WITHDRAWN

Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on those outcomes and to investigate the potentiality of conducting a future larger randomized controlled trial, which the investigators will assess quantitatively the benefits of cryoanalgesia.

Official Title

Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain, General Physical and Emotional Disability, and Opioid Consumption: a Randomized Pilot Trial

Quick Facts

Study Start:2024-06-01
Study Completion:2024-09-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT06284109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults at least 18 years of age.
  2. * Scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone.
  1. * Pregnancy
  2. * Incarceration
  3. * Morbid obesity (body mass index greater than 40 kg/m2
  4. * Contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria, or Reynaud's syndrome.
  5. * Investigator opinion that the potential subject is a poor candidate for this trial.

Contacts and Locations

Principal Investigator

Alparslan Turan, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Alparslan Turan, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01
Study Completion Date2024-09-10

Study Record Updates

Study Start Date2024-06-01
Study Completion Date2024-09-10

Terms related to this study

Keywords Provided by Researchers

  • Postoperative Pain
  • Phantom limb syndrome
  • Postoperative movilization
  • Lower limb amputation

Additional Relevant MeSH Terms

  • Postoperative Pain