Evaluating pain and disability outcomes in patients after limb amputation
Pain and Disability Outcomes in Post Amputation Patients
This study is testing different treatments to see how well they help people manage pain after losing a limb.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05716321 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of various medical and procedural therapies for managing pain following limb amputation. It will measure pain severity at rest and during movement using a Numerical Rating Scale (NRS) at multiple time points post-surgery, including day 1, day 7, 30 days, 90 days, 6 months, and 1 year. The study will also evaluate secondary outcomes such as phantom limb pain, residual limb pain, and overall pain disability. By analyzing the timing and type of interventions, the study seeks to understand their long-term effects on pain management in post-amputation patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 89 who are scheduled for surgical limb amputation at Penn State Hershey Medical Center.
Not a fit: Patients with chronic regional pain syndromes or those unable to cooperate or consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing limb amputation.
How similar studies have performed: While there have been studies on pain management post-amputation, this specific evaluation of varied therapies and their timing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hershey, Pennsylvania
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Sanjib Adhikary, M.B.B.S., MD — Milton S. Hershey Medical Center
- Study coordinator: Sanjib Adhikary, M.B.B.S, MD
- Email: sadhikary@pennstatehealth.psu.edu
- Phone: 717-531-6140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.