Carpal Tunnel Syndrome (CTS)Phase 4INSTinCTSNCT02038452
Injection Versus Splinting in Carpal Tunnel Syndrome
A Phase 4 study testing Depo-Medrone and Wrist Splint in people with Carpal Tunnel Syndrome (CTS), run by Keele University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Depo-Medrone and Wrist Splint
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to 26 Feb 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Staffordshire and Stoke on Trent Partnership NHS Trust
Newcastle-under-Lyme, Staffordshire, ST5 1QG
About this study
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)
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.
Read more
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.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Depo-Medrone, Wrist Splint
- Keywords
- hand, wrist, carpal, tunnel, syndrome, pragmatic, randomised, steroid, splint
- Medical subject headings
- Carpal Tunnel Syndrome, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo-MedroneDrug
Steroid Injection
Wrist SplintDevice
Also called Generic wrist splint
Simple wrist splint
| Study group | Role | What they receive |
|---|---|---|
| Steroid Injection | Active comparator | Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg) Receives: Drug: Depo-Medrone |
| Wrist Splint | Active comparator | Wrist splint to be worn at night Receives: Device: Wrist Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (64)
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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Referral to Surgery 6 Months
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months.
Measured: 6 months
Surgery 6 Months
Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks
NHS Cost Differences at 6 Months
Cost of interventions at 6 months
Measured: 6 months
NHS Cost Differences at 6 Months (CC)
Complete case analysis on the cost of interventions at 6 months
Measured: 6 months
NHS Cost Differences at 12 Months
Cost of interventions at 12 months
Measured: 12 months
NHS Cost Differences at 24 Months
Cost of interventions at 24 months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startApr 2014
- Primary completion31 Dec 2016
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK
- Responsible party
- Sponsor
- Investigators
- Edward Roddy, Fellow RCP, Principal investigator, Keele University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038452
- Sponsor's protocol ID
- 464/11
- Other IDs
- 20105, 2013-001435-48, 13/NW/0280, 09392969
- Acronym
- INSTinCTS
- Status last verified
- Mar 2023
- First submitted
- 9 Jan 2014
- Last updated
- 21 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
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.
PubMed 27716159Chesterton 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.
PubMed 30343858
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02038452
- Acronym / sponsor ID
- INSTinCTS / 464/11
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- hand, wrist, carpal, tunnel, syndrome, pragmatic, randomised, steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Collaborators
- Arthritis Research UK
- Study start
- Apr 2014
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Posted 21 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid Injection | Active comparator | Drug: Depo-MedroneSingle steroid injection into Carpal Tunnel (as Depo-medrone 20mg) |
| Wrist Splint | Active comparator | Device: Wrist SplintWrist splint to be worn at night |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depo-MedroneSteroid Injection | Drug | Steroid Injection |
| Wrist SplintAlso: Generic wrist splintSimple wrist splint | Device | Wrist Splint |
Primary outcome
Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
Time frame: 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
64 secondary outcomes
BCTQ Symptom Severity Subscale 6 Weeks
Time frame: 6 weeks
BCTQ Functional Limitations Subscale 6 Weeks
Time frame: 6 weeks
Hand-wrist Pain Intensity 6 Weeks
Time frame: 6 weeks
Insomnia Due to Hand-wrist Problems 6 Weeks
Time frame: 6 weeks
Referral for Surgery 6 Weeks
Time frame: 6 weeks
Surgery 6 Weeks
Time frame: 6 weeks
BCTQ Symptom Severity and Functional Limitations 6 Months
Time frame: 6 months
BCTQ Symptom Severity Subscale 6 Months
Time frame: 6 months
BCTQ Functional Limitations Subscale 6 Months
Time frame: 6 months
Hand-wrist Pain Intensity 6 Months
Time frame: 6 months
Insomnia Due to Hand-wrist Problems 6 Months
Time frame: 6 months
Referral to Surgery 6 Months
Time frame: 6 months
Surgery 6 Months
Time frame: 6 months
Herbal Remedies and Vitamin Use 6 Months
Time frame: 6 months
Over the Counter Pain Medication 6 Months
Time frame: 6 months
Prescribed Pain Medication 6 Months
Time frame: 6 months
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
Time frame: 6 weeks
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
Time frame: 6 months
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
Time frame: 12 months
Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
Time frame: 24 months
Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
Time frame: 6 weeks
Hand-wrist Pain Intensity Over 24 Months: 6 Months
Time frame: 6 months
Hand-wrist Pain Intensity Over 24 Months: 12 Months
Time frame: 12 months
Hand-wrist Pain Intensity Over 24 Months: 24 Months
Time frame: 24 months
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
Time frame: 6 weeks
BCTQ Symptom Severity Subscale 6 Weeks (CC)
Time frame: 6 weeks
BCTQ Functional Limitations Subscale 6 Weeks (CC)
Time frame: 6 weeks
Hand-wrist Pain Intensity 6 Weeks (CC)
Time frame: 6 weeks
Insomnia Due to Hand-wrist Problems 6 Weeks (CC)
Time frame: 6 weeks
BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
Time frame: 6 months
BCTQ Symptom Severity Subscale 6 Months (CC)
Time frame: 6 months
BCTQ Functional Limitations Subscale 6 Months (CC)
Time frame: 6 months
Hand-wrist Pain Intensity 6 Months (CC)
Time frame: 6 months
Insomnia Due to Hand-wrist Problems 6 Months (CC)
Time frame: 6 months
Referral to Surgery 6 Months (CC)
Time frame: 6 months
Herbal Remedies and Vitamin Use 6 Months (CC)
Time frame: 6 months
Over the Counter Pain Medication 6 Months (CC)
Time frame: 6 months
Prescribed Pain Medication 6 Months (CC)
Time frame: 6 months
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
Time frame: 6 weeks
BCTQ Symptom Severity Subscale 6 Weeks (PP)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27716159Chesterton 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.
- Results publication: PubMed 30343858Chesterton 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Roddy, Fellow RCP principal investigator
Keele University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Depo-Medrone and Wrist Splint in people with Carpal Tunnel Syndrome (CTS), run by Keele University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02038452, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.