Overview

This trial is active, not recruiting.

Condition chronic lower back pain
Treatments manual therapy, mind body intervention
Phase phase 3
Sponsor Canandaigua VA Medical Center
Start date July 2013
End date August 2017
Trial size 30 participants
Trial identifier NCT01894282, MBI001

Summary

This pilot study will evaluate the feasibility of having a non-behavioral health provider deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the combined intervention of CBT-p and MT and those undergoing MT alone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Spinal Manipulative therapy (SMT) for the purpose of this study we will allow the use of other types of MT, including non-thrust spinal mobilization and flexion-distraction technique.
manual therapy Spinal Manipulative Therapy
Manual Therapy Arm
(Experimental)
Mind Body Intervention will consist of a combination of the previously described "manual therapy" and Cognitive Behavioral Therapy for pain (CBT-p). Cognitive Behavioral Therapy for pain management has three basic components. The treatment rationale, coping skills training and application and maintenance of learned coping skills.
manual therapy Spinal Manipulative Therapy
Manual Therapy Arm
mind body intervention Manual Therapy
Combination of manual therapy and cognitive behavioral therapy for pain.

Primary Outcomes

Measure
Visual Analogue Scale
time frame: Baseline and 6 weeks post baseline (immediately post intervention)

Secondary Outcomes

Measure
PROMIS Global Health Scale (GHS)
time frame: Baseline and 6 weeks post baseline (immediately post intervention)

Eligibility Criteria

Male or female participants from 18 years up to 69 years old.

Inclusion Criteria: - 18 to 69 years of age with CLBP who are - "high risk" for poor prognosis based on SBST - currently undergoing chiropractic care. Exclusion Criteria: - Contraindications to either MT or CBT-p. - Patients who are currently undergoing CBT-p - who have been treated for substance abuse in the past year.

Additional Information

Official title Mind Body Intervention for Chronic Lower Back Pain: A Pilot Study
Principal investigator Paul Dougherty, DC
Description Given that this is a pilot study we will use simple descriptive statistics for patient characteristics, including age, sex, BMI and baseline scores on outcome measures. In addition we will assess the inter-rater reliability of the scoring of the delivery of the CBT-p by the two trained practitioners utilizing kappa statistics. We will perform data analyses using SPSS.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Canandaigua VA Medical Center.