Pain and Disability Outcomes in Post Amputation Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Limb Pain, Phantom, Residual Limbs Pain, Disability Physical. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Detailed description
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.
Primary outcome measures
- Change in Pain Severity at rest and movement [Time frame: 1 year]
Secondary outcome measures (5)
- Using NRS to rate phantom limb pain change in severity [Time frame: 1 year]
- Using NRS to rate severity of change in pain [Time frame: 1 year]
- Using NRS to rate of change in severity of Phantom limb sensations. [Time frame: 1 year]
- Using NRS to rate Pain Disabiliy [Time frame: 1 year]
- The amount of pain medication used. [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Penn State Health Milton S. Hershey Medical Center — Hershey
Identifiers
NCT: NCT05716321 · STUDY20483