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Effects of a Stretching Protocol in Patients With Hip Osteoarthritis

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hip flexors stretching protocol
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Hip Osteoarthritis, Manual therapy, physiotherapy

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sandra Jiménez del Barrio
  • Luis Ceballos Laita

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional group

Arm Description

Hip flexors stretching protocol

Outcomes

Primary Outcome Measures

Changes from baseline in pain intensity
Visual Analogic Scale

Secondary Outcome Measures

Functional Capacity
The investigators measure the functional capacity with Timed Up and Go test (TUG)
WOMAC questionnaire
WOMAC questionnaire
Hip Range of Motion
Digital inclinometer according to Pua et al., 2008
Muscular strength
The investigators measure the hip strength with a hand held dynamometer (Lafayette)
Muscular length
The investigators measure the muscular length with an inclinometer
Pressure Pain threshold
Pressure algometry measured by digital algometer
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS)

Full Information

First Posted
August 17, 2018
Last Updated
January 17, 2020
Sponsor
Universidad de Zaragoza
Collaborators
University of Valladolid
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1. Study Identification

Unique Protocol Identification Number
NCT03702595
Brief Title
Effects of a Stretching Protocol in Patients With Hip Osteoarthritis
Official Title
Effects of a Stretching Protocol of Hip Flexors in Patients With Mild to Moderate Hip Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
Collaborators
University of Valladolid

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Hip Osteoarthritis, Manual therapy, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Hip flexors stretching protocol
Intervention Type
Other
Intervention Name(s)
Hip flexors stretching protocol
Intervention Description
Stretching protocol of rectus femoris, vastus lateralis and iliopsoas according to Kaltenborn- Evjenth Orthopaedic Manual Therapy Concept (OMT)
Primary Outcome Measure Information:
Title
Changes from baseline in pain intensity
Description
Visual Analogic Scale
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Functional Capacity
Description
The investigators measure the functional capacity with Timed Up and Go test (TUG)
Time Frame
3 weeks
Title
WOMAC questionnaire
Description
WOMAC questionnaire
Time Frame
3 weeks
Title
Hip Range of Motion
Description
Digital inclinometer according to Pua et al., 2008
Time Frame
3 weeks
Title
Muscular strength
Description
The investigators measure the hip strength with a hand held dynamometer (Lafayette)
Time Frame
3 weeks
Title
Muscular length
Description
The investigators measure the muscular length with an inclinometer
Time Frame
3 weeks
Title
Pressure Pain threshold
Description
Pressure algometry measured by digital algometer
Time Frame
3 weeks
Title
Anxiety and Depression
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sandra Jiménez del Barrio
City
Soria
ZIP/Postal Code
42004
Country
Spain
Facility Name
Luis Ceballos Laita
City
Zaragoza
ZIP/Postal Code
50008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The patient data were confidential and were assigned a number to each patient to maintain confidentiality

Learn more about this trial

Effects of a Stretching Protocol in Patients With Hip Osteoarthritis

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