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

NCT ID: NCT01794988

Last Updated: 2013-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Cognitive Behavioral Therapy

Participants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.

Group Type EXPERIMENTAL

Group Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Each CBT session will last 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.

Pain Education

Participants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan.

Group Type ACTIVE_COMPARATOR

Pain Education

Intervention Type BEHAVIORAL

Subjects will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics.

Therapeutic Interactive Voice Response

Four months of therapeutic interactive voice response (TIVR).

Group Type EXPERIMENTAL

Therapeutic Interactive Voice Response

Intervention Type BEHAVIORAL

Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls.

No TIVR

Control - no intervention

Group Type ACTIVE_COMPARATOR

NO TIVR

Intervention Type BEHAVIORAL

Control - no intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group Cognitive Behavioral Therapy

Each CBT session will last 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.

Intervention Type BEHAVIORAL

Pain Education

Subjects will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics.

Intervention Type BEHAVIORAL

Therapeutic Interactive Voice Response

Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls.

Intervention Type BEHAVIORAL

NO TIVR

Control - no intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Magdalena Naylor, MD, PhD

Magdalena R. Naylor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Magdalena Naylor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty, University of Vermont College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Vermont College of Medicine, MindBody Medicine Clinic

Burlington, Vermont, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marcia A. Davis, CAGS

Role: CONTACT

802-847-8241

Magdalena R. Naylor, MD, PhD

Role: CONTACT

802-847-4644

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marcia A. Davis, CAGS

Role: primary

802-847-8241

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AR059674-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01AR059674-03

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.