Fulfillment of Expectations for Patients With FAI Syndrome
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/11/2017 |
| Start Date: | November 7, 2017 |
| End Date: | September 2020 |
| Contact: | Michael Reiman, DPT |
| Email: | michael.reiman@duke.edu |
| Phone: | 919-668-3014 |
The Mediating Effect of Baseline Expectations of Conservative Care and Surgery Outcomes on Fulfillment of Expectations for Patients With Femoroacetabular Impingement Syndrome
A total of 63 participants will be recruited through 3 local surgeons in Durham, North
Carolina after distinctive differential diagnostic methods, all with extensive expertise in
intra-articular hip pathology and arthroscopy. The surgeons will offer the opportunity to
participate in the trial by providing information to the recipient. Potential participants
that do not contact project team members will be contacted by phone if they do not respond to
the initial invitation. Potential participants will be initially screened by telephone
interview, followed by a clinical examination to confirm study eligibility. The blinded
researchers will obtain informed consent and will perform outcome assessments
Purpose of the Study: 1) measure the mediating effect of baseline patient expectations on
fulfillment of expectations (for both conservative care and surgery, measured at 6 weeks and
at 1 year respectively) in a cohort of patients with a diagnosis of FAI Syndrome who receive
six weeks of conservative physical therapy intervention and 2) measure the effect of baseline
expectations on patient reported outcomes (e.g., HAGOS, pain, global rating of change) at six
weeks.
Carolina after distinctive differential diagnostic methods, all with extensive expertise in
intra-articular hip pathology and arthroscopy. The surgeons will offer the opportunity to
participate in the trial by providing information to the recipient. Potential participants
that do not contact project team members will be contacted by phone if they do not respond to
the initial invitation. Potential participants will be initially screened by telephone
interview, followed by a clinical examination to confirm study eligibility. The blinded
researchers will obtain informed consent and will perform outcome assessments
Purpose of the Study: 1) measure the mediating effect of baseline patient expectations on
fulfillment of expectations (for both conservative care and surgery, measured at 6 weeks and
at 1 year respectively) in a cohort of patients with a diagnosis of FAI Syndrome who receive
six weeks of conservative physical therapy intervention and 2) measure the effect of baseline
expectations on patient reported outcomes (e.g., HAGOS, pain, global rating of change) at six
weeks.
FAI Syndrome is a morphological hip condition that can cause hip/groin pain and impaired
performance.1 FAI Syndrome is caused by abnormal morphology of the femoral head (referred to
as cam FAI Syndrome), excessive acetabular coverage of the femoral head (referred to as
pincer FAI Syndrome) or a combination of the two (mixed FAI Syndrome).2 Not only can FAI
Syndrome give rise to symptoms and impair function, the repetitive bony contact can also lead
to a cascade of structural damage including tearing at the chondrolabral junction, full
thickness cartilage delamination, and potentially hip osteoarthritis.
Presently, there is uncertainty involving the best treatment approach for symptomatic FAI
Syndrome.2 The principal two management options are 1) physical therapy management of
impairments and function and/or 2) surgery. Although presently, both modalities have been
shown to improve symptoms in the short term,2 surgery is by far the most commonly
incorporated approach.1, The incidence of the surgery has notably increased in recent years.
There has been an 18-fold increase in surgical procedures for FAI Syndrome between 1999 and
2009, varying by geographic region in the USA.3
As an elective procedure, surgery for correction of FAI Syndrome is likely influenced by
patients' perspectives and expectations of outcome.4 The extent to which these expectations
influence specific treatment choices, as well as subsequent outcomes is currently unclear,
although recent findings suggest that across various pathologies both patients5 and
clinicians6 rarely have accurate expectations of treatment benefits or harms.
Non-operative, conservative treatments may have a role in managing FAI Syndrome to alleviate
symptoms, potentially resulting in postponement or avoidance of surgery. Bony morphological
changes can be present without symptoms, and nearly all participants with symptomatic FAI
Syndrome undergo a variable asymptomatic period in the presence of structural FAI Syndrome.
Recent studies have been hampered by retrospective and case cohort design, very small sample
sizes, short-term follow up, and self-report measures only.4 A recent systematic review
stated "although the available literature with experimental data is limited, there is a
suggestion that physical therapy and activity modification confer some benefit to patients.
Non-operative treatment regimens, particularly physical therapy, need to be evaluated more
extensively and rigorously".6 Further, it is well known that patient expectations can mediate
outcomes. Those who have high expectations about the potential benefit of the conservative
approach are more likely to experience improvements. Conversely, those who have low
expectations are more likely to fail to see improvement.
