Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05716321

Pain and Disability Outcomes in Post Amputation Patients

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Limb Pain, Phantom Disability Physical Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Residual Limbs Pain Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

About this study

The objective of this study is to evaluate efficacy of varied medical and procedural therapies used to treat pain for surgical amputation of a limb.

At present there are number of different type of therapies are performed in the patients who is going through an amputation of any limb for management of their pain adequately such as peripheral nerve block, epidurals, peripheral nerve stimulators etc. However, the effects of these different procedures performed at different time intervals have not been evaluated for their effects on phantom pain and somatic pain long term after the procedures in these group of patients.

We will be collecting the following data from these patients to see if there is any particular intervention done at particular time of the procedure ( before the amputation vs. after the amputation) affect the long term outcome of these patients such as development of Phantom pain, or chronic pain

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 postoperative day 1, day 7, 30 days, 90 days, 6 months, and 1 year (+/- 3 days at each time point).

The secondary outcomes will be 1) phantom limb pain severity as rated on NRS 2) Residual limb (stump) pain as rated on NRS 3) phantom limb sensations 4) Pain Disability Index scores 5) Morphine milligram equivalents. These secondary outcomes will be assessed at the same intervals as the primary outcome.

This study will help us to find out if there is any utility of any of these procedures performed at particular time of the procedure helps them more than the others for development of somatic or phantom pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Change in Pain Severity at rest and movement

    Time frame: 1 year

    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.

Secondary outcomes

  1. Using NRS to rate phantom limb pain change in severity

    Time frame: 1 year

    The secondary outcomes will be phantom limb pain severity as rated on 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.

  2. Using NRS to rate severity of change in pain

    Time frame: 1 year

    The third outcomes will be Residual limb (stump) pain as rated on 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.

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

    Time frame: 1 year

    The fourth outcomes will be phantom limb sensations. 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 sensation and 10 means the worst feeling ever.

  4. Using NRS to rate Pain Disabiliy

    Time frame: 1 year

    The Fifth outcomes will be Pain Disability Index scores. 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). of 0 means no disability at all, and a score of 10 signifies that all of the activities in which you would normally be involved have been totally disrupted or prevented by your pain.

  5. The amount of pain medication used.

    Time frame: 1 year

    The sixth outcomes will be the amount of Morphine milligram equivalents. The amount taken on post-operative day 1, Day 1 to day 7, day 8 to 30 days, 31 days to 90 days, 91 days to 6 months, and from 6 months to 1 year (+/- 3 days at each time point).

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Reed, BS

CONTACT

[email protected]

717-531-0003 ext. 282465

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

CONTACT

[email protected]

717-531-6140

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 8, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.