Splinting vs Exercise in De Quervain's Tenosynovitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKonya Beyhekim Training and Research Hospital

About this trial

De Quervain's disease is a painful tenosynovitis of the abductor pollicis longus and extensor pollicis brevis muscle tendons located in the first dorsal compartment. The primary treatment for De Quervain's disease is conservative; surgical intervention is rarely required. Currently, there is no standardized treatment protocol supported by strong, up-to-date evidence.

The aim of this study is to compare the effectiveness of a static hand-wrist resting splint and exercise therapy in the conservative treatment of De Quervain's tenosynovitis. Patients will be evaluated in terms of pain levels, functional/symptom status, hand-finger strength, pressure pain threshold (PPT), tendon cross-sectional area measured by ultrasound, and the presence of effusion findings (semiquantitative; 0-3), and patient satisfaction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged between 18 and 65 years

Disqualifiers

History of trauma

Trial design

Design model

Parallel

Treatments tested in this trial

  • splint

    Other intervention

    static wrist-hand splint + education on activity modification and positioning in daily life

  • Exercise Therapy

    Other intervention

    Home-based Exercise Therapy + Education on activity modification and positioning in daily life

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Static Hand-Wrist SplintingOther 1 intervention
Group B: Exercise TherapyOther 1 intervention

Trial outcomes

Primary outcomes

1

VAS pain

VAS pain activity and rest: 0 no pain; 10 unbearable/max. pain.

Time frame
baseline, week 2 and week 6
2

Patient Rated Wrist Evaluation( PRWE)

The Patient-Rated Wrist Evaluation (PRWE) is a brief and effective self-report questionnaire that allows patients to assess their own wrist and hand problems. The PRWE consists of two main subscales: the Pain Subscale (0-50 points) and the Function Subscale (0-50 points). The total score ranges from 0 (no disability) to 100 (maximum pain and functional impairment).

Time frame
baseline, week 2 and week 6
3

The Disabilities of the Arm, Shoulder and Hand (DASH)

The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a self-reported outcome measure used to assess the impact of upper extremity disorders on daily activities. It consists of 30 items, each scored on a 5-point Likert scale ranging from 1 (no difficulty) to 5 (unable to perform). The total score ranges from 0 to 100, where 0 indicates no disability and 100 indicates severe functional limitation.

Time frame
baseline, week 2 and week 6

Secondary outcomes

1

Hand grip strength

Hand Grip Strength (HGS): Following the definitions outlined in the literature, HGS will be measured using Jamar hand dynamometers. The patients will be asked to squeeze the dynamometer three times with maximum strength, allowing 30-60 seconds of rest between each attempt. The average force (in pounds/kg) will then be recorded.

Time frame
baseline, week 2 and week 6
2

Finger pinch strength

Finger Pinch Strength (FGS): Following the definitions outlined in the literature, FGS will be measured using Baseline pinch dynamometers. The patients will be asked to squeeze the dynamometer three times with maximum strength, allowing 30-60 seconds of rest between each attempt. The average force (in pounds/kg) will then be recorded.

Time frame
baseline, week 2 and week 6
3

Ultrasonographic evaluation of the first dorsal compartment tendons

Ultrasonographic evaluation of the Abductor Pollicis Longus (APL) Extensor Pollicis Brevis (EPB) will be performed with a LA2-14A transducer /superficial linear probe(Samsung).The patient is seated with the forearm in a neutral position and the palm resting on a flat surface. The wrist is slightly extended to expose the radial side. A high-frequency linear transducer (typically 10-18 MHz) is placed transversely over the radiocarpal joint at the wrist, just proximal to the radial styloid. The first dorsal compartment is visualized in cross-sectional (short axis) view. Both tendons (APL and EPB) appear as oval or round hyperechoic structures within the tendon sheath. Peritendinous edema is assessed semiquantitatively (0-3based on its visual appearance around the tendon.CSA (mm2) measurements will be performed using USG with high sensitivity, reflecting tendon thickening or swelling due to inflammation. The mean of three measurements will be calculated for analysis.

Time frame
Baseline, week 2 and week 6
4

Patient satisfaction

Patient satisfaction (Subjective impression of improvement): Satisfaction levels of patients will be questioned. In the assessment consisting of five clauses with Likert-type scales, the clauses will be described as follows: 1, 'no satisfaction at all'; 2, 'no satisfaction'; 3, neutral (no positive or negative effect); 4, 'satisfied'; and 5, 'very satisfied'.

Time frame
week 2 and week 6

Other outcomes

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