Limb Pain, PhantomNCT05716321
Pain and Disability Outcomes in Post Amputation Patients
An observational study of Limb Pain, Phantom and Residual Limbs Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Limb Pain, Phantom, Residual Limbs Pain, Disability Physical
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2023to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center
Who may be able to join
- Ages between 18 and 89 years old, inclusive
- Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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).
Read the 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.
- Conditions
- Limb Pain, Phantom, Residual Limbs Pain, Disability Physical
- Keywords
- Amputation
- Medical subject headings
- Phantom Limb
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start5 Apr 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb Pain, PhantomStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjib D Adhikary, Milton S. Hershey Medical Center
- Investigators
- Sanjib Adhikary, M.B.B.S., MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716321
- Sponsor's protocol ID
- STUDY20483
- Status last verified
- May 2026
- First submitted
- 5 Jan 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be assigned a Study ID to protect the participants PHI. NO information will be shared with other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Disability Outcomes in Post Amputation Patients
- ClinicalTrials.gov ID
- NCT05716321
- Acronym / sponsor ID
- STUDY20483
- Conditions
- Limb Pain, Phantom, Residual Limbs Pain, Disability Physical
- Keywords
- Amputation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center
Key inclusion criteria (2 listed)
- Ages between 18 and 89 years old, inclusive
- Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pain Severity at rest and movement
Time frame: 1 year
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. The IPD will be assigned a Study ID to protect the participants PHI. NO information will be shared with other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjib Adhikary, M.B.B.S., MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Pain, Phantom and Residual Limbs Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjib Adhikary, M.B.B.S, MD (717-531-6140, sadhikary@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Severity at rest and movement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.