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Dry Needling Versus Stretching for Muscle Extensibility

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring physiotherapy, stretching, dry needling

Eligibility Criteria

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

Inclusion Criteria:

  • unilateral hip OA diagnosed medically with a X-Ray tess and following the 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
  • DN contraindications or fear of needles

Sites / Locations

  • Luis Ceballos Laita

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling

Stretching

Arm Description

Dry needling of 3 active MTrPs at most.

Stretching of the main hip flexors (rectus femoris, iliopsoas and tensor fasciae latae)

Outcomes

Primary Outcome Measures

muscle extensibility
the examiners assess the muscle extensibility using an inclinomenter
muscle extensibility
the examiners assess the muscle extensibility using an inclinomenter

Secondary Outcome Measures

Stiffness
the examiners assess the stiffness using the WOMAC stiffness subscale
Stiffness
the examiners assess the stiffness using the WOMAC stiffness subscale

Full Information

First Posted
May 19, 2020
Last Updated
November 2, 2020
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT04400825
Brief Title
Dry Needling Versus Stretching for Muscle Extensibility
Official Title
Comparing Dry Needling and Stretching for the Management of Muscle Extensibility in Patients With Hip Osteoarthritis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
July 19, 2020 (Actual)
Study Completion Date
July 19, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Currently several authors have shown the presence of active myofascial trigger points (MTrP) in the muscles surrounding the hip joint that reproduce the symptoms of the patients with hip OA. Despite of the beneficial effects that have shown may conservative non-pharmacological treatments, there is a lack of studies evaluating the effects of the conservative treatments on muscle extensibility. According to the new paradigm about the presence of MTrPs, the investigators decided to conduct a randomized clinical trial to compare the effects of DN intervention and stretching protocol on muscle extensibility in patients with hip OA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
physiotherapy, stretching, dry needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
Outcomes Assessor
Masking Description
single-blind
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
Dry needling of 3 active MTrPs at most.
Arm Title
Stretching
Arm Type
Active Comparator
Arm Description
Stretching of the main hip flexors (rectus femoris, iliopsoas and tensor fasciae latae)
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Dry needling of the active MTrPs following the technique described by Hong et al (1994,1995)
Primary Outcome Measure Information:
Title
muscle extensibility
Description
the examiners assess the muscle extensibility using an inclinomenter
Time Frame
Baseline
Title
muscle extensibility
Description
the examiners assess the muscle extensibility using an inclinomenter
Time Frame
up to 3 weeks
Secondary Outcome Measure Information:
Title
Stiffness
Description
the examiners assess the stiffness using the WOMAC stiffness subscale
Time Frame
Baseline
Title
Stiffness
Description
the examiners assess the stiffness using the WOMAC stiffness subscale
Time Frame
up to 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: unilateral hip OA diagnosed medically with a X-Ray tess and following the 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 DN contraindications or fear of needles
Facility Information:
Facility Name
Luis Ceballos Laita
City
Soria
ZIP/Postal Code
42004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Dry Needling Versus Stretching for Muscle Extensibility

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