osteoarthritis; Hand Osteoarthritis

Keywords

High Intesity Laser Therapy; Exercise; Hand Osteoarthritis; First Carpometacarpal Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  A 100-mm horizontal line is used, with the two extremes of the parameter to be assessed labeled at each end. The patient is asked to indicate their perceived condition by marking a point or drawing a line on the scale that best reflects their current state. VAS is commonly employed to numerically document pain intensity as well as the patient's subjective global health assessment.

  Patients will be assessed before and after the intervention, and at the 1st and 3rd months following the treatment.

Secondary Outcomes (6)

• Australian Canadian Osteoarthritis Hand Index (AUSCAN)

  Patients will be assessed before and after the intervention, and at the 1st and 3rd months following the treatment.

• Duruöz Hand Index (DHI)

  Patients will be assessed before and after the intervention, and at the 1st and 3rd months following the treatment.

• Functional Index of Hand Osteoarthritis (FIHOA)

  Patients will be assessed before and after the intervention, and at the 1st and 3rd months following the treatment.

• Short Form-36 (SF-36)

  Patients will be assessed before and after the intervention, and at the 1st and 3rd months following the treatment.

• Pinch Strength

  Patients will be assessed before and after the intervention, and at the 1st and 3rd months following the treatment.

Study Arms (2)

High-Intensity Laser Therapy and Exercise

EXPERIMENTAL

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.

Device: High-Intensity Laser Therapy and Exercise

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

ACTIVE COMPARATOR

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.

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

Interventions

High-Intensity Laser Therapy and Exercise 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 and Exercise

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

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

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-08

Locations

TU (1)