SplintsNCT06995534
Splinting vs Exercise in De Quervain's Tenosynovitis
A study testing splint and Exercise Therapy in people with Splints and Exercise Therapy, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Splints, Exercise Therapy, De Quervains Tenosynovitis
- What is being tested?
- splint and Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2025to 30 Apr 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
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, 1 recruiting
- Recruiting
Konya Beyhekim Training and Research Hospital
Konya
About this study
Official title: Comparison of Static Hand-Wrist Splinting and Exercise Therapy in the Management of De Quervain's Tenosynovitis
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.
Read the detailed description
Patients who meet the inclusion and exclusion criteria will undergo a detailed clinical examination and medical history review, after which written informed consent will be obtained. They will then be randomly assigned to one of the two treatment groups using block randomization.
Baseline sociodemographic data (age, sex, body mass index, employment status, education level, marital status) and clinical variables (dominant hand, symptom duration, comorbidities, affected hand, presence of the Finkelstein sign, pain severity, functional/symptom status, hand-finger strength, pressure pain threshold (PPT), and ultrasonographic findings) will be recorded.
Patients in the first group will be provided with a static wrist-hand resting splint with thumb support, extending to the distal forearm. They will be instructed to wear the splint for at least 6-8 hours per day for a minimum of 4 weeks. Additionally, both groups will receive training on activity modification and positioning.
Patients in the second group will be given a home exercise program. They will perform the exercises twice daily for 6 weeks, with each exercise consisting of 10 repetitions. All patients will be evaluated at baseline, at the second week of treatment, and at the end of the sixth week.
Outcome measures will include clinical examination findings (Finkelstein test), pain severity [Visual Analog Scale (VAS) at rest and during activity], the Turkish versions of the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire, Health Assessment Questionnaire (HAQ), and Patient-Rated Wrist Evaluation (PRWE), patient satisfaction, handgrip and finger pinch strength measurements, and pain pressure threshold using an algometer.
Ultrasound evaluations of the abductor pollicis longus and extensor pollicis brevis tendons in the first dorsal compartment including the measurement of the cross-sectional area (csa) will be performed at baseline, week 2, and week 6.
All assessments will be conducted by the same blinded investigator who is unaware of the group allocations
- Being tested
- splint, Exercise Therapy
- Keywords
- pain, De Quervains Tenosynovitis, exercise therapy, splints, Ultrasonographic
- Medical subject headings
- De Quervain Disease, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splintOther
static wrist-hand splint + education on activity modification and positioning in daily life
Exercise TherapyOther
Home-based Exercise Therapy + Education on activity modification and positioning in daily life
| Study group | Role | What they receive |
|---|---|---|
| Static Hand-Wrist Splinting | Other | Not described Receives: Other: splint |
| Exercise Therapy | Other | Not described Receives: Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain
VAS pain activity and rest: 0 no pain; 10 unbearable/max. pain.
Measured: 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).
Measured: 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.
Measured: baseline, week 2 and week 6
Secondary outcomes (4)
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.
Measured: baseline, week 2 and week 6
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.
Measured: baseline, week 2 and week 6
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.
Measured: Baseline, week 2 and week 6
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'.
Measured: week 2 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start29 May 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SplintsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Other: Static Wrist-Hand Resting Splint (Thumb Spica Splint) Other: Exercise Therapy
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, eda ünal madıoğlu, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995534
- Sponsor's protocol ID
- KonyaBeyhekimTRH2023/4689
- Status last verified
- Mar 2026
- First submitted
- 12 May 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Static Hand-Wrist Splinting and Exercise Therapy in the Management of De Quervain's Tenosynovitis
- ClinicalTrials.gov ID
- NCT06995534
- Acronym / sponsor ID
- KonyaBeyhekimTRH2023/4689
- Keywords
- pain, De Quervains Tenosynovitis, exercise therapy, splints, Ultrasonographic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 29 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who meet the inclusion and exclusion criteria will undergo a detailed clinical examination and medical history review, after which written informed consent will be obtained. They will then be randomly assigned to one of the two treatment groups using block randomization.
Baseline sociodemographic data (age, sex, body mass index, employment status, education level, marital status) and clinical variables (dominant hand, symptom duration, comorbidities, affected hand, presence of the Finkelstein sign, pain severity, functional/symptom status, hand-finger strength, pressure pain threshold (PPT), and ultrasonographic findings) will be recorded.
Patients in the first group will be provided with a static wrist-hand resting splint with thumb support, extending to the distal forearm. They will be instructed to wear the splint for at least 6-8 hours per day for a minimum of 4 weeks. Additionally, both groups will receive training on activity modification and positioning.
Patients in the second group will be given a home exercise program. They will perform the exercises twice daily for 6 weeks, with each exercise consisting of 10 repetitions. All patients will be evaluated at baseline, at the second week of treatment, and at the end of the sixth week.
Outcome measures will include clinical examination findings (Finkelstein test), pain severity [Visual Analog Scale (VAS) at rest and during activity], the Turkish versions of the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire, Health Assessment Questionnaire (HAQ), and Patient-Rated Wrist Evaluation (PRWE), patient satisfaction, handgrip and finger pinch strength measurements, and pain pressure threshold using an algometer.
Ultrasound evaluations of the abductor pollicis longus and extensor pollicis brevis tendons in the first dorsal compartment including the measurement of the cross-sectional area (csa) will be performed at baseline, week 2, and week 6.
All assessments will be conducted by the same blinded investigator who is unaware of the group allocations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Other: Static Wrist-Hand Resting Splint (Thumb Spica Splint) Other: Exercise Therapy
| Arm | Type | Receives |
|---|---|---|
| Static Hand-Wrist Splinting | Other | Other: splint |
| Exercise Therapy | Other | Other: Exercise Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- History of trauma
- Wrist fractures
- Local infection
- Presence of rheumatologic diseases (e.g., rheumatoid arthritis, psoriatic arthritis)
- Presence of symptomatic hand osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| splintstatic wrist-hand splint + education on activity modification and positioning in daily life | Other | Static Hand-Wrist Splinting |
| Exercise TherapyHome-based Exercise Therapy + Education on activity modification and positioning in daily life | Other | Exercise Therapy |
Primary outcome
VAS pain
Time frame: baseline, week 2 and week 6
VAS pain activity and rest: 0 no pain; 10 unbearable/max. pain.
Patient Rated Wrist Evaluation( PRWE)
Time frame: baseline, week 2 and week 6
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).
The Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: baseline, week 2 and week 6
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.
4 secondary outcomes
Hand grip strength
Time frame: baseline, week 2 and week 6
Finger pinch strength
Time frame: baseline, week 2 and week 6
Ultrasonographic evaluation of the first dorsal compartment tendons
Time frame: Baseline, week 2 and week 6
Patient satisfaction
Time frame: week 2 and week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing splint and Exercise Therapy in people with Splints and Exercise Therapy, run by Konya Beyhekim Training and Research Hospital 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 12 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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?
Contact Eda Ünal Madıoğlu(MD) (905530970738, ade.1997.lanu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain (time frame: baseline, week 2 and week 6). The study lists 3 primary outcomes in all. 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 24 Mar 2026.