Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

Real RepetitiveTranscranial Magnetic Stimulation 5 sessions: 5 consecutive treatment sessions will be provided using a protocol based on the updated guideline (Lefaucheur, 2014) and on Pinot-Monange et al. (2019). Each treatment session will last approximately 30 minutes. Acceptability, adverse events and side effects will be recorded after each session, while the researchers will also record the total treatment time, difficulties encountered during implementation, and any modifications to the intervention.

Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions: 5 consecutive sham treatment sessions will be provided using a protocol based on the updated guideline (Lefaucheur, 2014) and on Pinot-Monange et al. (2019). Each treatment session will last approximately 30 minutes. Acceptability, adverse events and side effects will be recorded after each session, while the researchers will also record the total treatment time, difficulties encountered during implementation, and any modifications to the intervention

Real RepetitiveTranscranial Magnetic Stimulation 10 sessions: 10 consective treatment sessions will be provided using a protocol based on the updated guideline (Lefaucheur, 2014) and on Pinot-Monange et al. (2019). Each treatment session will last approximatly 30 minutes. Acceptability, adverse events and side effects will be recorded after each session, while the researchers will also record the total treatment time, difficulties encountered during implementation, and any modifications to the intervention.

Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions: 10 consective sham treatment sessions will be provided using a protocol based on the updated guideline (Lefaucheur, 2014) and on Pinot-Monange et al. (2019). Each treatment session will last approximatly 30 minutes. Acceptability, adverse events and side effects will be recorded after each session, while the researchers will also record the total treatment time, difficulties encountered during implementation, and any modifications to the intervention.

Study summary

The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP.

The objectives of this trial are:

1. to evaluate the effectiveness of an rTMS intervention for pain reduction among those with recalcitrant post-operative EAP,
2. to inform on the utility of a long (10 session) vs short (5 session) protocol for pain reduction among those with recalcitrant post-operative EAP
3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later
4. to identify physical and psychosocial mediators that impact the successful reduction of pain among patients with EAP treated using rTMS.
5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP.

Eligibility

Primary outcome measure(s)

• Numeric rating scale (NRS) used to record daily pain over 30 days — Baseline -30 days after enrolment and before allocation
  Pain intensity, using a numeric rating scale (NRS), will be recorded daily for 30 days prior to trial entry to provide a suitable baseline, It will measure the average and worst overall pain intensity, menstrual and sexual activity related pain (if applicable). The questions will be applied as described below: Please rate any pain you experienced today (over the past 24 hours) that you attribute to your endometriosis using a scale from 0 (no pain) to 10 (worst pain imaginable). Is today your first day of menstrual cycle? Did you attempt any sexual activity or tampon insertion in the last 24hs? Please rate the pain associated with this activity on a scale from 0 (no pain) to 10 (worst pain imaginable),for sexual activity and/or tampon insertion (if applicable).
• Numeric rating scale(NRS) used to record daily pain over 30 days — 30 days following intervention
  Pain intensity, using a numeric rating scale (NRS), will be recorded daily after the intervention period for 30 days. It will measure the average and worst overall pain intensity, menstrual and sexual activity related pain (if applicable). The questions will be applied as described below: Please rate any pain you experienced today (over the past 24 hours) that you attribute to your endometriosis using a scale from 0 (no pain) to 10 (worst pain imaginable). Is today your first day of menstrual cycle? Did you attempt any sexual activity or tampon insertion in the last 24hs? Please rate the pain associated with this activity on a scale from 0 (no pain) to 10 (worst pain imaginable), for sexual activity and/or tampon insertion (if applicable).
• Patient Global Impression of Change (PGIC) in pain — After the Intervention on the final intervention day
  PGIC is a single question through which participants provide a ordinal rating based on their overall perception of change in their pain attributed to the intervention: Very Much Better, Much Better, Somewhat better, About the same, somewhat worse, much worse, very much worse
• Patient Global Impression of Change (PGIC) in pain — 30 days after completing the intervention
  PGIC is a single question through which participants provide a ordinal rating based on their overall perception of change in their pain attributed to the intervention: Very Much Better, Much Better, Somewhat better, About the same, somewhat worse, much worse, very much worse
• Patient Global Impression of Change (PGIC) in pain — 6 months after the intervention
  PGIC is a single question through which participants provide a ordinal rating based on their overall perception of change in their pain attributed to the intervention: Very Much Better, Much Better, Somewhat better, About the same, somewhat worse, much worse, very much worse

Trial sites (1)

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