Return to Work for Persistent Spinal Pain Syndrome Type II Patients

Failed Back Surgery Syndrome Clinical Trial

— OPERA  

Official title:

Objectifying Performance Assessments and Personalized Rehabilitation Trajectories to Improve Return to Work in Patients With Persistent Spinal Pain Syndrome Type II: a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269212
• Other study ID #: OPERA
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: August 2025

Study information

• Verified date: May 2022
• Source: Universitair Ziekenhuis Brussel
• Contact: Maarten Moens, Prof. dr.
• Phone: +3224775514
• Email: stimulusresearchgroup[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II (PSPS-T2) patients after SCS implantation is different after a personalized biopsychosocial rehabilitation program specifically targeting return to work (RTW) compared with usual care.

Description:

A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II patients after SCS implantation is different after a personalized biopsychosocial rehabilitation program specifically targeting return to work compared with usual care. The primary scientific objective is to examine whether the ability to work in PSPS-T2 patients after SCS implantation is different with a personalized biopsychosocial rehabilitation program specifically targeting RTW, compared to usual care. The secondary objective of the study is to examine if a personalized biopsychosocial rehabilitation program specifically targeting RTW, compared to usual care, is different in improving functional capacity, improving work status and participation, obtaining pain relief, increasing health-related quality of life, increasing functioning and physical activity, improving sleep quality, decreasing kinesiophobia, increasing self-management, decreasing anxiety and depression and decreasing healthcare expenditure. Patients will be randomly allocated (1:1 ratio) to a personalized rehabilitation program or usual care using random, permuted blocks of 2 or 4 patients stratified by investigational site and the duration of sick leave. Participants randomly allocated to the usual care intervention will undergo the usual care trajectory. This program is delivered at each of the participating centres. Patients will follow the usual care as it is implemented in Belgian hospitals, after SCS implantation. Participants randomly allocated to the personalized biopsychosocial return to work program will receive an individualized 14-week rehabilitation program. Therapy is provided at each implantation centres and will start 6 weeks after definitive SCS implantation. Within a 14-week period, patients in this group receive treatment sessions from trained physiotherapists, occupational therapists and psychologists. All therapists will be trained by experts in the different therapy modalities. Outcome assessments will take place at baseline, immediately before the intervention, immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Persistent Spinal Pain Syndrome Type II (PSPS-T2)
• Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment.
• Dutch speaking persons
• Patient has been informed of the study procedures and has given written informed consent
• Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria:

• Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma).
• Pregnancy

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Spinal Cord Stimulation
• Syndrome

Intervention

Other:
• Usual Care trajectory
Usual care after Spinal Cord Stimulation implantation
• A biopsychosocial rehabilitation program
A personalized biopsychosocial rehabilitation program specifically targeting return to work.

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Universitair Ziekenhuis Brussel	Jette
Belgium	AZ Nikolaas	Sint-Niklaas
Belgium	AZ Turnhout	Turnhout

Sponsors (4)

Lead Sponsor	Collaborator
Moens Maarten	KU Leuven, University Ghent, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work ability	Work ability, evaluated with the Work Ability Index	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Functional capacity evaluation	Functional capacity evaluation will be performed using a shortened version of the Isernhagen Work Systems.	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Work status and participation	Work Rehabilitation Questionnaire will be used to evaluate functioning in Vocational Rehabilitation	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Overall pain intensity with Visual Analogue Scale (VAS)	Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm).	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Health related quality of life	Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels.	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Physical activity	Physical activity will be objectively measured with actigraphy.	The change between the baseline screening and the evaluation immediately after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Functional disability	The functional disabilities will be assessed with the Oswestry Disability Index (ODI).	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Sleep quality	Perceived sleep quality will be measured with the Pittsburgh Sleep Quality Index.	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Kinesiophobia	The Tampa Scale for Kinesiophobia will be used to measure kinesiophobia.	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Healthcare utilisation	Healthcare expenditure will be investigated by self-reporting methods.	The change in healthcare utilisation starting from the the baseline screening up to 12 months after the intervention.
Secondary	Anxiety and depression	The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression.	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary	Patients' individual competencies for self-management	Patient activation measure-13 (PAM) is a 13-item instrument which assesses self-reported behaviour, knowledge, and confidence for self-management of one's health.	The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.