Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03986489
Other study ID # 1810006694
Secondary ID 7R34AT009555-02
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date July 2022

Study information

Verified date December 2020
Source Drexel University
Contact Minjung Shim, PhD
Phone 267-359-5592
Email ms344@drexel.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date July 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness-based dance/movement therapy (M-DMT)
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 group
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.

Locations

Country Name City State
United States Drexel Universitsy Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Drexel University National Center for Complementary and Integrative Health (NCCIH), Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Physical Function PROMIS® Physical function-20a (A 5-point (5= without any difficulty to 1= Unable to do) rating scale is used in each of the 20 items; higher values reflect higher abilities to physically function Change from Baseline physical function at 6, 12, and 24-week time points
Other Depression PROMIS® Emotional Distress-Depression-SF 4a (A 5-point (1= Never to 5= Always) rating scale is used in each of the 4 items; higher values reflect higher levels of depression Change from Baseline depression at 6, 12, and 24-week time points
Other Sleep Disturbance PROMIS® Sleep Disturbance-4a (A 5-point (5= Very poor to 1= Very good) rating scale is used in each of the 4 items; higher values reflect higher levels of sleep disturbances Change from Baseline sleep disturbance at 6, 12, and 24-week time points
Other Pain Catastrophizing: Pain Catastrophizing Scale Pain Catastrophizing Scale - short form(SF)-4a (A 4-point (0= Not at all to 4= All the time) rating scale is used in each of the 4 items; higher scores reflect greater pain catastrophizing Change from Baseline pain catastrophizing at 6, 12, and 24-week time points
Other Kinesiophobia Tampa Scale of Kinesiophobia (A 4-point (1= Strongly disagree to 4= Strongly agree) rating scale is used in each of the 11 items; higher values reflect higher levels of kinesiophobia Change from Baseline kinesiophobia at 6, 12, and 24-week time points
Other Patient Perception of Change Score on single item Patient Global Impression of Change Rating (range: 1 (No change) to 7 (a great deal better)) 12 weeks
Primary Feasibility of Recruitment: Number of participants eligible Number of participants eligible for randomization to the study intervention Baseline
Primary Recruitment Rate Proportion of participants randomized relative to total trial referrals Baseline
Primary Recruitment time Number of participate enrolled per month Baseline
Primary Feasibility of recruiting male participants: Proportion of male participant enrolled Proportion of male participant enrolled to the study Baseline
Primary Treatment Completion Rate We expect 80% of participants to complete at least 9/12 M-DMT sessions 12 weeks following receipt of treatment
Primary Retention Rate Proportion of participants who complete follow-up questionnaires 24 weeks
Primary 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 12 weeks following receipt of treatment
Primary M-DMT intervention credibility and expectancy Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility) 1 week
Primary 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) 1-12 weeks
Primary 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). 12 weeks post-randomization
Primary M-DMT intervention acceptability Exit interview based on an interview protocol developed by the researcher 12 weeks
Primary Adverse Event Number of adverse events 1 -12 weeks
Secondary 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. Change from Baseline pain intensity at 6, 12, and 24-week time points
Secondary 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 Change from Baseline pain interference at 6, 12, and 24-week time points
Secondary 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) Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points
Secondary 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 Change from Baseline mindfulness at 6, 12, and 24-week time points
Secondary 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) Change from Baseline physical activity at 12, and 24-week time points
Secondary 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) Change from Baseline physical activity at 6, 12, and 24-week time points
See also
  Status Clinical Trial Phase
Recruiting NCT05963451 - Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Completed NCT04283370 - A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain N/A
Completed NCT04824547 - Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals N/A
Completed NCT04046419 - In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
Completed NCT04399772 - COgNitive FuncTional Therapy+ for Chronic Low Back paIn N/A
Recruiting NCT05780021 - Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation N/A
Completed NCT04555278 - Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain N/A
Completed NCT04530071 - Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain Phase 1/Phase 2
Not yet recruiting NCT06347328 - The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain N/A
Not yet recruiting NCT06080464 - Clinician Satisfaction With the VERABAND™ N/A
Not yet recruiting NCT04940715 - Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain N/A
Recruiting NCT04683718 - A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System With HomeStream Remote Management N/A
Recruiting NCT05724160 - Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain N/A
Recruiting NCT06030128 - Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults N/A
Recruiting NCT05846087 - Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia N/A
Active, not recruiting NCT05396014 - The BEST Trial: Biomarkers for Evaluating Spine Treatments Phase 4
Active, not recruiting NCT06140862 - Ankle Spine Syndrome "RAFFET Syndrome II N/A
Completed NCT05512338 - Motivation and Adherence to Exercise Recommendations N/A
Recruiting NCT05021146 - Essential Oil for Chronic Low Back Pain N/A
Completed NCT05690178 - Deep Tissue Massage in Office Workers With Chronic Low Back Pain N/A