Chronic Low-back PainNCT03986489
Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain
A study testing Mindfulness-based dance/movement therapy (M-DMT) and Chronic pain social support group in people with Chronic Low-back Pain, run by Drexel University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Mindfulness-based dance/movement therapy (M-DMT) and Chronic pain social support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel Universitsy
Philadelphia, Pennsylvania, 19102
About this study
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Mindfulness-based dance/movement therapy (M-DMT), Chronic pain social support group
- Keywords
- Dance/movement therapy, Mindfulness-based dance/movement therapy, Chronic pain management, Creative Arts Therapies, Non-pharmacological intervention, Online intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based dance/movement therapy (M-DMT)Behavioural
Also called Dance/Movement Therapy
M-DMT includes benefits of physical activity, group psychotherapy, mindfulness training, and an art-based intervention in a unified practice. Each online session focuses on different psycho-educational topics about chronic low back pain management and links these topics with specific M-DMT activities that incorporate mindfulness-based principles and techniques.
Chronic pain social support groupBehavioural
The therapist will facilitate online open group discussions about participants' experiences with or reactions to the topic of discussion and will promote empathy among group members. The therapist will use client-centered, reflective listening techniques but will not prescribe any specific recommendations for change.
Each week, SSG participants will receive emails with brief information about the topic discussed during the group session.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based dance/movement therapy | Experimental | Participants assigned to the M-DMT group condition will receive care as usual plus 12 weekly 90-minute group M-DMT sessions delivered online by a board-certified dance/movement therapist. The therapist is instructed to follow the M-DMT manualized protocol. Receives: Behavioral: Mindfulness-based dance/movement therapy (M-DMT) |
| Chronic pain social support group | Active comparator | Participants assigned to the control condition will participate in a 12-session (90-minute session/week) online social support group. Receives: Behavioral: Chronic pain social support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment: Number of participants eligible
Number of participants eligible for randomization to the study intervention
Measured: Baseline
Recruitment Rate
Proportion of participants randomized relative to total trial referrals
Measured: Baseline
Recruitment time
Number of participate enrolled per month
Measured: Baseline
Feasibility of recruiting male participants: Proportion of male participant enrolled
Proportion of male participant enrolled to the study
Measured: Baseline
Treatment Completion Rate
We expect 80% of participants to complete at least 9/12 M-DMT sessions
Measured: 12 weeks following receipt of treatment
Retention Rate
Proportion of participants who complete follow-up questionnaires
Measured: 24 weeks
Reason for withdrawal
Assessed by an open-ended question, "What was the reason for discontinuing your participation?" administered by a study staff during a phone interview
Measured: 12 weeks following receipt of treatment
M-DMT intervention credibility and expectancy
Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility)
Measured: 1 week
Treatment Fidelity
Treatment fidelity assessment form developed by the researcher (range: varies between sessions depending on the number of items included in the particular session; A total score of 80% and higher reflects adequate treatment fidelity)
Measured: 1-12 weeks
Treatment satisfaction and acceptability: Likert-scale survey
via Likert-scale surveys; on scale of 1 to 5, 1 being not satisfied; 5 being very satisfied (i.e higher number, better outcome).
Measured: 12 weeks post-randomization
M-DMT intervention acceptability
Exit interview based on an interview protocol developed by the researcher
Measured: 12 weeks
Adverse Event
Number of adverse events
Measured: 1 -12 weeks
Secondary outcomes (6)
Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a
PROMIS® Pain Intensity-Short Form (SF)3a (A 5-point (from 1= Had no pain to 5= Very Severe) rating scale is used in each of the 3 items; higher results mean higher intensity of pain.
