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Mind Body Intervention for Chronic Lower Back Pain

Primary Purpose

Chronic Lower Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Manual Therapy
Mind Body Intervention
Sponsored by
Canandaigua VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lower Back Pain focused on measuring Chronic Lower Back Pain, Manual Therapy, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rochester Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual Therapy

Mind Body Intervention (MBI)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 1, 2013
Last Updated
March 29, 2022
Sponsor
Canandaigua VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01894282
Brief Title
Mind Body Intervention for Chronic Lower Back Pain
Official Title
Mind Body Intervention for Chronic Lower Back Pain: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canandaigua VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lower Back Pain
Keywords
Chronic Lower Back Pain, Manual Therapy, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Mind Body Intervention (MBI)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Manual Therapy
Other Intervention Name(s)
Spinal Manipulative Therapy, Spinal Mobilization, Flexion Distraction Therapy
Intervention Description
Manual Therapy Arm
Intervention Type
Procedure
Intervention Name(s)
Mind Body Intervention
Other Intervention Name(s)
Manual Therapy, Cognitive Behavioral Therapy for Pain
Intervention Description
Combination of manual therapy and cognitive behavioral therapy for pain.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
Baseline and 6 weeks post baseline (immediately post intervention)
Secondary Outcome Measure Information:
Title
PROMIS Global Health Scale (GHS)
Description
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.
Time Frame
Baseline and 6 weeks post baseline (immediately post intervention)
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction Questionnaire
Description
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.
Time Frame
Baseline and post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Dougherty, DC
Organizational Affiliation
Canandaigua VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rochester Outpatient Clinic
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Mind Body Intervention for Chronic Lower Back Pain

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