Carpal Tunnel Syndrome (CTS)NCT07042282
Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting
A study testing Nighttime Splinting, Corticosteroid Injection and Evaluation and Dynamic Adjustment in people with Carpal Tunnel Syndrome (CTS) and Rheumatic Diseases, run by Yun Qian at 3 sites in China.
Trial summary
The aim of this study is to evaluate the effects of corticosteroid injection verses nighttime splinting as initial treatments on wrist function, quality of life, and sleep quality in patients with rheumatoid disease-related carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Rheumatic Diseases
- What is being tested?
- Nighttime Splinting, Corticosteroid Injection and Evaluation and Dynamic Adjustment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 3 sitesChina
- Study dates
- 1 Aug 2025to 1 Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged no less than 18 years old with unilateral or bilateral carpal tunnel syndrome diagnosed by a specialist according to the Katz diagnostic criteria, and with at least one associated rheumatic disease;
- Patients have had symptoms of CTS for at least six weeks, and the side with more severe symptoms is designated as the target side for the study.
- During the current episode, the target side has not been treated.
Who cannot join
- Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
- Received corticosteroid injections in the wrist within the past 6 months;
- Patients who are unable to wear a splint due to trauma or other reasons;
- Patients with clinical manifestations or electrophysiological changes indicative of significant axonal loss or denervation, including thenar muscle atrophy, sensory loss (two-point discrimination greater than 8 mm), absence of SNAP (sensory nerve action potential), absence of CMAP (compound muscle action potential) in the thenar muscles, etc.;
- Patients who require long-term use of any form of opioids.
- Patients who have used opioids (e.g., tramadol) or neuropathic pain medications (gabapentin, pregabalin, etc.) within the past 2 weeks;
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- Patients who have received non-recommended wrist injection treatments (e.g., 5% glucose, platelet-rich plasma, ozone, chitosan, hyaluronic acid, etc.) within the past 6 months;
- Patients who have undergone non-recommended physical therapies (e.g., electrotherapy, magnetotherapy, laser therapy, etc.) within the past 6 months;
- Patients who are pregnant or plan to become pregnant within the next 6 months.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Jinjiang Municipal Hospital(Shanghai Sixth People's Hospital Fujian Campus)
Jinjiang, Fujian
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Yun Qian, 86 21 64369181, sakio@sjtu.edu.cn
Yancheng Third People's Hospital
Yancheng, Jiangsu
About this study
Official title: Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting - A Pragmatic, Open-Label, Multicenter, Randomized Clinical Trial
The aim of this study is to evaluate the effects of corticosteroid injection verses nighttime splinting as initial treatments on wrist function, quality of life, and sleep quality in patients with rheumatoid disease-related carpal tunnel syndrome. Participants will be randomly assigned to two groups and will receive the following interventions: one group will wear a neutral position night splint for 6 weeks, and the other group will receive a single local injection of methylprednisolone 40 mg as the initial treatment. Follow-up evaluations will be conducted at 6, 12, and 18 weeks to assess wrist function, sleep quality, and quality of life, and to dynamically adjust the treatment plan.
- Conditions
- Carpal Tunnel Syndrome (CTS), Rheumatic Diseases
- Being tested
- Nighttime Splinting, Corticosteroid Injection, Evaluation and Dynamic Adjustment
- Medical subject headings
- Carpal Tunnel Syndrome, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nighttime SplintingDevice
Also called Wrist Splint
Nighttime splinting for 6 weeks.
Corticosteroid InjectionDrug
Also called Steroid Injection
Local corticosteroid injection (triamcinolone acetonide 40mg). A single injection of triamcinolone acetonide 40mg mixed with an equal volume of 1% lidocaine is administered. The injection is performed under ultrasound guidance and anatomical landmarks to target the proximal carpal tunnel. With the wrist extended, the needle is typically inserted on the ulnar side of the palmaris longus tendon, approximately 1 cm proximal to the wrist crease. If blood is aspirated or the patient reports paresthesia (which usually indicates nerve irritation), the injection site should be adjusted.
