Validation of the ASI-SR Form in a Population of Chronic Non-cancer Pain Patients

NCT04998734 | Terminated

• 1 other identifier: 2020-001-5
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The Swedish version of ASI-SR has shown good feasibility in assessment of addiction patients functioning compare to long and time-consuming ASI, which is upp to date golden standard in Sweden. This study investigate if ASI-SR is suitable instrument for the assessment of the chronic pain patient addicted to opioids. The validation process is designed according to the COSMIN guidelines. Preliminary results are expected by December 2022.

Conditions

Chronic Pain; Opioid-use Disorder; Quality of Life; Risk Reduction; Assessment, Self

Keywords

opioids; ASI-SR; pain; opioid-use disorder; dependence; validation; assessment

Outcome Measures

Primary Outcomes (1)

• Addiction Severity Index - Short version

  The main objective with this study is to test the psychometric properties of the ASI-SR in a population of CNCP patients.Consistency of CS between the interview and the self-report will be evaluated on the individual basis by interclass correlation analysis (ICC) and at group level with paired t-test or Wilcoxon signed rank test if data is not normally distributed. ICC coefficient is considered to be poor if it is less than 0.40, fair between 0.40-0.59 , good between 0.60-0.70 and excellent between 0.75-1.00.

  Baseline

Secondary Outcomes (8)

• Patient Global Impression of Change

  Baseline

• Addiction Severity Index -Short version

  4-7 days later

• Generalised Anxiety Disorder 7

  baseline

• Research and Development 36-Item Health Survey RAND-36

  Baseline

• Pain Disability Index

  Baseline

Other Outcomes (1)

• Descriptive characteristics of the group

  Baseline

Study Arms (1)

Chronic pain

Patients with chronic non-cancer pain referred to secondary and tertiary care

Diagnostic Test: ASI-SR

Interventions

ASI-SR DIAGNOSTIC_TEST

Psychometric properties of ASI-SR

Chronic pain

Eligibility Criteria

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

Study Population

In this days there are approx. 100 patients treated in the substitution program, 1300 patients receiving referral to the pain clinic in Uppsala Pain Center.

You may qualify if:

• Chronic non-cancer related pain
• ongoing treatment in the clinic

You may not qualify if:

• severe cognitive impairment
• illiterate in Swedish
• inability to give informed consent.

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University Hospital, Pain Center

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders; Risk Reduction Behavior; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Pernilla Åsenlöf, Profesor

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 10, 2021
• Study Start: August 5, 2021
• Primary Completion: June 1, 2022
• Study Completion: March 28, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)