Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain

Not Applicable

Terminated

• Conditions: Neuropathic Pain
• Interventions: Device: Spinal Cord Stimulation (SCS); Other: Physiotherapy

• Registration Number: NCT03740763
• Lead Sponsor: Göteborg University

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.

Study Timeline

• Study Start: 2018-05-09
• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Primary Completion: 2022-05-25
• Study Completion: 2023-11-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation (SCS)	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
Physiotherapy	Spinal Cord Stimulation (SCS)	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
Physiotherapy	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
Spinal Cord Stimulation (SCS)	Physiotherapy	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

Primary Outcome Measures

Name	Time	Method
Pain intensity according to numeric rating scale (NRS)	3 months after implantation	Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.

Secondary Outcome Measures

Name	Time	Method
Pain intensity according to NRS	21 months after implantation	Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Days of sick-leave	21 months	Number of days of sick-leave
Patient treatment satisfaction according to NRS	21 months after implantation	Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Health Related Quality of Life (HRQL) according to SF36	21 months after implantation	Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Return to work	21 months	Number of patients who return to work part time or full time.
Number of hospital and primary care visits	21 months	Number of hospital and primary care visits
Physical activity	21 months	Assessed with accelerometer
Health Related Quality of Life (HRQL) assessed with EQ-5D	21 months after implantation	Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.; The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Medicine consumption	21 months	Number of pills and dosage.

Trial Locations

Locations (1)

Pain center, Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden