NCT05828121

Brief Summary

The investigators do research on chronic pain treatment to minimize the risks associated with opioids.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

February 8, 2023

Last Update Submit

April 12, 2023

Conditions

Chronic PainOpioid Use

Outcome Measures

Primary Outcomes (4)

  • Change From Baseline in Audit C at 12 Weeks

    Audit C

    12 weeks

  • Change from baseline in Pain Scores on the Visual Analog Scale at 12 Weeks

    Visual Analog Scale

    12 weeks

  • Change from baseline in Bergen Insomnia scale at 12 Weeks

    BIS

    12 weeks

  • Change from baseline in Health-related quality of life at 12 Weeks

    HQ5D5L

    12 weeks

Study Arms (1)

Point1

EXPERIMENTAL

Receiving treatment

Behavioral: POINT1

Interventions

POINT1BEHAVIORAL

Receiving treatment

Point1

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-malignant, chronic pain
  • Registered in Stavanger municipality
  • Consent to participation.
  • Age 18 - 67 years
  • Pain duration \<10 years

You may not qualify if:

  • malignant pain condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger municipality

Stavanger, 4010, Norway

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kine Gjesdal, PhD

CONTACT

004748136702kine.gjesdal@sus.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: MRC framework for a complex intervention
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 8, 2023

First Posted

April 25, 2023

Study Start

October 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
2023

Locations

NO(1)