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Psychosocial Interventions for Young Adults With Hip Pain

Primary Purpose

Hip Dysplasia, Hip Pain Chronic, Hip Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cell Phone Based Cognitive Based Therapy (Pacifica App)
Control
Sponsored by
Michael C Willey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Dysplasia focused on measuring Hip Pain, Hip Instability, Hip Impingement, Cognitive Based Therapy, Psychosocial Conditions

Eligibility Criteria

15 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • We will enroll young adults (15-39) presenting to one of several physical therapy and orthopedic practices in the state of Iowa for treatment of nonarthritic hip pain.
  • Chief complaint of hip pain or dysfunction, and a diagnosis of a nonarthritic hip condition including labral tear, femoroacetabular impingement (FAI), snapping hip, femoral anteversion or dysplasia.

Exclusion Criteria:

  • Exclusion criteria will include age <15 or >40 years
  • Difficulty with written English
  • Treatment for alternative conditions such as trochanteric bursitis, hip dislocation, avascular necrosis or fracture.

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cell Phone Based Cognitive Based Therapy

Placebo

Arm Description

Young adults with hip pain

Young adults with hip pain

Outcomes

Primary Outcome Measures

Changes in level of Depression (DASS-21)
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire General adult population average total score: 9.43 (standard deviation (SD) 9.66), out of a total possible score of 63 points, Indication of significant difference from normative data: Average score >1 SD above the General adult population average total score General adult population average depression sub scale score: 2.83 (SD 3.87) Values above 9.03 points in the depression subsection score correlate with clinical depression and generalized anxiety disorders A change of 3.86 or more points in the depression subscore reliably represents clinical improvement.
Changes in level of Depression (PROMIS)
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Depression. An electronically administered patient reported outcome questionnaire Normative T-score generated from US adult population data: mean 50 (SD 10). For this study, an average T-score <40 would be considered significantly different compared to normative values. The minimally important difference (MID) of 3.0-3.1 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Changes in level of Anxiety (DASS-21)
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire General adult population average total score: 9.43 (SD 9.66) An average total score >1 SD above the mean would be considered significantly different from normative data General adult population average anxiety subscale scores: 1.88±2.95 Average anxiety subsection score above 6.27 correlate with clinical depression and generalized anxiety disorders A change of 3.85 or more points in the anxiety subscore reliably represents clinical improvement.
Changes in level of Anxiety (PROMIS)
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Anxiety. An electronically administered patient reported outcome questionnaire Normative T-score generated from US adult population data: mean 50 (SD 10). For this study, an average T-score <40 would be considered significantly different compared to normative values. The minimally important difference (MID) of 2.3 to 3.4 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Changes in level of Stress (DAAS-21)
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire General adult population average total score: 9.43 (SD 9.66) An average total score >1 SD above the mean would be considered significantly different from normative data General adult population average stress subscale scores: 4.73±4.20 Average stress subsection score above 12.27 correlate with clinical depression and generalized anxiety disorders A change of 4.90 or more points in the anxiety subscore reliably represents clinical improvement.
