Mind Body Intervention for Chronic Lower Back Pain

Phase 3

Completed

• Conditions: Chronic Lower Back Pain
• Interventions: Procedure: Manual Therapy; Procedure: Mind Body Intervention

• Registration Number: NCT01894282
• Lead Sponsor: Canandaigua VA Medical Center

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Primary Completion: 2017-08
• Study Completion: 2017-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind Body Intervention (MBI)	Mind Body Intervention	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.
Mind Body Intervention (MBI)	Manual Therapy	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.
Manual Therapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Rochester Outpatient Clinic; 🇺🇸 Rochester, New York, United States