Clinical trial NCT04039386: Psychosocial Interventions for Young Adults With Hip Pain
Official title: Psychosocial Interventions for Young Adults With Hip Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Dysplasia
Hip Pain Chronic
Hip Osteoarthritis
Hip Arthritis
Psychosocial Problem
Keywords: Hip Pain
Hip Instability
Hip Impingement
Cognitive Based Therapy
Psychosocial Conditions
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Changes in level of Depression (DASS-21)
timeFrame: 8 weeks
measure: Changes in level of Depression (PROMIS)
timeFrame: 8 weeks
measure: Changes in level of Anxiety (DASS-21)
timeFrame: 8 weeks
measure: Changes in level of Anxiety (PROMIS)
timeFrame: 8 weeks
measure: Changes in level of Stress (DAAS-21)
timeFrame: 8 Weeks
measure: Evaluating the presence and severity of Kinesiophobia
timeFrame: 8 weeks
measure: Evaluation of Resiliency
timeFrame: 8 weeks
measure: Evaluation of Grit
timeFrame: 8 weeks
measure: Evaluating the presence and severity of Pain Catastrophizing
timeFrame: 8 weeks
measure: Evaluating Self-Efficacy
timeFrame: 8 weeks
measure: Evaluating the presence and severity of Alcohol Use Disorders
timeFrame: 8 weeks
measure: Changes in Physical Function (PROMIS)
timeFrame: 8 weeks
measure: Changes in Physical Function (HOOS)
timeFrame: 8 weeks
measure: Reduced Opioid Use
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Elizabeth Scott, MD
role: PRINCIPAL_INVESTIGATOR
References: