Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial

Autor: Solveig Tenckhoff, Rezvan Ahmadi, Andreas Unterberg, Volker M. Tronnier, Colette Doerr-Harim, Mohammad Mehdi Hajiabadi, Thomas Bruckner, Dirk Rasche, Benito Campos, Jan Vesper
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Adult
Male
medicine.medical_specialty
Visual analogue scale
Medicine (miscellaneous)
Placebo
Neuropathic pain
Wireless stimulation
law.invention
Study Protocol
Diagnostic Self Evaluation
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
law
medicine
Clinical endpoint
Humans
Multicenter Studies as Topic
Pharmacology (medical)
030212 general & internal medicine
Pain Measurement
Randomized Controlled Trials as Topic
lcsh:R5-920
Cross-Over Studies
integumentary system
business.industry
Crossover study
Oswestry Disability Index
Clinical trial
Implantable Neurostimulators
Treatment Outcome
nervous system
Spinal cord stimulation
Quality of Life
Physical therapy
Neuralgia
Female
Chronic Pain
business
lcsh:Medicine (General)
Wireless Technology
tissues
030217 neurology & neurosurgery
Zdroj: Trials, Vol 22, Iss 1, Pp 1-9 (2021)
Trials
ISSN: 1745-6215
0001-8929
Popis: Background 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. Methods 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). Discussion 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. Trial registration German Clinical Trials Register, DRKS00018929. Registered on 14 January 2020.
Databáze: OpenAIRE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje