CONNACT OA Knee Cohort

Osteoarthritis, Knee Clinical Trial

— CONNACT  

Official title:

Collaborative Model of Care Between Orthopaedics and Allied Health Care Professionals (CONNACT) OA Knee Cohort

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04942236
• Other study ID #: WHC/2020-00076
• Status: Not yet recruiting
• Start date: June 30, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2021
• Source: Tan Tock Seng Hospital
• Contact: Bryan Tan
• Phone: 63577713
• Email: bryan_tan[@]whc.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

CONNACT OA knee cohort is a prospective longitudinal cohort study where we aim to collect sociodemographic, psychosocial, clinical, health utilization and cost data in order to better understand the Asian OA knee cohort and investigate for prognostic variables that can potentially influence a patients clinical outcome and treatment decisions.

In addition, the CONNACT OA knee cohort will form the basis for a cohort multiple randomized control trial (cmRCT) study design where multiple interventions can be tested in a randomized fashion. Each intervention is offered to a randomly selected sample of patients eligible for that intervention, who are then compared with the rest of the eligible patients from the cohort that are still being treated as usual.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 46 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Knee Osteoarthritis (based on NICE guidelines)

2. Age > 45 years

3. Community ambulator with or without walking aid

4. Conversant in English or Chinese

Exclusion Criteria:

1. Alternative diagnosis to Knee OA e.g. referred pain from spine or hip

2. Other forms of knee arthritis e.g. inflammatory, post-traumatic

3. Moderate to severe cognitive impairment e.g. dementia

4. Previous knee arthroplasty

5. Wheelchair bound patients

6. Medical conditions that will medically interfere with rehabilitation involvement e.g. decompensated heart failure, stroke with significant deficit, end stage renal failure

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Locations

Country	Name	City	State
Singapore	Khoo Teck Puat Hospital	Singapore
Singapore	St Luke's Eldercare (AMK Polyclinic, Hougang Central, Nee Soon Central)	Singapore
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Khoo Teck Puat Hospital, National Healthcare Group, Singapore, Woodlands Health Campus

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OsteoArthritis Quality Indicator (OA QI)	The 17-items OA-QI questionnaire includes quality indicators related to patient education and information, assessment of pain and function, referrals, and pharmacologic treatment for OA. This questionnaire is administer at patient's baseline visit, after consultation with an orthopaedic surgeon, to find out patient-perceived quality of OA management. Using this outcome to investigate the quality of care delivered in primary and secondary care for patients with knee OA.	Baseline
Other	University of California, Los Angeles (UCLA) activity score	1 question survey to understands patient physical activity level from a scale of 1 (wholly inactive) to 10 (regular participation in impact sports).	Baseline
Other	University of California, Los Angeles (UCLA) activity score	1 question survey to understands patient physical activity level from a scale of 1 (wholly inactive) to 10 (regular participation in impact sports).	Change from Baseline to 3 months
Other	University of California, Los Angeles (UCLA) activity score	1 question survey to understands patient physical activity level from a scale of 1 (wholly inactive) to 10 (regular participation in impact sports).	Change from Baseline to 6 months
Other	University of California, Los Angeles (UCLA) activity score	1 question survey to understands patient physical activity level from a scale of 1 (wholly inactive) to 10 (regular participation in impact sports).	Change from Baseline to 12 months
Other	Global perceived effect (GPE)	Patient will be asked to rate thier overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.	3 months
Other	Global perceived effect (GPE)	Patient will be asked to rate thier overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.	6 months
Other	Global perceived effect (GPE)	Patient will be asked to rate thier overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.	12 months
Other	Patient Acceptable Symptom State (PASS)	A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no. "When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life."	3 months
Other	Patient Acceptable Symptom State (PASS)	A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no. "When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life."	6 months
Other	Patient Acceptable Symptom State (PASS)	A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no. "When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life."	12 months
Other	Self-reported treatment failure	Patient who answers 'no' to PASS will be asked to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?"	3 months
Other	Self-reported treatment failure	Patient who answers 'no' to PASS will be asked to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?"	6 months
Other	Self-reported treatment failure	Patient who answers 'no' to PASS will be asked to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?"	12 months
Other	Cumulative Analgesia Consumption Score (CACS)	Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder (1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.	3 months
Other	Cumulative Analgesia Consumption Score (CACS)	Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder (1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.	6 months
Other	Cumulative Analgesia Consumption Score (CACS)	Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder (1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.	12 months
Other	Short dietary questionnaire	This questionnaire is to assess the eating habits and dietary choices over a period of time. It consists of 9 questions looking at the frequency of consumption in these categories - sugar, fats, fruits and vegetables, and wholegrains - and the degree of mindfulness in eating.	Baseline
Other	Short dietary questionnaire	This questionnaire is to assess the eating habits and dietary choices over a period of time. It consists of 9 questions looking at the frequency of consumption in these categories - sugar, fats, fruits and vegetables, and wholegrains - and the degree of mindfulness in eating.	Change from Baseline to 3 months
Other	Short dietary questionnaire	This questionnaire is to assess the eating habits and dietary choices over a period of time. It consists of 9 questions looking at the frequency of consumption in these categories - sugar, fats, fruits and vegetables, and wholegrains - and the degree of mindfulness in eating.	Change from Baseline to 6 months
Other	Short dietary questionnaire	This questionnaire is to assess the eating habits and dietary choices over a period of time. It consists of 9 questions looking at the frequency of consumption in these categories - sugar, fats, fruits and vegetables, and wholegrains - and the degree of mindfulness in eating.	Change from Baseline to 12 months
Other	Questionnaire measuring the direct and indirect costs	Cost questionnaire	3 months
Other	Questionnaire measuring the direct and indirect costs	Cost questionnaire	6 months
Other	Questionnaire measuring the direct and indirect costs	Cost questionnaire	12 months
Other	Arthritis Self-efficacy scale 8 (ASES-8)	This 8-items shortened version of the original 20-item instrument includes two items from the pain subscale, four items from the other symptoms subscale, and two new items that relate to preventing pain and fatigue from interfering with daily activities. The questionnaire measures patients' confidence on a scale of 1 (very uncertain) to 10 (very certain) in their ability to manage symptoms of arthritis. Responses were averaged to yield a score ranging from 1 to 10, the higher number being having greater self-efficacy.	Baseline
Other	Arthritis Self-efficacy scale 8 (ASES-8)	This 8-items shortened version of the original 20-item instrument includes two items from the pain subscale, four items from the other symptoms subscale, and two new items that relate to preventing pain and fatigue from interfering with daily activities. The questionnaire measures patients' confidence on a scale of 1 (very uncertain) to 10 (very certain) in their ability to manage symptoms of arthritis. Responses were averaged to yield a score ranging from 1 to 10, the higher number being having greater self-efficacy.	Change from Baseline to 3 months
Other	Arthritis Self-efficacy scale 8 (ASES-8)	This 8-items shortened version of the original 20-item instrument includes two items from the pain subscale, four items from the other symptoms subscale, and two new items that relate to preventing pain and fatigue from interfering with daily activities. The questionnaire measures patients' confidence on a scale of 1 (very uncertain) to 10 (very certain) in their ability to manage symptoms of arthritis. Responses were averaged to yield a score ranging from 1 to 10, the higher number being having greater self-efficacy.	Change from Baseline to 6 months
Other	Arthritis Self-efficacy scale 8 (ASES-8)	This 8-items shortened version of the original 20-item instrument includes two items from the pain subscale, four items from the other symptoms subscale, and two new items that relate to preventing pain and fatigue from interfering with daily activities. The questionnaire measures patients' confidence on a scale of 1 (very uncertain) to 10 (very certain) in their ability to manage symptoms of arthritis. Responses were averaged to yield a score ranging from 1 to 10, the higher number being having greater self-efficacy.	Change from Baseline to 12 months
Other	Brief Fear of Movement Scale for Osteoarthritis	This scale will be used to assess fear of pain. It is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The patient is asked to indicate 1 (strongly disagree), 2 (disagree), 3 (agree) or 4 (strongly agree) for each item. The higher number represents increasing fear.	Baseline
Other	Brief Fear of Movement Scale for Osteoarthritis	This scale will be used to assess fear of pain. It is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The patient is asked to indicate 1 (strongly disagree), 2 (disagree), 3 (agree) or 4 (strongly agree) for each item. The higher number represents increasing fear.	Change from Baseline to 3 months
Other	Brief Fear of Movement Scale for Osteoarthritis	This scale will be used to assess fear of pain. It is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The patient is asked to indicate 1 (strongly disagree), 2 (disagree), 3 (agree) or 4 (strongly agree) for each item. The higher number represents increasing fear.	Change from Baseline to 6 months
Other	Brief Fear of Movement Scale for Osteoarthritis	This scale will be used to assess fear of pain. It is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The patient is asked to indicate 1 (strongly disagree), 2 (disagree), 3 (agree) or 4 (strongly agree) for each item. The higher number represents increasing fear.	Change from Baseline to 12 months
Other	Chronic illness-related shame score (CISS)	This 7-items shame score aim to find out the participants' shame feelings derived from chronic illness-related experiences. Each item is rated on a 5-point Likert (0: Never True; 4: Always True). Higher scores reveal higher levels of shame specifically associated with the experience of having an illness and/or its symptomatology.	Baseline
Other	Chronic illness-related shame score (CISS)	This 7-items shame score aim to find out the participants' shame feelings derived from chronic illness-related experiences. Each item is rated on a 5-point Likert (0: Never True; 4: Always True). Higher scores reveal higher levels of shame specifically associated with the experience of having an illness and/or its symptomatology.	Change from Baseline to 3 months
Other	Chronic illness-related shame score (CISS)	This 7-items shame score aim to find out the participants' shame feelings derived from chronic illness-related experiences. Each item is rated on a 5-point Likert (0: Never True; 4: Always True). Higher scores reveal higher levels of shame specifically associated with the experience of having an illness and/or its symptomatology.	Change from Baseline to 6 months
Other	Chronic illness-related shame score (CISS)	This 7-items shame score aim to find out the participants' shame feelings derived from chronic illness-related experiences. Each item is rated on a 5-point Likert (0: Never True; 4: Always True). Higher scores reveal higher levels of shame specifically associated with the experience of having an illness and/or its symptomatology.	Change from Baseline to 12 months
Other	Multidimensional Scale of Perceived Social Support (MSPSS)	This scale is a 12-item questionnaire to identify the patients' perceived adequacy of social support from three sources: family, friends, & significant other. Each item is scored on a scale from 1 to 7 (0 = very strongly disagree, 7 = very strongly agree).	Baseline
Other	Multidimensional Scale of Perceived Social Support (MSPSS)	This scale is a 12-item questionnaire to identify the patients' perceived adequacy of social support from three sources: family, friends, & significant other. Each item is scored on a scale from 1 to 7 (0 = very strongly disagree, 7 = very strongly agree).	Change from Baseline to 3 months
Other	Multidimensional Scale of Perceived Social Support (MSPSS)	This scale is a 12-item questionnaire to identify the patients' perceived adequacy of social support from three sources: family, friends, & significant other. Each item is scored on a scale from 1 to 7 (0 = very strongly disagree, 7 = very strongly agree).	Change from Baseline to 6 months
Other	Multidimensional Scale of Perceived Social Support (MSPSS)	This scale is a 12-item questionnaire to identify the patients' perceived adequacy of social support from three sources: family, friends, & significant other. Each item is scored on a scale from 1 to 7 (0 = very strongly disagree, 7 = very strongly agree).	Change from Baseline to 12 months
Other	Built Environment	5-items questionnaire to assess the relationship of one's environment to the health outcomes.	Baseline
Other	Built Environment	5-items questionnaire to assess the relationship of one's environment to the health outcomes.	Change from Baseline to 3 months
Other	Built Environment	5-items questionnaire to assess the relationship of one's environment to the health outcomes.	Change from Baseline to 6 months
Other	Built Environment	5-items questionnaire to assess the relationship of one's environment to the health outcomes.	Change from Baseline to 12 months
Other	Religion/Spirituality	2-items questionnaire to find out the effects of having religion/spiritual beliefs on one's health outcomes.	Baseline
Other	Religion/Spirituality	2-items questionnaire to find out the effects of having religion/spiritual beliefs on one's health outcomes.	Change from Baseline to 3 months
Other	Religion/Spirituality	2-items questionnaire to find out the effects of having religion/spiritual beliefs on one's health outcomes.	Change from Baseline to 6 months
