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Completed

NCT Number: NCT02038452

Injection Versus Splinting in Carpal Tunnel Syndrome

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.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Disease Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sprains and Strains Syndrome Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Staffordshire and Stoke on Trent Partnership NHS Trust

Newcastle-under-Lyme, Staffordshire, ST5 1QG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Depo-Medrone

Drug

Steroid Injection

Wrist Splint

Device

Simple wrist splint

Other names: Generic wrist splint

Primary outcomes

  1. 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

Secondary outcomes

  1. BCTQ Symptom Severity Subscale 6 Weeks

    Time frame: 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

  2. BCTQ Functional Limitations Subscale 6 Weeks

    Time frame: 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

  3. Hand-wrist Pain Intensity 6 Weeks

    Time frame: 6 weeks

    Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain).

  4. Insomnia Due to Hand-wrist Problems 6 Weeks

    Time frame: 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.

  5. Referral for Surgery 6 Weeks

    Time frame: 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. Surgery 6 Weeks

    Time frame: 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.

  7. BCTQ Symptom Severity and Functional Limitations 6 Months

    Time frame: 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

  8. BCTQ Symptom Severity Subscale 6 Months

    Time frame: 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

  9. BCTQ Functional Limitations Subscale 6 Months

    Time frame: 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

  10. Hand-wrist Pain Intensity 6 Months

    Time frame: 6 months

    Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain.

  11. Insomnia Due to Hand-wrist Problems 6 Months

    Time frame: 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.

  12. Referral to Surgery 6 Months

    Time frame: 6 months

    Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months.

  13. Surgery 6 Months

    Time frame: 6 months

    Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months.

  14. Herbal Remedies and Vitamin Use 6 Months

    Time frame: 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

  15. Over the Counter Pain Medication 6 Months

    Time frame: 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.

  16. Prescribed Pain Medication 6 Months

    Time frame: 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.

  17. BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks

    Time frame: 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

  18. BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months

    Time frame: 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.

  19. BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months

    Time frame: 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.

  20. Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months

    Time frame: 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

  21. Hand-wrist Pain Intensity Over 24 Months: 6 Weeks

    Time frame: 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.

  22. Hand-wrist Pain Intensity Over 24 Months: 6 Months

    Time frame: 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.

  23. Hand-wrist Pain Intensity Over 24 Months: 12 Months

    Time frame: 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.

  24. Hand-wrist Pain Intensity Over 24 Months: 24 Months

    Time frame: 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.

  25. BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))

    Time frame: 6 weeks

    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

  26. BCTQ Symptom Severity Subscale 6 Weeks (CC)

    Time frame: 6 weeks

    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

  27. BCTQ Functional Limitations Subscale 6 Weeks (CC)

    Time frame: 6 weeks

    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

  28. Hand-wrist Pain Intensity 6 Weeks (CC)

    Time frame: 6 weeks

    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.

  29. Insomnia Due to Hand-wrist Problems 6 Weeks (CC)

    Time frame: 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. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.

  30. BCTQ Symptom Severity and Functional Limitations 6 Months (CC)

    Time frame: 6 months

    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

  31. BCTQ Symptom Severity Subscale 6 Months (CC)

    Time frame: 6 months

    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

  32. BCTQ Functional Limitations Subscale 6 Months (CC)

    Time frame: 6 months

    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

  33. Hand-wrist Pain Intensity 6 Months (CC)

    Time frame: 6 months

    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.

  34. Insomnia Due to Hand-wrist Problems 6 Months (CC)

    Time frame: 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. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.

  35. Referral to Surgery 6 Months (CC)

    Time frame: 6 months

    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.

  36. Herbal Remedies and Vitamin Use 6 Months (CC)

    Time frame: 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. 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.

  37. Over the Counter Pain Medication 6 Months (CC)

    Time frame: 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. Sensitivity analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.

  38. Prescribed Pain Medication 6 Months (CC)

    Time frame: 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. Sensitivity analysis for comparison of the odds of pain medication use between treatment groups at 6 months follow-up on participants with complete data.

  39. BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))

    Time frame: 6 weeks

    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

  40. BCTQ Symptom Severity Subscale 6 Weeks (PP)

    Time frame: 6 weeks

    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

  41. BCTQ Functional Limitations Subscale 6 Weeks (PP)

    Time frame: 6 weeks

    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

  42. Hand-wrist Pain Intensity 6 Weeks (PP)

    Time frame: 6 weeks

    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.

  43. Insomnia Due to Hand-wrist Problems 6 Weeks (PP)

    Time frame: 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. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.

  44. BCTQ Symptom Severity and Functional Limitations 6 Months (PP)

    Time frame: 6 months

    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

  45. BCTQ Symptom Severity Subscale 6 Months (PP)

    Time frame: 6 months

    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

  46. BCTQ Functional Limitations Subscale 6 Months (PP)

    Time frame: 6 months

    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

  47. Hand-wrist Pain Intensity 6 Months (PP)

    Time frame: 6 months

    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.

  48. Insomnia Due to Hand-wrist Problems 6 Months (PP)

    Time frame: 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. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.

  49. Referral to Surgery at 6 Months (PP)

    Time frame: 6 months

    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.

  50. Herbal Remedies and Vitamin Use 6 Months (PP)

    Time frame: 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. 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.

  51. Over the Counter Pain Medication 6 Months (PP)

    Time frame: 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. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data

  52. Prescribed Pain Medication 6 Months (PP)

    Time frame: 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. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.

  53. BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)

    Time frame: 6 weeks

    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

  54. BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)

    Time frame: 6 weeks

    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

  55. BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)

    Time frame: 6 weeks

    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

  56. BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)

    Time frame: 6 weeks

    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

  57. BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)

    Time frame: 6 weeks

    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

  58. NHS Cost Differences at 6 Months

    Time frame: 6 months

    Cost of interventions at 6 months

  59. NHS Cost Differences at 6 Months (CC)

    Time frame: 6 months

    Complete case analysis on the cost of interventions at 6 months

  60. NHS Cost Differences at 12 Months

    Time frame: 12 months

    Cost of interventions at 12 months

  61. NHS Cost Differences at 24 Months

    Time frame: 24 months

    Cost of interventions at 24 months

  62. QALYS at 6 Months (Cross-walk Tariff)

    Time frame: 6 months

    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.

  63. QALYS at 12 Months (Cross-walk Tariff)

    Time frame: 12 months

    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.

  64. QALYS at 24 Months (Cross-walk Tariff)

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Keele University

Other

Collaborators

  • Arthritis Research UK

Registry information

Official study 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)

Acronym: INSTinCTS

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Jan 16, 2014
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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