Mind Body Intervention for Chronic Lower Back Pain

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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