Injection Versus Splinting in Carpal Tunnel Syndrome (INSTinCTS)

Randomised, Multicentre, Open Label, Parallel Group Pragmatic Clinical Trial of Local Steroid Injection Versus Night Splinting in Mild to Moderate Carpal Tunnel Syndrome (CTS)

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome (CTS)
• Intervention / Treatment: Drug: Depo-Medrone; Device: Wrist Splint

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Staffordshire
    • Newcastle under Lyme, Staffordshire, United Kingdom, ST5 1QG
      • Staffordshire and Stoke on Trent Partnership NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Generic wrist splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks	Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCTQ Symptom Severity Subscale 6 Weeks	Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Functional Limitations Subscale 6 Weeks	Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
Hand-wrist Pain Intensity 6 Weeks	Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain).	6 weeks
Insomnia Due to Hand-wrist Problems 6 Weeks	Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.	6 weeks
Referral for Surgery 6 Weeks	Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 weeks. Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.	6 weeks
Surgery 6 Weeks	Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 weeks. Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.	6 weeks
BCTQ Symptom Severity and Functional Limitations 6 Months	Comparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire	6 months
BCTQ Symptom Severity Subscale 6 Months	Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire	6 months
BCTQ Functional Limitations Subscale 6 Months	Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire	6 months
Hand-wrist Pain Intensity 6 Months	Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain.	6 months
Insomnia Due to Hand-wrist Problems 6 Months	Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.	6 months
Referral to Surgery 6 Months	Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months.	6 months
Surgery 6 Months	Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months.	6 months
Herbal Remedies and Vitamin Use 6 Months	Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months	6 months
Over the Counter Pain Medication 6 Months	Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months.	6 months
Prescribed Pain Medication 6 Months	Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months.	6 months
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks	Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months	Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire.	6 months
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months	Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire.	12 months
Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months	Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire	24 months
Hand-wrist Pain Intensity Over 24 Months: 6 Weeks	Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks.	6 weeks
Hand-wrist Pain Intensity Over 24 Months: 6 Months	Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months.	6 months
Hand-wrist Pain Intensity Over 24 Months: 12 Months	Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months.	12 months
Hand-wrist Pain Intensity Over 24 Months: 24 Months	Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months.	24 months
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))	Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Symptom Severity Subscale 6 Weeks (CC)	Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Functional Limitations Subscale 6 Weeks (CC)	Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
Hand-wrist Pain Intensity 6 Weeks (CC)	Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.	6 weeks
Insomnia Due to Hand-wrist Problems 6 Weeks (CC)	Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.	6 weeks
BCTQ Symptom Severity and Functional Limitations 6 Months (CC)	Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 months
BCTQ Symptom Severity Subscale 6 Months (CC)	Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 months
BCTQ Functional Limitations Subscale 6 Months (CC)	Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 months
Hand-wrist Pain Intensity 6 Months (CC)	Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.	6 months
Insomnia Due to Hand-wrist Problems 6 Months (CC)	Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.	6 months
Referral to Surgery 6 Months (CC)	Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.	6 months
Herbal Remedies and Vitamin Use 6 Months (CC)	Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Complete case analysis as a sensitivity analysis was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.	6 months
Over the Counter Pain Medication 6 Months (CC)	Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.	6 months
Prescribed Pain Medication 6 Months (CC)	Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Sensitivity analysis for comparison of the odds of pain medication use between treatment groups at 6 months follow-up on participants with complete data.	6 months
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))	Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Symptom Severity Subscale 6 Weeks (PP)	Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Functional Limitations Subscale 6 Weeks (PP)	Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
Hand-wrist Pain Intensity 6 Weeks (PP)	Per protocol analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data.	6 weeks
Insomnia Due to Hand-wrist Problems 6 Weeks (PP)	Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.	6 weeks
BCTQ Symptom Severity and Functional Limitations 6 Months (PP)	Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 months
BCTQ Symptom Severity Subscale 6 Months (PP)	Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 months
BCTQ Functional Limitations Subscale 6 Months (PP)	Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 months
Hand-wrist Pain Intensity 6 Months (PP)	Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.	6 months
Insomnia Due to Hand-wrist Problems 6 Months (PP)	Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.	6 months
Referral to Surgery at 6 Months (PP)	Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Per protocol analysis for comparison of the odds of surgery between treatment groups at 6 months follow-up on participants with complete data.	6 months
Herbal Remedies and Vitamin Use 6 Months (PP)	Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Per protocol analysis on complete date was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.	6 months
Over the Counter Pain Medication 6 Months (PP)	Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data	6 months
Prescribed Pain Medication 6 Months (PP)	Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.	6 months
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)	Subgroup analysis was performed in patients who were allocated the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)	Subgroup analysis was performed in patients who did not receive the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)	Subgroup analysis was performed in patients who did not state a preference of intervention. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)	Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)	Subgroup analysis was performed in patients who preferred splint. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire	6 weeks
NHS Cost Differences at 6 Months	Cost of interventions at 6 months	6 months
NHS Cost Differences at 6 Months (CC)	Complete case analysis on the cost of interventions at 6 months	6 months
NHS Cost Differences at 12 Months	Cost of interventions at 12 months	12 months
NHS Cost Differences at 24 Months	Cost of interventions at 24 months	24 months
QALYS at 6 Months (Cross-walk Tariff)	The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.	6 months
QALYS at 12 Months (Cross-walk Tariff)	The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.	12 months
QALYS at 24 Months (Cross-walk Tariff)	The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.	24 months

Collaborators and Investigators

• Sponsor: Keele University
• Collaborators: Arthritis Research UK
• Investigators: Principal Investigator: Edward Roddy, Fellow RCP, Keele University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): February 26, 2019

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: hand; steroid; wrist; splint; randomised; carpal; tunnel; syndrome; pragmatic
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Keele University is a member of the UK Reproducibility Network and committed to the principles of the UK Concordat on Open Research Data. The School of Medicine and Keele Clinical Trials Unit have a longstanding commitment to sharing data from our studies to improve research reproducibility and to maximise benefits for patients, the wider public, and the health and care system. We encourage collaboration with those who collected the data, to recognise and credit their contributions.

The School of Medicine and Keele Clinical Trials Unit make data available to bona-fide researchers upon reasonable request via open or restricted access through a strict controlled access procedure. The release of data may be subject to a data use agreement (DUA) between the Sponsor and the third party requesting the data. In the first instance, data requests and enquiries should be directed to medicine.datasharing@keele.ac.uk.