Mind Body Intervention for Chronic Lower Back Pain

Canandaigua VA Medical Center

Status and phase: Completed; Phase 3

Conditions: Chronic Lower Back Pain

Treatments: Procedure: Manual Therapy; Procedure: Mind Body Intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01894282

MBI001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Manual Therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Manual Therapy

Mind Body Intervention (MBI)

Experimental group

Description:

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.

Treatment:

Procedure: Mind Body Intervention

Procedure: Manual Therapy