Requirements and Functional Schedule as a Part of Painrehabilitation.

NCT05080062 | Unknown

• 1 other identifier: 2019/01755
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Requirements and functional Schedule also calen Demand Ability Protocol (DAP) is an intervention that has been tested and found useful in occupational health service. The intervention aims to strengthen the collaboration between Health care, employers and employee. The intervention is based on a structured interview about the employers demands at work. This intervention (DAP) will in the present study be evaluated in pain rehabilitation both qualitatively and quantitatively.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Absence from work (sickleave) measured with a question to the participants

  Less absence from work

  Changes from baseline in absence from work to the end of the rehab program (average 4month)

• Absence from work (sickleave) measured with a question to the participants

  Less absence from work

  Changes from baseline in absence from work through study completion (average 1,5 years)

Secondary Outcomes (12)

• Changes in EuroQol 5-dimensions questionnaire (EQ-5D)

  Change from baseline in EuroQol 5-dimensions through study completion (average 1,5 years)

• Changes in EuroQol 5-dimensions

  Change from baseline in EuroQol 5-dimensions to the end of the rehab program (average foru month)

• Changes in Anxiety and depression

  Change from baseline in anxiety and depression through study completion (average 1,5 years)hs)

• Changes in Anxiety and depression

  Change from baseline in anxiety and depression to the end of the rehab program (average four month)

• Changes in sleep

  Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)

Study Arms (2)

Painrehabilitation + Demand and ability protocol

EXPERIMENTAL

Will receive pain-rehabilitation and the intervention ( an interview called Requirements and functional Schedule, with the patients employer and an occupational therapist)

Behavioral: Requirements and functional Schedule

Painrehabilitation

ACTIVE COMPARATOR

Will receive pain-rehabilitation

Behavioral: No intervention

Interventions

Requirements and functional Schedule BEHAVIORAL

An interview with the employee and the employer where the occupational worker is leading the interview and a pain rehabilitation-program

Painrehabilitation + Demand and ability protocol

No intervention BEHAVIORAL

a pain rehabilitation-program

Painrehabilitation

Eligibility Criteria

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

You may qualify if:

• Chronic pain, has an employment

You may not qualify if:

• no longer than 6 month of total sick-leave

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Katarina Danielsson

Uppsala, 75239, Sweden

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Therese Hellman, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarina Danielsson, MD

CONTACT

000186110000; katarina.danielsson@akademiska.se

Katarina Danielsson

CONTACT

000186110000; katarina.danielsson@akademiska.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, principal investigator

Model Details: 50 patients who are in painrehabilitation will also receive the intervention. The control Group will be based on patients from 2017 and 2018 who has underwent rehabilitation. This data will be extracted from the National register of pain rehabilitation in Sweden.

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: October 15, 2021
• Study Start: June 20, 2019
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2023
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)