Clinical trial NCT03740763: Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain
Official title: Treatment of Neuropathic Pain With Spinal Cord Stimulation and Physiotherapy for More Effective Pain Relief, Increased Physical Activity and Improved Health Related Quality of Life
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Pain
Quality of Life
Electric Stimulation Therapy
Physiotherapy
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2018-11-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity according to numeric rating scale (NRS)
timeFrame: 3 months after implantation
Secondary outcomes:
measure: Pain intensity according to NRS
timeFrame: 9 months after implantation
measure: Pain intensity according to NRS
timeFrame: 6 months after implantation
measure: Pain intensity according to NRS
timeFrame: 12 months after implantation
measure: Pain intensity according to NRS
timeFrame: 15 months after implantation
measure: Pain intensity according to NRS
timeFrame: 21 months after implantation
measure: Health Related Quality of Life (HRQL) according to SF36
timeFrame: 3 months after implantation
measure: Health Related Quality of Life (HRQL) according to SF36
timeFrame: 6 months after implantation
measure: Health Related Quality of Life (HRQL) according to SF36
timeFrame: 9 months after implantation
measure: Health Related Quality of Life (HRQL) according to SF36
timeFrame: 12 months after implantation
measure: Health Related Quality of Life (HRQL) according to SF36
timeFrame: 15 months after implantation
measure: Health Related Quality of Life (HRQL) according to SF36
timeFrame: 21 months after implantation
measure: Health Related Quality of Life (HRQL) assessed with EQ-5D
timeFrame: 3 months after implantation
measure: Health Related Quality of Life (HRQL) assessed with EQ-5D
timeFrame: 6 months after implantation
measure: Health Related Quality of Life (HRQL) assessed with EQ-5D
timeFrame: 9 months after implantation
measure: Health Related Quality of Life (HRQL) assessed with EQ-5D
timeFrame: 12 months after implantation
measure: Health Related Quality of Life (HRQL) assessed with EQ-5D
timeFrame: 15 months after implantation
measure: Health Related Quality of Life (HRQL) assessed with EQ-5D
timeFrame: 21 months after implantation
measure: Physical activity
timeFrame: 3 months
measure: Physical activity
timeFrame: 6 months
measure: Physical activity
timeFrame: 9 months
measure: Physical activity
timeFrame: 12 months
measure: Physical activity
timeFrame: 15 months
measure: Physical activity
timeFrame: 21 months
measure: Return to work
timeFrame: 9 months
measure: Return to work
timeFrame: 21 months
measure: Days of sick-leave
timeFrame: 9 months
measure: Days of sick-leave
timeFrame: 21 months
measure: Medicine consumption
timeFrame: 9 months
measure: Medicine consumption
timeFrame: 21 months
measure: Number of hospital and primary care visits
timeFrame: 9 months
measure: Number of hospital and primary care visits
timeFrame: 21 months
measure: Patient treatment satisfaction according to NRS
timeFrame: 3 months after implantation
measure: Patient treatment satisfaction according to NRS
timeFrame: 6 months after implantation
measure: Patient treatment satisfaction according to NRS
timeFrame: 9 months after implantation
measure: Patient treatment satisfaction according to NRS
timeFrame: 12 months after implantation
measure: Patient treatment satisfaction according to NRS
timeFrame: 15 months after implantation
measure: Patient treatment satisfaction according to NRS
timeFrame: 21 months after implantation
Other outcomes:
measure: Anxiety, depression
timeFrame: 3 months after implantation
measure: Anxiety, depression
timeFrame: 6 months after implantation
measure: Anxiety, depression
timeFrame: 9 months after implantation
measure: Anxiety, depression
timeFrame: 12 months after implantation
measure: Anxiety, depression
timeFrame: 15 months after implantation
measure: Anxiety, depression
timeFrame: 21 months after implantation
measure: Physical activity
timeFrame: 3 months after implantations
measure: Physical activity
timeFrame: 6 months after implantations
measure: Physical activity
timeFrame: 9 months after implantations
measure: Physical activity
timeFrame: 12 months after implantations
measure: Physical activity
timeFrame: 15 months after implantations
measure: Physical activity
timeFrame: 21 months after implantations
measure: Sleep quality according to Pittsburgh Sleep Quality Index
timeFrame: 3 months after implantation
measure: Sleep quality according to Pittsburgh Sleep Quality Index
timeFrame: 6 months after implantation
measure: Sleep quality according to Pittsburgh Sleep Quality Index
timeFrame: 9 months after implantation
measure: Sleep quality according to Pittsburgh Sleep Quality Index
timeFrame: 12 months after implantation
measure: Sleep quality according to Pittsburgh Sleep Quality Index
timeFrame: 15 months after implantation
measure: Sleep quality according to Pittsburgh Sleep Quality Index
timeFrame: 21 months after implantation
measure: Kinesiophobia
timeFrame: 3 months
measure: Kinesiophobia
timeFrame: 6 months
measure: Kinesiophobia
timeFrame: 9 months
measure: Kinesiophobia
timeFrame: 12 months
measure: Kinesiophobia
timeFrame: 15 months
measure: Kinesiophobia
timeFrame: 21 months
measure: Self-efficacy: A-SES-S
timeFrame: 3 months
measure: Self-efficacy: A-SES-S
timeFrame: 6 months
measure: Self-efficacy
timeFrame: 9 months
measure: Self-efficacy: A-SES-S
timeFrame: 12 months
measure: Self-efficacy: A-SES-S
timeFrame: 15 months
measure: Self-efficacy: A-SES-S
timeFrame: 21 months
measure: Self-efficacy for exercise
timeFrame: 3 months
measure: Self-efficacy for exercise
timeFrame: 6 months
measure: Self-efficacy for exercise
timeFrame: 9 months
measure: Self-efficacy for exercise
timeFrame: 12 months
measure: Self-efficacy for exercise
timeFrame: 15 months
measure: Self-efficacy for exercise
timeFrame: 21 months
Locations:
city: Göteborg
country: Sweden
facility: Pain center, Sahlgrenska University Hospital
Study officials:
affiliation: Göteborgs Universitet/Västra Götalandsregionen
name: Paulin Andréll, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.