Longitudinal observational study of the influence of selective nerve transfer on amputation-associated pain

Longitudinal observational study of the influence of selective nerve transfer on amputation-associated pain - TMB study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028600

Enrollment

Registered

2022-06-21

Start date

2022-10-01

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

D36.1 M79.65 M79.66 M79.67 M79.69

Interventions

Group 1: Selective nerve transfer at patients, who developed an aching stump neuroma after a transtibial or transfemoral amputation or Preventive selective nerve transfer during a transtibial or trans

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: • Condition after transtibial / transfemoral amputation with a painfull stump neuroma and phantom limp pain or scheduled transtibial / transfemoral major amputation • written consent

Exclusion criteria

Exclusion criteria: • Dysmelia • Amputation by the reason of peripheral arterial disease • Minor amputation of the lower extremity • Bilateral or threefold / fourfold amputation of extremities • Neurological cognitive comorbilities • Insufficient knowledge of the german language • Pregnancy

Design outcomes

Primary

Measure	Time frame
Evaluation of amputation-specific pain after selective nerve transfer at patients with an amputated leg measured by a numeric rating scale (NRS) before surgery and 6, 12, 24 and 36 month post surgery.	—

Secondary

Measure	Time frame
• Pain measured by questionnaires (von KORFF, DASS, Pain Detect, PDI, Pain Detect, PCS) before surgery and 6, 12, 24 and 36 month after surgery. • Health related quality of life measured by questionnaires (EQ-5D, PHQ-2) before surgery and 6, 12, 24 and 36 month after surgery. • Mobility and occupational inclusion measured by functional parameters and the PLUS-M questionnaire 6 and 12 month after surgery.	—

Measure

Time frame

• Pain measured by questionnaires (von KORFF, DASS, Pain Detect, PDI, Pain Detect, PCS) before surgery and 6, 12, 24 and 36 month after surgery. • Health related quality of life measured by questionnaires (EQ-5D, PHQ-2) before surgery and 6, 12, 24 and 36 month after surgery. • Mobility and occupational inclusion measured by functional parameters and the PLUS-M questionnaire 6 and 12 month after surgery.

—

Countries

Germany

Contacts

Public ContactTobias Ohmann

BG Klinikum Duisburg gGmbH

tobias.ohmann@bg-klinikum-duisburg.de0203 7688 3129

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026