Prospective observational study on the development of phantom limb pain after limb amputation

Prospective observational study on the development of phantom limb pain after limb amputation - prePANTA-MC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027853

Enrollment

Registered

2022-01-20

Start date

2022-02-14

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G54.6

Interventions

Group 1: Patients with planned surgical treatment by major amputation are followed up in this prospective non-interventional observational study for six months with different validated questionnaires.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of legal age, with planned surgical treatment by a major amputation. Own capacity to consent to the study and written informed consent

Exclusion criteria

Exclusion criteria: Placement in an institution by court or administrative order. Parallel participation in prospective clinical intervention study within 30 days. No sufficient communication in German language possible.

Design outcomes

Primary

Measure	Time frame
Time of onset of phantom limb pain Data collection time points are the day of inclusion in the study, a daily visit until discharge from the hospital, and weekly for six months after discharge. Measuring instruments: TAPES-R	—

Secondary

Measure	Time frame
Incidence of onset of residual limb and phantom limb pain. Intensity, quality of residual limb and phantom limb pain. Influence of co-factors on incidence of phantom limb pain (comorbidities, type of anesthesia, type of surgery, previous pain experience, quality of life, depression and anxiety). Association of blood corticosteroids (aldosterone, cortisol) at the time of amputation and inflammatory mediators (differential blood count, CRP, PCT, IL-6) with phantom limb pain incidence. Distribution of neuronal glucocorticoid and mineralocorticoid receptors in patients with phantom limb pain in tissue samples of the amputate. Measuring instruments: Pain Daily Protocol of the German Pain Society - Progress Protocol, PainDETECT, TAPES-R, PHQ-8, GAD-7, APAIS, AUDIT-C, HSI, Pack Years, and EQ-5D-5L. Furthermore, routine clinical data are requested, which are used in the following internationally validated scores: Updated Charlson comorbidity index (uCCI), ACS NSQIP, Medication Quantification Scale Version III (MQS III).	—

Measure

Time frame

Incidence of onset of residual limb and phantom limb pain. Intensity, quality of residual limb and phantom limb pain. Influence of co-factors on incidence of phantom limb pain (comorbidities, type of anesthesia, type of surgery, previous pain experience, quality of life, depression and anxiety). Association of blood corticosteroids (aldosterone, cortisol) at the time of amputation and inflammatory mediators (differential blood count, CRP, PCT, IL-6) with phantom limb pain incidence. Distribution of neuronal glucocorticoid and mineralocorticoid receptors in patients with phantom limb pain in tissue samples of the amputate. Measuring instruments: Pain Daily Protocol of the German Pain Society - Progress Protocol, PainDETECT, TAPES-R, PHQ-8, GAD-7, APAIS, AUDIT-C, HSI, Pack Years, and EQ-5D-5L. Furthermore, routine clinical data are requested, which are used in the following internationally validated scores: Updated Charlson comorbidity index (uCCI), ACS NSQIP, Medication Quantification Scale Version III (MQS III).

—

Countries

Germany

Contacts

Public ContactJan Wandrey

Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin

phantomschmerz@charite.de+49 30 450 531 012

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026