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Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain

NCT03986489 · Drexel University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
64
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The purpose of this study is to evaluate the feasibility, acceptability and credibility of a mindfulness-based dance/movement therapy (M-DMT) protocol that is delivered online; to assess and improve methodological procedures for conducting a randomized controlled trial (RCT) test of M-DMT; and to demonstrate proof of principle by gathering information about the process of change between M-DMT and a control condition. This is the first study to address the potential of M-DMT as a creative, non-opioid intervention for chronic back pain. Therefore, the findings of this study will provide important methodological and protocol data and substantive pilot data necessary for the next phase of this line of research, namely a fully powered RCT to evaluate efficacy and treatment mechanisms of action. Data obtained as part of this study will be instrumental for informing the systematic evaluation of M-DMT for chronic back pain care.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Feasibility of Recruitment: Number of participants eligible

    Measured over Baseline

  • Recruitment Rate

    Measured over Baseline

  • Recruitment time

    Measured over Baseline

  • Feasibility of recruiting male participants: Proportion of male participant enrolled

    Measured over Baseline

  • Treatment Completion Rate

    Measured over 12 weeks following receipt of treatment

  • Retention Rate

    Measured over 24 weeks

  • Reason for withdrawal

    Measured over 12 weeks following receipt of treatment

  • M-DMT intervention credibility and expectancy

    Measured over 1 week

  • Treatment Fidelity

    Measured over 1-12 weeks

  • Treatment satisfaction and acceptability: Likert-scale survey

    Measured over 12 weeks post-randomization

  • M-DMT intervention acceptability

    Measured over 12 weeks

  • Adverse Event

    Measured over 1 -12 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria * age \> 18 years * current non-specific cLBP that has persisted at least 3 months, and has resulted in pain on at least half the day in the past 6 months * proficient in English * average pain severity and interference ratings \>3/10 on a 0-10 numeric rating scale * if taking pain medication(s), dosage must be stabilized for a minimum of 3 months * patients agree not to seek additional therapies for the duration of this study beyond those already included in their current treatment regimen or new treatments prescribed by their physician * naïve to DMT. * those who have adequate computer literacy (e.g., know how to use a computer to perform basic tasks such as open/send emails, use internet, fill-out online surveys) and access to the virtual delivery format (i.e., internet service and a personal computer device such as laptop, desktop, tablet PC). Exclusion Criteria: * pregnancy * severe and/or progressive medical, neurological, substance dependence within the last 6 months or severe mental illness (i.e., psychosis, mania) that would prevent active participation * cognitive impairment that prohibits informed consent * back surgery in the last 6 months * low back pain attributable to a recognizable, known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome * wheelchair-bound or unable to move without assistance * involvement in impending litigation or judgment for disability or worker's compensation.

Where

1 study site

FacilityCityRegionCountry
Drexel UniversitsyPhiladelphiaPennsylvaniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03986489 on ClinicalTrials.gov →

Last updated in the registry 2021-04-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in