Crafted Communication for Biopsychosocial Care in Musculoskeletal Practice
NCT ID: NCT04482348
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
308 participants
INTERVENTIONAL
2019-08-01
2020-01-30
Brief Summary
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Detailed Description
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Outcomes measures Each patient read one of 7 randomly selected explanations for more pain than expected on a tablet. There were 2 cognitively-framed explanations ("the mind is a great story teller"; one positively- and one negatively framed), 2 emotionally-framed explanation ("stressed or down"; one positively- and one negatively framed), one mixed emotion and cognition ("mind and body work together"), and two physically based explanations ("over-excited state", "overstimulated")
Subjects completed the following questionnaires: (1) a demographic survey including the following variables: age, sex, race/ethnicity, marital status, work status, insurance status, level of education, number of i) people living in the household, ii) children living in the household, iii) adults living in the household, iv) adults who generate income; (2) the Generalized Anxiety Disorder 2-item version (GAD-2); (3) the Patient Health Questionnaire 2-item version (PHQ-2); (4) the Pain Self-Efficacy Questionnaire 2-item version (PSEQ-2); and (5) the Pain Catastrophizing Scale 4-item version (PCS-4).
Patients rated resonance with the explanation of more pain than expected on a 5-point Likert scale as follows from 1 to 5: "nope I don't buy it", "this doesn't make sense", "I'm not sure how I feel about this", "this makes sense", and "absolutely, that makes perfect sense".
Self-Assessment Manikins (SAM; a picture-oriented instrument) were used to measure 3 affective dimensions, happiness, excitement and control in response to the explanation.
The happiness dimension ranges from a smiling happy to a frowning unhappy SAM figure. The excitement dimension ranges from an excited wide-eyed to a relaxed sleepy SAM figure. The control dimension is represented with a changing size of the SAM figure and ranges from a small to a large SAM figure; the largest represents the most control in the situation.
The GAD-2 is a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of anxiety.
The PCS-4 measures less adaptive thoughts in response to nociception on a 4-item scale (0=not at all to 4=all the time). The scale contains two items on magnification, one item on rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores indicate more catastrophic thoughts.
The PSEQ-2 measures two beliefs: that one can engage in activities and enjoy life in spite of pain. The total score ranges from 0 (not at all confident) to 12 (completely confident).
The PHQ-2 is a 2-item questionnaire that measures symptoms of depression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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the mind is a great story teller-positively framed
explanations for more pain than expected
Explanation
Explanation provided to patients for more pain than expected
the mind is a great story teller-negatively framed
explanations for more pain than expected
Explanation
Explanation provided to patients for more pain than expected
emotionally-framed explanation-stressed or down-positive frame
explanations for more pain than expected
Explanation
Explanation provided to patients for more pain than expected
emotionally-framed explanation-stressed or down-negative frame
explanations for more pain than expected
Explanation
Explanation provided to patients for more pain than expected
mixed emotion and cognition ("mind and body work together")
explanations for more pain than expected
Explanation
Explanation provided to patients for more pain than expected
physically based explanations "over-excited state"
explanations for more pain than expected
Explanation
Explanation provided to patients for more pain than expected
physically based explanations "overstimulated"
explanations for more pain than expected
Explanation
Explanation provided to patients for more pain than expected
Interventions
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Explanation
Explanation provided to patients for more pain than expected
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cognitive problems which patient was not able to fill surveys
18 Years
89 Years
ALL
No
Sponsors
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University of Texas at Austin
OTHER
Responsible Party
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David Ring
Professor of surgery and perioperative care
Principal Investigators
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David Ring, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Austin
Locations
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Dell Medical School, University of Texas at Austin
Austin, Texas, United States
Countries
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References
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Gonzalez AI, Kortlever JTP, Brown LE, Ring D, Queralt M. Can Crafted Communication Strategies Allow Musculoskeletal Specialists to Address Health Within the Biopsychosocial Paradigm? Clin Orthop Relat Res. 2021 Jun 1;479(6):1217-1223. doi: 10.1097/CORR.0000000000001635.
Other Identifiers
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2019-01-0084
Identifier Type: -
Identifier Source: org_study_id
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