Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain

Neuropathic Pain Clinical Trial

— SCS-PHYSIO  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03740763
• Other study ID #: VGRFOU-216271
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: September 2025

Study information

• Verified date: November 2018
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: September 2025
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Spinal Cord Stimulation (SCS)
SCS for treatment of neuropathic pain

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

Locations

Country	Name	City	State
Sweden	Pain center, Sahlgrenska University Hospital	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety, depression	Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.	3 months after implantation
Other	Anxiety, depression	Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.	6 months after implantation
Other	Anxiety, depression	Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.	9 months after implantation
Other	Anxiety, depression	Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.	12 months after implantation
Other	Anxiety, depression	Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.	15 months after implantation
Other	Anxiety, depression	Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.	21 months after implantation
Other	Physical activity	Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.	3 months after implantations
Other	Physical activity	Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.	6 months after implantations
Other	Physical activity	Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.	9 months after implantations
Other	Physical activity	Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.	12 months after implantations
Other	Physical activity	Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.	15 months after implantations
Other	Physical activity	Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.	21 months after implantations
Other	Sleep quality according to Pittsburgh Sleep Quality Index	Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.	3 months after implantation
Other	Sleep quality according to Pittsburgh Sleep Quality Index	Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.	6 months after implantation
Other	Sleep quality according to Pittsburgh Sleep Quality Index	Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.	9 months after implantation
Other	Sleep quality according to Pittsburgh Sleep Quality Index	Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.	12 months after implantation
Other	Sleep quality according to Pittsburgh Sleep Quality Index	Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.	15 months after implantation
Other	Sleep quality according to Pittsburgh Sleep Quality Index	Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.	21 months after implantation
Other	Kinesiophobia	Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.	3 months
Other	Kinesiophobia	Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.	6 months
Other	Kinesiophobia	Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.	9 months
Other	Kinesiophobia	Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.	12 months
Other	Kinesiophobia	Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.	15 months
Other	Kinesiophobia	Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.	21 months
Other	Self-efficacy: A-SES-S	Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".	3 months
Other	Self-efficacy: A-SES-S	Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".	6 months
Other	Self-efficacy	Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".	9 months
Other	Self-efficacy: A-SES-S	Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".	12 months
Other	Self-efficacy: A-SES-S	Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".	15 months
Other	Self-efficacy: A-SES-S	Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".	21 months
Other	Self-efficacy for exercise	Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.	3 months
Other	Self-efficacy for exercise	Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.	6 months
Other	Self-efficacy for exercise	Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.	9 months
Other	Self-efficacy for exercise	Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.	12 months
Other	Self-efficacy for exercise	Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.	15 months
Other	Self-efficacy for exercise	Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.	21 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Physical activity	Assessed with accelerometer	3 months
Secondary	Physical activity	Assessed with accelerometer	6 months
Secondary	Physical activity	Assessed with accelerometer	9 months
Secondary	Physical activity	Assessed with accelerometer	12 months
Secondary	Physical activity	Assessed with accelerometer	15 months
Secondary	Physical activity	Assessed with accelerometer	21 months
Secondary	Return to work	Number of patients who return to work part time or full time.	9 months
Secondary	Return to work	Number of patients who return to work part time or full time.	21 months
Secondary	Days of sick-leave	Number of days of sick-leave	9 months
Secondary	Days of sick-leave	Number of days of sick-leave	21 months
Secondary	Medicine consumption	Number of pills and dosage.	9 months
Secondary	Medicine consumption	Number of pills and dosage.	21 months
Secondary	Number of hospital and primary care visits	Number of hospital and primary care visits	9 months
Secondary	Number of hospital and primary care visits	Number of hospital and primary care visits	21 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Project description in Swedish