Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain

NCT03740763 | Terminated FDA Device

• 1 other identifier: VGRFOU-216271
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Pain; Quality of Life; Electric Stimulation Therapy; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (37)

• Pain intensity according to NRS

  9 months after implantation

• Pain intensity according to NRS

  6 months after implantation

• Pain intensity according to NRS

  12 months after implantation

• Pain intensity according to NRS

  15 months after implantation

• Pain intensity according to NRS

  21 months after implantation

Other Outcomes (36)

• Anxiety, depression

  3 months after implantation

• Anxiety, depression

  6 months after implantation

• Anxiety, depression

  9 months after implantation

Study Arms (2)

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

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

Device: Spinal Cord Stimulation (SCS); Other: Physiotherapy

Interventions

Spinal Cord Stimulation (SCS) DEVICE

SCS for treatment of neuropathic pain

Physiotherapy; Spinal Cord Stimulation (SCS)

Physiotherapy OTHER

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

Physiotherapy; Spinal Cord Stimulation (SCS)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Pain center, Sahlgrenska University Hospital

Gothenburg, 416 50, Sweden

Location

Related Publications (2)

• 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 Jan 7:1-15. doi: 10.1080/17581869.2025.2608572. Online ahead of print.

  PMID: 41503863 DERIVED

• O'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.

  PMID: 34854473 DERIVED

Related Links

• Project description in Swedish

MeSH Terms

Conditions

Neuralgia; Pain

Interventions

Spinal Cord Stimulation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Rehabilitation

Study Officials

• Paulin Andréll, MD, PhD

  Göteborgs Universitet/Västra Götalandsregionen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Care Provider and Participants ar not masked. Data analysis of accelerometer data is masked (outcome assessor).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: November 14, 2018
• Study Start: May 9, 2018
• Primary Completion: May 25, 2022
• Study Completion: November 22, 2023
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)