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临床试验/NCT07112742
NCT07112742Enrolling By Invitation不适用

Evaluation of Short and Mid Term Effects of High Intensity Laser Therapy and Exercise in Thumb Osteoarthritis

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
48
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: High-Intensity Laser Therapy and Exercise (Device)

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.

干预措施: High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With Exercise (Device)

结局指标

主要结局

Visual Analog Scale (VAS)

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

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.

次要结局

  • 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.)
  • Grip Strength(Patients will be assessed before and after the intervention, and at the 1st and 3rd months following the treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gizem Cengiz

Associate Professor

TC Erciyes University

研究点 (1)

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