Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain (SCS-PHYSIO)

Göteborg University

Status: Terminated

Conditions: Neuropathic Pain

Treatments: Device: Spinal Cord Stimulation (SCS); Other: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03740763

VGRFOU-216271

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Spinal Cord Stimulation (SCS)

Active Comparator group

Description:

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

Treatment:

Other: Physiotherapy

Device: Spinal Cord Stimulation (SCS)

Physiotherapy

Active Comparator group

Description:

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

Treatment:

Other: Physiotherapy

Device: Spinal Cord Stimulation (SCS)