Injection Versus Splinting in Carpal Tunnel Syndrome (INSTinCTS)
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|ClinicalTrials.gov Identifier: NCT02038452|
Recruitment Status : Active, not recruiting
First Posted : January 16, 2014
Last Update Posted : March 6, 2017
Carpal Tunnel Syndrome (CTS) is a common condition in which a nerve (known as the median nerve) is squeezed where it passes through the wrist. It can cause pain or aching, tingling or numbness in the affected hand. It may disturb sleep, or affect ability to do day to day things.
There have been several studies into the best treatment of patients with severe symptoms of CTS who are referred to a hospital for treatment. However, little is known about the best treatments for patients with mild to moderate symptoms who visit their GP but do not require hospital treatment.
The study will investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term (6 weeks) compared to a night splint in people consulting with mild to moderate CTS in primary care.We will study the effects of these 2 treatments over 6 weeks and at 6 months. Subject to further funding, the Study will also look at whether these 6 weeks of treatment are effective 1 year and 2 years later.
The study will take place in up to 50 GP practices and hospital clinics across the UK. Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks will be eligible for inclusion.
The steroid is a drug called "DepoMedrone." This drug is already widely used to treat CTS. In this study, one injection will be given. The splint is made of elastic and has an aluminium bar which sits on the palm of the hand. In this study, the splint will be worn at night for 6 weeks. Each participant will receive either a single steroid injection or a splint, and will be asked to complete up to 5 questionnaires over 2 years.
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome (CTS)||Drug: Depo-Medrone Device: Wrist Splint||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised, Multicentre, Open Label, Parallel Group Pragmatic Clinical Trial of Local Steroid Injection Versus Night Splinting in Mild to Moderate Carpal Tunnel Syndrome (CTS)|
|Study Start Date :||April 2014|
|Primary Completion Date :||December 31, 2016|
|Estimated Study Completion Date :||December 31, 2018|
Active Comparator: Steroid Injection
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Active Comparator: Wrist Splint
Wrist splint to be worn at night
Device: Wrist Splint
Simple wrist splint
Other Name: Generic wrist splint
- Symptom severity and limitations in hand function as assessed by the Boston CTS questionnaire [ Time Frame: 6 weeks ]
- Hand-wrist symptom intensity (0-10 numerical rating scale) [ Time Frame: 6 weeks, 6 months, 12 months 24 months ]
- Interrupted sleep [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
- Adherence to splinting where indicated [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
- Patients' perceived benefit and satisfaction with treatment [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
- Impact of CTS on work and other activities (including work absence and reduction in performance measured by a 0-10 rating scale for work performance) [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
- Referral for surgery [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
- General health (EQ-5D-5L) [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
- Health care utilisation [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
- Use of co-interventions such as supplements, pain relief, etc [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
- Patient incurred costs [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038452
|Staffordshire and Stoke on Trent Partnership NHS Trust|
|Newcastle under Lyme, Staffordshire, United Kingdom, ST5 1QG|
|Principal Investigator:||Elaine M Hay, Professor||Keele University|