NCT02117921

Brief Summary

To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

April 16, 2014

Last Update Submit

September 28, 2024

Conditions

Chronic Pain

Keywords

Mind Body SyndromeMBSChronic Pain

Outcome Measures

Primary Outcomes (2)

  • Brief Pain Inventory Questionnaire

    To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.

    4 weeks

  • SF-12 Health Survey Scoring Demonstration

    4 weeks

Secondary Outcomes (1)

  • SF-12 Health Survey Scoring Demonstration and Brief Pain Inventory Score

    2 weeks, 4 weeks, 6 months

Study Arms (1)

MBS therapy education

EXPERIMENTAL
Behavioral: One-on-one interview and educational sessions. Reading material for educational series provided.

Interventions

One-on-one interview and educational sessions. Reading material for educational series provided.BEHAVIORAL

A one-on-one interview with the patient and the principal investigator and group educational sessions.

MBS therapy education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient 18 \> years old
  • Chronic pain without clear organic etiology after full evaluation by primary care physician or subspecialist
  • Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment

You may not qualify if:

  • 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)
  • Pregnancy
  • Severe depression or recent suicide attempt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael W Donnino, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michael W. Donnino, MA

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)