Mind Body Therapy for the Treatment of Chronic Pain

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2020-04-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Chronic pain syndromes without identified organic etiology remain a challenge for physicians. Many syndromes, including back pain, are believed to have potential underlying psychological etiology; however, the exact link remains elusive. The goal of this study is to determine if mind body therapies can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of Mind Body Syndrome Therapy (MBST) in reducing disability from back pain and alleviating back pain. The investigators will secondarily investigate whether MBST can improve participant quality of life and reduce the need for pain-related hospitalization. The design of the this study consists of 3 arms with one being the intervention (MBST), one being usual care, and one being a second mind-body intervention (active control). This education program consists of a series of personal interviews and group and/or individualized lectures/sessions. Participants will also be provided reading material to study during the intervention period, and asked to continue their usual care while going through the MBST program.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mind Body Syndrome Therapy for Chronic Pain

NCT04689646

Chronic Pain Chronic Pain Syndrome

RECRUITING NA

Mind-body Treatments for Chronic Back Pain

NCT03294148

Chronic Pain Back Pain Lower Back Chronic Back Pain, Low

COMPLETED NA

Mind Body Intervention for Chronic Lower Back Pain

NCT01894282

Chronic Lower Back Pain

COMPLETED PHASE3

Group-based Mindfulness for Chronic Pain in the Primary Care Setting

NCT04129450

Chronic Pain Back Pain

COMPLETED NA

Development and Feasibility of Mindfulness Based Pain Reduction

NCT04980612

Chronic Low-back Pain

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Chronic Pain Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Usual Care, Intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants will be partially blinded. Participants in the usual care arm will be blinded to the specifics of the interventions. Intervention participants will be blinded to the specifics of the intervention until after they have been randomized into that arm. Data analysis will be conducted by persons who are completely blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Care

Participants will continue their usual care for 26 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

Participants will receive a mind body educational-based intervention to learn the techniques comprising intervention 1. Further details are not provided for blinding purposes.

Group Type EXPERIMENTAL

Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

Intervention Type BEHAVIORAL

Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.

Mind Body Intervention 2

Participants will receive a mind-body educational-based intervention to learn the techniques comprising intervention 2. Further details are not provided for blinding purposes.

Group Type ACTIVE_COMPARATOR

Mind Body Intervention 2

Intervention Type BEHAVIORAL

Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.

Intervention Type BEHAVIORAL

Mind Body Intervention 2

Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MBST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patient 18 \> years old
* Chronic back pain
* Pain persistent for ≥3 days/week for the past 3 months prior to enrollment
* Willingness to consider mind-body intervention

Exclusion Criteria

* Patients \< 18 years of age
* Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome. Pain related to disc disease is not an exclusion unless there are neurological impairments.
* Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia and bipolar disorder.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No