Injection Versus Splinting in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome (CTS) Clinical Trial

— INSTinCTS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038452
• Other study ID #: 464/11
• Secondary ID: 201052013-001435
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: February 26, 2019

Study information

• Verified date: March 2023
• Source: Keele University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: February 26, 2019
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Carpal Tunnel Syndrome (CTS)
• Syndrome

Intervention

Drug:
• Depo-Medrone
Steroid Injection

Device:
• Wrist Splint
Simple wrist splint

Locations

Country	Name	City	State
United Kingdom	Staffordshire and Stoke on Trent Partnership NHS Trust	Newcastle under Lyme	Staffordshire

Sponsors (2)

Lead Sponsor	Collaborator
Keele University	Arthritis Research UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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 tu — View Citation

Chesterton LS, Dziedzic KS, van der Windt DA, Davenport G, Myers HL, Rathod T, Blagojevic-Bucknall M, Jowet SM, Burton C, Roddy E, Hay EM. The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol. BMC Musculoskelet Disord. 2016 Oct 6;17(1):415. doi: 10.1186/s12891-016-1264-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Referral to Surgery 6 Months	Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months.	6 months
Secondary	Surgery 6 Months	Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	NHS Cost Differences at 6 Months	Cost of interventions at 6 months	6 months
Secondary	NHS Cost Differences at 6 Months (CC)	Complete case analysis on the cost of interventions at 6 months	6 months
Secondary	NHS Cost Differences at 12 Months	Cost of interventions at 12 months	12 months
Secondary	NHS Cost Differences at 24 Months	Cost of interventions at 24 months	24 months
Secondary	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
Secondary	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
Secondary	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