Clinical trial NCT05716321: Pain and Disability Outcomes in Post Amputation Patients
Official title: Pain and Disability Outcomes in Post Amputation Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Limb Pain, Phantom
Residual Limbs Pain
Disability Physical
Keywords: Amputation
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center

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).

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.

Eligibility 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

Primary outcomes:
measure: Change in Pain Severity at rest and movement
timeFrame: 1 year
Secondary outcomes:
measure: Using NRS to rate phantom limb pain change in severity
timeFrame: 1 year
measure: Using NRS to rate severity of change in pain
timeFrame: 1 year
measure: Using NRS to rate of change in severity of Phantom limb sensations.
timeFrame: 1 year
measure: Using NRS to rate Pain Disabiliy
timeFrame: 1 year
measure: The amount of pain medication used.
timeFrame: 1 year
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Sanjib Adhikary, M.B.B.S., MD
role: PRINCIPAL_INVESTIGATOR
References: