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Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
Time frame: Week 1, 2, 3, 4, 5, 6 post-baseline (screening)
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
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Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
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Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
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Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
The NDI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to neck pain.
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Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
The NPQ evaluates functional impairment for the past 3 days in this study and is a patient reported outcome of subjective neck pain and pain reduction. The NPQ is a 9-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 5 levels, each representing a score of 0-4. Higher scores indicate greater limitation relating to neck pain.
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Patient Global Impression of Change (PGIC)
Time frame: Week 6, Month 3, 6, 9, 12 post-baseline (screening)
PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
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Physical examination
Time frame: Week 1, 6 post-baseline (screening)
Pain upon movement in cervical range of motion (ROM) will be assessed.
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Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).
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Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
EQ-VAS uses a vertical 10cm line labeled at each end with scale anchors. EQ-VAS is used to indicate the patient's health state and patients are asked to mark a point that represents their health state between the anchors of 'worst health state' and 'best health state imaginable'. Scores are recorded in millimeters with a total range of 0-100 millimeters.
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Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
SF-12 is a simplified version of SF-36. SF-12 assesses health-related quality of life (HRQoL) across 8 domains with 1-2 items per domain: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Higher scores indicate better HRQoL.
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Economic evaluation (medical costs)
Time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.
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Economic evaluation (time-related costs)
Time frame: Week 2 post-baseline (screening)
Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.
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Economic evaluation (lost productivity costs)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.
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Credibility and Expectancy Questionnaire
Time frame: Week 1 post-baseline (screening)
The credibility and expectancy questionnaire will be used to assess treatment expectation on a 9-point Likert scale. Participants will be asked to select an answer to the following questions on their first visit of Week 1 (1='not at all'; and 5='somewhat'; to 9='very much'): "How much do you expect that treatment will alleviate your symptoms during the study period?"
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Drug Consumption (drug type)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
The drug type of prescription intake for medicine or rescue medicine (acetaminophen) will be recorded.
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Drug Consumption (drug dose)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
The drug dose of prescription intake for medicine or rescue medicine (acetaminophen) will be recorded.
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Other treatments (treatment type)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
The type of other treatments received (e.g. physical therapy, injections) will be recorded.
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Other treatments (treatment frequency)
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
The frequency of other treatments received (e.g. physical therapy, injections) will be recorded.
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Adverse events
Time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit)
Physicians will monitor and record any unexpected or unintended patient reaction to Chuna or usual care at each visit. Adverse events (AEs) associated with Chuna will include, but not be limited to, AEs anticipated from previous reports of manual therapy, and will stay open to all possibilities taking into consideration other potential, unknown AEs.