Femoroacetabular ImpingementNCT03846817
Diagnosis and Treatment of Patients With Femoroacetabular Impingement Syndrome
A study testing Physiotherapist-led treatment in people with Femoroacetabular Impingement, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
This prospective study with a two-group comparison design investigates the effectiveness of 12-weeks of semi-structured and supervised physiotherapist-led treatment on self-reported hip and groin function in patients with femoroacetabular impingement syndrome with and without intra-articular hip pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Physiotherapist-led treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Mar 2019to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Activity-related longstanding hip and/or groin pain for >3 months
- Known anterior and/or medial groin pain during the FADIR test with a pain severity of ≥2/10 on NRS.
- Radiological findings on plain radiographs of cam morphology defined as alpha angle >55° on a lateral view.
Who cannot join
- Inguinal-related groin pain diagnosed according to Doha Agreement.
- Pubic-related groin pain diagnosed according to Doha Agreement.
- Evidence of pre-existing hip osteoarthritis, defined as a joint space width <3 mm at the lateral sourcil on anterior-posterior pelvic radiograph.
- Previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia defined as a Lateral Center Edge Angle <25°, or avascular necrosis.
- Other causes of hip and groin pain identified by the orthopedic surgeon during the clinical examination, such as stress fracture of the femoral neck, referred pain from the facet joint, referred pain from the sacroiliac joint, or other competing diagnosis (rheumatoid arthritis, cancer etc.)
- Previous hip injury such as acetabular fracture, hip dislocation, or femoral neck fracture.
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- Previous intra- or extra-articular hip surgery.
- Pregnant.
- Intra-articular steroid hip injection during the preceding 3 months.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
All part of the study is conducted at Department of Orthopedic Department, Hvidovre Hospital
Copenhagen
Lasse Ishøi, 0045 20438110, lasse.ishoei@gmail.com
Lasse Ishøi
About this study
Official title: Optimization of the Diagnostic Process and Physiotherapist-led Treatment of Patients With Femoroacetabular Impingement Syndrome: a Prospective Cohort Study
This prospective study with a two-group comparison design investigates the effectiveness of 12-weeks of semi-structured and supervised physiotherapist-led treatment on self-reported hip and groin function in patients with femoroacetabular impingement syndrome with and without intra-articular hip pain. Determination of intra-articular hip pain is based on pain relief following an ultrasound-guided intra-articular anesthetic hip injection performed prior to commencing treatment.
Read the detailed description
The treatment of femoroacetabular impingement syndrome (FAIS) consists of wait-and-see, physiotherapist-led treatment, and/or hip surgery. The primary indication for hip surgery is based on imaging findings, however, limited correlation has been observed between such findings and hip symptoms. As patients with FAIS often show physical impariments, such as impaired hip muscle function, physiotherapist-led treatment aiming to address such factors may be effective in improving hip function and pain in some patients. However, several factors may confound the effect of physiotherapist-led treatement of FAIS, such as whether the patient presents with intra-articular hip joint pain or not.
Thus, the purpose of this prospective study with a two-group comparison design is to investigate the effect of 12-weeks of physiotherapist-led treatment on self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS), in subjects diagnosed with FAIS, but with and without intra-articular hip pain. Determination of intra-articular hip pain is based on the response to an ultrasound-guided intra-articular anesthetic hip injection performed prior to commencing treatment.
Subjects diagnosed with FAIS based on symptoms, clinical signs and imaging findings will be prospectively recruited from a specialized outpatient hip and groin clinic at Hvidovre Hospital. Following inclusion subjects undergo 12-weeks of semi-structured and supervised physiotherapist-led treatment. The primary outcome measure is the between-group (intra-articular pain vs. no intra-articular pain) difference in mean change of the HAGOS sport subscale from baseline (week 0) to follow-up (week 12).
The primary outcome measure will be publised in the primary paper, which will also include information on between-group difference in change in hip muscle strength and single-leg hop performance as secondary outcome measures.
Secondary papers will be reported with a clear reference to the primary paper.
