- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03702595
Effects of a Stretching Protocol in Patients With Hip Osteoarthritis
Effects of a Stretching Protocol of Hip Flexors in Patients With Mild to Moderate Hip Osteoarthritis
Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Clinical guidelines recommend non-pharmacological conservative treatments for the management of OA. Hip flexors seems to play an important role in the development of hip OA but there is no published studies evaluating the results of a stretching protocol of hip flexors in hip OA patients.
The objective of this trial is to evaluate if a stretching protocol of hip flexors is more effective in symptoms, functional capacity , range of motion, strength, muscular length, pain threshold and anxiety and depression compared to control.
For this purpose the investigators conduct a single-group, pretest-posttest clinical trial.The investigators included patients diagnosed of hip osteoarthritis Grade I-III by Scale of Kellgren and Lawrence.
The variables are measured at the beginning and at the end of treatment of the control phase, and at the end of the stretching protocol phase.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Soria, Spain, 42004
- Sandra Jiménez del Barrio
-
Zaragoza, Spain, 50008
- Luis Ceballos Laita
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed medically with a X-Ray test
- American College of Rheumatology Criteria
Exclusion Criteria:
- Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
- Vascular or neurological disease.
- Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
- Grade IV in Kellgren and Laurence Scale
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional group
Hip flexors stretching protocol
|
Stretching protocol of rectus femoris, vastus lateralis and iliopsoas according to Kaltenborn- Evjenth Orthopaedic Manual Therapy Concept (OMT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in pain intensity
Time Frame: 3 weeks
|
Visual Analogic Scale
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Capacity
Time Frame: 3 weeks
|
The investigators measure the functional capacity with Timed Up and Go test (TUG)
|
3 weeks
|
WOMAC questionnaire
Time Frame: 3 weeks
|
WOMAC questionnaire
|
3 weeks
|
Hip Range of Motion
Time Frame: 3 weeks
|
Digital inclinometer according to Pua et al., 2008
|
3 weeks
|
Muscular strength
Time Frame: 3 weeks
|
The investigators measure the hip strength with a hand held dynamometer (Lafayette)
|
3 weeks
|
Muscular length
Time Frame: 3 weeks
|
The investigators measure the muscular length with an inclinometer
|
3 weeks
|
Pressure Pain threshold
Time Frame: 3 weeks
|
Pressure algometry measured by digital algometer
|
3 weeks
|
Anxiety and Depression
Time Frame: 3 weeks
|
Hospital Anxiety and Depression Scale (HADS)
|
3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1955
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Osteoarthritis
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