Pathophysiology of Post Amputation Pain

NCT01632709 | Completed Phase 4 Results

• 1 other identifier: DOD_PAP 12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how Post Amputation Pain (PAP) affects the body and brain by using sensory testing (such as pinprick testing), taking pictures of your brain (using a functional magnetic resonance imaging (fMRI) machine) and biomedical interventions (such as an injection of pain medicine). All medicines and the fMRI machine used during this study are FDA approved. The investigators hope that by learning the causes of PAP, the investigators can help future amputees.

Conditions

Amputation Stumps; Neuroma

Outcome Measures

Primary Outcomes (1)

• Change in Pain

  Pain rating before and after injection on a 0-10 NRS pain scale (0=no pain, 10= worst pain imaginable)

  Pain rating before and at 15 minutes and 1 hour post injection

Secondary Outcomes (4)

• Change in Perceived Disability (PDI)

  PDI collected pre injection and 1 week post injection

• Change in Perceived Anxiety (PASS)

  PASS collected pre injection and 1 week post injection

• Change in Depression (CES-D 10)

  CES-D 10 collected pre injection and 1 week post injection

• Pain Visual Analogue Scale (VAS)

  VAS collected pre injection and 1 week post injection

Study Arms (4)

Sympathetic nerve block of bupivacaine

ACTIVE COMPARATOR

Sympathetic nerve block of bupivacaine

Drug: Bupivacaine

Dry needling at the sympathetic ganglion

PLACEBO COMPARATOR

Placebo/ Dry needling at the sympathetic ganglion

Drug: Placebo

Neuroma injection of bupivacaine

ACTIVE COMPARATOR

Neuroma injection of bupivacaine

Drug: Bupivacaine

dry needling at the neuroma

PLACEBO COMPARATOR

Placebo/ dry needling at the neuroma

Drug: Placebo

Interventions

Bupivacaine DRUG

one injection of 10ml of .25%

Neuroma injection of bupivacaine; Sympathetic nerve block of bupivacaine

Placebo DRUG

Dry needling

Also known as: Dry needling

Dry needling at the sympathetic ganglion; dry needling at the neuroma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Able to read and speak English and provide informed consent
• Single Amputation, upper or lower.
• Subject has chronic post amputation pain lasting longer than three months
• Subject has healed amputation wounds
• Pain must be ≥3 on a scale of 0-10, 0 being no pain, 10 being the worse pain imaginable.
• If subjects pain is non-existent during fMRI scans, the subject needs to be willing to have their pain induced by targeting pain trigger points (for example, study's postdoctoral fellow would massage certain regions of the affected limb to trigger PAP).
• Subject agrees to 1) Stop taking all aspirin seven days prior to their second visit (Bayer,Ecotrin,Alka Seltzer, etc.) 2) All inflammatory medications 48 hours prior to their second visit (Advil, Motrin, Indocin, Lodine , Ibuprofen, Aleve, Naproxen, etc. 3) Supplements such as Vitamin E and Fish Oil 48 hours prior to their second visit.
• Subject agrees to continue other prescribed medications.
• Subject is willing to have hypodermic needle injections and images taken of them (digital, thermal, and fMRI).
• Able to understand and comply with all data collection methodology including electronic diary.
• If female, is not pregnant and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl).

You may not qualify if:

• Subject is allergic to Isovue 300 or amide-type local anesthetics such as bupivicaine, lidocaine, or mepivacaine.
• Subject has a diagnosis of bleeding diathesis or an immune compromise.
• Subject has pain that is more severe than their post amputation pain.
• Subject has a clinical diagnosis of fibromyalgia.
• Subject has metal shavings and or is frequently in an environment where there is metal work being done or significant amounts of metal shavings.
• Subject has ferrous metal implants, aneurism clips, bioelectric devices, and other implants which can be affected by the magnetic field of the MRI.
• Subject is claustrophobic.
• Subject weighs more than 300 pounds.
• Subject plans to start new pain treatments or therapies during the study (e.g. new pain medication, injections, PT, surgery).

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• United States Department of Defense: collaborator
• Northwestern University: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Neuroma

Interventions

Bupivacaine; Dry Needling

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Complementary Therapies; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Center for Pain Studies
• Organization: Rehabilitation Institute of Chicago

centerforpainstudies@ric.org

312.238.5654

Study Officials

• Norman Harden, M.D.

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: July 3, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 21, 2015
• Results First Posted: July 21, 2015

Record last verified: 2015-07

Locations

US (1)