Trials, 2021-01-25, Vol.22 (1), p.87-87
Spinal cord stimulation (SCS) is an effective method to treat neuropathic pain; however, it is challenging to compare different stimulation modalities in an individual patient, and thus, it is largely unknown which of the many available SCS modalities is most effective. Specifically, electrodes leading out through the skin would have to be consecutively connected to different, incompatible SCS devices and be tested over a time period of several weeks or even months. The risk of wound infections for such a study would be unacceptably high and blinding of the trial difficult. The PARS-trial seizes the capacity of a new type of wireless SCS device, which enables a blinded and systematic intra-patient comparison of different SCS modalities over extended time periods and without increasing wound infection rates.
The PARS-trial is designed as a double-blinded, randomized, and placebo-controlled multi-center crossover study. It will compare the clinical effectiveness of the three most relevant SCS paradigms in individual patients. The trial will recruit 60 patients suffering from intractable neuropathic pain of the lower extremities, who have been considered for SCS therapy and were already implanted with a wireless SCS device prior to study participation. Over a time period of 35 days, patients will be treated consecutively with three different SCS paradigms ("burst," "1 kHz," and "1.499 kHz") and placebo stimulation. Each SCS paradigm will be applied for 5 days with a washout period of 70 h between stimulation cycles. The primary endpoint of the study is the level of pain self-assessment on the visual analogue scale after 5 days of SCS. Secondary, exploratory endpoints include self-assessment of pain quality (as determined by painDETECT questionnaire), quality of life (as determined by Quality of Life EQ-5D-5L questionnaire), anxiety perception (as determined by the Hospital Anxiety and Depression Scale), and physical restriction (as determined by the Oswestry Disability Index).
Combining paresthesia-free SCS modalities with wireless SCS offers a unique opportunity for a blinded and systematic comparison of different SCS modalities in individual patients. This trial will advance our understanding of the clinical effectiveness of the most relevant SCS paradigms.
German Clinical Trials Register, DRKS00018929 . Registered on 14 January 2020.
Adult ; Analysis ; Care and treatment ; Chronic Pain - diagnosis ; Chronic Pain - therapy ; Clinical trials ; Cross-Over Studies ; Diagnostic Self Evaluation ; Double-Blind Method ; Female ; Health aspects ; Humans ; Implantable Neurostimulators - adverse effects ; Infection ; Male ; Medical research ; Medicine, Experimental ; Multicenter Studies as Topic ; Neuralgia - diagnosis ; Neuralgia - therapy ; Neuropathic pain ; Pain ; Pain Measurement ; Physiological aspects ; Quality of Life ; Randomized controlled trial ; Randomized Controlled Trials as Topic ; Spinal cord ; Spinal cord stimulation ; Spinal Cord Stimulation - adverse effects ; Spinal Cord Stimulation - instrumentation ; Spinal Cord Stimulation - methods ; Study Protocol ; Treatment Outcome ; Wireless stimulation ; Wireless Technology - instrumentation
BioMedCentral Open Access
Academic Search Ultimate
DOAJ Directory of Open Access Journals - Not for CDI Discovery
Permalink to record
https://www.ncbi.nlm.nih.gov/pubmed/33494781$$D View this record in MEDLINE/PubMed