The sample size calculation is based on the primary outcome measure, being the between-group (intra-articular pain vs. no intra-articular pain) difference in change in the HAGOS Sport subscale following 12 weeks of physiotherapist-led treatment. Based on an expected 1/1 recruitment ratio between subjects with and without intra-articular hip pain and a clinically relevant between-group contrast in change of 15 points corresponding to a moderate effect size 0.6 (Cohen's d), a power and alpha value of 80% and 0.05, respectively, 44 subjects in each group is adequate (G*power software, v.3.1, Heinrich-Heine-Universität, Düsseldorf, Germany). To minimize the risk of underpowering the study in case of uneven allocation to groups, based on the intra-articular anesthetic hip injection, inclusion of participants will continue until a minimum of 55 (44 including 25% dropouts in each group) subjects has been recruited in each group. A blinded member of the research team will be responsible for monitoring this.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Physiotherapist-led treatment
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist-led treatmentOther
Also called Exercise-based treatment
12-week of semi-standardized, progressive physiotherapist-led treatment aiming to increase hip muscle strength and load capacity.
| Study group | Role | What they receive |
|---|---|---|
| FAIS with intra-articular hip pain | Experimental | 12-week of semi-standardized, progressive physiotherapist-led treatment supervised by a physiotherapist blinded to clinical and objective findings.
The treatment program will consist of one weekly exercise training session at Hvidovre Hospital supervised by a physiotherapist and twice-weekly unsupervised exercise training sessions performed at home for a consecutive period of 12-weeks (12 supervised sessions; 24 unsupervised sessions).
In conjunction with the physiotherapist-led treatment, participants will be advised to modify potential aggravating physical activitie, and gradually increase their level of activity during the treatment period. Receives: Other: Physiotherapist-led treatment |
| FAIS without intra-articular hip pain | Experimental | 12-week of semi-standardized, progressive physiotherapist-led treatment supervised by a physiotherapist blinded to clinical and objective findings.
The treatment program will consist of one weekly exercise training session at Hvidovre Hospital supervised by a physiotherapist and twice-weekly unsupervised exercise training sessions performed at home for a consecutive period of 12-weeks (12 supervised sessions; 24 unsupervised sessions).
In conjunction with the physiotherapist-led treatment, participants will be advised to modify potential aggravating physical activitie, and gradually increase their level of activity during the treatment period. Receives: Other: Physiotherapist-led treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HAGOS Sport subscale
The primary outcome measure is the between-group (intra-articular pain vs. no intra-articular pain) difference in change in self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) Sport subscale from baseline to follow-up in subjects diagnosed with FAIS.
The HAGOS Sport subcale is scored on a scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems).
Measured: 12 weeks
Secondary outcomes (8)
Change in HAGOS subscales
Between-group (intra-articular pain vs. no intra-articular pain) difference in change in self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS; all subscales exept Sport) from baseline to follow-up in subjects diagnosed with FAIS.
The HAGOS subcales are scored on a scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems).
Measured: 12 weeks
Change in hip peak torque
Between-group (intra-articular pain vs. no intra-articular pain) difference in change in peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion.
Measured: 12 weeks
Change in hip rate of torque development
Between-group (intra-articular pain vs. no intra-articular pain) difference in change in 0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion
Measured: 12 weeks
Change in single leg hop performance
Between-group (intra-articular pain vs. no intra-articular pain) difference in change in reactive strength index obtained during a single leg drop jump test
Measured: 12 weeks
Change in isometric adduction squeeze torque
Between-group (intra-articular pain vs. no intra-articular pain) difference in change in peak isometric hip adduction squeeze torque (Nm/kg)
Measured: 12 weeks
Return to sport
Obtained at follow-up (week 12) using a return to sport questionnaire to determine the proportion the patients who have returned to preinjury sport at preinjury level including optimal sport performance in each group (intra-articular pain vs. no intra-articular pain).
The outcome will be reported as proportion/frequency.
