NCT03202056

Brief Summary

Dry needling is a new treatment technique, addressed to mechanical pain of the neuromusculoskeletal system. Recent investigations has developed new hypothesis about the etiology of the osteoarthritis and could be in relation to musculoskeletal disorders, but there is no published studies evaluating the results of this technique in hip osteoarthritis patients. The objective of this trial is to evaluate if dry needling is more effective in symptoms, function, range of motion, strength, muscular length, pain threshold and compared to sham dry needling and control. For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of hip osteoarthritis Grade I-III by Scale of Kellgren and Lawrence. Patients included are randomized into 3 groups one receive Dry needling, other sham dry needling and the other is a control. Groups receive 3 treatment sessions. The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session. Patients who participated in sham dry needling or control group, when the intervention finish the investigators will be given the opportunity to receive the actual technique.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

June 13, 2017

Last Update Submit

October 10, 2018

Conditions

Keywords

hip osteoarthritisphysiotherapymanual therapy

Outcome Measures

Primary Outcomes (4)

  • Functional Capacity with functional tests

    The investigators measure the functional capacity with functional test: "test Up and Go" (TUG), "20 and 40 meters self-placed" and "30 seconds-chair stand" at baseline

    Baseline

  • Intensity symptoms

    The investigators measure the intensity of with a visual analogic scale pre-intervention at baseline

    Baseline

  • Intensity symptoms

    The investigators measure the intensity of with a visual analogic scale at the end of the intervention (3 weeks after baseline the investigators measure the intensity of symptoms through study completion, an average 21 days)

    through study completion, an average 21 days

  • Functional Capacity with functional tests

    The investigator measure the functional capacity with functional test: "Test Up and Go" (TUG test), "20 and 40 meters self-placed" and "30 seconds-chair and stand" at the end of the intervention (through study completion, an average 21 days).

    through study completion, an average 21 days

Secondary Outcomes (14)

  • Hip Range of motion

    Baseline

  • Hip Range of motion

    through study completion, an average 21 days

  • Muscular strength

    Baseline

  • Muscular strength

    through study completion, an average 21 days

  • Muscular length

    Baseline

  • +9 more secondary outcomes

Study Arms (3)

Dry needling

EXPERIMENTAL

Dry needling technique in each active myofascial trigger point once per week for 3 weeks.

Other: Dry needling

Sham Dry needling

SHAM COMPARATOR

Sham Dry needling technique in each active myofascial trigger point once per week for 3 weeks.

Other: Sham Dry needling

Control

NO INTERVENTION

Control group. No intervention.

Interventions

Dry needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments.

Dry needling

Sham Dry needling use a non-penetrating acupuncture needle

Sham Dry needling

Eligibility Criteria

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

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
  • Fear of needles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luis Ceballos Laita

Zaragoza, 50008, Spain

Location

Related Publications (1)

  • Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effects of dry needling in HIP muscles in patients with HIP osteoarthritis: A randomized controlled trial. Musculoskelet Sci Pract. 2019 Oct;43:76-82. doi: 10.1016/j.msksp.2019.07.006. Epub 2019 Jul 24.

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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 28, 2017

Study Start

January 1, 2018

Primary Completion

November 1, 2018

Study Completion

January 1, 2019

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

The patient data were confidential and were assigned a number to each patient to maintain confidentiality

Locations