Testing a support programme for opioid reduction for people with chronic non-malignant pain: the I-WOTCH randomised controlled trial protocol.

Testing a support programme for opioid reduction for people with chronic non-malignant pain: the I-WOTCH randomised controlled trial protocol.

Publication date: Aug 08, 2019

Chronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain.

A pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years.

Full approval was given by Yorkshire & The Humber – South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website.

ISRCTN49470934; Pre-results.

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Sandhu, H.K., Abraham, C., Alleyne, S., Balasubramanian, S., Betteley, L., Booth, K., Carnes, D., Furlan, A.D., Haywood, K., Iglesias Urrutia, C.P., Lall, R., Manca, A., Mistry, D., Nichols, V.P., Noyes, J., Rahman, A., Seers, K., Shaw, J., Tang, N.K.Y., Taylor, S., Tysall, C., Underwood, M., Withers, E.J., and Eldabe, S. Testing a support programme for opioid reduction for people with chronic non-malignant pain: the I-WOTCH randomised controlled trial protocol. 03888. 2019 BMJ Open (9):8.

Concepts Keywords
Chronic Pain Healthcare
Compact Disc Clinical cost effectiveness
Healthcare Controlled trial protocol
Humber Pain
Malignant Self management
NHS Relaxation
Opioid Pain
Opioids Perception
Pain Acute pain
Patient Reported Outcomes Nociception
Primary Endpoint Morphine
Protocol RTT
Randomised Controlled Trial Pain management
Sleep Chronic pain
South Yorkshire Opioid
Yorkshire Patient-reported outcome
Heroin
Opioid-induced hyperalgesia
Controlled trial protocol

Semantics

Type Source Name
gene UNIPROT ACTA1
drug DRUGBANK Copper
disease MESH leg ulcers
gene UNIPROT CCAR1
disease DOID constipation
disease MESH back pain
drug DRUGBANK Tricyclazole
gene UNIPROT PDF
gene UNIPROT GDF15
gene UNIPROT ELK3
gene UNIPROT EPHB1
gene UNIPROT SLC6A2
gene UNIPROT BPI
gene UNIPROT FGFR1OP
gene UNIPROT CHTOP
disease MESH Musculoskeletal Pain
disease MESH Opioid dependence
gene UNIPROT PROC
gene UNIPROT SCN8A
gene UNIPROT RAB35
gene UNIPROT ENG
disease DOID Arthritis
disease MESH Arthritis
gene UNIPROT NCKIPSD
disease MESH retirement
drug DRUGBANK Ilex paraguariensis leaf
gene UNIPROT EGR3
gene UNIPROT CISH
gene UNIPROT CXCL17
gene UNIPROT TESC
gene UNIPROT TSC1
gene UNIPROT SLC12A3
drug DRUGBANK Glycine betaine
gene UNIPROT ARID1A
gene UNIPROT CRH
gene UNIPROT C1QL1
drug DRUGBANK Corticorelin
disease DOID CRF
drug DRUGBANK Etoperidone
gene UNIPROT KIDINS220
disease MESH satisfaction
disease MESH depression
disease DOID anxiety
disease MESH anxiety
gene UNIPROT MENT
drug DRUGBANK Trestolone
gene UNIPROT CDS1
gene UNIPROT FYB1
disease MESH withdrawal symptoms
disease MESH Chronic headache
gene UNIPROT FANCE
gene UNIPROT ELOVL6
disease DOID face
gene UNIPROT SLC35G1
gene UNIPROT DESI1
gene UNIPROT DNMT1
gene UNIPROT CD69
disease MESH relapse
disease MESH stillbirths
disease MESH miscarriages
disease DOID GPs
gene UNIPROT PHB2
drug DRUGBANK Tramadol
drug DRUGBANK Meperidine
drug DRUGBANK Pentazocine
drug DRUGBANK Oxycodone
drug DRUGBANK Methadone
drug DRUGBANK Hydromorphone
drug DRUGBANK Fentanyl
drug DRUGBANK Diamorphine
drug DRUGBANK Morphine
drug DRUGBANK Dipipanone
drug DRUGBANK Buprenorphine
disease DOID analgesia
disease MESH diagnosis
disease DOID cancer
disease MESH cancer
gene UNIPROT MET
gene UNIPROT SLTM
drug DRUGBANK Methionine
gene UNIPROT PRAC1
drug DRUGBANK Coenzyme M
gene UNIPROT AATF
gene UNIPROT APP
gene UNIPROT LARGE1
disease DOID fibromyalgia
disease MESH fibromyalgia
disease MESH neuropathic pain
disease DOID osteoarthritis
disease MESH osteoarthritis
disease MESH low back pain
gene UNIPROT EHD1
disease MESH community
gene UNIPROT DYNAP
gene UNIPROT NHS
disease MESH chronic pain
gene UNIPROT IMPACT

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