Return to Work for Persistent Spinal Pain Syndrome Type II Patients (OPERA)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Failed Back Surgery Syndrome; Spinal Cord Stimulation
• Intervention / Treatment: Other: Usual Care trajectory; Other: A biopsychosocial rehabilitation program

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maarten Moens, Prof. dr.; Phone Number: +3224775514; Email: stimulusresearchgroup@gmail.com

Study Locations

• Belgium
  • Gent, Belgium
    • Recruiting
    • UZ Gent
    • Contact: Sam Schelfout, MD
  • Hasselt, Belgium
    • Recruiting
    • Jessa Ziekenhuis
    • Contact: Mark Plazier, MD PhD
  • Jette, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Maarten Moens, MD PhD
  • Sint-Niklaas, Belgium
    • Not yet recruiting
    • AZ Nikolaas
    • Contact: Jean-Pierre Van Buyten, MD PhD
  • Turnhout, Belgium
    • Not yet recruiting
    • AZ Turnhout

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Usual care	Other: Usual Care trajectory; Usual care after Spinal Cord Stimulation implantation
ACTIVE_COMPARATOR: Personalized biopsychosocial rehabilitation program	Other: A biopsychosocial rehabilitation program; A personalized biopsychosocial rehabilitation program specifically targeting return to work.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Moens Maarten
• Collaborators: KU Leuven; University Ghent; Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2022
• Primary Completion (ANTICIPATED): August 1, 2025
• Study Completion (ANTICIPATED): August 1, 2025

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (ACTUAL): March 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Back Pain; Syndrome; Failed Back Surgery Syndrome
• Other Study ID Numbers: OPERA (Alias Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No