Recruiting

Observational Study

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT05716321

Conditions

Limb Pain, Phantom

Residual Limbs Pain

Disability Physical

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05716321

Start date

Apr 5, 2023

Status verified date

May, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who cannot cooperate or consent
2. Patients who cannot understand or speak English
3. Patients with a history of chronic regional pain syndromes
4. Patients suffering from alcohol and/or drug abuse -based on previous Dx listed in the MRN
5. BMI >50

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in Pain Severity at rest and movement [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

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

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

Cynthia Reed, BS

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

Locations

Penn State Health Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Amputation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-05-07.