Splinting vs Exercise in De Quervain's Tenosynovitis

NCT06995534 | Recruiting

• 1 other identifier: KonyaBeyhekimTRH2023/4689
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Splints; Exercise Therapy; De Quervains Tenosynovitis; Pain Management; Ultrasonographic

Keywords

pain; De Quervains Tenosynovitis; exercise therapy; splints; Ultrasonographic

Outcome Measures

Primary Outcomes (3)

• VAS pain

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

  baseline, week 2 and week 6

• 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).

  baseline, week 2 and week 6

• 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.

  baseline, week 2 and week 6

Secondary Outcomes (4)

• Hand grip strength

  baseline, week 2 and week 6

• Finger pinch strength

  baseline, week 2 and week 6

• Ultrasonographic evaluation of the first dorsal compartment tendons

  Baseline, week 2 and week 6

• Patient satisfaction

  week 2 and week 6

Study Arms (2)

Static Hand-Wrist Splinting

OTHER

Other: splint

Exercise Therapy

OTHER

Other: Exercise Therapy

Interventions

splint OTHER

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

Static Hand-Wrist Splinting

Exercise Therapy OTHER

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

Exercise Therapy

Eligibility Criteria

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

You may qualify if:

• Adults aged between 18 and 65 years
• Patients experiencing wrist pain and tenderness for less than 3 months and clinically diagnosed with acute or subacute De Quervain's tenosynovitis
• Visual Analog Scale (VAS) pain score ≥ 3

You may not qualify if:

• History of trauma
• Wrist fractures
• Local infection
• Presence of rheumatologic diseases (e.g., rheumatoid arthritis, psoriatic arthritis)
• Presence of symptomatic hand osteoarthritis
• Continuous use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids
• Receipt of physical therapy for the hand or wrist within the past 3 months
• Corticosteroid injection into the hand or wrist within the past 3 months
• Diagnosed with significant neurological disorders (e.g., upper motor neuron disease)
• Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, congestive heart failure, chronic kidney disease, hepatic failure)
• Major psychiatric disorders
• Communication difficulties

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead

Study Sites (1)

Konya Beyhekim Training and Research Hospital

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

De Quervain Disease; Agnosia; Pain

Interventions

Splints; Exercise Therapy

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Eda Ünal Madıoğlu(MD)

CONTACT

905530970738; ade.1997.lanu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: Other: Static Wrist-Hand Resting Splint (Thumb Spica Splint) Other: Exercise Therapy

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 29, 2025
• Study Start: May 29, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)