Crafted Communication for Biopsychosocial Care in Musculoskeletal Practice

Can Crafted Communication Strategies Allow Musculoskeletal Specialists to Address Health Within the Biopsychosocial Paradigm?

New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations. Reactions were measured as resonance (Likert scale) and Self-Assessment Manikins (SAM) for happiness, excitement, and control. Patients also completed demographic and mental and emotional health surveys. Overall 304 patients were included (mean age 49 -17, range 18 to 87; 51% men). Multilevel multivariable linear regression models were constructed to assess factors associated with resonance, happiness, excitement, and control.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness 1
• Intervention / Treatment: Other: Explanation

Detailed Description

Study design the investigators obtained institutional review board approval and prospectively enrolled 308 patients in this cross-sectional study over a 4-month period. All patients were seen at one of four participating orthopaedic offices in a large urban area. the investigators included all new or return orthopaedic patients aged 18 to 89 years old. After the visit with the surgeon, a research assistant not involved in patient care explained the study to the patient and asked them to participate. the investigators obtained a waiver for written consent; completing the questionnaires represented consent.

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.

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78701
      • Dell Medical School, University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• all new or return orthopaedic patients aged 18 to 89 years old

Exclusion Criteria:

• Illiteracy
• Cognitive problems which patient was not able to fill surveys

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the mind is a great story teller-positively framed; explanations for more pain than expected	Other: Explanation; Explanation provided to patients for more pain than expected
Active Comparator: the mind is a great story teller-negatively framed; explanations for more pain than expected	Other: Explanation; Explanation provided to patients for more pain than expected
Active Comparator: emotionally-framed explanation-stressed or down-positive frame; explanations for more pain than expected	Other: Explanation; Explanation provided to patients for more pain than expected
Active Comparator: emotionally-framed explanation-stressed or down-negative frame; explanations for more pain than expected	Other: Explanation; Explanation provided to patients for more pain than expected
Active Comparator: mixed emotion and cognition ("mind and body work together"); explanations for more pain than expected	Other: Explanation; Explanation provided to patients for more pain than expected
Active Comparator: physically based explanations "over-excited state"; explanations for more pain than expected	Other: Explanation; Explanation provided to patients for more pain than expected
Active Comparator: physically based explanations "overstimulated"; explanations for more pain than expected	Other: Explanation; Explanation provided to patients for more pain than expected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
resonance with the explanation of more pain than expected	Patients rated resonance with the explanation of more pain than expected on a 5-point Likert scale from 1 to 5, as follows: "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." Likert scales are valid for measuring variation in opinion. This specific Likert scale is new and specific to this study, and so no minimum clinically important difference has been defined. Given how the scale is anchored, a difference of about 1 point seems relevant.	up to 24 weeks
Self-Assessment Manikins(SAM)	Self-assessment manikins (SAMs), a picture-oriented instrument, were used to measure three affective dimensions of happiness, stimulation/excitement, and security/control in response to the explanations. The happiness dimension ranges from a smiling, happy SAM figure to a frowning, unhappy figure. The excitement dimension ranges from an excited, wide-eyed SAM figure to a relaxed, sleepy figure. The control dimension is represented by an SAM figure that changes in size and ranges from a small SAM figure to a large one; the largest figure represents the greatest feeling of security and control. With respect to written explanations of the mind-body connection, we favored greater feelings of happiness and control and relatively neutral feelings of excitement.	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
demographic survey	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	up to 24 weeks
GAD-2	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	up to 24 weeks
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	up to 24 weeks
PHQ-2	a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of depression in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of depression	up to 24 weeks
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).	up to 24 weeks

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: David Ring, MD, PhD, University of Texas at Austin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: emotional health; cognitive health; social health
• Other Study ID Numbers: 2019-01-0084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No