A feasibility study regarding physical activity in Spinal Cord Stimulation for patients with Failed Back Surgery Syndrome

Recruiting

Conditions: Patients suffering FBSS with low back pain and/ or leg pain

Registration Number: NL-OMON21829

Lead Sponsor: Radboudumc, Nijmegen, The Netherlands

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Age between 18 and 75 years
- Diagnosed with a Failed Back Surgery Syndrome with low back pain and leg pain. Pain radiating in lumbar segments L4, L5 and S1
- Experienced chronic pain for = six months with a pain score = 5 for the weighted Visual Analogue Scale (VAS)
- No option for further surgical intervention
- Previous pain treatments have been unsuccessful (insufficient pain relief or unacceptable side effects)
- Psychological screened-
- Willing to provide informed consent

Exclusion Criteria

- Presence of any other clinically significant or disabling chronic pain condition
- The expected inability of the patients to properly operate the neurostimulation system
- An SCS procedure in the history
- Addiction to drugs, alcohol (= 5 E / day) or medication
- Insufficient cooperation (little motivation, understanding)
- History of coagulation disorders, lupus erythematosus, diabetes mellitus, rheumatoid arthritis or Morbus Bechterew
- Current use of medication affecting coagulation which cannot be temporarily stopped
- Unable to speak or understand the Dutch language
- Life expectancy < 1 year
- Pacemaker
- Local infection or other skin problems in the operation area
- Existing or planned pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- The feasibility of collecting objective data of the AdaptiveStim™, externally located on the left buttock and internally placed in the left buttock, measured physical activity in different body positions. <br>- The feasibility of collecting objective data of the smartwatch measured physical activities and bodily functions before and after SCS implant.<br>- Overview of the self-supporting questionnaires before and after SCS implant.

Secondary Outcome Measures

Name	Time	Method
- Overview of the diagram of Positive Health before and after SCS implant.<br>- Codes and themes derived from face to face in-depth interviews guided by the diagram of Positive Health by Huber et al. <br>- Overview of the evaluation forms from patients and clinicians<br>