Mind Body Intervention for Chronic Lower Back Pain

Mind Body Intervention for Chronic Lower Back Pain: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Lower Back Pain
• Intervention / Treatment: Procedure: Manual Therapy; Procedure: Mind Body Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Rochester Outpatient Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual Therapy; 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.	Procedure: Manual Therapy; Manual Therapy Arm; Other Names: Spinal Manipulative Therapy; Spinal Mobilization; Flexion Distraction Therapy
Experimental: Mind Body Intervention (MBI); 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.	Procedure: Manual Therapy; Manual Therapy Arm; Other Names: Spinal Manipulative Therapy; Spinal Mobilization; Flexion Distraction Therapy; Procedure: Mind Body Intervention; Combination of manual therapy and cognitive behavioral therapy for pain.; Other Names: Manual Therapy; Cognitive Behavioral Therapy for Pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	The VAS is a patient completed analogue measure that evaluates pain intensity on a 100 mm long horizontal line, which is anchored at each end with a statement representing the extremes of the dimension being measured. In this case the left hand side reads, "no pain" and the right hand side reads "worst pain possible". The VAS scale utilized will assess pain at the current time. The VAS has been established as a reliable, valid and generalizable measure that can be administered in a wide range of clinical and experimental settings.	Baseline and 6 weeks post baseline (immediately post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Global Health Scale (GHS)	Health outcomes assessment has advanced to a point where generic health-related quality of life (HRQL) measures are often used to examine the health status of populations and the effects of medical interventions. Generic HRQL profile measures, such as the SF-36 Health Survey, provide multiple health domains scores (e.g., physical function, mental health, pain, vitality, etc.), but not an overall index score. Patient reported outcome measurement information system has developed a quality of life tool that provides an overall index score for quality of life. The main advantage of the PROMIS measures over other static health status measures is that the PROMIS domain item banks and scores allow flexibility in administration using either targeted short forms or computerized adaptive testing. This form has recently been validated in comparison to the EuroQual.	Baseline and 6 weeks post baseline (immediately post intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Questionnaire	Cherkin et al, in the evaluation of a physician education program developed a patient satisfaction questionnaire which was found to be reliable and valid. The questionnaire utilized in this study will incorporate these same questions. Additional questions to be included focus on the burden of the data collection activities, and suggestions for subject recruitment.	Baseline and post intervention

Collaborators and Investigators

• Sponsor: Canandaigua VA Medical Center
• Investigators: Principal Investigator: Paul Dougherty, DC, Canandaigua VA Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy; Manual Therapy; Chronic Lower Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: MBI001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided