Subthreshold SCS or BMT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-07

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Failed Back Surgery Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Best Medical Treatment

Group Type ACTIVE_COMPARATOR

Best Medical Treatment

Intervention Type OTHER

For each patient who is randomized to BMT, an optimal individual treatment plan will be developed by the treating physician.

Subthreshold Spinal Cord Stimulation

Group Type ACTIVE_COMPARATOR

Subthreshold Spinal Cord Stimulation

Intervention Type OTHER

SCS will be programmed at subthreshold stimulation.

Interventions

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Best Medical Treatment

For each patient who is randomized to BMT, an optimal individual treatment plan will be developed by the treating physician.

Intervention Type OTHER

Subthreshold Spinal Cord Stimulation

SCS will be programmed at subthreshold stimulation.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No