Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain

Study Overview
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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.

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.

Official Title
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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

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulation (SCS)
* Other: Physiotherapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal Cord Stimulation (SCS)<br>Spinal Cord Stimulation (SCS) Pharmacological analgetic treatment and treatment with SCS for 3 months Add-on physiotherapy for 6 months to SCS and pharmacological analgetic treatment Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months | Device: Spinal Cord Stimulation (SCS)<br>* SCS for treatment of neuropathic pain<br>Other: Physiotherapy<br>* Physiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain<br>|
| Active Comparator: Physiotherapy<br>Physiotherapy Pharmacological analgetic treatment for 3 months Physiotherapy for 3 months and pharmacological analgetic treatment Add-on SCS in combination with physiotherapy and pharmacological analgetic treatment for 3 months Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months | Device: Spinal Cord Stimulation (SCS)<br>* SCS for treatment of neuropathic pain<br>Other: Physiotherapy<br>* Physiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity according to numeric rating scale (NRS) | 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. | 3 months after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity according to NRS | 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. | 9 months after implantation | 
| Pain intensity according to NRS | 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. | 6 months after implantation | 
| Pain intensity according to NRS | 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. | 12 months after implantation | 
| Pain intensity according to NRS | 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. | 15 months after implantation | 
| Pain intensity according to NRS | 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. | 21 months after implantation | 
| Health Related Quality of Life (HRQL) according to SF36 | 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. | 3 months after implantation | 
| Health Related Quality of Life (HRQL) according to SF36 | 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. | 6 months after implantation | 
| Health Related Quality of Life (HRQL) according to SF36 | 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. | 9 months after implantation | 
| Health Related Quality of Life (HRQL) according to SF36 | 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. | 12 months after implantation | 
| Health Related Quality of Life (HRQL) according to SF36 | 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. | 15 months after implantation | 
| Health Related Quality of Life (HRQL) according to SF36 | 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. | 21 months after implantation | 
| Health Related Quality of Life (HRQL) assessed with EQ-5D | 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. | 3 months after implantation | 
| Health Related Quality of Life (HRQL) assessed with EQ-5D | 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. | 6 months after implantation | 
| Health Related Quality of Life (HRQL) assessed with EQ-5D | 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. | 9 months after implantation | 
| Health Related Quality of Life (HRQL) assessed with EQ-5D | 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. | 12 months after implantation | 
| Health Related Quality of Life (HRQL) assessed with EQ-5D | 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. | 15 months after implantation | 
| Health Related Quality of Life (HRQL) assessed with EQ-5D | 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. | 21 months after implantation | 
| Physical activity | Assessed with accelerometer | 3 months | 
| Physical activity | Assessed with accelerometer | 6 months | 
| Physical activity | Assessed with accelerometer | 9 months | 
| Physical activity | Assessed with accelerometer | 12 months | 
| Physical activity | Assessed with accelerometer | 15 months | 
| Physical activity | Assessed with accelerometer | 21 months | 
| Return to work | Number of patients who return to work part time or full time. | 9 months | 
| Return to work | Number of patients who return to work part time or full time. | 21 months | 
| Days of sick-leave | Number of days of sick-leave | 9 months | 
| Days of sick-leave | Number of days of sick-leave | 21 months | 
| Medicine consumption | Number of pills and dosage. | 9 months | 
| Medicine consumption | Number of pills and dosage. | 21 months | 
| Number of hospital and primary care visits | Number of hospital and primary care visits | 9 months | 
| Number of hospital and primary care visits | Number of hospital and primary care visits | 21 months | 
| Patient treatment satisfaction according to NRS | 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). | 3 months after implantation | 
| Patient treatment satisfaction according to NRS | 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). | 6 months after implantation | 
| Patient treatment satisfaction according to NRS | 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). | 9 months after implantation | 
| Patient treatment satisfaction according to NRS | 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). | 12 months after implantation | 
| Patient treatment satisfaction according to NRS | 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). | 15 months after implantation | 
| Patient treatment satisfaction according to NRS | 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). | 21 months after implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Quality of Life, Electric Stimulation Therapy, Physiotherapy