Clinical trial NCT05169047: Subthreshold SCS or BMT
Official title: The Holistic Response of Patients With Persistent Spinal Pain Syndrome Type II by Subthreshold Spinal Cord Stimulation Compared to Best Medical Treatment, Investigated by a Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Failed Back Surgery Syndrome
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Given the substantial socioeconomic impact of Spinal Cord Stimulation (SCS) implantations and given that currently no direct high-quality evidence with a relevant outcome measurement is available to guide the treatment choice between subthreshold SCS versus best medical treatment in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), we here propose a scientifically well-constructed randomized controlled trial to answer this question.

The primary scientific objective is to examine whether subthreshold SCS, compared to best medical treatment, provided to patients with PSPS-T2 results in a higher percentage of clinical holistic responders at 6 months. The secondary objective of the study is to examine if subthreshold SCS compared with BMT is having more efficacy in improving patients' individual competencies for self-management, increasing the likelihood to return to work, work status and healthcare expenditure, improving pain relief, obtaining pain medication reduction, decreasing anxiety and depression, increasing quality of life and decreasing disability.

Detailed description: After filling in the questionnaires at the 6 months follow-up visit, patients could change treatment groups (in both directions). This decision will be a shared decisions between patient and treating physician in case the randomized intervention did not provided enough pain relief.

Eligibility criteria: 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.
* PSPS-T2 patients eligible for subthreshold SCS
* Age \> 18 years
* 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:

* Expected inability of patients to receive or properly operate the spinal cord stimulation system
* Evidence of an active psychiatric disorder
* Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma).
* Pregnancy

Primary outcomes:
measure: Clinical holistic responder status
timeFrame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Secondary outcomes:
measure: Overall pain intensity with Visual Analogue Scale (VAS)
timeFrame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
measure: Pain medication use
timeFrame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
measure: Functional disability
timeFrame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
measure: Health related quality of life
timeFrame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
measure: Patient global impression of change
timeFrame: Evaluated at 1 month, 6 months and 12 months.
measure: Work status
timeFrame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
measure: Patients' individual competencies for self-management
timeFrame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
measure: Healthcare utilisation.
timeFrame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
measure: Anxiety and Depression.
timeFrame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Mechelen
country: Belgium
facility: Emmaüs, AZ Sint-Maarten
city: Roeselare
country: Belgium
facility: AZ Delta
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
References: