Neuropathic PainSCS-PHYSIONCT03740763
Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain
A study testing Spinal Cord Stimulation (SCS) and Physiotherapy in people with Neuropathic Pain, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Spinal Cord Stimulation (SCS) and Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- 9 May 2018to 22 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Neuropathic Pain
- Being tested
- Spinal Cord Stimulation (SCS), Physiotherapy
- Keywords
- Pain, Quality of Life, Electric Stimulation Therapy, Physiotherapy
- Medical subject headings
- Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation (SCS)Device
SCS for treatment of neuropathic pain
PhysiotherapyOther
Physiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation (SCS) | Active comparator | 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 Receives: Device: Spinal Cord Stimulation (SCS); Other: Physiotherapy |
| Physiotherapy | Active comparator | 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 Receives: Device: Spinal Cord Stimulation (SCS); Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after implantation
Secondary outcomes (37)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 21 months after implantation
Physical activity
Assessed with accelerometer
Measured: 3 months
Physical activity
Assessed with accelerometer
Measured: 6 months
Physical activity
Assessed with accelerometer
Measured: 9 months
Physical activity
Assessed with accelerometer
Measured: 12 months
Physical activity
Assessed with accelerometer
Measured: 15 months
Physical activity
Assessed with accelerometer
Measured: 21 months
Return to work
Number of patients who return to work part time or full time.
Measured: 9 months
Return to work
Number of patients who return to work part time or full time.
Measured: 21 months
Days of sick-leave
Number of days of sick-leave
Measured: 9 months
Days of sick-leave
Number of days of sick-leave
Measured: 21 months
Medicine consumption
Number of pills and dosage.
Measured: 9 months
Medicine consumption
Number of pills and dosage.
Measured: 21 months
Number of hospital and primary care visits
Number of hospital and primary care visits
Measured: 9 months
Number of hospital and primary care visits
Number of hospital and primary care visits
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 21 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start9 May 2018
- Primary completion25 May 2022
- Study completion22 Nov 2023
Why it stopped: The study was terminated prematurely due to slow inclusion rate due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Paulin Andréll, MD, PhD, Principal investigator, Göteborgs Universitet/Västra Götalandsregionen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740763
- Sponsor's protocol ID
- VGRFOU-216271
- Acronym
- SCS-PHYSIO
- Status last verified
- May 2025
- First submitted
- 9 May 2018
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gottfridsson R, Varkey E, Wolf A, Gatzinsky K, Liljencrantz J, Thorn SE, Borjesson M, Arvidsson D, Andrell P. Effects of spinal cord stimulation on pain, physical activity, and self-efficacy among patients with neuropathic pain. Pain Manag. 2026 Mar;16(3):185-199. doi: 10.1080/17581869.2025.2608572. Epub 2026 Jan 7.
PubMed 41503863O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03740763
- Acronym / sponsor ID
- SCS-PHYSIO / VGRFOU-216271
- Conditions
- Neuropathic Pain
- Keywords
- Pain, Quality of Life, Electric Stimulation Therapy, Physiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to slow inclusion rate due to the COVID-19 pandemic.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 9 May 2018 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the combined effect of optimized pharmacological treatment, spinal cord stimulation and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. All patients will receive optimized pharmacological treatment before start of spinal cord stimulation treatment. Half of the participants will be randomized to physiotherapy before start of spinal cord stimulation treatment while the other half will start physiotherapy after spinal cord stimulation treatment.
