Table 1.
Procedures | Telephone Call |
Baseline Visit | First Visit | Visit 2–Visit 17 | Final Visit | 6-Month Follow-Up |
---|---|---|---|---|---|---|
Eligibility Assessment | ✓ | |||||
Informed consent | ✓ | |||||
Blood Tests: Full blood count, Urea and electrolytes, Liver function tests, HbA1c (if diabetic) | ||||||
Demographics: Age, Gender, Marital status, Employment status, Educational level, Ethnicity | ✓ | |||||
Medical History: Chronic pain symptom duration, Co-morbidities, Medications | ✓ | ✓ | ||||
Measurements: Height, Weight, BMI, Blood pressure, Heart rate, Oxygen saturations | ✓ | ✓ ✓ | ||||
Participant-reported outcomes measures (PROMs): Brief Pain Inventory Widespread Pain Index/Symptom Severity Score Fatigue Severity Scale Jenkins Sleep Questionnaire Patient Global Impression of Change Revised Fibromyalgia Impact Questionnaire Hospital Anxiety and Depression Scale |
✓ ✓ ✓ ✓ ✓ ✓ |
✓ ✓ ✓ ✓ ✓ ✓ ✓ |
✓ ✓ |
|||
Performance-based outcome measures (PBOMs): Tender Point Count Stroop Test |
✓ ✓ |
✓ ✓ |
||||
Treatment | ✓ ✓ | ✓ | ✓ | |||
Weekly Numerical Rating Scale (NRS) Participant-reported experience measure (PREM) |
✓ |
✓ ✓ ✓ |
||||
Audio-recorded qualitative interviews (optional) | ✓ | ✓ | ✓ ✓ |