- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04039386
Psychosocial Interventions for Young Adults With Hip Pain
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael C Willey
- Phone Number: 3193561616
- Email: michael-willey@uiowa.edu
Study Contact Backup
- Name: John Davison, MPH
- Phone Number: 3193846529
- Email: john-davison@uiowa.edu
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa
-
Contact:
- Michael C Willey, MD
- Phone Number: 3193561616 319-356-1616
- Email: michael-willey@uiowa.edu
-
Contact:
- Michael C Willey
- Phone Number: 3193561616 3193561616
- Email: michael-willey@uiowa.edu
-
Sub-Investigator:
- John Davison, MPH
-
Principal Investigator:
- Elizabeth Scott, MD
-
Sub-Investigator:
- Robert Westermann, MD
-
Sub-Investigator:
- Jason Wilken, DPT, PhD
-
Sub-Investigator:
- Amanda Paulsen, DPT
-
Sub-Investigator:
- Michael Willey, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cell Phone Based Cognitive Based Therapy
Young adults with hip pain
|
Cell phone application that provides support for individuals with psychosocial conditions.
|
Placebo Comparator: Placebo
Young adults with hip pain
|
Subjects in the control group will receive standard care.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in level of Depression (DASS-21)
Time Frame: 8 weeks
|
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire
|
8 weeks
|
Changes in level of Depression (PROMIS)
Time Frame: 8 weeks
|
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Depression. An electronically administered patient reported outcome questionnaire
|
8 weeks
|
Changes in level of Anxiety (DASS-21)
Time Frame: 8 weeks
|
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire
|
8 weeks
|
Changes in level of Anxiety (PROMIS)
Time Frame: 8 weeks
|
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Anxiety. An electronically administered patient reported outcome questionnaire
|
8 weeks
|
Changes in level of Stress (DAAS-21)
Time Frame: 8 Weeks
|
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire
|
8 Weeks
|
Evaluating the presence and severity of Kinesiophobia
Time Frame: 8 weeks
|
Assessed via the Shortened Tampa Scale for Kinesiophobia (TSK-11) electronically administered patient reported outcome questionnaire
|
8 weeks
|
Evaluation of Resiliency
Time Frame: 8 weeks
|
Assessed via The Brief Resiliency Scale (BRS) electronically administered patient reported outcome questionnaire
|
8 weeks
|
Evaluation of Grit
Time Frame: 8 weeks
|
Assessed via The Short Grit Scale (GRIT-S) electronically administered patient reported outcome questionnaire
|
8 weeks
|
Evaluating the presence and severity of Pain Catastrophizing
Time Frame: 8 weeks
|
Assessed via Pain Catastrophizing Scale (PCS) electronically administered patient reported outcome questionnaire
|
8 weeks
|
Evaluating Self-Efficacy
Time Frame: 8 weeks
|
Assessed via The General Self-Efficacy Scale (GSE) electronically administered patient reported outcome questionnaire
|
8 weeks
|
Evaluating the presence and severity of Alcohol Use Disorders
Time Frame: 8 weeks
|
Assessed via Alcohol Use Disorders Identification Test (AUDIT) electronically administered patient reported outcome questionnaire
|
8 weeks
|
Changes in Physical Function (PROMIS)
Time Frame: 8 weeks
|
Measured via the following electronically administered patient reported outcome questionnaires.
|
8 weeks
|
Changes in Physical Function (HOOS)
Time Frame: 8 weeks
|
Measured via the following electronically administered patient reported outcome questionnaires.
|
8 weeks
|
Reduced Opioid Use
Time Frame: 8 weeks
|
Measured via self reported opioid use after surgery
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Scott, MD, University of Iowa
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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