Evaluation and Dynamic AdjustmentOther
6 weeks later, all patients will undergo evaluation of their initial treatment. Further therapeutic decisions will be made based on physician assessment, including: continuing nighttime splinting, administering corticosteroid injections to patients who initially received only the splint, adding nighttime splinting for patients initially received only corticosteroid injections, and transitioning from nighttime splint use to continuous wear. Subsequently, evaluations will be conducted every 6 weeks, with dynamic adjustments to the treatment plan. Throughout the study period, physicians will perform electrophysiological examinations according to changes in patients' clinical status.
| Study group | Role | What they receive |
|---|---|---|
| Nighttime splinting | Other | Wear a wrist neutral position splint at night for 6 weeks as the initial treatment. Receives: Device: Nighttime Splinting; Other: Evaluation and Dynamic Adjustment |
| Corticosteroid injection | Other | Local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment. Receives: Drug: Corticosteroid Injection; Other: Evaluation and Dynamic Adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BCTQ function status subscale at 6 weeks
Change from baseline in the score of the BCTQ function status subscale (Boston Carpal Tunnel Questionnaire Function Status Subscale) will be compared between treatment groups at 6 weeks follow-up.
Measured: 0,6 weeks
Change from baseline in BCTQ symptom severity subscale at 6 weeks
Change from baseline in the score of the BCTQ symptom severity subscale (Boston Carpal Tunnel Questionnaire Symptom Severity subscale) will be compared between treatment groups at 6 weeks follow-up.
Measured: 0,6 weeks
Secondary outcomes (6)
Change from baseline in BCTQ symptom severity subscale
Change from baseline in the score of the BCTQ symptom severity subscale (Boston Carpal Tunnel Questionnaire Symptom Severity subscale) will be compared between treatment groups at 12,18 weeks follow-up.
Measured: 0,12,18 weeks
Change from baseline in BCTQ function status subscale
Change from baseline in the score of the BCTQ function status subscale (Boston Carpal Tunnel Questionnaire Function Status Subscale) will be compared between treatment groups at 12,18 weeks follow-up.
Measured: 0,12,18 weeks
Change from baseline of EQ-VAS
The EQ-VAS is a measure of the overall health of respondents on the day of the survey. Change from baseline in the score of EQ-VAS will be compared between treatment groups at 6, 12, 18 weeks follow-up.
Measured: 0,6,12,18 weeks
Change from baseline of PSQI
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality. Change from baseline in the score of the PSQI will be compared between treatment groups at 6 ,12 and 18 weeks follow-up.
Measured: 0,6,12,18 weeks
Change from baseline of the cross-sectional area of the median nerve
The median nerve cross-sectional area will be measured with musculoskeletal ultrasound. Change from baseline of the cross-sectional area will be compared at 18 weeks follow-up.
Measured: 0,18 weeks
Surgical rate within 18 weeks
Participants will be asked if they undergo surgery (carpal tunnel decompression) in the last 18 week.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yun Qian
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 6th People's Hospital
- Responsible party
- Sponsor-investigator, Yun Qian, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042282
- Sponsor's protocol ID
- 2025-KY-096
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study for publication, by reasonable request via email to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting - A Pragmatic, Open-Label, Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07042282
- Acronym / sponsor ID
- 2025-KY-096
- Conditions
- Carpal Tunnel Syndrome (CTS), Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Yun QianUniversity, hospital or other
- Collaborators
- Shanghai 6th People's Hospital
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 29 Jun 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.
The aim of this study is to evaluate the effects of corticosteroid injection verses nighttime splinting as initial treatments on wrist function, quality of life, and sleep quality in patients with rheumatoid disease-related carpal tunnel syndrome. Participants will be randomly assigned to two groups and will receive the following interventions: one group will wear a neutral position night splint for 6 weeks, and the other group will receive a single local injection of methylprednisolone 40 mg as the initial treatment. Follow-up evaluations will be conducted at 6, 12, and 18 weeks to assess wrist function, sleep quality, and quality of life, and to dynamically adjust the treatment plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nighttime splinting | Other | Device: Nighttime Splinting, Other: Evaluation and Dynamic AdjustmentWear a wrist neutral position splint at night for 6 weeks as the initial treatment. |
| Corticosteroid injection | Other | Drug: Corticosteroid Injection, Other: Evaluation and Dynamic AdjustmentLocal corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged no less than 18 years old with unilateral or bilateral carpal tunnel syndrome diagnosed by a specialist according to the Katz diagnostic criteria, and with at least one associated rheumatic disease;
- Patients have had symptoms of CTS for at least six weeks, and the side with more severe symptoms is designated as the target side for the study.
