Type 1 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
PAINLESS is a two-centre randomized cross-over feasibility study with blinded outcome assessment of patients with painful diabetic neuropathy (defined as pain severity of =4 on an 11-point numerical r
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of type 1 diabetes for at least 5 years (commenced on insulin treatment within 1 year of diagnosis) 2. Daily neuropathic pain for at least 3 months 3. Distal symmetrical polyneuropathy confirmed by the Toronto Clinical Neuropathy Score >5 4. 24-hr average pain score >4 (BPI-MSF) 5. HbA1c between 6.5 and 13% 6. On stable neuropathic pain medications for the past 3 months 7. Mean total pain intensity of at least 4 on an 11-point numeric rating scale (NRS; with 0 being ‘no pain’ and 10 ‘worst pain imaginable’) during the last week of the screening period 8. Willing and able to comply with the study schedule and be available for the treatment duration 9. Able to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Non-diabetic neuropathies 2. Other chronic pain disorders are more severe than painful diabetic neuropathy 3. History of major psychiatric disorders 4. Pregnancy/breastfeeding or planning pregnancy during the course of the study 5. Hearing or visual impairment, which would impede the ability to use the technological interventions (as per PI discretion)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion reaching 30% (moderate) and 50% (substantial) reduction in pain NRS in 7-day average 24-hour pain, as measured by pain diary, from baseline to the last week of each intervention period (week 12) 2. Area under the curve (AUC) for all daily NRS scores, comparing the two different 12-week intervention periods 3. Pain measured using the Brief Pain Inventory (Modified Short Form) – BPI (MSF), Neuropathic Pain Symptom Inventory (NPSI) at baseline screening period and after each 12-week intervention period 4. Physical and emotional functioning measured using EQ-5D-5L, 36-Item Short Form Health Survey (SF-36), Beck Depression Inventory (BDI), and Type 1 Diabetes-Specific Distress (T1-DDS) at baseline screening and after each 12-week intervention period 5. Average rating of overall improvement measured using the Patient- and Clinician-rated Global Impression of Change (PGIC and CGIC) after each 12-week intervention period 6. Key glycaemic metrics derived from CGM data (Dexcom G7), including time in range (TIR), time above/below range, coefficient of variation (CV), standard deviation (SD), glucose management indicator (GMI), between the 4-week screening period and the final 4 weeks of each 12-week intervention period 7. Haemoglobin A1c (HbA1c) measured using capillary electrophoresis method using boronate affinity chromatography at baseline and the end of each 12-week intervention period. 8. The frequency of adverse and serious adverse events as reported by participants during any visit | — |
Countries
England, United Kingdom
Contacts
Public ContactDinesh Selvarajah
Outcome results
None listed