Trans-spinal Magnetic Stimulation (TsMS) in Parkinson's Disease- Related Musculoskeletal Pain
Condition: Musculoskeletal Pain; Parkinson Disease
MeSH terms: Musculoskeletal Pain; Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson disease is the second most common neurodegenerative disease. Pain is the frequent
      non-motor symptom that significantly compromises the quality of life, affecting 80% of
      patients during the course of the disease. There is currently no evidence-based treatment for
      PD-related pain in general. Nociceptive pain is the most frequent pain in PD an is frequently
      musculoskeletal in nature. Epidural spinal cord stimulation is known to provide analgesic
      effects in several types of pain syndromes. Here we test analgesic effects of a non-invasive
      trans-spinal magnetic stimulation as an add-on treatment for nociceptive (musculoskeletal)
      pain directly related to Parkinson disease.
    

Detailed description: 
      Background: pain is frequent non-motor symptom in Parkinson's disease (PD) that significantly
      compromises the quality of life, affecting 80% of patients during the course of the disease.
      Nociceptive pain is the most frequent subtype, mainly musculoskeletal in nature. There is
      currently no evidence-based treatment for PD-related pain in general. The present study tests
      the effectiveness and safety of non-invasive trans-spinal magnetic stimulation (TsMS) to
      treat musculoskeletal pain directly related to PD in a sham-controlled randomized approach.

      Patients and Methods: this is a randomized, sham-controlled trial including 40 subjects, aged
      between 18 and 85 years, with musculoskeletal pain directly related to PD, that will be
      randomized to receive TsMS active or TsMS sham in a 1:1 ratio. Enrollment will take place at
      the Pain Center of the University of São Paulo and Movement Disorders Center of the
      University of São Paulo.

      We have decided to perform an interim analysis when 24 patients will be included in the trial
      in order to assess safety and calculate effect size of the active intervention, after meeting
      with the research and statistical board. A decision will thereafter be made to, either: 1:
      halt the study due to futility, 2: continue the study with a new target sample size based on
      the calculations made with the effect from the n= 24 sample.

      Expected results: the study hypothesis is that non-invasive trans-spinal magnetic stimulation
      is superior to sham and it is safe to use that device in patients with nociceptive
      (musculoskeletal) pain in PD.
    

Intervention name(s): Trans-spinal Magnetic Stimulation (TsMS); Sham Trans-spinal Magnetic Stimulation (TsMS)
Intervention type(s): Device; Device
Intervention description(s): Patients undergoing real TsMS with coil; Patients undergoing placebo TsMS with coil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: non-motor symptom; Musculoskeletal Pain; Parkinson disease; treatment; Trans-spinal Magnetic Stimulation