Mind Body Intervention for Chronic Lower Back Pain

NCT ID: NCT01894282

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Chronic Lower Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Manual Therapy

Intervention Type PROCEDURE

Manual Therapy Arm

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.

Group Type EXPERIMENTAL

Manual Therapy

Intervention Type PROCEDURE

Manual Therapy Arm

Mind Body Intervention

Intervention Type PROCEDURE

Combination of manual therapy and cognitive behavioral therapy for pain.

Interventions

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Manual Therapy

Manual Therapy Arm

Intervention Type PROCEDURE

Mind Body Intervention

Combination of manual therapy and cognitive behavioral therapy for pain.

Intervention Type PROCEDURE

Other Intervention Names

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Spinal Manipulative Therapy Spinal Mobilization Flexion Distraction Therapy Manual Therapy Cognitive Behavioral Therapy for Pain

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canandaigua VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Paul Dougherty, DC

Chiropractor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Dougherty, DC

Role: PRINCIPAL_INVESTIGATOR

Canandaigua VA Medical Center

Locations

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Rochester Outpatient Clinic

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MBI001

Identifier Type: -

Identifier Source: org_study_id

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