Other	Religion/Spirituality	2-items questionnaire to find out the effects of having religion/spiritual beliefs on one's health outcomes.	Change from Baseline to 12 months
Other	Oxford Knee Score (OKS)	This 12 items self-reported questionnaire measures patient's pain and level of function. Each item is rated from least to most difficultly or severity. The scoring system ranges from 0 to 4 for each question with 4 representing maximum function and 0 representing poorest function. The lowest (worse) score is 0, and the highest (best) score is 48.	Baseline
Other	Knee Society Score (KSS) Function	The 3 items patient-reported portion (Function Score) of the KSS covers the patient's mobility (walking distance and stairs) and potential walking aids. Score range of the KSS is from 0 to 100 points for each portion, with higher scores indicating better outcome.	Baseline
Primary	Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)	Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.	Baseline
Primary	Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)	Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.	Change from Baseline to 3 months
Primary	Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)	Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.	Change from Baseline to 6 months
Primary	Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)	Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.	Change from Baseline to 12 months
Secondary	Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL	The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 items); KOOS QoL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the three scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	Baseline
Secondary	Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL	The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 items); KOOS QoL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the three scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	Change from Baseline to 3 months
Secondary	Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL	The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 items); KOOS QoL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the three scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	Change from Baseline to 6 months
Secondary	Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL	The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 items); KOOS QoL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the three scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	Change from Baseline to 12 months
Secondary	EuroQol-5 Dimensions (EQ-5D)	EuroQol-5 Dimensions (EQ-5D) consists of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by selecting the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.	Baseline
Secondary	EuroQol-5 Dimensions (EQ-5D)	EuroQol-5 Dimensions (EQ-5D) consists of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by selecting the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.	Change from Baseline to 3 months
Secondary	EuroQol-5 Dimensions (EQ-5D)	EuroQol-5 Dimensions (EQ-5D) consists of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by selecting the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.	Change from Baseline to 6 months
Secondary	EuroQol-5 Dimensions (EQ-5D)	EuroQol-5 Dimensions (EQ-5D) consists of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by selecting the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.	Change from Baseline to 12 months
Secondary	Patient Health Questionnaire 4 (PHQ-4)	Measurement for depression and anxiety rated on a 4 point Likert-type scale. 0 refers to 'Not at all', 3 refers 'Nearly everyday'. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).; Total score =3 for first 2 questions suggest anxiety. Total score =3 for last 2 questions suggest depression.	Baseline
Secondary	Patient Health Questionnaire 4 (PHQ-4)	Measurement for depression and anxiety rated on a 4 point Likert-type scale. 0 refers to 'Not at all', 3 refers 'Nearly everyday'. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).; Total score =3 for first 2 questions suggest anxiety. Total score =3 for last 2 questions suggest depression.	Change from Baseline to 3 months
Secondary	Patient Health Questionnaire 4 (PHQ-4)	Measurement for depression and anxiety rated on a 4 point Likert-type scale. 0 refers to 'Not at all', 3 refers 'Nearly everyday'. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).; Total score =3 for first 2 questions suggest anxiety. Total score =3 for last 2 questions suggest depression.	Change from Baseline to 6 months
Secondary	Patient Health Questionnaire 4 (PHQ-4)	Measurement for depression and anxiety rated on a 4 point Likert-type scale. 0 refers to 'Not at all', 3 refers 'Nearly everyday'. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).; Total score =3 for first 2 questions suggest anxiety. Total score =3 for last 2 questions suggest depression.	Change from Baseline to 12 months
Secondary	Pain, Enjoyment, General Activity Scale (PEG)	Measures the pain intensity and interference level using a three-item scale. Scale of 0 to 10 is used for each item. 0 refers 'no pain', 10 refers 'worse pain'. Add the responses to the three questions, then divide by three to get a mean score (out of 10) on overall impact of points.	Baseline
Secondary	Pain, Enjoyment, General Activity Scale (PEG)	Measures the pain intensity and interference level using a three-item scale. Scale of 0 to 10 is used for each item. 0 refers 'no pain', 10 refers 'worse pain'. Add the responses to the three questions, then divide by three to get a mean score (out of 10) on overall impact of points.	Change from Baseline to 3 months
Secondary	Pain, Enjoyment, General Activity Scale (PEG)	Measures the pain intensity and interference level using a three-item scale. Scale of 0 to 10 is used for each item. 0 refers 'no pain', 10 refers 'worse pain'. Add the responses to the three questions, then divide by three to get a mean score (out of 10) on overall impact of points.	Change from Baseline to 6 months
Secondary	Pain, Enjoyment, General Activity Scale (PEG)	Measures the pain intensity and interference level using a three-item scale. Scale of 0 to 10 is used for each item. 0 refers 'no pain', 10 refers 'worse pain'. Add the responses to the three questions, then divide by three to get a mean score (out of 10) on overall impact of points.	Change from Baseline to 12 months