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Recruiting NCT04689646

Mind Body Syndrome Therapy for Chronic Pain

No phase Interventional Chronic Pain Chronic Pain Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mind Body Intervention 1, Mind body intervention 2.
Who it may be relevant to
Registry conditions: Chronic Pain, Chronic Pain Syndrome. Basic parameters: 18 years — 67 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mind Body Syndrome Therapy for the Treatment of Chronic Pain

Overview

The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

Detailed description

The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care (control arm) and an active control arm. The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

Interventions

  • Behavioral Mind Body Intervention 1
    Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
  • Behavioral Mind body intervention 2
    Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.

Primary outcome measures

  • Pain Disability [Time frame: 26 weeks]
Secondary outcome measures (6)
  • Average pain [Time frame: Baseline, 4, 8, 13, and 26 weeks after initiation of the study.]
  • Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
  • Anxiety from pain [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
  • Resolution of pain disability [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
  • Pain affecting enjoyment of life [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
  • Resolution of back pain bothersomeness [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]

Eligibility criteria

Inclusion criteria

  • Adult patient 18 ≥ years old
  • Chronic back pain
  • Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment
  • Willingness to consider mind-body intervention
  • At least score of 2 or more on Roland Disability Questionnaire
  • At least score of 3 or more back pain bothersomeness

Exclusion criteria

  • Patients < 18 years of age
  • Patients > 67 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 (note that 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT04689646 · 2020P000147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