- During the current episode, the target side has not been treated.
Key exclusion criteria (9 listed)
- Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
- Received corticosteroid injections in the wrist within the past 6 months;
- Patients who are unable to wear a splint due to trauma or other reasons;
- Patients with clinical manifestations or electrophysiological changes indicative of significant axonal loss or denervation, including thenar muscle atrophy, sensory loss (two-point discrimination greater than 8 mm), absence of SNAP (sensory nerve action potential), absence of CMAP (compound muscle action potential) in the thenar muscles, etc.;
- Patients who require long-term use of any form of opioids.
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 |
|---|---|---|
| Nighttime SplintingAlso: Wrist SplintNighttime splinting for 6 weeks. | Device | Nighttime splinting |
| Corticosteroid InjectionAlso: Steroid InjectionLocal corticosteroid injection (triamcinolone acetonide 40mg). A single injection of triamcinolone acetonide 40mg mixed with an equal volume of 1% lidocaine is administered. The injection is performed under ultrasound guidance and anatomical landmarks to target the proximal carpal tunnel. With the wrist extended, the needle is typically inserted on the ulnar side of the palmaris longus tendon, approximately 1 cm proximal to the wrist crease. If blood is aspirated or the patient reports paresthesia (which usually indicates nerve irritation), the injection site should be adjusted. | Drug | Corticosteroid injection |
| Evaluation and Dynamic Adjustment6 weeks later, all patients will undergo evaluation of their initial treatment. Further therapeutic decisions will be made based on physician assessment, including: continuing nighttime splinting, administering corticosteroid injections to patients who initially received only the splint, adding nighttime splinting for patients initially received only corticosteroid injections, and transitioning from nighttime splint use to continuous wear. Subsequently, evaluations will be conducted every 6 weeks, with dynamic adjustments to the treatment plan. Throughout the study period, physicians will perform electrophysiological examinations according to changes in patients' clinical status. | Other | Corticosteroid injection, Nighttime splinting |
Primary outcome
Change from baseline in BCTQ function status subscale at 6 weeks
Time frame: 0,6 weeks
Change from baseline in the score of the BCTQ function status subscale (Boston Carpal Tunnel Questionnaire Function Status Subscale) will be compared between treatment groups at 6 weeks follow-up.
Change from baseline in BCTQ symptom severity subscale at 6 weeks
Time frame: 0,6 weeks
Change from baseline in the score of the BCTQ symptom severity subscale (Boston Carpal Tunnel Questionnaire Symptom Severity subscale) will be compared between treatment groups at 6 weeks follow-up.
6 secondary outcomes
Change from baseline in BCTQ symptom severity subscale
Time frame: 0,12,18 weeks
Change from baseline in BCTQ function status subscale
Time frame: 0,12,18 weeks
Change from baseline of EQ-VAS
Time frame: 0,6,12,18 weeks
Change from baseline of PSQI
Time frame: 0,6,12,18 weeks
Change from baseline of the cross-sectional area of the median nerve
Time frame: 0,18 weeks
Surgical rate within 18 weeks
Time frame: 18 weeks
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 29 Jun 2025.
- Individual participant dataSharing planned: Yes. Upon completion of the study for publication, by reasonable request via email to the corresponding author.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nighttime Splinting, Corticosteroid Injection and Evaluation and Dynamic Adjustment in people with Carpal Tunnel Syndrome (CTS) and Rheumatic Diseases, run by Yun Qian at 3 sites in China.
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 9 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: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 Jiaqi Su (86 21 64369181, sjqjswy@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in BCTQ function status subscale at 6 weeks (time frame: 0,6 weeks). The study lists 2 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 29 Jun 2025.