Symptomatic Femoroacetabular ImpingementNCT02368483
Conservative Treatment in Patients With Symptomatic Femoroacetabular Impingement
A study testing Neuromuscular training in people with Symptomatic Femoroacetabular Impingement, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
This is a single-group, prospective, intervention study. A total of 30 participants with unilateral symptomatic femoroacetabular impingement will be included into the study. The intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2 times/week supervised training, 2 times/week home… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Symptomatic Femoroacetabular Impingement
- What is being tested?
- Neuromuscular training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Mar 2017
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of unilateral symptomatic FAI according to clinical, radiographic and magnetic resonance imaging criteria
- Living place: Canton of Zurich or neighbouring Cantons
- Signed written informed consent to participate into the study
Who cannot join
- Previous hip surgery
- Any surgery to the lower limbs in the prior 6 months
- Congenital/developmental dysplasia
- Hip osteoarthritis
- Initiation of opioid analgesia and corticosteroid injection for hip pain within the prior 30 days
- BMI >35 kg/m2
- Significant cardiorespiratory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Neuromuscular Training of the Lower Limb Muscles in Reducing the Hip Symptoms in Patients With Symptomatic Femoroacetabular Impingement: a Prospective Intervention Study
This is a single-group, prospective, intervention study. A total of 30 participants with unilateral symptomatic femoroacetabular impingement will be included into the study. The intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2 times/week supervised training, 2 times/week home training). The training includes physical exercises routinely used worldwide in clinical settings. No control intervention group was included into the study because nowadays there is no standard conservative treatment for patients with symptomatic femoroacetabular impingement. Assessments will be performed at (1) baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. Clinical, functional, neuromuscular and self-reported parameters will be collected during assessments.
- Conditions
- Symptomatic Femoroacetabular Impingement
- Being tested
- Neuromuscular training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular trainingOther
Neuromuscular training for the hip and lower limb muscles.The training program is divided into 3 phases, and includes specific exercises for improving the hip range of motion, muscle strength of the hip and lower limb muscles, as well as the trunk stability and coordination. The intervention lasts 12 weeks. Patients will train 2 times/week with a physical therapist and 2 times/weeks alone at home.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular training | Experimental | Not described Receives: Other: Neuromuscular training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Function as measured using the Hip Outcome Score questionnaire
Hip Function was assessed using the Hip Outcome Score. The Hip Outcome score is a questionnaire used to evaluate hip function during daily and sport activities. Two independent scores are obtained: one for activities of daily living and one for sport activities.
Measured: Change from Baseline in Hip Function at 12 weeks
Secondary outcomes (2)
Hip Muscle Strength as measured using dynamometry
Hip abduction, adduction, internal rotation and external rotation isometric maximal voluntary contraction strength is evaluated with hand-held dynamometry. Hip flexion and extension isometric maximal voluntary contraction strength is evaluated with isokinetic dynamometry.
Measured: Change from Baseline in Hip Muscle Strength at 12 weeks
Movement Control Quality as measured using a visual rating scale
Overall body movement pattern quality is visually assessed during the performance of 5 lower extremity functional tests (single-leg squat, lunge, hop lunge, single-leg bridge, single-leg ventral plank).
Measured: Change from Baseline in Movement Control Quality at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Maffiuletti, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368483
- Sponsor's protocol ID
- FAI conservative treatment 1
- Status last verified
- Jun 2019
- First submitted
- 29 Jan 2015
- Last updated
- 18 Jun 2019
- Results posted
- No
Publications
Casartelli NC, Bizzini M, Maffiuletti NA, Sutter R, Pfirrmann CW, Leunig M, Naal FD. Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: Preliminary Results of Clinical Responsiveness. Arthritis Care Res (Hoboken). 2019 Aug;71(8):1074-1083. doi: 10.1002/acr.23728. Epub 2019 Jul 9.
PubMed 30133164
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neuromuscular Training of the Lower Limb Muscles in Reducing the Hip Symptoms in Patients With Symptomatic Femoroacetabular Impingement: a Prospective Intervention Study
- ClinicalTrials.gov ID
- NCT02368483
- Acronym / sponsor ID
- FAI conservative treatment 1
- Conditions
- Symptomatic Femoroacetabular Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Feb 2015 (estimated)
- 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 is a single-group, prospective, intervention study. A total of 30 participants with unilateral symptomatic femoroacetabular impingement will be included into the study. The intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2 times/week supervised training, 2 times/week home training). The training includes physical exercises routinely used worldwide in clinical settings. No control intervention group was included into the study because nowadays there is no standard conservative treatment for patients with symptomatic femoroacetabular impingement. Assessments will be performed at (1) baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. Clinical, functional, neuromuscular and self-reported parameters will be collected during assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular training | Experimental | Other: Neuromuscular training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of unilateral symptomatic FAI according to clinical, radiographic and magnetic resonance imaging criteria
- Living place: Canton of Zurich or neighbouring Cantons
- Signed written informed consent to participate into the study
Key exclusion criteria (7 listed)
- Previous hip surgery
- Any surgery to the lower limbs in the prior 6 months
- Congenital/developmental dysplasia
- Hip osteoarthritis
- Initiation of opioid analgesia and corticosteroid injection for hip pain within the prior 30 days
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 |
|---|---|---|
| Neuromuscular trainingNeuromuscular training for the hip and lower limb muscles.The training program is divided into 3 phases, and includes specific exercises for improving the hip range of motion, muscle strength of the hip and lower limb muscles, as well as the trunk stability and coordination. The intervention lasts 12 weeks. Patients will train 2 times/week with a physical therapist and 2 times/weeks alone at home. | Other | Neuromuscular training |
Primary outcome
Hip Function as measured using the Hip Outcome Score questionnaire
Time frame: Change from Baseline in Hip Function at 12 weeks
Hip Function was assessed using the Hip Outcome Score. The Hip Outcome score is a questionnaire used to evaluate hip function during daily and sport activities. Two independent scores are obtained: one for activities of daily living and one for sport activities.
2 secondary outcomes
Hip Muscle Strength as measured using dynamometry
Time frame: Change from Baseline in Hip Muscle Strength at 12 weeks
Movement Control Quality as measured using a visual rating scale
Time frame: Change from Baseline in Movement Control Quality at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 30133164Casartelli NC, Bizzini M, Maffiuletti NA, Sutter R, Pfirrmann CW, Leunig M, Naal FD. Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: Preliminary Results of Clinical Responsiveness. Arthritis Care Res (Hoboken). 2019 Aug;71(8):1074-1083. doi: 10.1002/acr.23728. Epub 2019 Jul 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular training in people with Symptomatic Femoroacetabular Impingement, run by Schulthess Klinik at 1 site in Switzerland.
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 7 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: finished, as of the sponsor's last update on 18 Jun 2019. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Function as measured using the Hip Outcome Score questionnaire (time frame: Change from Baseline in Hip Function at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02368483, which also lists 1 linked publication.
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 18 Jun 2019.