NCT04400825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

May 19, 2020

Last Update Submit

November 2, 2020

Conditions

Keywords

physiotherapystretchingdry needling

Outcome Measures

Primary Outcomes (2)

  • muscle extensibility

    the examiners assess the muscle extensibility using an inclinomenter

    Baseline

  • muscle extensibility

    the examiners assess the muscle extensibility using an inclinomenter

    up to 3 weeks

Secondary Outcomes (2)

  • Stiffness

    Baseline

  • Stiffness

    up to 3 weeks

Study Arms (2)

Dry needling

EXPERIMENTAL

Dry needling of 3 active MTrPs at most.

Other: Dry needling

Stretching

ACTIVE COMPARATOR

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

Other: Dry needling

Interventions

Dry needling of the active MTrPs following the technique described by Hong et al (1994,1995)

Dry needlingStretching

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luis Ceballos Laita

Soria, 42004, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
single-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 26, 2020

Study Start

May 1, 2020

Primary Completion

July 19, 2020

Study Completion

July 19, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations