Coxa Saltans ExternalNCT03703362
Resistance Training for Patients Diagnosed With External Snapping Hip
A study testing Resistance training in people with Coxa Saltans External, run by University of Aarhus at 3 sites in Denmark.
Trial summary
The purpose of this study is to investigate whether targeted progressive resistance training is safe and feasible for patients with external snapping hip. Dropout rates, adverse events and training adherence are investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coxa Saltans External
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesDenmark
- Study dates
- 8 Aug 2018to 30 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Greater Trochanteric Pain Syndrome at the Orthopedic Surgery Department at Aarhus University Hospital in the period 2013-2015. In case of too few participants from this sample, we plan to include patients diagnosed during 2018
- Minimum 18 years old
- Able to read and understand Danish
- Have experienced jump/click from the outside of the hip associated with pain within the last 14 days
- Have a residence of a maximum of 55 km from Aarhus C
- The participants must not have participated in regular resistance training of the hip muscles for more than 1 day per week in the last 6 months leading up to the start of the intervention
Show all 9Show fewer
- The participants must not have undergone a total hip replacement, a Periacetabular Osteotomy, a Z-plastic surgery or arthroscopy in the hip within 6 months before the start of the intervention or have a planned hip surgery during the intervention period
- The participants must not suffer from neurological, rheumatological, metabolic or respiratory diseases that will influence the effect of the intervention
- The participants must not have a planned vacation lasting more than 14 days during the intervention period, while not having the opportunity to extend the training period accordingly
Who cannot join
- BMI >40
- No longer suffering from external snapping hip
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital
Aarhus, 8000
Horsens Regional Hospital
Horsens, 8700
Silkeborg Regional Hospital
Silkeborg, 8600
About this study
Official title: Resistance Training for Patients Diagnosed With External Snapping Hip. A Feasibility Study
The purpose of this study is to investigate whether targeted progressive resistance training is safe and feasible for patients with external snapping hip. Dropout rates, adverse events and training adherence are investigated. The secondary purpose is to investigate whether it is possible through targeted progressive resistance training to improve participants' muscle strength, functional status and hip-related quality of life.
Read the detailed description
Snapping hip (coxa saltans) is a disorder where the hip tends to make an audible click-through movement, often but not necessarily associated with pain. A prevalence of 5-10% of the general population has been reported. Snapping hip is divided into three forms of snapping hip; intraarticular, internal and external snapping hip. External snapping hip (coxa saltans external) is the most common form, and patients may experience pain when the iliotibial band or anterior part of the gluteus maximus slides over the greater trochanter at femur. Patients with external snapping hip are typically between 15 and 40 years, and physically active.
- Conditions
- Coxa Saltans External
- Being tested
- Resistance training
- Keywords
- Resistance training, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
30 supervised training-sessions over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Progressive resistance training | Experimental | Progressive resistance training tested in patients with external snapping hip Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events.
A muscle or joint injury caused by the training program reported by a patient, or a canceled training session due to pain associated with exercise, or other harmful incidents associated with the training program.
Measured: Measured at each training session during the 12 week intervention.
Pain during exercise.
Pain during the exercises, measured by the Visual Analogue Scale (VAS). The score range from 0-10, where 0 means no pain and 10 means maximum pain
Measured: Measured for each exercise performed during the 12 week intervention.
Adherence to the training.
Measured by how many of the training sessions the participants completed. High adherence defined >80% of completed sessions. Drop out is defined as a person included in the study who chooses to leave before the final test.
Measured: Measured during the 12 week intervention.
Secondary outcomes (6)
Change in muscle strength measured by dynamometer.
Muscle strength in hip-abduction and hip-extension is measured isometrically, eccentrically and concentrically with a dynamometer (model Humac Norm).
Measured: Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
Change in hip function.
Hip function is measured with the questionnaire the Copenhagen Hip and Groin Outcome Score (HAGOS). HAGOS consists of 37 items in 6 subscales: 7 items to cover symptoms, 10 items to cover pain, 5 items to cover physical function in daily living, 8 items to cover physical function in sport and recreation, 2 items to cover participation in physical activities and 5 items to cover hip and groin related quality of life. There is no total score. Each subscale has a range from 0-100. A high score indicates no problem and a low score indicates severe problems.
Measured: Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
Hypermobility status.
Hypermobility status is measured with the Beighton Score. The test consists of 9 activities and each of the 9 tests can result in a score of 0 or 1 depending on whether the patient can perform the test or not. A total score is summed and has a range of 0-9. Hypermobility is defined by a score of 5 or higher.
