Painful diabetic neuropathy (PDN) Nervous System Diseases
Conditions
Interventions
Patients will be randomised to either the ACT condition (66%) or waiting list condition (33%) using a secure (24-hour) web-based randomisation programme controlled centrally by the Liverpool Clinical
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older, who have normal or corrected to normal vision and hearing by having a visual acuity of at least decimal 0.5 (6/12) measured on the Snellen scale (e.g., without metal-rimmed glasses or hearing aids) 2. Willing to participate in the study and complete the scientific protocol 3. People with type 1 or type 2 diabetes, with a glycated hemoglobin (HbA1c) level =11% at the screening visit, will be considered eligible to participate in the study
Exclusion criteria
Exclusion criteria: 1. Current or planned hospitalisation during the period of study 2. Patients not giving consent to participate 3. Patients who cannot communicate fluently in English 4. Unable, in the opinion of the research investigator, to comply or adhere to the requirements of the study. This may include, for example, an inability to understand the written documentation for the study 5. A history of serious head injury, brain surgery or brain injury 6. A history of neurological disease or psychiatric disorder which would negate involvement in the study. For example, Alzheimer's disease, Huntington’s Disease, Epilepsy, Parkinson Disease, large territory cerebrovascular accidents, severe depression, schizoaffective disorders, current under active therapy in psychiatric services 7. Patients that have any underlying medical condition that in the opinion of the investigator will interfere with the study findings. For example: Patients with renal impairment, or hypothyroidism or hyperthyroidism; patients with a previous or current problem of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, hepatitis B or C, HIV infection or peripheral neuropathy due to a non-diabetic cause; pregnant; patients participating in any other interventional research trial, will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility-related outcomes will include the following: number of referrals, the number of interviews with researchers, time taken to fill in questionnaires, missing data, and follow-up response rates, measured at T2 (post-treatment periods) 2. Acceptability of the treatment assessed using qualitative methods to provide a better insight into the following: a barrier screening evaluation, burden for not taking part/discontinuation or dropping out, sessions attended rates, homework completion, time dedicated to homework practice, experience (satisfaction, perceptions), acceptability of the protocol to the Aintree Diabetes Centre, measured at T2 (post-treatment periods) 3. The means and standard deviations (SDs) of the SF36 scale and its subscales in the neuropathic pain population are estimated in order to compute a more robust estimate of the sample size and effect size required for future efficacy trials | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neuroimaging outcomes: brain plasticity in relation to the neural substrates of pain modulation measured using high-resolution anatomical images obtained using T1- and T2-weighted scans for grey matter anatomy assessments and DTI for white matter assessment. Comparison of functional information will use Blood Oxygen Level Dependent (BOLD) echo-planar imaging in response to painful stimuli and emotional conflicts, and in the resting-state, measured at T1 (pre-treatment periods), T2 (post-treatment periods). 2. Computer-based/neuropsychological tests: neurocognitive functioning measured using Cambridge Neuropsychological Test Automated Battery (CANTAB®) at T1 (pre-treatment periods), T2 (post-treatment periods), T3 (2-month follow-up) 3. Self-report questionnaires: 3.1. Catastrophic thinking measured using the Pain Catastrophizing Scale (PCS) at T1 (pre-treatment periods), T2 (post-treatment periods), T3 (2-month follow-up) 3.2. Perceived control over pain, and Medical utilisation measured using the Survey of Pain Attitudes (SOPA) at T1 (pre-treatment periods), T2 (post-treatment periods), T3 (2-month follow-up) 3.3. Patients' readiness to adopt a self-management approach to their chronic pain and in monitoring their progress in rehabilitation measured using the Pain Stages of Change questionnaire (PSOCQ) at T1 (pre-treatment periods), T2 (post-treatment periods), T3 (2-month follow-up) 3.4. Quality of life (QOL) measured using the SF-36 Health Survey and the General health: EQ-5D-5L at T1 (pre-treatment periods), T2 (post-treatment periods), T3 (2-month follow-up) 3.5. Self-care activity associated with glycaemic control measured using the Diabetes Self-Management Questionnaire (DSMQ) at T1 (pre-treatment periods), T2 (post-treatment periods), T3 (2-month follow-up) 3.6. Fatigue measured using the Single-item Rhoten Fatigue Scale at T1 (pre-treatment periods), T2 (post-treatment periods), T3 (2-month follow-up) 3.7. Patient's perception of how treatment has affect | — |
Countries
England, United Kingdom
Contacts
Public ContactHanaa Alonezi
Outcome results
None listed