Evaluating the presence and severity of Kinesiophobia
Assessed via the Shortened Tampa Scale for Kinesiophobia (TSK-11) electronically administered patient reported outcome questionnaire The survey is a 11-question test scored from 11-44, where higher scores indicate increasing fear of movement. A value of 11 is presumed in a nonpainful population. Adults with chronic musculoskeletal pain undergoing outpatient chronic pain therapy report an average TSK score of 30.4 (+/- 6.6). Successful evaluation of Kinesiophobia will be indicated if increases in TSK-11 scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Evaluation of Resiliency
Assessed via The Brief Resiliency Scale (BRS) electronically administered patient reported outcome questionnaire An 8 question survey scored from 1-5 points The average score for US adults age 24-34 is 3.2 (SD 0.7) A statistically significant lower Grit score would be >1SD below this average value. Successful evaluation of Grit will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Evaluation of Grit
Assessed via The Short Grit Scale (GRIT-S) electronically administered patient reported outcome questionnaire A 6-question test with low resiliency defined as a score of <3.00. Prior descriptive studies indicate an average score of 3.57 (SD 0.76) for young adults age 19.8±3.0 years. Statistically significant lower resilience would be >1SD below this average value. Successful evaluation of Resiliency will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents (for those tests where this data exists) would also be considered a successful finding.
Evaluating the presence and severity of Pain Catastrophizing
Assessed via Pain Catastrophizing Scale (PCS) electronically administered patient reported outcome questionnaire Scored on a 13 point scale. Normative average values from a population of adults adults age 42.2 (17-63 years) with low back pain: mean 20.90 (SD 12.5), Successful evaluation of Pain Catastrophization will be indicated if increases in PCS scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Evaluating Self-Efficacy
Assessed via The General Self-Efficacy Scale (GSE) electronically administered patient reported outcome questionnaire 10-question test, scored from 10-40, with lower scores representing low self efficacy. Average US adult values: 29.48 (SD 5.13) Successful evaluation of Self-Efficacy will be indicated if increases in GSE scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Evaluating the presence and severity of Alcohol Use Disorders
Assessed via Alcohol Use Disorders Identification Test (AUDIT) electronically administered patient reported outcome questionnaire A 10-question test with a threshold score >7 considered "AUDIT-positive", indicating risky or hazardous alcohol use behavior. National data suggests 15-20% of US 14-18 year olds screen positive Successful evaluation of Alcohol Use Disorders will be indicated if increases in AUDIT scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Changes in Physical Function (PROMIS)
Measured via the following electronically administered patient reported outcome questionnaires. PROMIS: Physical Function (PF) Normative T-score generated from US adult population data: mean 50 (SD 10). For this study, an average T-score <40 would be considered significantly different compared to normative values. The minimally important difference (MID) of 1.9 - 2.2 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Changes in Physical Function (HOOS)
Measured via the following electronically administered patient reported outcome questionnaires. The Hip disability and osteoarthritis outcome score (HOOS) Scored from 0-100 Increasing score represent better function. Average scopres for hip preservation patients prior to surgery is well established
Reduced Opioid Use
Measured via self reported opioid use after surgery

