Mind Body Intervention for Chronic Lower Back Pain
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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:
|
| 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:
Procedure: Mind Body Intervention
Combination of manual therapy and cognitive behavioral therapy for pain.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Visual Analogue Scale [Baseline and 6 weeks post baseline (immediately post intervention)]
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) [Baseline and 6 weeks post baseline (immediately post intervention)]
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.
Other Outcome Measures
- Patient Satisfaction Questionnaire [Baseline and post intervention]
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.
Eligibility Criteria
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:
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Contraindications to either MT or CBT-p.
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Patients who are currently undergoing CBT-p
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who have been treated for substance abuse in the past year.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rochester Outpatient Clinic | Rochester | New York | United States | 14620 |
Sponsors and Collaborators
- Canandaigua VA Medical Center
Investigators
- Principal Investigator: Paul Dougherty, DC, Canandaigua VA Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MBI001