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Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study.
Neuromodulation. 2019 Dec; 22(8):970-977.N

Abstract

OBJECTIVE

Different approaches in neuromodulation have been used to treat chronic low back pain in failed back surgery syndrome (FBSS) patients. We previously randomized 52 FBSS patients to be treated with spinal cord stimulation (SCS) and additional peripheral nerve field stimulation (PNFS) or SCS alone. At three months, we found a significant reduction of back pain in the PNFS-SCS group compared to the SCS group. In the subsequent open phase part of the study, all patients received optimal SCS and PNFS simultaneously. Here, we present the 12-month follow-up data on back and leg pain.

MATERIALS AND METHODS

Data regarding back and leg pain, function, quality of life, patient satisfaction, anxiety and depression, and use of medication were collected by analyzing patients' questionnaires at 12 months and compared with data collected at baseline. Data were analyzed using multilevel regression models.

RESULTS

A combined group of 50 subjects completed the 12-month follow-up. Back pain, measured on a 100-mm visual analog scale (VAS), significantly decreased over this period by 30.0 mm (95% CI: [-37.7/-22.4]; p < 0.001), while leg pain decreased by 43.7 mm (95% CI: [-51.5/-36.2]; p < 0.001). We observed statistically significant improvement in almost all secondary outcome measurements.

CONCLUSIONS

At 12-month follow-up, PNFS in addition to SCS continues to provide a statistically significant and clinically relevant relief of low back pain in FBSS patients in whom SCS alone is effective for relief of leg pain only.

Authors+Show Affiliations

Department of Anesthesiology, Unit of Pain Medicine, Albert Schweitzer Hospital, Sliedrecht, The Netherlands.Department of Neurosurgery, Maastricht University Medical Centre, Maastricht, The Netherlands.Department of Anesthesiology, Unit of Pain Medicine, Albert Schweitzer Hospital, Sliedrecht, The Netherlands.Department of Anesthesiology, Unit of Pain Medicine, Albert Schweitzer Hospital, Sliedrecht, The Netherlands.Department of Anesthesiology, Rijnland Hospital, Leiderdorp, The Netherlands.Department of Anesthesiology, Rijnstate Hospital, Velp, The Netherlands.Department of Neurosurgery, Maastricht University Medical Centre, Maastricht, The Netherlands.Department of Anesthesiology, Diakonessenhuis, Zeist, The Netherlands.Department of Anesthesiology, Sint Maartenskliniek, Nijmegen, The Netherlands.Department of Cariology and Preventive Dentistry, Radboud University Medical Centre, Nijmegen, The Netherlands.Department of Anesthesiology, Pain Medicine and Palliative Care, Radboud University Medical Centre, Nijmegen, The Netherlands.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29608807

Citation

van Gorp, Eric-Jan J A A., et al. "Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: a 12-Month Follow-Up of a Randomized Controlled Study." Neuromodulation : Journal of the International Neuromodulation Society, vol. 22, no. 8, 2019, pp. 970-977.
van Gorp EJAA, Teernstra O, Aukes HJ, et al. Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study. Neuromodulation. 2019;22(8):970-977.
van Gorp, E. J. A. A., Teernstra, O., Aukes, H. J., Hamm-Faber, T., Bürger, K., Kallewaard, J. W., Spincemaille, G., Schapendonk, J. W. L. C., Vonhögen, L., Bronkhorst, E., & Vissers, K. C. P. (2019). Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study. Neuromodulation : Journal of the International Neuromodulation Society, 22(8), 970-977. https://doi.org/10.1111/ner.12776
van Gorp EJAA, et al. Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: a 12-Month Follow-Up of a Randomized Controlled Study. Neuromodulation. 2019;22(8):970-977. PubMed PMID: 29608807.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study. AU - van Gorp,Eric-Jan J A A, AU - Teernstra,Onno, AU - Aukes,Hans J, AU - Hamm-Faber,Tanja, AU - Bürger,Katja, AU - Kallewaard,Jan Willem, AU - Spincemaille,Geert, AU - Schapendonk,Johannes W L C, AU - Vonhögen,Leon, AU - Bronkhorst,Ewald, AU - Vissers,Kris C P, Y1 - 2018/04/02/ PY - 2017/11/20/received PY - 2018/01/14/revised PY - 2018/02/07/accepted PY - 2018/4/3/pubmed PY - 2020/6/2/medline PY - 2018/4/3/entrez KW - Chronic low back pain KW - failed back surgery syndrome KW - peripheral nerve field stimulation KW - spinal cord stimulation KW - subcutaneous stimulation SP - 970 EP - 977 JF - Neuromodulation : journal of the International Neuromodulation Society JO - Neuromodulation VL - 22 IS - 8 N2 - OBJECTIVE: Different approaches in neuromodulation have been used to treat chronic low back pain in failed back surgery syndrome (FBSS) patients. We previously randomized 52 FBSS patients to be treated with spinal cord stimulation (SCS) and additional peripheral nerve field stimulation (PNFS) or SCS alone. At three months, we found a significant reduction of back pain in the PNFS-SCS group compared to the SCS group. In the subsequent open phase part of the study, all patients received optimal SCS and PNFS simultaneously. Here, we present the 12-month follow-up data on back and leg pain. MATERIALS AND METHODS: Data regarding back and leg pain, function, quality of life, patient satisfaction, anxiety and depression, and use of medication were collected by analyzing patients' questionnaires at 12 months and compared with data collected at baseline. Data were analyzed using multilevel regression models. RESULTS: A combined group of 50 subjects completed the 12-month follow-up. Back pain, measured on a 100-mm visual analog scale (VAS), significantly decreased over this period by 30.0 mm (95% CI: [-37.7/-22.4]; p < 0.001), while leg pain decreased by 43.7 mm (95% CI: [-51.5/-36.2]; p < 0.001). We observed statistically significant improvement in almost all secondary outcome measurements. CONCLUSIONS: At 12-month follow-up, PNFS in addition to SCS continues to provide a statistically significant and clinically relevant relief of low back pain in FBSS patients in whom SCS alone is effective for relief of leg pain only. SN - 1525-1403 UR - https://www.unboundmedicine.com/medline/citation/29608807/Long_Term_Effect_of_Peripheral_Nerve_Field_Stimulation_as_Add_On_Therapy_to_Spinal_Cord_Stimulation_to_Treat_Low_Back_Pain_in_Failed_Back_Surgery_Syndrome_Patients:_A_12_Month_Follow_Up_of_a_Randomized_Controlled_Study_ L2 - https://doi.org/10.1111/ner.12776 DB - PRIME DP - Unbound Medicine ER -