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Injection Versus Splinting in Carpal Tunnel Syndrome (INSTinCTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Keele University
Sponsor:
Collaborator:
Arthritis Research UK
Information provided by (Responsible Party):
Keele University
ClinicalTrials.gov Identifier:
NCT02038452
First received: January 9, 2014
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Carpal Tunnel Syndrome (CTS)
Drug: Depo-Medrone
Device: Wrist Splint
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Keele University:

Primary Outcome Measures:
  • Symptom severity and limitations in hand function as assessed by the Boston CTS questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hand-wrist symptom intensity (0-10 numerical rating scale) [ Time Frame: 6 weeks, 6 months, 12 months 24 months ] [ Designated as safety issue: No ]
  • Interrupted sleep [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Adherence to splinting where indicated [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Patients' perceived benefit and satisfaction with treatment [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Referral for surgery [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • General health (EQ-5D-5L) [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Health care utilisation [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Use of co-interventions such as supplements, pain relief, etc [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Patient incurred costs [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: April 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Steroid Injection
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Drug: Depo-Medrone
Steroid Injection
Active Comparator: Wrist Splint
Wrist splint to be worn at night
Device: Wrist Splint
Simple wrist splint
Other Name: Generic wrist splint

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038452

Contacts
Contact: Linda S Chesterton, PhD +441782734721 nstccg.keeleinstincts@nhs.net
Contact: Helen L Myers, PhD +441782734864 nstccg.keeleinstincts@nhs.net

Locations
United Kingdom
Staffordshire and Stoke on Trent Partnership NHS Trust Recruiting
Newcastle under Lyme, Staffordshire, United Kingdom, ST5 1QG
Principal Investigator: Dr E Roddy         
Sponsors and Collaborators
Keele University
Arthritis Research UK
Investigators
Principal Investigator: Elaine M Hay, Professor Keele University
  More Information

No publications provided

Responsible Party: Keele University
ClinicalTrials.gov Identifier: NCT02038452     History of Changes
Other Study ID Numbers: 464/11, 20105, 2013-001435-48, 13/NW/0280, 09392969
Study First Received: January 9, 2014
Last Updated: June 18, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Keele University:
hand
wrist
carpal
tunnel
syndrome
pragmatic
randomised
steroid
splint

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Syndrome
Cumulative Trauma Disorders
Disease
Median Neuropathy
Mononeuropathies
Nerve Compression Syndromes
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Sprains and Strains
Wounds and Injuries
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on November 23, 2014