Pain and Disability Outcomes in Post Amputation Patients

Disability Physical Clinical Trial

Official title:

Pain and Disability Outcomes in Post Amputation Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716321
• Other study ID #: STUDY20483
• Status: Recruiting
• Start date: April 5, 2023
• Est. completion date: November 2027

Study information

• Verified date: April 2024
• Source: Milton S. Hershey Medical Center
• Contact: Sanjib Adhikary, M.B.B.S, MD
• Phone: 717-531-6140
• Email: sadhikary[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: November 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Disability Physical
• Phantom Limb

Locations

Country	Name	City	State
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	The amount of pain medication used.	The sixth outcomes will be the amount of Morphine milligram equivalents. The amount taken on post-operative day 1, Day 1 to day 7, day 8 to 30 days, 31 days to 90 days, 91 days to 6 months, and from 6 months to 1 year (+/- 3 days at each time point).	1 year