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Resistance Training for Patients Diagnosed With External Snapping Hip

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ClinicalTrials.gov Identifier: NCT03703362
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Coxa Saltans External Other: Resistance training Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resistance Training for Patients Diagnosed With External Snapping Hip. A Feasibility Study
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Progressive resistance training
Progressive resistance training tested in patients with external snapping hip
Other: Resistance training
30 supervised training-sessions over 12 weeks




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Increase in muscle strength measured by dynamometer. [ Time Frame: Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended. ]
    Muscle strength in hip-abduction and hip-extension is measured isometrically, eccentrically and concentrically with a dynamometer (model Humac Norm).

  2. Increase in hip function. [ Time Frame: Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended. ]
    Hip function is measured with the questionnaire the Copenhagen Hip and Groin Outcome Score (HAGOS).

  3. Hypermobility status. [ Time Frame: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended. ]
    Hypermobility status is measured with the Beighton Score with a cutoff at 5 points.

  4. Increase in one repetition muscle strength. [ Time Frame: At the start of the intervention and 12 weeks later at the end of the intervention. ]
    Muscle strength is measured with the One-Repetition-Max test for hip-abduction and leg press.

  5. Increase in hip function. [ Time Frame: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended. ]
    Increase in function is measured with a Loaded stair test.

  6. Hip awareness. [ Time Frame: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended. ]
    Hip awareness is measured with the Forgotten Joint Score questionnaire.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • BMI >40
  • No longer suffering from external snapping hip
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703362


Contacts
Contact: Troels Kjeldsen 60137627 troels.kjeldsen@post.au.dk
Contact: Inger Mechlenburg 21679062 inger.mechlenburg@clin.au.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Inger Mechlenburg, PhD         
Horsens Regional Hospital Recruiting
Horsens, Denmark, 8700
Contact: Bent Lund, MD    0045 2490 1231    sk@clin.au.dk   
Silkeborg Regional Hospital Recruiting
Silkeborg, Denmark, 8600
Contact: Lone R Mikkelsen, MSc.    +45 8722 2851    lonemike@rm.dk   
Principal Investigator: Lone R Mikkelsen, MSc.         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03703362     History of Changes
Other Study ID Numbers: SnappingHip
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Resistance training
Feasibility