Pain and Disability Outcomes in Post Amputation Patients

NCT05716321 | Recruiting DMC

• 1 other identifier: STUDY20483
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate efficacy of varied medical and procedural therapies used to treat pain after surgical amputation of a limb. The primary outcome will be assessment of pain severity at rest and with movement as measured by pain scores on Numerical Rating Scale (NRS) 0 to 10, where 0 is not pain and 10 is the worst pain possible, taken on post-operative day 1, day 7, 30 days, 90 days, 6 months, and 1 year (+/- 3 days at each time point).

Conditions

Limb Pain, Phantom; Residual Limbs Pain; Disability Physical

Keywords

Amputation

Outcome Measures

Primary Outcomes (1)

• Change in Pain Severity at rest and movement

  The primary outcome will be assessment of pain severity at rest and with movement as measured by pain scores on Numerical Rating Scale (NRS) 0 to 10 taken on post-operative day 1, day 7, 30 days, 90 days, 6 months, and 1 year (+/- 3 days at each time point). 0 means no pain and 10 means the worst pain ever.

  1 year

Secondary Outcomes (5)

• Using NRS to rate phantom limb pain change in severity

  1 year

• Using NRS to rate severity of change in pain

  1 year

• Using NRS to rate of change in severity of Phantom limb sensations.

  1 year

• Using NRS to rate Pain Disabiliy

  1 year

• The amount of pain medication used.

  1 year

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center

You may qualify if:

• Ages between 18 and 89 years old, inclusive
• Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center

You may not qualify if:

• 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 Dx listed in the MRN
• BMI \>50

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Sanjib Adhikary, M.B.B.S., MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

717-531-6140; sadhikary@pennstatehealth.psu.edu

Cynthia Reed, BS

CONTACT

717-531-0003; creed@pennstatehealth.psu.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology,

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: February 8, 2023
• Study Start: April 5, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)