Detailed description
Previous studies have indicated that almost half of the patients with moderate-severe pain receive inadequate pain relief. Neuropathic pain is a common pain condition, affecting 1.5-8% of the population. Conventional pharmacological treatment reduces pain but is often insufficient. Spinal cord stimulation (SCS) is associated with improved pain relief and health-related quality of life compared to conventional medical management. Despite SCS treatment, only half of the patients report >50% pain relief. Other studies have indicated that active, specific physiotherapy led by professionals reduces pain in chronic pain conditions. The aim of the study is to access the combined effect of optimized pharmacological treatment, SCS and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. Furthermore, the study evaluates when it is most effective to start the physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation (SCS) | Active comparator | Device: Spinal Cord Stimulation (SCS), Other: PhysiotherapySpinal Cord Stimulation (SCS) 1. Pharmacological analgetic treatment and treatment with SCS for 3 months 2. Add-on physiotherapy for 6 months to SCS and pharmacological analgetic treatment 3. Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months |
| Physiotherapy | Active comparator | Device: Spinal Cord Stimulation (SCS), Other: PhysiotherapyPhysiotherapy 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord Stimulation (SCS)SCS for treatment of neuropathic pain | Device | Physiotherapy, Spinal Cord Stimulation (SCS) |
| PhysiotherapyPhysiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain | Other | Physiotherapy, Spinal Cord Stimulation (SCS) |
Primary outcome
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.
37 secondary outcomes
Pain intensity according to NRS
Time frame: 9 months after implantation
Pain intensity according to NRS
Time frame: 6 months after implantation
Pain intensity according to NRS
Time frame: 12 months after implantation
Pain intensity according to NRS
Time frame: 15 months after implantation
Pain intensity according to NRS
Time frame: 21 months after implantation
Health Related Quality of Life (HRQL) according to SF36
Time frame: 3 months after implantation
Health Related Quality of Life (HRQL) according to SF36
Time frame: 6 months after implantation
Health Related Quality of Life (HRQL) according to SF36
Time frame: 9 months after implantation
Health Related Quality of Life (HRQL) according to SF36
Time frame: 12 months after implantation
Health Related Quality of Life (HRQL) according to SF36
Time frame: 15 months after implantation
Health Related Quality of Life (HRQL) according to SF36
Time frame: 21 months after implantation
Health Related Quality of Life (HRQL) assessed with EQ-5D
Time frame: 3 months after implantation
Health Related Quality of Life (HRQL) assessed with EQ-5D
Time frame: 6 months after implantation
Health Related Quality of Life (HRQL) assessed with EQ-5D
Time frame: 9 months after implantation
Health Related Quality of Life (HRQL) assessed with EQ-5D
Time frame: 12 months after implantation
Health Related Quality of Life (HRQL) assessed with EQ-5D
Time frame: 15 months after implantation
Health Related Quality of Life (HRQL) assessed with EQ-5D
Time frame: 21 months after implantation
Physical activity
Time frame: 3 months
Physical activity
Time frame: 6 months
Physical activity
Time frame: 9 months
Physical activity
Time frame: 12 months
Physical activity
Time frame: 15 months
Physical activity
Time frame: 21 months
Return to work
Time frame: 9 months
Return to work
Time frame: 21 months
Days of sick-leave
Time frame: 9 months
Days of sick-leave
Time frame: 21 months
Medicine consumption
Time frame: 9 months
Medicine consumption
Time frame: 21 months
Number of hospital and primary care visits
Time frame: 9 months
Number of hospital and primary care visits
Time frame: 21 months
Patient treatment satisfaction according to NRS
Time frame: 3 months after implantation
Patient treatment satisfaction according to NRS
Time frame: 6 months after implantation
Patient treatment satisfaction according to NRS
Time frame: 9 months after implantation
Patient treatment satisfaction according to NRS
Time frame: 12 months after implantation
Patient treatment satisfaction according to NRS
Time frame: 15 months after implantation
Patient treatment satisfaction according to NRS
Time frame: 21 months after implantation
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to slow inclusion rate due to the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 41503863Gottfridsson R, Varkey E, Wolf A, Gatzinsky K, Liljencrantz J, Thorn SE, Borjesson M, Arvidsson D, Andrell P. Effects of spinal cord stimulation on pain, physical activity, and self-efficacy among patients with neuropathic pain. Pain Manag. 2026 Mar;16(3):185-199. doi: 10.1080/17581869.2025.2608572. Epub 2026 Jan 7.
- Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
- Project description in SwedishLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulin Andréll, MD, PhD principal investigator
Göteborgs Universitet/Västra Götalandsregionen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation (SCS) and Physiotherapy in people with Neuropathic Pain, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated prematurely due to slow inclusion rate due to the COVID-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity according to numeric rating scale (NRS) (time frame: 3 months after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740763, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.