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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740763
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Device: Spinal Cord Stimulation (SCS) Other: Physiotherapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Care Provider and Participants ar not masked. Data analysis of accelerometer data is masked (outcome assessor).
Primary Purpose: Treatment
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
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : September 2025

Arm Intervention/treatment
Active Comparator: 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
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

Active Comparator: 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
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




Primary Outcome Measures :
  1. Pain intensity according to numeric rating scale (NRS) [ Time Frame: 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 :
  1. Pain intensity according to NRS [ Time Frame: 9 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.

  2. Pain intensity according to NRS [ Time Frame: 6 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.

  3. Pain intensity according to NRS [ Time Frame: 12 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.

  4. Pain intensity according to NRS [ Time Frame: 15 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.

  5. Pain intensity according to NRS [ Time Frame: 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.

  6. Health Related Quality of Life (HRQL) according to SF36 [ Time Frame: 3 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.

  7. Health Related Quality of Life (HRQL) according to SF36 [ Time Frame: 6 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.

  8. Health Related Quality of Life (HRQL) according to SF36 [ Time Frame: 9 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.

  9. Health Related Quality of Life (HRQL) according to SF36 [ Time Frame: 12 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.

  10. Health Related Quality of Life (HRQL) according to SF36 [ Time Frame: 15 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.

  11. Health Related Quality of Life (HRQL) according to SF36 [ Time Frame: 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.

  12. Health Related Quality of Life (HRQL) assessed with EQ-5D [ Time Frame: 3 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.


  13. Health Related Quality of Life (HRQL) assessed with EQ-5D [ Time Frame: 6 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.


  14. Health Related Quality of Life (HRQL) assessed with EQ-5D [ Time Frame: 9 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.


  15. Health Related Quality of Life (HRQL) assessed with EQ-5D [ Time Frame: 12 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.


  16. Health Related Quality of Life (HRQL) assessed with EQ-5D [ Time Frame: 15 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.


  17. Health Related Quality of Life (HRQL) assessed with EQ-5D [ Time Frame: 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.


  18. Physical activity [ Time Frame: 3 months ]
    Assessed with accelerometer

  19. Physical activity [ Time Frame: 6 months ]
    Assessed with accelerometer

  20. Physical activity [ Time Frame: 9 months ]
    Assessed with accelerometer

  21. Physical activity [ Time Frame: 12 months ]
    Assessed with accelerometer

  22. Physical activity [ Time Frame: 15 months ]
    Assessed with accelerometer

  23. Physical activity [ Time Frame: 21 months ]
    Assessed with accelerometer

  24. Return to work [ Time Frame: 9 months ]
    Number of patients who return to work part time or full time.

  25. Return to work [ Time Frame: 21 months ]
    Number of patients who return to work part time or full time.

  26. Days of sick-leave [ Time Frame: 9 months ]
    Number of days of sick-leave

  27. Days of sick-leave [ Time Frame: 21 months ]
    Number of days of sick-leave

  28. Medicine consumption [ Time Frame: 9 months ]
    Number of pills and dosage.

  29. Medicine consumption [ Time Frame: 21 months ]
    Number of pills and dosage.

  30. Number of hospital and primary care visits [ Time Frame: 9 months ]
    Number of hospital and primary care visits

  31. Number of hospital and primary care visits [ Time Frame: 21 months ]
    Number of hospital and primary care visits

  32. Patient treatment satisfaction according to NRS [ Time Frame: 3 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").

  33. Patient treatment satisfaction according to NRS [ Time Frame: 6 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").

  34. Patient treatment satisfaction according to NRS [ Time Frame: 9 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").

  35. Patient treatment satisfaction according to NRS [ Time Frame: 12 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").

  36. Patient treatment satisfaction according to NRS [ Time Frame: 15 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").

  37. Patient treatment satisfaction according to NRS [ Time Frame: 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").


Other Outcome Measures:
  1. Anxiety, depression [ Time Frame: 3 months after implantation ]
    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.

  2. Anxiety, depression [ Time Frame: 6 months after implantation ]
    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. Anxiety, depression [ Time Frame: 9 months after implantation ]
    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.

  4. Anxiety, depression [ Time Frame: 12 months after implantation ]
    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.

  5. Anxiety, depression [ Time Frame: 15 months after implantation ]
    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. Anxiety, depression [ Time Frame: 21 months after implantation ]
    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.

  7. Physical activity [ Time Frame: 3 months after implantations ]
    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.

  8. Physical activity [ Time Frame: 6 months after implantations ]
    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. Physical activity [ Time Frame: 9 months after implantations ]
    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.

  10. Physical activity [ Time Frame: 12 months after implantations ]
    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.

  11. Physical activity [ Time Frame: 15 months after implantations ]
    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. Physical activity [ Time Frame: 21 months after implantations ]
    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.

  13. Sleep quality according to Pittsburgh Sleep Quality Index [ Time Frame: 3 months after implantation ]
    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.

  14. Sleep quality according to Pittsburgh Sleep Quality Index [ Time Frame: 6 months after implantation ]
    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. Sleep quality according to Pittsburgh Sleep Quality Index [ Time Frame: 9 months after implantation ]
    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.

  16. Sleep quality according to Pittsburgh Sleep Quality Index [ Time Frame: 12 months after implantation ]
    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.

  17. Sleep quality according to Pittsburgh Sleep Quality Index [ Time Frame: 15 months after implantation ]
    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.

  18. Sleep quality according to Pittsburgh Sleep Quality Index [ Time Frame: 21 months after implantation ]
    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.

  19. Kinesiophobia [ Time Frame: 3 months ]
    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.

  20. Kinesiophobia [ Time Frame: 6 months ]
    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. Kinesiophobia [ Time Frame: 9 months ]
    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.

  22. Kinesiophobia [ Time Frame: 12 months ]
    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.

  23. Kinesiophobia [ Time Frame: 15 months ]
    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.

  24. Kinesiophobia [ Time Frame: 21 months ]
    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.

  25. Self-efficacy: A-SES-S [ Time Frame: 3 months ]
    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".

  26. Self-efficacy: A-SES-S [ Time Frame: 6 months ]
    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".

  27. Self-efficacy [ Time Frame: 9 months ]
    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".

  28. Self-efficacy: A-SES-S [ Time Frame: 12 months ]
    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".

  29. Self-efficacy: A-SES-S [ Time Frame: 15 months ]
    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".

  30. Self-efficacy: A-SES-S [ Time Frame: 21 months ]
    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".

  31. Self-efficacy for exercise [ Time Frame: 3 months ]
    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.

  32. Self-efficacy for exercise [ Time Frame: 6 months ]
    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.

  33. Self-efficacy for exercise [ Time Frame: 9 months ]
    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.

  34. Self-efficacy for exercise [ Time Frame: 12 months ]
    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.

  35. Self-efficacy for exercise [ Time Frame: 15 months ]
    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.

  36. Self-efficacy for exercise [ Time Frame: 21 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740763


Locations
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Sweden
Pain center, Sahlgrenska University Hospital
Göteborg, Sweden, 416 50
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
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Principal Investigator: Paulin Andréll, MD, PhD Göteborgs Universitet/Västra Götalandsregionen

Additional Information:
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03740763     History of Changes
Other Study ID Numbers: VGRFOU-216271
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Göteborg University:
Pain
Quality of Life
Electric Stimulation Therapy
Physiotherapy

Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms