Musculoskeletal Pain, Parkinson Disease
Conditions
Keywords
non-motor symptom, Musculoskeletal Pain, Parkinson disease, treatment, Trans-spinal Magnetic Stimulation
Brief 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.
Interventions
DEVICETrans-spinal Magnetic Stimulation (TsMS)
Patients undergoing real TsMS with coil
DEVICESham Trans-spinal Magnetic Stimulation (TsMS)
Patients undergoing placebo TsMS with coil
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Parkinson disease * Parkinsson disease related musculoskeletal Pain * Signed term of informed consent
Exclusion criteria
* Pregnant or lacting women * Predominant neuropathic pain * The presence of psychiatric disorders such as uncontrolled posttraumatic stress disorder, uncontrolled depression, uncontrolled anxiety disorder and suicidal ideation; * Who wishes at any time to abandon the study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of responders | base line (moment of inclusion) and the last day of the patient assessment (2x in two months) | Number of individuals presenting 50% pain intensity reduction (on VNS 0-10 average pain of BPI item 5) in the active vs the sham group at the last (8th week) assessment compared to baseline values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Immediately after the intervention (session of stimulation) | The safety of trans-spinal magnetic stimulation (TsMS) will be assessed by measuring the number of participants who experience serious events. Each serious adverse event be described in detail |
| Mood | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | Assess mood by hospital anxiety and depression scale |
| Quality of life related to pain relief | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | Assess by EuroQol- 5 Dimension |
| Change in baseline of Pain | base line (moment of inclusion) and in the last day after the final session of TMS-e (2x in two months) | Assessing by score derivated of Parkinson's Disease Pain Classification System (PD-PCS). This score range from 0 (minimum) to 90 (maximum), being considered an effective improvement in the patient's pain when the pain decreases at least in 50% from the basal score. |
| Interference in daily activities | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | measured by brief pain inventory |
| Global impression of change | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | Assess % of very much and much improved |
| Parkinson's disease motor symptoms | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | Assess by UPDRS part III |
Countries
Brazil
Outcome results
None listed