Injection Versus Splinting in Carpal Tunnel Syndrome (INSTinCTS)

• ClinicalTrials.gov Identifier: NCT02038452
• Recruitment Status: Completed
• First Posted: January 16, 2014
• Last Update Posted: June 5, 2019
• Sponsor: Keele University
• Collaborator: Arthritis Research UK
• Information provided by (Responsible Party): Keele University

Tracking Information

• First Submitted Date: January 9, 2014
• First Posted Date: January 16, 2014
• Last Update Posted Date: June 5, 2019
• Study Start Date: April 2014
• Actual Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 16, 2014): Symptom severity and limitations in hand function as assessed by the Boston CTS questionnaire [ Time Frame: 6 weeks ]

Original Primary Outcome Measures (submitted: January 15, 2014)

Symptom severity and limitations in hand function as assessed by the Boston CTS questionnaire [ Time Frame: 6 weeks ]

To 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.

Current Secondary Outcome Measures (submitted: January 15, 2014)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Injection Versus Splinting in Carpal Tunnel Syndrome
• 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)

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carpal Tunnel Syndrome (CTS)

Intervention

• Drug: Depo-Medrone
  Steroid Injection
• Device: Wrist Splint
  Simple wrist splint
  Other Name: Generic wrist splint

Study Arms

• Active Comparator: Steroid Injection
  Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
  Intervention: Drug: Depo-Medrone
• Active Comparator: Wrist Splint
  Wrist splint to be worn at night
  Intervention: Device: Wrist Splint

Publications *

• Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1.
• Chesterton LS, Dziedzic KS, van der Windt DA, Davenport G, Myers HL, Rathod T, Blagojevic-Bucknall M, Jowet SM, Burton C, Roddy E, Hay EM. The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol. BMC Musculoskelet Disord. 2016 Oct 6;17(1):415.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 3, 2017): 234
• Original Estimated Enrollment (submitted: January 15, 2014): 240
• Actual Study Completion Date: February 26, 2019
• Actual Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male or female aged ≥ 18 years
• A clinical diagnosis of unilateral or bilateral CTS as made by a GP or trained clinician according to the diagnostic criteria
• Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature
• Symptom duration of episode of at least 6 weeks
• Written informed consent provided by the patient, prior to any trial specific procedures

Exclusion Criteria:

• Steroid injection or night splints for CTS in the affected wrist within preceding 6 months
• Any previous surgery on the affected wrist
• Severe CTS exhibiting constant numbness or pain, constant sensory loss, severe thenar muscle atrophy or symptom severity which requires the patient to be referred for a surgical opinion
• Clinical suspicion of local or systemic sepsis or infection
• Current or previous infection of the affected wrist
• Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months
• Unable to tolerate the study interventions
• Unable to understand and complete self-report questionnaires written in English

• Inter-current illness including, but not limited to:

  • poorly controlled thyroid disease
  • poorly controlled diabetes mellitus
  • vibration-induced neuropathy
  • inflammatory joint disease
  • suspected complex neurological conditions
  • any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation
• Pregnant or lactating females
• Receiving anticoagulants
• Any history of hypersensitivity to Depo-Medrone or any of its excipients
• Allergy to any of the splint materials
• Known abuse of drugs or alcohol
• Involved in on-going litigation cases for their condition

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02038452
• Other Study ID Numbers: 464/11; 20105 ( Other Grant/Funding Number: Arthritis Research UK ); 2013-001435-48 ( EudraCT Number ); 13/NW/0280 ( Other Identifier: UK NHS Research Ethics Committee ); 09392969 ( Registry Identifier: ISRCTN )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Keele University
• Study Sponsor: Keele University
• Collaborators: Arthritis Research UK

Investigators

• Principal Investigator: Ed Roddy, Fellow RCP; Keele University

• PRS Account: Keele University
• Verification Date: June 2019