Pain and Disability Outcomes in Post Amputation Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorMilton S. Hershey Medical Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages between 18 and 89 years old, inclusive
Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center
Disqualifiers
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
Trial population
Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
Using NRS to rate phantom limb pain change in severity
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.
Time frame
1 year2
Using NRS to rate severity of change in pain
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.
Time frame
1 year3
Using NRS to rate of change in severity of Phantom limb sensations.
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.
Time frame
1 year4
Using NRS to rate Pain Disabiliy
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov