N/A
N=26
OPEN Study: Pain Management Treatment Needs Interviews
HIV · Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT02972606 ↗Enrolled (actual)
26
Serious AEs
—
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants Who Completed a Semi-Structure Interview — 26 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- King's College London
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed a Semi-Structure Interview |
26 | — |
Summary
Presently, there are few options for medically managing HIV-related painful peripheral sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN. However, there is a scarcity of research on psychological treatment approaches for pain management in people with HIV. This study will use in-depth semi-structured interviews to examine the needs of people with painful HIV-SN for a psychologically-based pain management treatment that may be delivered over the Internet. Interview questions will examine participants' needs in terms of treatment content and delivery format. Men and women, ethnic minorities, and people who use recreational drugs will be sampled to ensure that interview responses reflect the views of people most commonly suffering from this condition. Approximately 30 people will be recruited for the study. The interviews will be audio recorded, transcribed verbatim, and coded to identify themes. The interview responses will be used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped that tailoring the treatment based on the qualitative interview responses will increase the acceptability of the treatment and will improve treatment adherence rates for a future study.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Living with HIV.
- A positive screen for peripheral sensory neuropathy, as indicated by: presence of self-reported bilateral foot pain and/or numbness in a symmetrical distribution.
- Positive screen for symptoms of neuropathic pain in the feet, as indicated by a score of greater than or equal to 3 on the patient reported outcomes section of the Neuropathic Pain Interview.
- Pain in the feet present most days for at least 3 months.
- Average pain intensity of greater than or equal to 4/10.
- Average interference of pain with daily activities is greater than or equal to 4/10.
Exclusion Criteria
- Presence of excessive alcohol consumption, hypothyroidism, vitamin B12 deficiency, diabetes, exposure to isoniazid or chemotherapy drug treatment, or a known history of a neuropathy due to a cause other than HIV or antiretroviral treatment
- Unable to conduct interview in English.
- Current diagnosis of dementia or learning disability.
- Unwilling to provide written informed consent.
Data sourced from ClinicalTrials.gov (NCT02972606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.