Using cryoanalgesia before amputation to reduce phantom limb pain
Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain, General Physical and Emotional Disability, and Opioid Consumption: a Randomized Pilot Trial
NA · The Cleveland Clinic · NCT06284109
This study is testing if using cold therapy before amputation can help reduce phantom limb pain and improve mobility in patients after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06284109 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of preoperative cryoanalgesia on phantom limb pain, mobility, opioid use, and overall physical and emotional disability in patients undergoing lower limb amputation. It employs a pilot randomized trial design to compare outcomes between those receiving cryoanalgesia and those receiving a sham treatment. The primary aim is to determine if cryoneurolysis can significantly reduce phantom limb pain over a three-month period post-surgery. Secondary aims include assessing improvements in mobility and reductions in opioid consumption and disability levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for unilateral lower limb amputation distal to the femoral head.
Not a fit: Patients who are pregnant, morbidly obese, or have contraindications to cryoneurolysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce phantom limb pain and improve recovery outcomes for patients undergoing lower limb amputation.
How similar studies have performed: While the specific approach of preoperative cryoanalgesia is novel, similar studies have shown promise in managing postoperative pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults at least 18 years of age. * Scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone. Exclusion Criteria: * Pregnancy * Incarceration * Morbid obesity (body mass index greater than 40 kg/m2 * Contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria, or Reynaud's syndrome. * Investigator opinion that the potential subject is a poor candidate for this trial.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Alparslan Turan, MD — The Cleveland Clinic
- Study coordinator: Fabio Rodriguez, MD
- Email: rodrigf3@ccf.org
- Phone: 216 444-9950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Pain, Phantom limb syndrome, Postoperative movilization, Lower limb amputation