Mind-body Treatments for Chronic Back Pain

Status Completed

Clinical Trial Summary

Participants with chronic back pain will complete an online prescreen. They will then be randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid use. Participants will then complete an in-person eligibility session, and eligible participants will be scheduled for the baseline assessment session. Following the baseline assessment session, participants will then be randomized to the treatment group or the waitlist group (with a ratio of 2:1 treatment:waitlist), using a computer-generated random sequence. This scheme will result in three equally sized groups-placebo, psychotherapy, and waitlist-as the investigators will collapse data from the waitlist arms in the two studies for analyses. The investigators do not use a standard three-way randomization because the investigators do not want placebo participants to think they are in a control condition. Thus, the investigators constrain participant's expectations to either injection vs. waitlist or to psychotherapy vs. waitlist. The placebo treatment is a subcutaneous injection of saline into the back. Participants will know that the treatment is a placebo, i.e., it is an "open label" placebo. Psychotherapy (8 sessions) will be supervised by Alan Gordon and Howard Schubiner. Functional MRI brain imaging, self-reported clinical outcomes, and behavioral measures will be collected pre- and post-treatment. A brief follow-up survey will be sent at months 1, 2, 3, 6, and 12 after the final assessment session. These will provide longer term data about the trajectory and durability of patient improvement. Additionally, a group of healthy controls, with no history of back pain, will complete the baseline assessment. They will serve as a comparison group to probe whether the patterns of observed brain activity is specific to CBP patients.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03294148
Study type	Interventional
Source	University of Colorado, Boulder
Contact
Status	Completed
Phase	N/A
Start date	August 7, 2017
Completion date	November 26, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01659073` - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation	N/A
Recruiting	`NCT05914311` - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration	N/A
Recruiting	`NCT05422456` - The Turkish Version of Functional Disability Inventory
Enrolling by invitation	`NCT05422443` - The Turkish Version of Pain Coping Questionnaire
Completed	`NCT05057988` - Virtual Empowered Relief for Chronic Pain	N/A
Completed	`NCT04385030` - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury	N/A
Recruiting	`NCT06206252` - Can Medical Cannabis Affect Opioid Use?
Completed	`NCT05103319` - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed	`NCT03687762` - Back on Track to Healthy Living Study	N/A
Completed	`NCT04171336` - Animal-assisted Therapy for Children and Adolescents With Chronic Pain	N/A
Completed	`NCT03179475` - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury	Phase 4
Completed	`NCT03418129` - Neuromodulatory Treatments for Pain Management in TBI	N/A
Completed	`NCT03268551` - MEMO-Medical Marijuana and Opioids Study
Recruiting	`NCT06204627` - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain	N/A
Recruiting	`NCT06060028` - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain	N/A
Completed	`NCT00983385` - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics	Phase 3
Recruiting	`NCT05118204` - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization	Phase 4
Terminated	`NCT03538444` - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder	N/A
Not yet recruiting	`NCT05812703` - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
Completed	`NCT05036499` - PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain	N/A