Mind Body Intervention for Chronic Lower Back Pain

Chronic Lower Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894282
• Other study ID #: MBI001
• Status: Completed
• Phase: Phase 3
• Start date: July 2013
• Est. completion date: November 2017

Study information

• Verified date: March 2022
• Source: Canandaigua VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Lower Back Pain
• Low Back Pain

Intervention

Procedure:
• Manual Therapy
Manual Therapy Arm
• Mind Body Intervention
Combination of manual therapy and cognitive behavioral therapy for pain.

Locations

Country	Name	City	State
United States	Rochester Outpatient Clinic	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Canandaigua VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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)