Carpal Tunnel Syndrome (CTS)NCT07043179
Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome
A study testing Nighttime Splinting, Corticosteroid Injection and Evaluation and Dynamic Adjustment in people with Carpal Tunnel Syndrome (CTS), run by Yun Qian at 3 sites in China.
Trial summary
The goal of this clinical trial is to compare the efficacy of corticosteroid injection, night splinting, and their combined use as initial treatments for adults with moderate to severe carpal tunnel syndrome (CTS), and to assess the safety and tolerability of these interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- 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
- 318 participants
- Where
- 3 sitesChina
- Study dates
- 15 Jul 2025to 15 Jul 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 idiopathic carpal tunnel syndrome of the target side diagnosed by a specialist according to the Katz diagnostic criteria;
- The current episode has occurred within 6 weeks without treatment before eligibility assessment, and the target side has moderate-to-severe symptoms.
Who cannot join
- Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
- Any secodary CTS caused by comorbid diseases, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, CPPD (calcium pyrophosphate dihydrate deposition disease), etc.;
- History of fracture or surgery on the target side of the wrist;
- Bilateral CTS with moderate or severe symptoms in both hands;
- 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;
Show all 11Show fewer
- 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 analgesic medication, such as NSAIDs (nonsteroidal anti-inflammatory drugs), opioids, acetaminophen, etc.;
- Patients who have used NSAIDs, opioids (e.g., tramadol), neuropathic pain medications (gabapentin, pregabalin, etc.), or oral corticosteroids within the past 2 weeks;
- 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.
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, 200233
Yun Qian, 86 21 64369181, sakio@sjtu.edu.cn
Yancheng Third People's Hospital
Yancheng, Jiangsu
About this study
Official title: Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome: A Pragmatic, Three-Armed, Open-Label, Multicenter, Randomized Clinical Trial
The goal of this clinical trial is to compare the efficacy of corticosteroid injection, night splinting, and their combined use as initial treatments for adults with moderate to severe carpal tunnel syndrome (CTS), and to assess the safety and tolerability of these interventions. The primary research questions include:
- Doe corticosteroid injection, night splinting, and their combined use as initial treatments reduce the need for surgery in participants with moderate to severe CTS?
- How do these interventions affect the improvement of patient symptoms?
Read more
Participants will:
- Receive corticosteroid injection, night splinting, or their combination as initial treatments.
- Visit the clinic once every 6 weeks over a period of one year for assessments and dynamic adjustment of the treatment plan.
- Undergo periodic assessments of wrist function, quality of life, and sleep quality using standardized questionnaires.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Nighttime Splinting, Corticosteroid Injection, Evaluation and Dynamic Adjustment
- Medical subject headings
- Carpal Tunnel Syndrome
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. Corticosteroid injections will be administered at least 24 weeks apart, and the second injection dosage may be adjusted based on the patient's condition, with a maximum dose of 80mg. 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 |
| Combination | Other | Nighttime splinting for 6 weeks combined with local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment. Receives: Device: Nighttime Splinting; 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.
Surgical rate within 52 weeks
Participants will be asked if they have undergone surgery for carpal tunnel syndrome in the last 52 weeks.
Measured: 52 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 6 ,12, 24 and 52 weeks follow-up.
Measured: 0,6,12,24,52 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 6 ,12, 24 and 52 weeks follow-up.
Measured: 0,6,12,24,52 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, 24 and 52 weeks follow-up.
Measured: 0,6,12,24,52 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, 24 and 52 weeks follow-up.
Measured: 0,6,12,24,52 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 52 weeks follow-up.
Measured: 0,52 weeks
The incidence rate of clinical and electrophysiological changes indicative of new-onset axonal loss or denervation within 52 weeks
Researchers will assess and record whether there are any new clinical or electrophysiological changes indicating axonal loss or denervation during follow-up. The incidence rates of these changes in different treatment groups will be compared at the 52-week follow-up.
Measured: 52 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 start15 Jul 2025 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 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
- 318 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
- NCT07043179
- Sponsor's protocol ID
- 2025-KY-097
- Status last verified
- Jun 2025
- First submitted
- 22 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 Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome: A Pragmatic, Three-Armed, Open-Label, Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07043179
- Acronym / sponsor ID
- 2025-KY-097
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Yun QianUniversity, hospital or other
- Collaborators
- Shanghai 6th People's Hospital
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 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 goal of this clinical trial is to compare the efficacy of corticosteroid injection, night splinting, and their combined use as initial treatments for adults with moderate to severe carpal tunnel syndrome (CTS), and to assess the safety and tolerability of these interventions. The primary research questions include:
- Doe corticosteroid injection, night splinting, and their combined use as initial treatments reduce the need for surgery in participants with moderate to severe CTS?
- How do these interventions affect the improvement of patient symptoms?
Participants will:
- Receive corticosteroid injection, night splinting, or their combination as initial treatments.
- Visit the clinic once every 6 weeks over a period of one year for assessments and dynamic adjustment of the treatment plan.
- Undergo periodic assessments of wrist function, quality of life, and sleep quality using standardized questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| 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. |
| Combination | Other | Device: Nighttime Splinting, Drug: Corticosteroid Injection, Other: Evaluation and Dynamic AdjustmentNighttime splinting for 6 weeks combined with local 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 (2 listed)
- Patients aged no less than 18 years old with idiopathic carpal tunnel syndrome of the target side diagnosed by a specialist according to the Katz diagnostic criteria;
- The current episode has occurred within 6 weeks without treatment before eligibility assessment, and the target side has moderate-to-severe symptoms.
Key exclusion criteria (11 listed)
- Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
- Any secodary CTS caused by comorbid diseases, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, CPPD (calcium pyrophosphate dihydrate deposition disease), etc.;
- History of fracture or surgery on the target side of the wrist;
- Bilateral CTS with moderate or severe symptoms in both hands;
- Received corticosteroid injections in the wrist within the past 6 months;
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 | Combination, 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 | Combination, 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. Corticosteroid injections will be administered at least 24 weeks apart, and the second injection dosage may be adjusted based on the patient's condition, with a maximum dose of 80mg. Throughout the study period, physicians will perform electrophysiological examinations according to changes in patients' clinical status. | Other | Combination, Corticosteroid injection, Nighttime splinting |
Primary outcome
Surgical rate within 52 weeks
Time frame: 52 weeks
Participants will be asked if they have undergone surgery for carpal tunnel syndrome in the last 52 weeks.
6 secondary outcomes
Change from baseline in BCTQ symptom severity subscale
Time frame: 0,6,12,24,52 weeks
Change from baseline in BCTQ function status subscale
Time frame: 0,6,12,24,52 weeks
Change from baseline of EQ-VAS
Time frame: 0,6,12,24,52 weeks
Change from baseline of PSQI
Time frame: 0,6,12,24,52 weeks
Change from baseline of the cross-sectional area of the median nerve
Time frame: 0,52 weeks
The incidence rate of clinical and electrophysiological changes indicative of new-onset axonal loss or denervation within 52 weeks
Time frame: 52 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), 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 2 inclusion and 11 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?
Surgical rate within 52 weeks (time frame: 52 weeks). 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.