Bilateral sensory and motor effects of unilateral combined treatment in patients with carpo-metacarpal osteoarthritis

Bilateral sensory and motor effects of unilateral combined treatment in patients with carpo-metacarpal osteoarthritis: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37143779

Enrollment

Registered

2012-08-09

Start date

2012-01-16

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thumb carpo-metacarpal osteoarthritis Musculoskeletal Diseases Arthrosis of first carpometacarpal joint

Interventions

Treatment group Kaltenborn mobilization: 1. The therapist grasps the right thumb metacarpal bone of the patient with his right thumb-index fingers 2. T

elbow 90-165° extension depending on the tissue resistance 5. The slider intervention was completed over 5-10 minutes in two sets of 5min each with 1min rest between sets

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who used the dominant hand systematically such as ex-factory workers and home workers 2. Diagnosed with secondary thumb carpometacarpal osteoarthritis (CMC OA) in the dominant hand by X-ray detection of stage III and IV according to the Eaton-Littler-Burton Classification

Exclusion criteria

Exclusion criteria: 1. Patients if they scored more than 4 on the Beck?s Depression Inventory and/or more than 30 on the State Trait Anxiety Inventory (STAI) 2. Patients with a medical history of carpal tunnel syndrome, arthritis, surgical interventions on the thumb CMC joint, or D?Quervain?s tenosynovitis 3. Patients presenting degenerative or non-degenerative neurological conditions in which pain perception was altered

Design outcomes

Primary

Measure	Time frame
1. Mechanical pain sensitivity: 1.1. Pain sensitivity was determined by measuring pressure pain threshold (PPT) 1.2. Measurements were performed with a Mechanical Pressure Algometer (Wagner Instruments, Greenwich, Connecticut, USA) with a 1cm2 rubber-tipped plunger mounted on a force transducer was used for measuring PPT 1.3. Pressure was applied at a rate of 30 kPa/s 1.4. The mean of three measurements was calculated and used for the main analysis 1.5. Previous papers have reported an intraexaminer reliability of this procedure ranging from 0.6 to 0.97, while the interexaminer reliability ranged from 0.4 to 0.98 1.6. The following points were evaluated: 1.6.1. TM joint at the bottom of the anatomical snuffbox, tubercle of the scaphoid bone and unciform apophysis of the hamate bone 1.6.2. Three measurements were made with a one-minute pause between them 1.6.3. Although pain from deep tissue is difficult to assess precisely, PPT have been found useful in assessing pain reactions in OA patients 2. Pain evaluation: 2.1. The main outcome of the study was pain intensity 2.2. The intensity of thumb CMC joint pain was assessed with a 100mm visual analogue scale (VAS) 2.3. The VAS is a 100mm line anchored with a 0 at one end representing no pain and 100 at the other end representing the worst pain imaginable. 2.4. The VAS was selected as the main outcome measure based on its ability to detect changes with a minimal clinically important difference (MCID) ranging from 9 to 11 mm 3. Motor performance: 3.1. Pinch strength 3.1.1. The pinch strength was evaluated with a mechanical pinch gauge (Baseline, NY, USA) in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90°	—

Measure

Time frame

1. Mechanical pain sensitivity: 1.1. Pain sensitivity was determined by measuring pressure pain threshold (PPT) 1.2. Measurements were performed with a Mechanical Pressure Algometer (Wagner Instruments, Greenwich, Connecticut, USA) with a 1cm2 rubber-tipped plunger mounted on a force transducer was used for measuring PPT 1.3. Pressure was applied at a rate of 30 kPa/s 1.4. The mean of three measurements was calculated and used for the main analysis 1.5. Previous papers have reported an intraexaminer reliability of this procedure ranging from 0.6 to 0.97, while the interexaminer reliability ranged from 0.4 to 0.98 1.6. The following points were evaluated: 1.6.1. TM joint at the bottom of the anatomical snuffbox, tubercle of the scaphoid bone and unciform apophysis of the hamate bone 1.6.2. Three measurements were made with a one-minute pause between them 1.6.3. Although pain from deep tissue is difficult to assess precisely, PPT have been found useful in assessing pain reactions in OA patients 2. Pain evaluation: 2.1. The main outcome of the study was pain intensity 2.2. The intensity of thumb CMC joint pain was assessed with a 100mm visual analogue scale (VAS) 2.3. The VAS is a 100mm line anchored with a 0 at one end representing no pain and 100 at the other end representing the worst pain imaginable. 2.4. The VAS was selected as the main outcome measure based on its ability to detect changes with a minimal clinically important difference (MCID) ranging from 9 to 11 mm 3. Motor performance: 3.1. Pinch strength 3.1.1. The pinch strength was evaluated with a mechanical pinch gauge (Baseline, NY, USA) in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90°

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Secondary

Measure	Time frame
1. The Beck Depression Inventory (BDI) 1.1. Review of internal consistency for the BDI ranges from 0.73 to 0.92, with a mean of 0.86, with alpha coefficients of 0.86 and 0.81 for psychiatric and non-psychiatric populations, respectively 1.2. The BDI observed showed high discrimination of depressive symptoms (75-100%) 2. State-Trait Anxiety Inventory (STAI) 2.1. This is a self rated questionnaire divided in two parts: anxiety-trait (referring to personality aspects) and anxiety-state (referring to systemic aspects of the context) 2.2. Responses are in a 1-4 scale 2.3. Anxiety-state refers to how individuals feel ?at the moment? and anxiety-trait to how they ?generally feel? 2.4. Each part varies from 20 to 80 points, and the scores indicate low (0-30), medium (31-49) or high (50 or more) anxiety levels Measurements were taken before intervention and after 1 and 2 months.	—

Measure

Time frame

1. The Beck Depression Inventory (BDI) 1.1. Review of internal consistency for the BDI ranges from 0.73 to 0.92, with a mean of 0.86, with alpha coefficients of 0.86 and 0.81 for psychiatric and non-psychiatric populations, respectively 1.2. The BDI observed showed high discrimination of depressive symptoms (75-100%) 2. State-Trait Anxiety Inventory (STAI) 2.1. This is a self rated questionnaire divided in two parts: anxiety-trait (referring to personality aspects) and anxiety-state (referring to systemic aspects of the context) 2.2. Responses are in a 1-4 scale 2.3. Anxiety-state refers to how individuals feel ?at the moment? and anxiety-trait to how they ?generally feel? 2.4. Each part varies from 20 to 80 points, and the scores indicate low (0-30), medium (31-49) or high (50 or more) anxiety levels Measurements were taken before intervention and after 1 and 2 months.

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026