Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain

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

TERMINATED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2023-11-22

Brief Summary

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The study evaluates the combined effect of optimized pharmacological treatment, spinal cord stimulation and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. All patients will receive optimized pharmacological treatment before start of spinal cord stimulation treatment. Half of the participants will be randomized to physiotherapy before start of spinal cord stimulation treatment while the other half will start physiotherapy after spinal cord stimulation treatment.

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Detailed Description

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Previous studies have indicated that almost half of the patients with moderate-severe pain receive inadequate pain relief. Neuropathic pain is a common pain condition, affecting 1.5-8% of the population. Conventional pharmacological treatment reduces pain but is often insufficient. Spinal cord stimulation (SCS) is associated with improved pain relief and health-related quality of life compared to conventional medical management. Despite SCS treatment, only half of the patients report \>50% pain relief. Other studies have indicated that active, specific physiotherapy led by professionals reduces pain in chronic pain conditions. The aim of the study is to access the combined effect of optimized pharmacological treatment, SCS and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. Furthermore, the study evaluates when it is most effective to start the physiotherapy.

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Care Provider and Participants ar not masked. Data analysis of accelerometer data is masked (outcome assessor).

Study Groups

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Spinal Cord Stimulation (SCS)

Spinal Cord Stimulation (SCS)

1. Pharmacological analgetic treatment and treatment with SCS for 3 months
2. Add-on physiotherapy for 6 months to SCS and pharmacological analgetic treatment
3. Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months

Group Type ACTIVE_COMPARATOR

Spinal Cord Stimulation (SCS)

Intervention Type DEVICE

SCS for treatment of neuropathic pain

Physiotherapy

Intervention Type OTHER

Physiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain

Physiotherapy

Physiotherapy

1. Pharmacological analgetic treatment for 3 months
2. Physiotherapy for 3 months and pharmacological analgetic treatment
3. Add-on SCS in combination with physiotherapy and pharmacological analgetic treatment for 3 months
4. Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months

Group Type ACTIVE_COMPARATOR

Spinal Cord Stimulation (SCS)

Intervention Type DEVICE

SCS for treatment of neuropathic pain

Physiotherapy

Intervention Type OTHER

Physiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain

Interventions

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Spinal Cord Stimulation (SCS)

SCS for treatment of neuropathic pain

Intervention Type DEVICE

Physiotherapy

Physiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Neuropathic pain \> 6 months
* Pain intensity ≥ 5 according to NRS (for neuropathic pain component to be treated with SCS)
* Known cause of the pain
* Neuroanatomical correlation to the pain
* ≥50% of the painful area is to be treated with SCS
* The patient has a physical and psychological health status that allows the patient to participate in physiotherapy and undergo SCS implantation.

Exclusion Criteria

* Not able to undergo SCS implantation
* Inadequate knowledge of the Swedish language
* Alcohol or substance abuse
* Severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition
* Incapacitating pain conditions of other causes than neuropathic pain
* Pregnancy
* Insufficient compliance
* Malignant disease with short expected survival

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No