Chronic Low-back Pain
Conditions
Keywords
Transcranial Magnetic Stimulation, Motor Control Exercises, Randomized Controlled Trial
Brief summary
The aim of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation alone and in combination with motor control exercises on pain and disability for patients with chronic non-specific low back pain.
Interventions
DEVICEActive rTMS
A figure-of-8 coil connected to a biphasic Magstim Rapid 2 stimulator (The MagstimCo, Whitland, UK) will be used. Coil orientation and position will be guided throughout the experiment by a neuronavigation system (Brainsight, Rogue research, Montreal, QC, Canada). The intensity of rTMS will be set at 95 % of the first dorsal interosseous (FDI) resting motor threshold (RMT). Active rTMS will consist of 40 trains of 5 seconds each at 10 Hz (25-s intertrain interval) applied over M1 (on FDI cortical representation), for a total of 2000 stimulations lasting 20 minutes.
DEVICESham rTMS
A sham coil will be use (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS (30 min).
The rehabilitation program will consist of a 30-minute session of motor control exercises following the rTMS (Active or Sham) intervention. This approach aims to improve spine health through the optimization of spine loading. The first session will be preceded by an individualized evaluation of the participant's abilities and deficiencies to tailor the training program to each participant.
Sponsors
Hugo Massé-Alarie
Pfizer
The Canadian Pain Society
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will be masked to rTMS intervention (real or sham) but cannot be blinded to the exercise intervention. However, participants will not be aware of the study design (other arms). Therapist delivering the exercise intervention will be masked to rTMS intervention (active vs. sham) but cannot be blinded to exercise intervention (yes vs. no). Experimenter delivering the rTMS intervention will be masked to exercise intervention but not to rTMS intervention (real or sham). Outcomes assessor will be completely masked to all interventions as all outcomes are questionnaires that will be completed online. Data will be de-identified and the data analyst will be masked to participants and group allocation.
Intervention model description
Pseudo-factorial design (rTMS: Active/Sham \| Exercises: Yes/No)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic low back pain, defined as "pain in the low back area with or without leg pain above the knee limiting activities or daily routine which has been present for more than 3 months"; * a minimal average pain intensity of 3 out of 10 during the preceding week on a pain numerical rating scale; * a minimal score of 10 points on the Oswestry disability index (ODI).
Exclusion criteria
* specific spinal pathology (fracture, tumor, radiculopathy, spinal infection, etc.); * a history of back surgery; * a major orthopedic, neurological, cardiovascular or psychiatric illness; * low back pain is not the main pain complaint; * currently using an exercise program to treat their LBP; * presenting with any specific TMS/rTMS-related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (average pain over the last week) | Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks | Pain score on a 11-point pain numerical rating scale (PNRS) ranging from 0 to 10, with 0 meaning no pain and 10 the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability (ODI) | Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks | The Oswestry Disability Index (ODI) version 2.1 is a self-completed questionnaire giving a subjective percentage score of disability. Includes 10 questions rated on a 6-item scale, from 0 to 5 points. The total score ranges from "0" (No disability) to "100" (Maximal disability). |
| Tampa scale of kinesiophobia (TSK) | Change from baseline to 8 weeks, 12 weeks and 24 weeks | TSK is used to assess pain-related fear of movement with a 17-item questionnaire. Each item is scored on a 4-point Likert scale. Total score ranges from 17 (minimal pain-related fear of movement) to 58 (maximal pain-related fear of movement). |
| Global rating of change | Change from baseline to 8 weeks | A 11-point scale ranging from -5 to 5, to evaluate the perceived change of health status after the intervention. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORHugo Massé-Alarie, PhD
Laval University
Outcome results
None listed