NCT02706756

Brief Summary

  1. 1.Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups.
  2. 2.Interventions will be provided based on randomized assignment. Group 1 will receive treatment based on identified impairments and treated twice weekly to address said impairments with hip manual therapy and exercise, as well as a prescriptive exercise for strengthening and mobility of the hip. Group 2 will receive only the prescriptive exercise program. Group 3 will be a control group (supervised neglect)
  3. 3.Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for assessment of the primary outcome measure of the HAGOS. Secondary analyses will include chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and expectations measures), or other appropriate comparative measures. None of the proposed treatment is considered outside of 'standard of practice'.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

March 8, 2016

Last Update Submit

February 3, 2017

Conditions

Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (1)

  • Did subject elect to undergo surgery?

    Determination of whether the subject had surgery for femoroacetabular impingement or not

    up to 6 months after intervention

Secondary Outcomes (9)

  • Change in Stanford Expectations of Treatment Scale (SETS)

    initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit

  • Change in Patient Acceptable Symptom State (PASS)

    initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit

  • Change in numeric pain rating scale

    initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit

  • Change in Hip and Groin Outcome Score

    initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit

  • Change in Single leg stance (SLS)

    initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit

  • +4 more secondary outcomes

Study Arms (3)

Education, exercise and manual therapy

EXPERIMENTAL

One group will receive education and advice, manual therapy that is applied toward the impairments of the subject, 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. Subjects will be seen twice weekly for 4 to 6 weeks, depending on the progression. All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study.

Other: Manual therapyOther: Education and advice

Education and exercise

ACTIVE COMPARATOR

Group will receive a prescriptive intervention designed to strengthen the hip and surrounding regions as well as improve flexibility of the lower extremity. This group will not receive additional physiotherapy management but will be schedule bi-weekly to review the home exercises and to receive appropriate educational support. All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study.

Other: ExerciseOther: Education and advice

Supervised neglect

PLACEBO COMPARATOR

Group will receive supervised neglect. We will monitor this group for changes or emergent situations but no formal care will be provided. All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study.

Other: Education and adviceOther: Supervised neglect

Interventions

Manual therapyOTHER

Hip joint and spine manual therapy techniques applied toward the impairments of the subject.

Education, exercise and manual therapy
ExerciseOTHER

Prescriptive exercise program of self-mobilization and/or strengthening program to address impairments of the subject.

Education and exercise
Education and adviceOTHER

All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).

Education and exerciseEducation, exercise and manual therapySupervised neglect
Supervised neglectOTHER

Monitoring of group without formal intervention.

Supervised neglect

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Musculoskeletal ManipulationsExerciseEducational StatusCounseling

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation CharacteristicsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 11, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

February 6, 2017

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share