Measured: 12 weeks
Treatment expectations and fulfilment of expectations
Treatment expectations and fulfilment of expectations will be obtained using a modified version of a questionnaire previously used and validated for patients undergoing spine surgery, which has been used previously to assess treatment expectations and fulfilment of treatment expectations in patients undergoing surgery for FAIS. Expectations and fulfilment are assessed on a 5-point Likert scale as: much better (0), better (1), somewhat better (2), unchanged (3), worse (4).
Measured: 12 weeks
Patient acceptable symptom state
Patient Acceptable Symptom State (PASS) will be assessed at 12-weeks follow-up. The PASS defines a level of symptoms that discriminates between feeling well and unwell. Subjects will be instructed to answer the following question with yes/no: ''Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?''
The outcome will be reported as proportion/frequency.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start12 Mar 2019
- Primary completion12 Mar 2021 (estimated)
- Study completion12 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- La Trobe University, Duke University
- Responsible party
- Principal investigator, Lasse Ishøi, Hvidovre University Hospital
- Investigators
- Lasse Ishøi, Principal investigator, Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre HospitalPer Hölmich, Study director, Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre HospitalKristian Thorborg, Study director, Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre HospitalJoanne Kemp, Study chair, La Trobe Sport and Exercise Medicine Research Centre, La Trobe UniversityMichael Reiman, Study chair, Duke University Medical Center, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846817
- Sponsor's protocol ID
- Physio treatment FAI
- Status last verified
- Jul 2020
- First submitted
- 18 Feb 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Diagnostic Process and Physiotherapist-led Treatment of Patients With Femoroacetabular Impingement Syndrome: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03846817
- Acronym / sponsor ID
- Physio treatment FAI
- Conditions
- Femoroacetabular Impingement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- La Trobe University, Duke University
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 12 Mar 2021 (estimated)
- Study completion
- 12 Mar 2021 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study with a two-group comparison design investigates the effectiveness of 12-weeks of semi-structured and supervised physiotherapist-led treatment on self-reported hip and groin function in patients with femoroacetabular impingement syndrome with and without intra-articular hip pain. Determination of intra-articular hip pain is based on pain relief following an ultrasound-guided intra-articular anesthetic hip injection performed prior to commencing treatment.
Detailed description
The treatment of femoroacetabular impingement syndrome (FAIS) consists of wait-and-see, physiotherapist-led treatment, and/or hip surgery. The primary indication for hip surgery is based on imaging findings, however, limited correlation has been observed between such findings and hip symptoms. As patients with FAIS often show physical impariments, such as impaired hip muscle function, physiotherapist-led treatment aiming to address such factors may be effective in improving hip function and pain in some patients. However, several factors may confound the effect of physiotherapist-led treatement of FAIS, such as whether the patient presents with intra-articular hip joint pain or not.
Thus, the purpose of this prospective study with a two-group comparison design is to investigate the effect of 12-weeks of physiotherapist-led treatment on self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS), in subjects diagnosed with FAIS, but with and without intra-articular hip pain. Determination of intra-articular hip pain is based on the response to an ultrasound-guided intra-articular anesthetic hip injection performed prior to commencing treatment.
Subjects diagnosed with FAIS based on symptoms, clinical signs and imaging findings will be prospectively recruited from a specialized outpatient hip and groin clinic at Hvidovre Hospital. Following inclusion subjects undergo 12-weeks of semi-structured and supervised physiotherapist-led treatment. The primary outcome measure is the between-group (intra-articular pain vs. no intra-articular pain) difference in mean change of the HAGOS sport subscale from baseline (week 0) to follow-up (week 12).
The primary outcome measure will be publised in the primary paper, which will also include information on between-group difference in change in hip muscle strength and single-leg hop performance as secondary outcome measures.
Secondary papers will be reported with a clear reference to the primary paper.
