None listed
Conditions
Brief summary
This study is investigating whether a non-invasive light therapy, called photobiomodulation (PBM), can help reduce persistent pelvic pain in people with endometriosis. Persistent pelvic pain in endometriosis is often difficult to treat and may involve changes in how the nervous system processes pain signals. This preliminary study will assess the safety, tolerability, and feasibility of PBM, and explore how different treatment doses influence pain and related symptoms. PBM will be applied to target neural regions involved in pelvic pain processing across a series of treatment sessions. It is hypothesised that PBM will be safe and well tolerated, and may reduce pain and improve function, helping inform the design of a future larger clinical trial.
Interventions
Participants will receive photobiomodulation (PBM) therapy delivered using infrared laser light targeting the dorsal root ganglia (T10–L1 and S2–S4) associated with pelvic innervation. The intervention is applied transcutaneously over paraspinal and sacral regions corresponding to the targeted neural structures.
PBM is delivered using a SYMBYX ProSeries device with a three-diode 808 nm probe operating in pulsed mode. Each diode delivers an average output power of 400 mW. Pulse frequency will be
Participants will receive photobiomodulation (PBM) therapy delivered using infrared laser light targeting the dorsal root ganglia (T10–L1 and S2–S4) associated with pelvic innervation. The intervention is applied transcutaneously over paraspinal and sacral regions corresponding to the targeted neural structures. PBM is delivered using a SYMBYX ProSeries device with a three-diode 808 nm probe operating in pulsed mode. Each diode delivers an average output power of 400 mW. Pulse frequency will be standardised prior to study commencement. Treatment is administered by a trained physiotherapist following a standardised protocol. Participants receive up to 12 treatment sessions over an 8-week period. The intervention will be delivered individually within a clinical research environment. Laser energy is applied to 12 predefined treatment sites. Dose is expressed as energy density (J/cm²), with dwell time per site determined by the target fluence. Total PBM delivery time varies according to dose. The starting baseline dose is 3.5 J/cm². Total session duration is up to approximately 30 minutes, including setup, positioning, and safety procedures. A structured dose-escalation framework is used. For the first participant, treatment begins at 3.5 J/cm² (6 seconds dwell time per site) and increases in fixed increments of 3.5 J/cm² per session to a maximum dose of 21 J/cm² (33 seconds dwell time per site), over the first six sessions unless escalation is withheld due to predefined safety or response criteria. The dose is then maintained at this level for the remaining sessions. For subsequent participants, the starting dose is derived from the preceding participant’s Session 7 dose (reference dose). This dose is maintained for the first six sessions (latency-hold phase) to allow delayed and cumulative biological responses to emerge. From Session 7 onward, dose escalation may occur in increments of 3.5 J/cm², with up to six escalation opportunities, guided by inter-session pain-response criteria and tolerability rules defined in the protocol. All dose-escalation decisions, delivered doses, and session parameters are recorded in the study database. Intervention adherence and safety are monitored throughout the study, including documentation of adverse events and participant-reported responses.
Sponsors
Mater Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
Individuals assigned female at birth aged 18–39 years Confirmed endometriosis (imaging or histopathology) Persistent pelvic pain of 3 months or greater, localised to pelvic/lumbopelvic region Pain consistent with segmental/central sensitisation, defined by: – Convergences Pelvic Pain Score (CPPS) score of 5 or greater – Fibromyalgia Patient Self-Report Survey (FM Survey) score of 1–11 Preserved but hormonally regulated ovarian function (not fully suppressed) Stable hormonal regimen Body Mass Index (BMI) 18–30 kg/m² Fitzpatrick skin type I–III Able to provide consent and comply with study procedures
Exclusion criteria
Pregnancy or breastfeeding Absent, suppressed, or unregulated ovarian function (e.g. menopause, GnRH therapy, natural cycling without regulation) Pain profile inconsistent with pelvic sensitisation (CPPS score of less than 5; FM Survey score of 12 or greater) Clinically significant PTSD or neurodevelopmental conditions affecting sensory processing (e.g. ADHD, ASD) Unstable medical or psychiatric illness Contraindications to PBM (e.g. implanted devices, photosensitivity, impaired sensation at treatment sites) Recent pelvic pathology (infection, significant bleeding, or surgery within 3 months) Active malignancy or serious systemic disease BMI outside 18–30 kg/m² or Fitzpatrick IV–VI Inability to comply with study procedures or provide informed consent
Outcome results
None listed