Objective Data on Daily Activity in Patients Treated with SCS: the Intellis Study

NCT04710355 | Completed

• 1 other identifier: Dnr 2020-00785
• Study Type: observational
• Target: 50
• Locations: 4 countries
• Sites: 7

Brief Summary

In spinal cord stimulation (SCS), most outcome data are based on patient questionnaires. The lack of tools for objective evaluation of the effects of SCS on chronic pain has posed a barrier for providing solid proof of the therapy. Currently, however, SCS-devices with an accelerator included are available on the market. The position orientation data provided by the neurostimulator therefore gives new possibilities for objective measurement of gross activity in daily life.

Conditions

Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

• Position reporting: Intellis SnapShot Reporting

  The Intellis neurostimulator provides reports (extracted with the physician programmer) on the position of the patient over a certain time-period. The built-in software provides summary reports over periods of weeks.

  Change from baseline Intellis SnapShot Reporting at 12 months

Secondary Outcomes (4)

• Pain: Visual Analogue Scale (VAS)

  Change from baseline VAS at 12 months

• Health Related Quality of Life: EuroQoL Group - 5 Dimensional (EQ-5D)

  Change from baseline EQ-5D at 12 months

• Disability: Oswestry Disability Index (ODI)

  Change from baseline ODI at 12 months

• Sleep: Pain and Sleep Questionnaire eight item index (PSQ-8)

  Change from baseline PSQI at 12 months

Study Arms (1)

Chronic pain

Failed back surgery syndrome

Device: Spinal cord stimulation

Interventions

Spinal cord stimulation DEVICE

Adhesion of Intellis spinal cord stimulator to the skin of the abdomen for 4 weeks for baseline recording of activity level prior to trial with spinal cord stimulation.

Chronic pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with failed back surgery syndrome (FBSS) with chronic back and leg pain that have been evaluated as candidates for SCS will be included.

You may qualify if:

• Refractory chronic pain in low-back and/or legs that persists for at least 6 months following the most recent spinal surgery
• years of age. Patients \>70 years will not be included due to the reduction in general activity level that is usually seen in older patient cohorts.
• Mean pain intensity should be 5 or higher measured on a Visual Analogue Scale (VAS).
• Patient has been informed of the study procedures and has given written informed consent.

You may not qualify if:

• Expected inability of patients to receive or properly operate the spinal cord stimulation system
• History of coagulation disorders, lupus erythematosus, rheumatoid arthritis
• Addiction to drugs, alcohol (5E/day) and/or medication
• Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
• Active malignancy
• Life expectancy \< 1 year
• Local infection or other skin disorder at site of incision
• Pregnancy

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (7)

AZ Delta Hospital

Roeselare, Belgium

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

MCL Leeuwarden

Leeuwarden, Netherlands

Location

Bravis Hospital

Roosendaal, Netherlands

Location

Diakonissenhuis Hospital

Zeist, Netherlands

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (1)

• Hallen T, Meier K, Kallewaard JW, Billet B, Elzinga L, Schapendonk J, Van den Bosch E, Zuidema X, Eygloardottir KL, Gulisano H, Gatzinsky K. Objective, long-term mobility data in patients with chronic pain after lumbar spine surgery treated with spinal cord stimulation-a prospective, multicenter trial. Reg Anesth Pain Med. 2025 Jul 10:rapm-2025-106726. doi: 10.1136/rapm-2025-106726. Online ahead of print.

  PMID: 40639954 DERIVED

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kliment Gatzinsky, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: August 1, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); DK (1); SE (1); NL (4)