NCT07393139

Brief Summary

The primary aim of this study is to characterize the trajectory of pain and functional recovery in the first post-operative period following a limb amputation. Secondarily, this study aims to conduct an exploratory analysis to evaluate potential associations between clinical, demographical and therapeutical variables and primary outcomes including pain intensity, pain control and functional recovery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 16, 2026

Last Update Submit

January 30, 2026

Conditions

Amputation, SurgicalPain ManagementRehabilitation

Keywords

Phantom limb painAmputationPost-operative

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain intensity was assessed using Numeric Rating Scale (NRS). The NRS is an 11 point scale from 0 to 10, with 0 indicating no pain and 10 representing the worst pain imaginable.

    up to 30 days

Secondary Outcomes (1)

  • Functional Recovery

    up to 30 days

Study Arms (1)

Amputees

Patients that underwent an amputation to any limb at the IRCCS Istituto Ortopedico Rizzoli between January 1st 2023 and December 31st 2025

Other: Pain assessment

Interventions

Pain assessmentOTHER

During hospitalization, patients were asked three times daily to rate their pain using the 11 point NRS scale. The highest rating of each day will be extracted from their medical records.

Amputees

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that underwent an amputation to any limb at the IRCCS Istituto Ortopedico Rizzoli.

You may qualify if:

  • Patients ≥ 18 years of age
  • Patients who underwent an amputation to any limb, regardless of location or diagnosis

You may not qualify if:

  • Patients with severe cognitive impairment or diagnosed with dementia
  • Patients deceased or in critical conditions within 48 hours of the intervention
  • Previous amputation to any limb
  • Admission to the hospital because of a stump revision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (6)

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

    PMID: 26827847BACKGROUND

  • Hsu E, Cohen SP. Postamputation pain: epidemiology, mechanisms, and treatment. J Pain Res. 2013;6:121-36. doi: 10.2147/JPR.S32299. Epub 2013 Feb 13.

    PMID: 23426608BACKGROUND

  • Kent ML, Hsia HJ, Van de Ven TJ, Buchheit TE. Perioperative Pain Management Strategies for Amputation: A Topical Review. Pain Med. 2017 Mar 1;18(3):504-519. doi: 10.1093/pm/pnw110.

    PMID: 27402960BACKGROUND

  • Limakatso K, Ndhlovu F, Usenbo A, Rayamajhi S, Kloppers C, Parker R. The prevalence and risk factors for phantom limb pain: a cross-sectional survey. BMC Neurol. 2024 Feb 6;24(1):57. doi: 10.1186/s12883-024-03547-w.

    PMID: 38321380BACKGROUND

  • Moore RA, Chi CC, Wiffen PJ, Derry S, Rice AS. Oral nonsteroidal anti-inflammatory drugs for neuropathic pain. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010902. doi: 10.1002/14651858.CD010902.pub2.

    PMID: 26436601BACKGROUND

  • Spezia MC, Dy CJ, Brogan DM. Phantom Limb Pain Management. J Hand Surg Am. 2025 Feb;50(2):208-215. doi: 10.1016/j.jhsa.2024.09.007. Epub 2024 Oct 21.

    PMID: 39436344BACKGROUND

MeSH Terms

Conditions

AgnosiaPhantom Limb

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain, PostoperativePostoperative ComplicationsPathologic ProcessesPain

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

February 6, 2026

Study Start

January 9, 2026

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)