OPEN Study: Pain Management Treatment Needs Interviews

NCT02972606 | Completed Results

• 1 other identifier: 205949
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV; Peripheral Neuropathy

Keywords

HIV; Peripheral Neuropathy; Chronic Pain; Qualitative Research

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed a Semi-Structure Interview

  Semi-structured interview performed at one occasion where the patient describes his/her experience living with painful peripheral neuropathy and his/her thoughts about a psychological treatment for managing pain.

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with HIV and painful peripheral neuropathy. We will purposively sample men, women, ethnic minorities, and people who use recreational drugs .

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Imperial College London: collaborator
• Chelsea and Westminster NHS Foundation Trust: collaborator
• University College, London: collaborator

Study Sites (2)

King's College London

London, SE1 9RT, United Kingdom

Location

Chelsea & Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

Related Publications (1)

• Scott W, Garcia Calderon Mendoza Del Solar M, Kemp H, McCracken LM, C de C Williams A, Rice ASC. A qualitative study of the experience and impact of neuropathic pain in people living with HIV. Pain. 2020 May;161(5):970-978. doi: 10.1097/j.pain.0000000000001783.

  PMID: 31855944 BACKGROUND

Related Links

• Published peer-reviewed paper

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Chronic Pain

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Whitney Scott
• Organization: King's College London

whitney.scott@kcl.ac.uk

02071885421

Study Officials

• Whitney Scott, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: January 11, 2023
• Results First Posted: January 11, 2023

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)