Return to Work for Persistent Spinal Pain Syndrome Type II Patients

Not Applicable

Recruiting

• Conditions: Spinal Cord Stimulation; Failed Back Surgery Syndrome
• Interventions: Other: Usual Care trajectory; Other: A biopsychosocial rehabilitation program

• Registration Number: NCT05269212
• Lead Sponsor: Moens Maarten

Brief 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.

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 Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-07
• Status Verified: 2022-05
• Study Start: 2022-05-10
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual Care trajectory	-
Personalized biopsychosocial rehabilitation program	A biopsychosocial rehabilitation program	-

Primary Outcome Measures

Name	Time	Method
Work ability	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 ability, evaluated with the Work Ability Index

Secondary Outcome Measures

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

Trial Locations

Locations (5)

UZ Gent; 🇧🇪 Gent, Belgium

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

AZ Turnhout; 🇧🇪 Turnhout, Belgium