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Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study

University of Vermont logo

University of Vermont

Status

Unknown

Conditions

Chronic Pain

Treatments

Behavioral: Therapeutic Interactive Voice Response
Behavioral: Pain Education
Behavioral: NO TIVR
Behavioral: Group Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01794988
R01AR059674-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to investigate whether a psycho-therapeutic approach, group Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural circuitry associated with chronic pain.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • At least 12 months of muscular-skeletal, non-neuropathic pain

Exclusion criteria

  • Malignancy causing or influencing chronic pain
  • Radiation or chemotherapy, or metastatic cancer of any type
  • Reflex Sympathetic Dystrophy (RSD) and/or neuropathic pain
  • Neurological disorders such as epilepsy or stroke, or other medical conditions
  • Psychiatric disorders
  • Opioid medication use for pain management
  • Past year history of illicit drug use that can result in altered cognition
  • Pregnancy
  • Exceeding weight limit of the MRI scanner
  • Incompatible implants due to MRI safety
  • Awaiting pain related surgical procedure
  • Involved in pain-related litigation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

120 participants in 4 patient groups

Group Cognitive Behavioral Therapy
Experimental group
Description:
Participants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
Treatment:
Behavioral: Group Cognitive Behavioral Therapy
Pain Education
Active Comparator group
Description:
Participants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan.
Treatment:
Behavioral: Pain Education
Therapeutic Interactive Voice Response
Experimental group
Description:
Four months of therapeutic interactive voice response (TIVR).
Treatment:
Behavioral: Therapeutic Interactive Voice Response
No TIVR
Active Comparator group
Description:
Control - no intervention
Treatment:
Behavioral: NO TIVR

Trial contacts and locations

1

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Central trial contact

Marcia A. Davis, CAGS; Magdalena R. Naylor, MD, PhD

Data sourced from clinicaltrials.gov

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