4. Design & Procedures: Reporting of the study will conform to STROBE guidelines for
observational studies. The proposed study is a prospective case series:
1) Patients will receive:
1. A prescription of progressive rehabilitation exercises designed to strengthen weakened
muscle groups and stretch joint movements that demonstrate range of motion limitations.
Treatment is based on clinical presentation and identification of impairments by the
treating clinician.
2. Education on progression of exercise based on scientific exercise progression principle.
Participants will be seen for 3 visits over 6 weeks (with weekly contact with the
patient via email or phone call) and a final visit 1 year post-surgery for those
electing to undergo surgery.
performance.1 FAI Syndrome is caused by abnormal morphology of the femoral head (referred to
as cam FAI Syndrome), excessive acetabular coverage of the femoral head (referred to as
pincer FAI Syndrome) or a combination of the two (mixed FAI Syndrome).2 Not only can FAI
Syndrome give rise to symptoms and impair function, the repetitive bony contact can also lead
to a cascade of structural damage including tearing at the chondrolabral junction, full
thickness cartilage delamination, and potentially hip osteoarthritis.
Presently, there is uncertainty involving the best treatment approach for symptomatic FAI
Syndrome.2 The principal two management options are 1) physical therapy management of
impairments and function and/or 2) surgery. Although presently, both modalities have been
shown to improve symptoms in the short term,2 surgery is by far the most commonly
incorporated approach.1, The incidence of the surgery has notably increased in recent years.
There has been an 18-fold increase in surgical procedures for FAI Syndrome between 1999 and
2009, varying by geographic region in the USA.3
As an elective procedure, surgery for correction of FAI Syndrome is likely influenced by
patients' perspectives and expectations of outcome.4 The extent to which these expectations
influence specific treatment choices, as well as subsequent outcomes is currently unclear,
although recent findings suggest that across various pathologies both patients5 and
clinicians6 rarely have accurate expectations of treatment benefits or harms.
Non-operative, conservative treatments may have a role in managing FAI Syndrome to alleviate
symptoms, potentially resulting in postponement or avoidance of surgery. Bony morphological
changes can be present without symptoms, and nearly all participants with symptomatic FAI
Syndrome undergo a variable asymptomatic period in the presence of structural FAI Syndrome.
Recent studies have been hampered by retrospective and case cohort design, very small sample
sizes, short-term follow up, and self-report measures only.4 A recent systematic review
stated "although the available literature with experimental data is limited, there is a
suggestion that physical therapy and activity modification confer some benefit to patients.
Non-operative treatment regimens, particularly physical therapy, need to be evaluated more
extensively and rigorously".6 Further, it is well known that patient expectations can mediate
outcomes. Those who have high expectations about the potential benefit of the conservative
approach are more likely to experience improvements. Conversely, those who have low
expectations are more likely to fail to see improvement.
4. Design & Procedures: Reporting of the study will conform to STROBE guidelines for
observational studies. The proposed study is a prospective case series:
1) Patients will receive:
1. A prescription of progressive rehabilitation exercises designed to strengthen weakened
muscle groups and stretch joint movements that demonstrate range of motion limitations.
Treatment is based on clinical presentation and identification of impairments by the
treating clinician.
2. Education on progression of exercise based on scientific exercise progression principle.
Participants will be seen for 3 visits over 6 weeks (with weekly contact with the
patient via email or phone call) and a final visit 1 year post-surgery for those
electing to undergo surgery.
Inclusion Criteria:
- Individuals age 18 to 60 years,
- diagnosed with FAI by an orthopedic surgeon and exhibiting
- hip/groin symptoms for at least 3 months (symptomatic); and
- signs, symptoms and imaging findings conducive to FAI will be recruited from a
surgical practice of an orthopedic surgeon in Durham, North Carolina.
Exclusion Criteria:
- subjects that have radiographic evidence of hip osteoarthritis that is more than mild
in severity defined as Tonnis >grade 1 or Kellgren-Lawrence >2;
- have other concurrent injury/conditions that will affect their ability to participate
in the rehabilitation program and/or assessment procedures;
- exhibit hip dysplasia (center edge angle <20 degrees on AP radiograph
- are unable to attend a study physiotherapist or participate in the rehabilitation
program if randomized to the PT group;
- are unable to understand English.
We found this trial at
3
sites
4709 Creekstone Drive
Durham, North Carolina 27703
Durham, North Carolina 27703
Phone: 919-668-3014
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