Clinical trial NCT02038452: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: hand
wrist
carpal
tunnel
syndrome
pragmatic
randomised
steroid
splint
Lead sponsor: Keele University
Sponsor class: OTHER
Collaborators: name: Arthritis Research UK
First posted: 2014-01-16
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: BCTQ Symptom Severity Subscale 6 Weeks
timeFrame: 6 weeks
measure: BCTQ Functional Limitations Subscale 6 Weeks
timeFrame: 6 weeks
measure: Hand-wrist Pain Intensity 6 Weeks
timeFrame: 6 weeks
measure: Insomnia Due to Hand-wrist Problems 6 Weeks
timeFrame: 6 weeks
measure: Referral for Surgery 6 Weeks
timeFrame: 6 weeks
measure: Surgery 6 Weeks
timeFrame: 6 weeks
measure: BCTQ Symptom Severity and Functional Limitations 6 Months
timeFrame: 6 months
measure: BCTQ Symptom Severity Subscale 6 Months
timeFrame: 6 months
measure: BCTQ Functional Limitations Subscale 6 Months
timeFrame: 6 months
measure: Hand-wrist Pain Intensity 6 Months
timeFrame: 6 months
measure: Insomnia Due to Hand-wrist Problems 6 Months
timeFrame: 6 months
measure: Referral to Surgery 6 Months
timeFrame: 6 months
measure: Surgery 6 Months
timeFrame: 6 months
measure: Herbal Remedies and Vitamin Use 6 Months
timeFrame: 6 months
measure: Over the Counter Pain Medication 6 Months
timeFrame: 6 months
measure: Prescribed Pain Medication 6 Months
timeFrame: 6 months
measure: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
timeFrame: 6 weeks
measure: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
timeFrame: 6 months
measure: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
timeFrame: 12 months
measure: Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
timeFrame: 24 months
measure: Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
timeFrame: 6 weeks
measure: Hand-wrist Pain Intensity Over 24 Months: 6 Months
timeFrame: 6 months
measure: Hand-wrist Pain Intensity Over 24 Months: 12 Months
timeFrame: 12 months
measure: Hand-wrist Pain Intensity Over 24 Months: 24 Months
timeFrame: 24 months
measure: BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
timeFrame: 6 weeks
measure: BCTQ Symptom Severity Subscale 6 Weeks (CC)
timeFrame: 6 weeks
measure: BCTQ Functional Limitations Subscale 6 Weeks (CC)
timeFrame: 6 weeks
measure: Hand-wrist Pain Intensity 6 Weeks (CC)
timeFrame: 6 weeks
measure: Insomnia Due to Hand-wrist Problems 6 Weeks (CC)
timeFrame: 6 weeks
measure: BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
timeFrame: 6 months
measure: BCTQ Symptom Severity Subscale 6 Months (CC)
timeFrame: 6 months
measure: BCTQ Functional Limitations Subscale 6 Months (CC)
timeFrame: 6 months
measure: Hand-wrist Pain Intensity 6 Months (CC)
timeFrame: 6 months
measure: Insomnia Due to Hand-wrist Problems 6 Months (CC)
timeFrame: 6 months
measure: Referral to Surgery 6 Months (CC)
timeFrame: 6 months
measure: Herbal Remedies and Vitamin Use 6 Months (CC)
timeFrame: 6 months
measure: Over the Counter Pain Medication 6 Months (CC)
timeFrame: 6 months
measure: Prescribed Pain Medication 6 Months (CC)
timeFrame: 6 months
measure: BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
timeFrame: 6 weeks
measure: BCTQ Symptom Severity Subscale 6 Weeks (PP)
timeFrame: 6 weeks
measure: BCTQ Functional Limitations Subscale 6 Weeks (PP)
timeFrame: 6 weeks
measure: Hand-wrist Pain Intensity 6 Weeks (PP)
timeFrame: 6 weeks
measure: Insomnia Due to Hand-wrist Problems 6 Weeks (PP)
timeFrame: 6 weeks
measure: BCTQ Symptom Severity and Functional Limitations 6 Months (PP)
timeFrame: 6 months
measure: BCTQ Symptom Severity Subscale 6 Months (PP)
timeFrame: 6 months
measure: BCTQ Functional Limitations Subscale 6 Months (PP)
timeFrame: 6 months
measure: Hand-wrist Pain Intensity 6 Months (PP)
timeFrame: 6 months
measure: Insomnia Due to Hand-wrist Problems 6 Months (PP)
timeFrame: 6 months
measure: Referral to Surgery at 6 Months (PP)
timeFrame: 6 months
measure: Herbal Remedies and Vitamin Use 6 Months (PP)
timeFrame: 6 months
measure: Over the Counter Pain Medication 6 Months (PP)
timeFrame: 6 months
measure: Prescribed Pain Medication 6 Months (PP)
timeFrame: 6 months
measure: BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)
timeFrame: 6 weeks
measure: BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)
timeFrame: 6 weeks
measure: BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)
timeFrame: 6 weeks
measure: BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)
timeFrame: 6 weeks
measure: BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)
timeFrame: 6 weeks
measure: NHS Cost Differences at 6 Months
timeFrame: 6 months
measure: NHS Cost Differences at 6 Months (CC)
timeFrame: 6 months
measure: NHS Cost Differences at 12 Months
timeFrame: 12 months
measure: NHS Cost Differences at 24 Months
timeFrame: 24 months
measure: QALYS at 6 Months (Cross-walk Tariff)
timeFrame: 6 months
measure: QALYS at 12 Months (Cross-walk Tariff)
timeFrame: 12 months
measure: QALYS at 24 Months (Cross-walk Tariff)
timeFrame: 24 months
Other outcomes:
Locations:
city: Newcastle under Lyme
country: United Kingdom
facility: Staffordshire and Stoke on Trent Partnership NHS Trust
state: Staffordshire
Study officials:
affiliation: Keele University
name: Edward Roddy, Fellow RCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/s12891-016-1264-8.
citation: 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.