Measured: Change from Baseline pain intensity at 6, 12, and 24-week time points
Pain interference: PROMIS® Pain Interference -8a
PROMIS® Pain Interference -8a (A 5-point (from 1= Not at all to 5= Very much) rating scale is used on each of the 8 items; higher scores reflect greater pain interference
Measured: Change from Baseline pain interference at 6, 12, and 24-week time points
Chronic pain acceptance: Chronic Pain Acceptance Questionnaire
Chronic Pain Acceptance Questionnaire (A seven-point (from 0= Never to 6 = Always) rating scale is used in each of the 20 items; higher results mean high pain acceptance)
Measured: Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points
Mindfulness
Cognitive and Affective Mindfulness Scale (A 4-point (Rarely/not at all to almost always) rating scale is used in each of the 12 items; higher values reflect higher mindful qualities
Measured: Change from Baseline mindfulness at 6, 12, and 24-week time points
Physical activity (Accelerometry data)
An accelerometer, ActiGraph GT9X will be used to measure the change in participants physical activity between baseline and 2 endpoints (12 and 24 weeks)
Measured: Change from Baseline physical activity at 12, and 24-week time points
Physical activity (Self-report data)
Self-report assessment of physical activity will be done through UCLA Activity Scale (One item out of 10 will be checked to best describe current activity level)
Measured: Change from Baseline physical activity at 6, 12, and 24-week time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start15 Apr 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Stony Brook University
- Responsible party
- Sponsor
- Investigators
- Minjung Shim, PhD, Principal investigator, Drexel UniversityAdam Gonzalez, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986489
- Sponsor's protocol ID
- 1810006694
- Other IDs
- 7R34AT009555-02
- Status last verified
- Sep 2026
- First submitted
- 29 May 2019
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03986489
- Acronym / sponsor ID
- 1810006694
- Conditions
- Chronic Low-back Pain
- Keywords
- Dance/movement therapy, Mindfulness-based dance/movement therapy, Chronic pain management, Creative Arts Therapies, Non-pharmacological intervention, Online intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Stony Brook University
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based dance/movement therapy | Experimental | Behavioral: Mindfulness-based dance/movement therapy (M-DMT)Participants assigned to the M-DMT group condition will receive care as usual plus 12 weekly 90-minute group M-DMT sessions delivered online by a board-certified dance/movement therapist. The therapist is instructed to follow the M-DMT manualized protocol. |
| Chronic pain social support group | Active comparator | Behavioral: Chronic pain social support groupParticipants assigned to the control condition will participate in a 12-session (90-minute session/week) online social support group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based dance/movement therapy (M-DMT)Also: Dance/Movement TherapyM-DMT includes benefits of physical activity, group psychotherapy, mindfulness training, and an art-based intervention in a unified practice. Each online session focuses on different psycho-educational topics about chronic low back pain management and links these topics with specific M-DMT activities that incorporate mindfulness-based principles and techniques. | Behavioural | Mindfulness-based dance/movement therapy |
| Chronic pain social support groupThe therapist will facilitate online open group discussions about participants' experiences with or reactions to the topic of discussion and will promote empathy among group members. The therapist will use client-centered, reflective listening techniques but will not prescribe any specific recommendations for change. Each week, SSG participants will receive emails with brief information about the topic discussed during the group session. | Behavioural | Chronic pain social support group |
Primary outcome
Feasibility of Recruitment: Number of participants eligible
Time frame: Baseline
Number of participants eligible for randomization to the study intervention
Recruitment Rate
Time frame: Baseline
Proportion of participants randomized relative to total trial referrals
Recruitment time
Time frame: Baseline
Number of participate enrolled per month
Feasibility of recruiting male participants: Proportion of male participant enrolled
Time frame: Baseline
Proportion of male participant enrolled to the study
Treatment Completion Rate
Time frame: 12 weeks following receipt of treatment
We expect 80% of participants to complete at least 9/12 M-DMT sessions
Retention Rate
Time frame: 24 weeks
Proportion of participants who complete follow-up questionnaires
Reason for withdrawal
Time frame: 12 weeks following receipt of treatment
Assessed by an open-ended question, "What was the reason for discontinuing your participation?" administered by a study staff during a phone interview
M-DMT intervention credibility and expectancy
Time frame: 1 week
Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility)
Treatment Fidelity
Time frame: 1-12 weeks
Treatment fidelity assessment form developed by the researcher (range: varies between sessions depending on the number of items included in the particular session; A total score of 80% and higher reflects adequate treatment fidelity)
Treatment satisfaction and acceptability: Likert-scale survey
Time frame: 12 weeks post-randomization
via Likert-scale surveys; on scale of 1 to 5, 1 being not satisfied; 5 being very satisfied (i.e higher number, better outcome).
M-DMT intervention acceptability
Time frame: 12 weeks
Exit interview based on an interview protocol developed by the researcher
Adverse Event
Time frame: 1 -12 weeks
Number of adverse events
6 secondary outcomes
Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a
Time frame: Change from Baseline pain intensity at 6, 12, and 24-week time points
Pain interference: PROMIS® Pain Interference -8a
Time frame: Change from Baseline pain interference at 6, 12, and 24-week time points
Chronic pain acceptance: Chronic Pain Acceptance Questionnaire
Time frame: Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points
Mindfulness
Time frame: Change from Baseline mindfulness at 6, 12, and 24-week time points
Physical activity (Accelerometry data)
Time frame: Change from Baseline physical activity at 12, and 24-week time points
Physical activity (Self-report data)
Time frame: Change from Baseline physical activity at 6, 12, and 24-week time points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minjung Shim, PhD principal investigator
Drexel University
Adam Gonzalez, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based dance/movement therapy (M-DMT) and Chronic pain social support group in people with Chronic Low-back Pain, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment: Number of participants eligible (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.