Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03391661
Other study ID # HUM00121358
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2017
Est. completion date February 28, 2019

Study information

Verified date July 2019
Source Wayne State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to determine if a brief educational program can alter the attitudes and knowledge of individuals with chronic back pain, which is likely to be non-structural in nature.

Individuals will be randomly assigned to an experimental condition (performs written educational and emotional awareness exercises) or a control condition (completes a general health activities questionnaire). Comparisons will be made to assess the degree of centralized pain features and functional improvements at 1-month follow-up. A 10-month follow-up as a secondary endpoint is also planned.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date February 28, 2019
Est. primary completion date May 17, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- English-speaking adults ages 18 years or older with internet access who are referred to the University of Michigan Health Service Physical Medicine and Rehabilitation Spine Program identified the physician with chronic nonspecific back pain (longer than 3 months) or fibromyalgia. Degenerative changes seen on imaging are considered nonspecific. Alternatively, enrolled in the University of Michigan Health Research Volunteer Pool with a profile that includes chronic low back pain or fibromyalgia.

Exclusion Criteria:

- Any signs of a serious underlying condition (cancer, infection, cauda equine), spinal stenosis or radiculopathy, or other specific spinal cause (vertebral compression fracture or ankylosing spondylitis). Those patients who are being considered for an interventional spine procedures or surgical consults would not be included in this study.

- Individuals receiving or applying for compensation or disability, the inability to provide written informed consent, severe physical impairment (e.g. blindness, deafness), co-morbid medical condition limiting function (e.g. malignant cancer), the use of illicit drug use, or a psychiatric condition that would limit judgment.

Study Design


Intervention

Behavioral:
Pain neuroscience education patient exercise
Patients complete a 15 to 20-minute on-line exercise that inquires about 5 domains: the degree of central sensitization symptoms, catastrophizing and kinesiophobia, personality factors, stressors that triggered or exacerbated the pain, and adverse childhood experiences.
Health behavior control intervention
Patients engage in a 15 to 20-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections.

Locations

Country Name City State
United States University of Michigan Physical Medicine and Rehabilitation Department Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
Wayne State University University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Pain Inventory Self-reported pain and dysfunction Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary Patient-Reported Outcomes Measurement Information System: Depression short form 8b Self-reported depression Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a Self-reported anxiety Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary Patient-Reported Outcomes Measurement Information System: Anger short form 5a Self-reported anger Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary Pain attributions questionnaires Two self-report questionnaires were developed to assess psychological and brain influences on pain. The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based. Mean scores will be computed for both scales separately (0-4; higher scores indicating greater belief that pain is a brain-related [brain attribution] construct and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution]) Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary Pain Stages of Change Questionnaire The Pain Stages of Change questionnaire (Kerns, Rosenberg, Jamison, Caudill, & Haythornthwaite, 1997): an overall readiness score will be calculated using mean scores of the four subscales. Readiness is the sum of patient mean ratings for contemplation (C; 1-5), action (A; 1-5), and maintenance (M; 1-5), minus the mean score for precontemplation (PC; 1-5): C + A + M - PC = Readiness. Higher scores indicate greater readiness. Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary Pain Catastrophizing Scale Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing) Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary Tampa Scale for Kinesiophobia The Tampa Kinesiophobia Scale (Miller, Kori, &Todd, 1991): A mean score of the 11 items will be computed (1-4, higher scores indicating greater kinesiophobia) Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary Satisfaction with Life Scale The Satisfaction with Life Scale (Emmons, Larsen, & Griffin, 1985): A mean score of the 5 items will be computed (1-7, higher scores indicating greater life satisfaction) Change from baseline to 1-month follow-up (with secondary 10-month follow-up)
See also
  Status Clinical Trial Phase
Completed NCT03593772 - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD N/A
Completed NCT05020470 - Pilot Testing A Theory-Driven Self-Management Intervention for Chronic Musculoskeletal Pain N/A
Completed NCT00861302 - Evaluating a Chronic Pain Treatment Program Phase 1
Recruiting NCT03863847 - A Neurofeedback Treatment for Chronic Musculoskeletal Pain N/A
Recruiting NCT06004804 - Group-Based Psychological Treatments Over Video Conference for Older Veterans With Chronic Pain N/A
Active, not recruiting NCT03283163 - Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD N/A
Completed NCT03890081 - Reliability and Validity of the Turkish Version of the Coping Strategies Questionnaire
Completed NCT04466605 - Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown N/A
Recruiting NCT04994249 - Diagnostic and Prognostic Biomarkers for High-impact Chronic Pain: Development and Validation
Completed NCT05097521 - Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health
Recruiting NCT05925192 - Profile of Chronic Musculoskeletal Pain Patients Related to Treatment Adherence and Virtual Reality
Terminated NCT04166136 - Efficacy of the Transition of the Foot Strike Pattern on Pain and Disability in Cadets With Musculoskeletal Pain N/A
Completed NCT03927846 - Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management N/A
Active, not recruiting NCT04291131 - BRAIN, Symptoms, and Physical Activity in COPD
Recruiting NCT05701982 - The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain N/A
Recruiting NCT05707559 - Knowledge Beliefs and Expectations of Chronic Musculoskeletal Patients About Their Physiotherapy Program
Completed NCT05709366 - Knowledge, Beliefs and Attitudes of Greek Physiotherapist About Pain Neuroscience Education
Not yet recruiting NCT05201365 - A Prospective Cohort Study of Compound Nanxing Zhitong Ointment
Recruiting NCT06175884 - Effectiveness of Physiotherapist's Communication Skills on Clinical Outcomes in Chronic Musculoskeletal Patients N/A
Active, not recruiting NCT06138314 - A Pilot Study of a Neural Mobilization Intervention Applied to Older Adults With Chronic Musculoskeletal Pain N/A