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Thumb OsteoarthritisNCT07112742

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

A study testing High-Intensity Laser Therapy and Exercise and High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With Exercise in people with Thumb Osteoarthritis and Hand Osteoarthritis, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Thumb Osteoarthritis, Hand Osteoarthritis
What is being tested?
High-Intensity Laser Therapy and Exercise and High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2025to 1 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Erciyes University

    Kayseri

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
High-Intensity Laser Therapy and Exercise, High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With Exercise
Keywords
High Intesity Laser Therapy, Exercise, Hand Osteoarthritis, First Carpometacarpal Osteoarthritis
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Intensity Laser Therapy and ExerciseDevice

    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 ExerciseDevice

    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.

Study groups in NCT07112742
Study groupRoleWhat they receive
High-Intensity Laser Therapy and ExerciseExperimentalHigh-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.
Receives: Device: High-Intensity Laser Therapy and Exercise
High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With ExerciseActive comparatorParticipants 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.
Receives: Device: High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)
  1. Australian Canadian Osteoarthritis Hand Index (AUSCAN)

    The AUSCAN Osteoarthritis Hand Index is a validated instrument used to assess the functional status of the hand in individuals with hand osteoarthritis. It evaluates disease-specific health status across three domains: pain (5 items), stiffness (1 item), and physical function (9 items). Patients are asked to report the severity of pain (5 questions; score range: 0-20), stiffness (1 question; score range: 0-4), and functional difficulty (9 questions; score range: 0-36) they have experienced over the past 48 hours. The scale consists of a total of 15 items, with an overall score ranging from 0 to 60. Each item is rated on a 5-point Likert scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.

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

  2. Duruöz Hand Index (DHI)

    The Duruöz Hand Index (DHI) is a self-administered functional disability questionnaire developed in 1996 specifically for the assessment of hand and wrist function in individuals with rheumatoid hand involvement. It consists of 18 items evaluating daily activities related to hand function, including tasks involving cooking, dressing, personal hygiene, office work, and other general activities. Responses are rated using a Likert scale ranging from 0 to 5 (0 = no difficulty, 5 = impossible to perform). The total score ranges from 0 to 90, with higher scores indicating greater functional impairment. Factor analysis of the DHI has identified a four-dimensional structure: activities requiring grip strength, manual dexterity, finger grip strength, and finger dexterity.

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

  3. Functional Index of Hand Osteoarthritis (FIHOA)

    The Functional Index for Hand Osteoarthritis (FIHOA) is a validated questionnaire consisting of 10 items that reflect daily activities requiring hand use. Each item is scored on a 4-point scale ranging from 0 to 3, where 0 indicates no difficulty, 1 = mild difficulty, 2 = considerable difficulty, and 3 = impossible to perform. The total score ranges from 0 to 30. Lower scores indicate better hand function, whereas higher scores reflect greater functional impairment.

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

  4. Short Form-36 (SF-36)

    The Short Form-36 (SF-36) is a widely used health-related quality of life questionnaire composed of 36 items distributed across eight subscales: physical functioning, role limitations due to physical health, role limitations due to emotional problems, bodily pain, social functioning, mental health, vitality, and general health perceptions. It assesses the individual's health status over the past four weeks. Each subscale is scored, and the responses are transformed into a 0 to 100 scale, with 0 representing the worst possible health status and 100 representing the best. The SF-36 also includes two summary component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS is derived from the physical functioning, role-physical, bodily pain, and general health subscales, whereas the MCS is composed of the vitality, social functioning, role-emotional, and mental health subscales.

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

  5. Pinch Strength

    Pinch strength will be assessed using a calibrated pinch gauge (Baseline® Hydraulic Pinch Gauge). The measurement will be performed with the patient seated, the shoulder in adduction and neutral rotation, the elbow flexed at 90°, the forearm in a neutral position, and the wrist positioned between 0°-30° of dorsiflexion and 0°-15° of ulnar deviation. To minimize the effects of fatigue, a one-minute rest interval will be provided between each measurement. The test will be repeated three times, and the mean of the three trials will be recorded.

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

  6. Grip Strength

    Grip strength will be measured using a calibrated hydraulic hand dynamometer (Jamar® Hydraulic Hand Dynamometer). Similar to the pinch strength assessment, a one-minute rest interval will be provided between each trial to minimize fatigue. The measurement will be repeated three times, and the average value will be recorded. During the assessment, the patient will be seated with the shoulder in adduction and neutral rotation, the elbow flexed at 90°, the forearm in a neutral position, and the wrist maintained between 0°-30° of dorsiflexion and 0°-15° of ulnar deviation.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07112742
Sponsor's protocol ID
2025/210
Status last verified
Aug 2025
First submitted
1 Aug 2025
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing High-Intensity Laser Therapy and Exercise and High-Intensity Laser Therapy at a Non-Therapeutic Dose Combined With Exercise in people with Thumb Osteoarthritis and Hand Osteoarthritis, run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: Patients will be assessed before and after the intervention, and at the 1st and 3rd months following the treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

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