Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients

Chronic Pain Clinical Trial

Official title:

Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559048
• Other study ID #: HBTS1411206
• Status: Recruiting
• Start date: September 15, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: The Second Hospital of Tangshan
• Contact: Gang Zhao, M.D.
• Phone: +8603152058037
• Email: tseyyjk[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation, and to treat T cell-mediated diseases such as eczema and atopic dermatitis. FK506 treatment often accompanies pain sensation in patients with atopic dermatitis or after organ transplantation. In previous studies, the investigators confirmed that FK506 treatment increased neuronal activity of primary afferent neurons and causes pain behavior in naïve mice. In order to further search for objective clinical evidence, the investigators proposed to investigate pain incidence after FK506 immunosuppressive therapy in liver transplantation patients. The investigators will investigate pain incidence and pain intensity in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association. The patients who were divided into two groups based on whether or not FK506 was used in the immunosuppressive therapy. The patients in control group (without FK506 treatment) and FK506-treated group report pain sensation 3 months and 12 months after liver transplant. The investigators will compare the pain incidence between the two groups at both time points. On the other hand, the investigators will further investigate changes in pain sensation after 1st and 2nd reductions of FK506 dose. Pain is reported subjectively by the patient using the visual analogue scale (VAS) 1 month after dose reduction. In our study, 1st and 2nd reductions of FK506 dose refers to the first two dose-adjustments (approximately 6 months apart) that occurred 3-6 months after the liver transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: March 15, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. had liver transplantation for end-stage liver disease

2. was =18 years of age at the time of liver transplantation -

Exclusion Criteria:

1. liver cancer

2. acute (fulminant) liver failure

3. multiorgan transplant

4. chronic postsurgical pain

5. fibromyalgia, osteoarthritis, low back pain and inflammatory pain of any origin

6. peripheral and central neuropathic pain of any origin

7. chronic secondary visceral pain

8. chronic cancer-related pain that is due to cancer or its treatment -

Related Conditions & MeSH terms

• Chronic Pain
• Liver Transplantation

Intervention

Drug:
• FK506
FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation

Locations

Country	Name	City	State
China	The Second Hospital of Tangshan	Tangshan	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Tangshan	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Malat GE, Dupuis RE, Kassman B, Rhoads JM, Freeman K, Lichtman S, Johnson MW, Gerber D, Andreoni K, Fair J. Tacrolimus-induced pain syndrome in a pediatric orthotopic liver transplant patient. Pediatr Transplant. 2002 Oct;6(5):435-8. doi: 10.1034/j.1399-3046.2002.02030.x. — View Citation

Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T; European Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol. 2002 Mar;109(3):547-55. doi: 10.1067/mai.2002.121832. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain incidence	Pain is defined as painful sensation that lasts or recurs for 1-3 months within 3 months after liver transplantation, or for longer than 3 months within 12 months after liver transplantation.	within 2 years after liver transplantation
Primary	pain intensity	Pain is reported subjectively by the patient using the visual analogue scale (VAS)	within 2 years after liver transplantation