Secondary Outcome Measures

Full Information

First Posted
May 16, 2019
Last Updated
September 18, 2023
Sponsor
Michael C Willey
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1. Study Identification

Unique Protocol Identification Number
NCT04039386
Brief Title
Psychosocial Interventions for Young Adults With Hip Pain
Official Title
Psychosocial Interventions for Young Adults With Hip Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2024 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael C Willey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Psychosocial conditions are common in young adults with hip pain including depression, anxiety, pain catastrophizing, and narcotic use. The incidence of these conditions is not well defined. Interventions to optimize psychosocial conditions with non-surgical or surgical treatments has not been investigated. The goal of this project is to determine the incidence of psychosocial conditions in the young adult population with hip pain and determine if cognitive based therapy can improve clinical outcomes in these individuals.
Detailed Description
Over the last 3 decades there has been a drastic increase in the number of joint preservation surgeries performed for pre-arthritic hip conditions in the United States. Despite advances in surgical technique and the understanding of the biomechanics of impingement and dysplasia, failure rates range from 5-20% at early follow up, and can be even higher with continued monitoring. These failures are often attributed to the presence of pre-operative osteoarthritis, increased age, or unaddressed structural deformity. The influence of psychosocial factors on surgical and rehabilitative outcomes has been recognized in multiple populations, but has largely been ignored in individuals with hip pathology, in spite of growing recognition by clinicians as to how psychosocial factors may contribute to patient outcomes. Previous investigations have demonstrated poor mental health is associated with pre-operative narcotic use and lower physical function. Further, the investigators have identified certain psychiatric diagnoses as independent factors associated with failure of hip arthroscopy. Addressing these often complex psychosocial issues using cognitive based therapy has been successful in improving outcomes across a range of medical conditions. Further investigation into the incidence of these psychosocial conditions, their contributions to surgical and non-surgical outcomes, and interventions for mental health optimization need to be performed in musculoskeletal medicine, specifically in the developing field of hip preservation surgery. The goal of this project is to (1) understand the burden of maladaptive psychosocial traits in young adult patients with hip pain, and (2) reduce pain, decrease narcotic use, and improve physical function through psychosocial intervention delivered concomitantly during physical therapy. The investigators seek to maximize outcomes of individuals with non-arthritic hip dysfunction by addressing maladaptive behaviors so subjects can more effectively participate in rehabilitative treatment, and potentially, avoid the need for surgical management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dysplasia, Hip Pain Chronic, Hip Osteoarthritis, Hip Arthritis, Psychosocial Problem
Keywords
Hip Pain, Hip Instability, Hip Impingement, Cognitive Based Therapy, Psychosocial Conditions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cell Phone Based Cognitive Based Therapy
Arm Type
Experimental
Arm Description
Young adults with hip pain
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Young adults with hip pain
Intervention Type
Device
Intervention Name(s)
Cell Phone Based Cognitive Based Therapy (Pacifica App)
Intervention Description
Cell phone application that provides support for individuals with psychosocial conditions.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Standard Care
Intervention Description
Subjects in the control group will receive standard care.
Primary Outcome Measure Information:
Title
Changes in level of Depression (DASS-21)
Description
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire General adult population average total score: 9.43 (standard deviation (SD) 9.66), out of a total possible score of 63 points, Indication of significant difference from normative data: Average score >1 SD above the General adult population average total score General adult population average depression sub scale score: 2.83 (SD 3.87) Values above 9.03 points in the depression subsection score correlate with clinical depression and generalized anxiety disorders A change of 3.86 or more points in the depression subscore reliably represents clinical improvement.
Time Frame
8 weeks
Title
Changes in level of Depression (PROMIS)
Description
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Depression. An electronically administered patient reported outcome questionnaire Normative T-score generated from US adult population data: mean 50 (SD 10). For this study, an average T-score <40 would be considered significantly different compared to normative values. The minimally important difference (MID) of 3.0-3.1 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Time Frame
8 weeks
Title
Changes in level of Anxiety (DASS-21)
Description
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire General adult population average total score: 9.43 (SD 9.66) An average total score >1 SD above the mean would be considered significantly different from normative data General adult population average anxiety subscale scores: 1.88±2.95 Average anxiety subsection score above 6.27 correlate with clinical depression and generalized anxiety disorders A change of 3.85 or more points in the anxiety subscore reliably represents clinical improvement.
Time Frame
8 weeks
Title
Changes in level of Anxiety (PROMIS)
Description
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Anxiety. An electronically administered patient reported outcome questionnaire Normative T-score generated from US adult population data: mean 50 (SD 10). For this study, an average T-score <40 would be considered significantly different compared to normative values. The minimally important difference (MID) of 2.3 to 3.4 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Time Frame
8 weeks
Title
Changes in level of Stress (DAAS-21)
Description
