Mind Body Intervention for Chronic Lower Back Pain

NCT01894282 | Completed Phase 3

• 1 other identifier: MBI001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lower Back Pain

Keywords

Chronic Lower Back Pain; Manual Therapy; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PROMIS Global Health Scale (GHS)

  Baseline and 6 weeks post baseline (immediately post intervention)

Other Outcomes (1)

• Patient Satisfaction Questionnaire

  Baseline and post intervention

Study Arms (2)

Manual Therapy

ACTIVE COMPARATOR

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

Mind Body Intervention (MBI)

EXPERIMENTAL

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; Procedure: Mind Body Intervention

Interventions

Manual Therapy PROCEDURE

Manual Therapy Arm

Also known as: Spinal Manipulative Therapy, Spinal Mobilization, Flexion Distraction Therapy

Manual Therapy; Mind Body Intervention (MBI)

Mind Body Intervention PROCEDURE

Combination of manual therapy and cognitive behavioral therapy for pain.

Also known as: Manual Therapy, Cognitive Behavioral Therapy for Pain

Mind Body Intervention (MBI)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 69 years of age with CLBP who are
• "high risk" for poor prognosis based on SBST
• currently undergoing chiropractic care.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canandaigua VA Medical Center: lead

Study Sites (1)

Rochester Outpatient Clinic

Rochester, New York, 14620, United States

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations; Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Paul Dougherty, DC

  Canandaigua VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chiropractor

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

US (1)