The sample size calculation is based on the primary outcome measure, being the between-group (intra-articular pain vs. no intra-articular pain) difference in change in the HAGOS Sport subscale following 12 weeks of physiotherapist-led treatment. Based on an expected 1/1 recruitment ratio between subjects with and without intra-articular hip pain and a clinically relevant between-group contrast in change of 15 points corresponding to a moderate effect size 0.6 (Cohen's d), a power and alpha value of 80% and 0.05, respectively, 44 subjects in each group is adequate (G*power software, v.3.1, Heinrich-Heine-Universität, Düsseldorf, Germany). To minimize the risk of underpowering the study in case of uneven allocation to groups, based on the intra-articular anesthetic hip injection, inclusion of participants will continue until a minimum of 55 (44 including 25% dropouts in each group) subjects has been recruited in each group. A blinded member of the research team will be responsible for monitoring this.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAIS with intra-articular hip pain | Experimental | Other: Physiotherapist-led treatment12-week of semi-standardized, progressive physiotherapist-led treatment supervised by a physiotherapist blinded to clinical and objective findings. The treatment program will consist of one weekly exercise training session at Hvidovre Hospital supervised by a physiotherapist and twice-weekly unsupervised exercise training sessions performed at home for a consecutive period of 12-weeks (12 supervised sessions; 24 unsupervised sessions). In conjunction with the physiotherapist-led treatment, participants will be advised to modify potential aggravating physical activitie, and gradually increase their level of activity during the treatment period. |
| FAIS without intra-articular hip pain | Experimental | Other: Physiotherapist-led treatment12-week of semi-standardized, progressive physiotherapist-led treatment supervised by a physiotherapist blinded to clinical and objective findings. The treatment program will consist of one weekly exercise training session at Hvidovre Hospital supervised by a physiotherapist and twice-weekly unsupervised exercise training sessions performed at home for a consecutive period of 12-weeks (12 supervised sessions; 24 unsupervised sessions). In conjunction with the physiotherapist-led treatment, participants will be advised to modify potential aggravating physical activitie, and gradually increase their level of activity during the treatment period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Activity-related longstanding hip and/or groin pain for >3 months
- Known anterior and/or medial groin pain during the FADIR test with a pain severity of ≥2/10 on NRS.
- Radiological findings on plain radiographs of cam morphology defined as alpha angle >55° on a lateral view.
Key exclusion criteria (9 listed)
- Inguinal-related groin pain diagnosed according to Doha Agreement.
- Pubic-related groin pain diagnosed according to Doha Agreement.
- Evidence of pre-existing hip osteoarthritis, defined as a joint space width <3 mm at the lateral sourcil on anterior-posterior pelvic radiograph.
- Previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia defined as a Lateral Center Edge Angle <25°, or avascular necrosis.
- Other causes of hip and groin pain identified by the orthopedic surgeon during the clinical examination, such as stress fracture of the femoral neck, referred pain from the facet joint, referred pain from the sacroiliac joint, or other competing diagnosis (rheumatoid arthritis, cancer etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapist-led treatmentAlso: Exercise-based treatment12-week of semi-standardized, progressive physiotherapist-led treatment aiming to increase hip muscle strength and load capacity. | Other | FAIS with intra-articular hip pain, FAIS without intra-articular hip pain |
Primary outcome
Change in HAGOS Sport subscale
Time frame: 12 weeks
The primary outcome measure is the between-group (intra-articular pain vs. no intra-articular pain) difference in change in self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) Sport subscale from baseline to follow-up in subjects diagnosed with FAIS. The HAGOS Sport subcale is scored on a scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems).
8 secondary outcomes
Change in HAGOS subscales
Time frame: 12 weeks
Change in hip peak torque
Time frame: 12 weeks
Change in hip rate of torque development
Time frame: 12 weeks
Change in single leg hop performance
Time frame: 12 weeks
Change in isometric adduction squeeze torque
Time frame: 12 weeks
Return to sport
Time frame: 12 weeks
Treatment expectations and fulfilment of expectations
Time frame: 12 weeks
Patient acceptable symptom state
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lasse Ishøi principal investigator
Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
Per Hölmich study director
Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
Kristian Thorborg study director
Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist-led treatment in people with Femoroacetabular Impingement, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lasse Ishøi, PhD student (20438110, lasse.ishoei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HAGOS Sport subscale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.