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire General adult population average total score: 9.43 (SD 9.66) An average total score >1 SD above the mean would be considered significantly different from normative data General adult population average stress subscale scores: 4.73±4.20 Average stress subsection score above 12.27 correlate with clinical depression and generalized anxiety disorders A change of 4.90 or more points in the anxiety subscore reliably represents clinical improvement.
Time Frame
8 Weeks
Title
Evaluating the presence and severity of Kinesiophobia
Description
Assessed via the Shortened Tampa Scale for Kinesiophobia (TSK-11) electronically administered patient reported outcome questionnaire The survey is a 11-question test scored from 11-44, where higher scores indicate increasing fear of movement. A value of 11 is presumed in a nonpainful population. Adults with chronic musculoskeletal pain undergoing outpatient chronic pain therapy report an average TSK score of 30.4 (+/- 6.6). Successful evaluation of Kinesiophobia will be indicated if increases in TSK-11 scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Time Frame
8 weeks
Title
Evaluation of Resiliency
Description
Assessed via The Brief Resiliency Scale (BRS) electronically administered patient reported outcome questionnaire An 8 question survey scored from 1-5 points The average score for US adults age 24-34 is 3.2 (SD 0.7) A statistically significant lower Grit score would be >1SD below this average value. Successful evaluation of Grit will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Time Frame
8 weeks
Title
Evaluation of Grit
Description
Assessed via The Short Grit Scale (GRIT-S) electronically administered patient reported outcome questionnaire A 6-question test with low resiliency defined as a score of <3.00. Prior descriptive studies indicate an average score of 3.57 (SD 0.76) for young adults age 19.8±3.0 years. Statistically significant lower resilience would be >1SD below this average value. Successful evaluation of Resiliency will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents (for those tests where this data exists) would also be considered a successful finding.
Time Frame
8 weeks
Title
Evaluating the presence and severity of Pain Catastrophizing
Description
Assessed via Pain Catastrophizing Scale (PCS) electronically administered patient reported outcome questionnaire Scored on a 13 point scale. Normative average values from a population of adults adults age 42.2 (17-63 years) with low back pain: mean 20.90 (SD 12.5), Successful evaluation of Pain Catastrophization will be indicated if increases in PCS scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Time Frame
8 weeks
Title
Evaluating Self-Efficacy
Description
Assessed via The General Self-Efficacy Scale (GSE) electronically administered patient reported outcome questionnaire 10-question test, scored from 10-40, with lower scores representing low self efficacy. Average US adult values: 29.48 (SD 5.13) Successful evaluation of Self-Efficacy will be indicated if increases in GSE scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Time Frame
8 weeks
Title
Evaluating the presence and severity of Alcohol Use Disorders
Description
Assessed via Alcohol Use Disorders Identification Test (AUDIT) electronically administered patient reported outcome questionnaire A 10-question test with a threshold score >7 considered "AUDIT-positive", indicating risky or hazardous alcohol use behavior. National data suggests 15-20% of US 14-18 year olds screen positive Successful evaluation of Alcohol Use Disorders will be indicated if increases in AUDIT scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Time Frame
8 weeks
Title
Changes in Physical Function (PROMIS)
Description
Measured via the following electronically administered patient reported outcome questionnaires. PROMIS: Physical Function (PF) Normative T-score generated from US adult population data: mean 50 (SD 10). For this study, an average T-score <40 would be considered significantly different compared to normative values. The minimally important difference (MID) of 1.9 - 2.2 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Time Frame
8 weeks
Title
Changes in Physical Function (HOOS)
Description
Measured via the following electronically administered patient reported outcome questionnaires. The Hip disability and osteoarthritis outcome score (HOOS) Scored from 0-100 Increasing score represent better function. Average scopres for hip preservation patients prior to surgery is well established
Time Frame
8 weeks
Title
Reduced Opioid Use
Description
Measured via self reported opioid use after surgery
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: We will enroll young adults (15-39) presenting to one of several physical therapy and orthopedic practices in the state of Iowa for treatment of nonarthritic hip pain. Chief complaint of hip pain or dysfunction, and a diagnosis of a nonarthritic hip condition including labral tear, femoroacetabular impingement (FAI), snapping hip, femoral anteversion or dysplasia. Exclusion Criteria: Exclusion criteria will include age <15 or >40 years Difficulty with written English Treatment for alternative conditions such as trochanteric bursitis, hip dislocation, avascular necrosis or fracture.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael C Willey
Phone
3193561616
Email
michael-willey@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Davison, MPH
Phone
3193846529
Email
john-davison@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Scott, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael C Willey, MD
Phone
319-356-1616
Ext
3193561616
Email
michael-willey@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Michael C Willey
Phone
3193561616
Ext
3193561616
Email
michael-willey@uiowa.edu
First Name & Middle Initial & Last Name & Degree
John Davison, MPH
First Name & Middle Initial & Last Name & Degree
Elizabeth Scott, MD
First Name & Middle Initial & Last Name & Degree
Robert Westermann, MD
First Name & Middle Initial & Last Name & Degree
Michael Willey, MD
First Name & Middle Initial & Last Name & Degree
Jason Wilken, DPT, PhD
First Name & Middle Initial & Last Name & Degree
Amanda Paulsen, DPT

12. IPD Sharing Statement

Plan to Share IPD
No

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Psychosocial Interventions for Young Adults With Hip Pain

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