Primary Parkinsonian Pain: Clinical Association and Phenotype

NCT07702266 — Not yet recruiting, 300 participants, University Hospital, Clermont-Ferrand

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Registry	NCT07702266, acronym PHENOPAIN
Status	Not yet recruiting
Study type	Observational
Enrollment	300 (Estimated)
Sponsor	University Hospital, Clermont-Ferrand (Other)
Conditions	Parkinson s Disease
Interventions	Online self-administered questionnaire (Other)
Dates	start 2026-09-01 (estimated), primary completion 2027-09-30 (estimated), completion 2027-10-01 (estimated), first posted 2026-07-14, last updated 2026-10-16
Locations	1 site in France

-Summary

Among the different types of pain observed in Parkinson's disease, primary parkinsonian pain (PPP) is the most severe, the most difficult to treat, but also the least well characterized and the hardest to describe, not only by patients but also by neurologists. Consequently, PPP remains difficult to identify, even for clinicians with expertise in Parkinson's disease.

Nevertheless, patients with Parkinson's disease who experience PPP appear to exhibit certain demographic and clinical characteristics that may help distinguish them from other patients, including a poorer motor response to levodopa, a stronger association with sleep disturbances, and cognitive and behavioral features such as impulse control disorders (ICDs). PPP may therefore be associated with a specific disease phenotype supported by distinct pathophysiological mechanisms.

Recently, a disease progression model proposed the existence of a "Brain-First" subtype (characterized by disease onset in the brainstem) and a "Body-First" subtype (characterized by disease onset in the gastrointestinal system). Several clinical markers appear to distinguish these subtypes, notably the presence of REM sleep behavior disorder (RBD), which has been associated with the Body-First phenotype.

The association between PPP and RBD, as well as between PPP and the Body-First subtype, has never been investigated. We hypothesize that PPP may be associated with several clinical markers of the Body-First phenotype. Identifying such associations could facilitate the routine clinical diagnosis of PPP and, consequently, improve its management, which remains inadequate at present.

The primary objective is to assess the proportion of patients with primary parkinsonian pain according to the presence of probable RBD in Parkinson's disease.

This prospective, cross-sectional, non-interventional category 3 study (RIPH 3) will be conducted in 300 patients. Patients contacted through the France Parkinson Association and interested in participating in the study will be able to access the online questionnaire via a QR code or a web link. Completion of the questionnaire is expected to take no more than 15 minutes. This self-administered questionnaire will include collection of general data (age, sex, disease duration, initial motor symptoms, side of symptom onset predominance, and comorbidities), assessments of pain, migraine, sleep, constipation, olfaction, anxiety and depression and impulse control disorders.

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+Arms and interventions

Arm	Type	Interventions	Description
Parkinsonian patients		Other: Online self-administered questionnaire	Patients with a diagnosis of Parkinson's disease confirmed by a neurologist

Online self-administered questionnaire (Other): Completion of the questionnaire is expected to take no more than 15 minutes. This self-administered questionnaire will include collection of general data (age, sex, disease duration, initial motor symptoms, side of symptom onset predominance, and comorbidities), assessments of pain, migraine, sleep, constipation, olfaction, anxiety and depression and impulse control disorders.

+Outcome measures

Primary outcomes

Presence of primary parkinsonian pain according to the 3PDQ questionnaire [at day 0]: This self-questionnaire is completed by the patient during the inclusion visit
Probable REM sleep behavior disorder (RBD), as identified using the RBD-1Q (REM Sleep Behavior Disorder Single-Question Screen). [at day 0]: This self-questionnaire is completed by the patient during the inclusion visit

Secondary outcomes

Presence of anosmia [at day 0]: Self-reported olfactory dysfunction
Presence of constipation [at day 0]: Self-reported constipation dysfunction
Presence of impulsive control disorders [at day 0]: Self reported impulse control disorders
Presence of Anxiety and/or depression according the HADs (Hospital Anxiety and Depression scale) [at day 0]: This self-questionnaire is completed by the patient during the inclusion visit
Presence of RBD according the RBD SQ (RBD-Screening Questionnaire) [at day 0]: This self-questionnaire is completed by the patient during the inclusion visit
Pain intensity according an EVA scale [at day 0]: patients will evaluate their pain with an EVA scale at inclusion visit
Presence of comorbidities [at day 0]: Patients will report if they had comorbidities such as diabete or osteoarticular disorders.
presence of migraines [at day 0]: patient will report if he had migraines
Current antiparkinsonian and analgesic treatments [at day 0]: Patient will report his current antiparkinsonian and analgesic treatments

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥ 18 years.
* French-speaking.
* Diagnosis of Parkinson's disease confirmed by a neurologist.

Exclusion Criteria:

* Atypical parkinsonian syndrome.
* Patients under legal protection (guardianship, curatorship, or legal safeguard measures).

+Locations (1)

Facility	City	Country	Status
CHU Clermont-Ferrand	Clermont-Ferrand	France