Effects of a Stretching Protocol in Patients With Hip Osteoarthritis
1 other identifier
interventional
15
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 17, 2018
CompletedFirst Posted
Study publicly available on registry
October 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedJanuary 21, 2020
January 1, 2020
4 months
August 17, 2018
January 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes from baseline in pain intensity
Visual Analogic Scale
3 weeks
Secondary Outcomes (7)
Functional Capacity
3 weeks
WOMAC questionnaire
3 weeks
Hip Range of Motion
3 weeks
Muscular strength
3 weeks
Muscular length
3 weeks
- +2 more secondary outcomes
Study Arms (1)
Interventional group
EXPERIMENTALHip flexors stretching protocol
Interventions
Stretching protocol of rectus femoris, vastus lateralis and iliopsoas according to Kaltenborn- Evjenth Orthopaedic Manual Therapy Concept (OMT)
Eligibility Criteria
You may qualify if:
- Diagnosed medically with a X-Ray test
- American College of Rheumatology Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad de Zaragozalead
- University of Valladolidcollaborator
Study Sites (2)
Sandra Jiménez del Barrio
Soria, 42004, Spain
Luis Ceballos Laita
Zaragoza, 50008, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 17, 2018
First Posted
October 11, 2018
Study Start
August 1, 2018
Primary Completion
November 30, 2018
Study Completion
December 30, 2018
Last Updated
January 21, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share
The patient data were confidential and were assigned a number to each patient to maintain confidentiality