Measured: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
Change in one repetition muscle strength.
Muscle strength is measured with the One-Repetition-Max test for hip-abduction and leg press.
Measured: At the start of the intervention and 12 weeks later at the end of the intervention.
Change in hip function.
Change in hip function is measured with a Loaded stair test.
Measured: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
Hip awareness.
Hip awareness is measured with the Forgotten Joint Score questionnaire (FJS), where each patient completes the 12 questions regarding awareness of their affected hip. Each question is answered with one of the following options; never, almost never, seldom, sometimes and mostly, corresponding to a score of 1-5. The sum of the scores will be converted into a score between 0-100. A high score will indicate lack of awareness and a low score will indicate great awareness of the affected hip.
Measured: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start8 Aug 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coxa Saltans ExternalStudies 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
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Inger Mechlenburg, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703362
- Sponsor's protocol ID
- SnappingHip
- Status last verified
- May 2018
- First submitted
- 29 May 2018
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training for Patients Diagnosed With External Snapping Hip. A Feasibility Study
- ClinicalTrials.gov ID
- NCT03703362
- Acronym / sponsor ID
- SnappingHip
- Conditions
- Coxa Saltans External
- Keywords
- Resistance training, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 11 Oct 2018 (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.
The purpose of this study is to investigate whether targeted progressive resistance training is safe and feasible for patients with external snapping hip. Dropout rates, adverse events and training adherence are investigated. The secondary purpose is to investigate whether it is possible through targeted progressive resistance training to improve participants' muscle strength, functional status and hip-related quality of life.
Detailed description
Snapping hip (coxa saltans) is a disorder where the hip tends to make an audible click-through movement, often but not necessarily associated with pain. A prevalence of 5-10% of the general population has been reported. Snapping hip is divided into three forms of snapping hip; intraarticular, internal and external snapping hip. External snapping hip (coxa saltans external) is the most common form, and patients may experience pain when the iliotibial band or anterior part of the gluteus maximus slides over the greater trochanter at femur. Patients with external snapping hip are typically between 15 and 40 years, and physically active.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Progressive resistance training | Experimental | Other: Resistance trainingProgressive resistance training tested in patients with external snapping hip |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with Greater Trochanteric Pain Syndrome at the Orthopedic Surgery Department at Aarhus University Hospital in the period 2013-2015. In case of too few participants from this sample, we plan to include patients diagnosed during 2018
- Minimum 18 years old
- Able to read and understand Danish
- Have experienced jump/click from the outside of the hip associated with pain within the last 14 days
- Have a residence of a maximum of 55 km from Aarhus C
Key exclusion criteria (3 listed)
- BMI >40
- No longer suffering from external snapping hip
- Pregnancy
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 |
|---|---|---|
| Resistance training30 supervised training-sessions over 12 weeks | Other | Progressive resistance training |
Primary outcome
Adverse events.
Time frame: Measured at each training session during the 12 week intervention.
A muscle or joint injury caused by the training program reported by a patient, or a canceled training session due to pain associated with exercise, or other harmful incidents associated with the training program.
Pain during exercise.
Time frame: Measured for each exercise performed during the 12 week intervention.
Pain during the exercises, measured by the Visual Analogue Scale (VAS). The score range from 0-10, where 0 means no pain and 10 means maximum pain
Adherence to the training.
Time frame: Measured during the 12 week intervention.
Measured by how many of the training sessions the participants completed. High adherence defined >80% of completed sessions. Drop out is defined as a person included in the study who chooses to leave before the final test.
6 secondary outcomes
Change in muscle strength measured by dynamometer.
Time frame: Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
Change in hip function.
Time frame: Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
Hypermobility status.
Time frame: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
Change in one repetition muscle strength.
Time frame: At the start of the intervention and 12 weeks later at the end of the intervention.
Change in hip function.
Time frame: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
Hip awareness.
Time frame: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
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 14 Apr 2021.
Related trials for Coxa Saltans External
Recruiting
Progressive Resistance Training for Adults With External Snapping Hip
External Snapping Hip, Coxa Saltans External
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.
Inger Mechlenburg study director
Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Coxa Saltans External, run by University of Aarhus at 3 sites 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 9 inclusion and 3 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Adverse events. (time frame: Measured at each training session during the 12 week intervention.). The study lists 3 primary outcomes in all. 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 14 Apr 2021.