Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence

Pain Clinical Trial

Official title:

Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940588
• Other study ID #: 1 - bjohnson
• Status: Completed
• Phase: Phase 0
• First received: September 9, 2013
• Last updated: January 5, 2015
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2015
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated with a neuropsychoanalytic paradigm.

Description:

Patients were detoxified from opioid analgesics and treated with NSAIDs and other non-opioid analgesics, received neuropsychoanalytic therapy and low dose naltrexone. Patients kept a daily diary of: 0 - 10 pain, 0 - 10 function, hours worked, amount of alcohol drunk, illicit and licit drug use, number of health care provider appointments attended, number of self-help groups meetings attended across each of the six months of study. Six month outcomes of this approach with primary outcomes being sobriety, pain scores and function scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have failed back surgery syndrome.

2. Have evidence of Opioid Dependence by meeting DSM-IV criteria and by Drug Abuse Screening Test > 4. (In case of a difference in these two measures, clinical staff will talk with the patient to adjudicate the difference.)

3. Over 18

4. Be able to understand spoken and written English

5. Reside within 30 miles of the site of treatment for ease of followup

6. Have health insurance or other ability to pay for treatment

Exclusion Criteria:

1. Homeless

2. Unable to give consent (e.g. neurological disorders, dementia, psychosis)

3. Co-occurring incapacitating psychiatric disorder such as schizophrenia

4. Pregnant

5. Financial incentive to stay ill, such as a pending disability claim

6. Member of a vulnerable population, including prisoners

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Pain

Intervention

Behavioral:
• Neuropsychoanalytic therapy
Psychotherapy, medication management

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	University at Buffalo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of pain	Detoxified patients followed for whether their pain improved.	Six months	No