Actively Recruiting

Age: 18Years - 89Years
All Genders
ID05716321

Pain and Disability Outcomes in Post Amputation Patients

Led by Milton S. Hershey Medical Center · Updated on 2026-05-07

350

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of various medical and procedural treatments used to manage pain after surgical limb amputation. The study focuses on understanding how different therapies, such as peripheral nerve blocks, epidurals, and peripheral nerve stimulators, impact phantom pain and somatic pain over the long term. The goal is to determine whether the timing of these interventions, before or after amputation, influences the development of chronic pain and phantom limb pain. Participants who have undergone limb amputation will be observed to assess pain severity at rest and with movement using a Numerical Rating Scale (NRS) from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable. Pain assessments will be collected on postoperative days 1 and 7, then at 30 days, 90 days, 6 months, and one year, with a small window of +/- 3 days for each. The study also measures other outcomes like phantom limb pain severity, residual limb pain, phantom limb sensations, pain disability scores, and the amount of pain medication used. During the study, participants will have regular pain evaluations at specified intervals up to one year. This includes questionnaires and pain scoring to track changes over time. Researchers will also gather data on phantom sensations and disability related to pain. The study aims to better understand which treatment methods and timing may reduce pain and improve quality of life after amputation. Participation involves scheduled assessments and follow-up visits over one year to monitor outcomes and medication use.

CONDITIONS

Brief Title

Pain and Disability Outcomes in Post Amputation Patients

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages between 18 and 89 years old, inclusive
  • Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center
Not Eligible

You will not qualify if you...

  • Patients who cannot cooperate or consent
  • Patients who cannot understand or speak English
  • Patients with a history of chronic regional pain syndromes
  • Patients suffering from alcohol and/or drug abuse based on previous diagnosis
  • Body mass index (BMI) greater than 50

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week

Participants undergo surgical limb amputation and immediate post-operative care where various medical and procedural pain therapies may be administered.

1 visit on postoperative day 1 and 1 visit on day 7

Post-operative Follow-up

Duration - Up to 1 year

Participants are followed up to assess pain severity, phantom limb pain, sensations, disability, and medication use over time.

Visits on postoperative days 30, 90, 6 months, and 1 year

Trial Site Locations

Total: 1 location

1

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

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Research Team

S

Sanjib Adhikary, M.B.B.S, MD

C

Cynthia Reed, BS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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