Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis

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.

Study Overview

• Status: Unknown
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Other: Dry needling; Other: Sham Dry needling

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50008
    • Luis Ceballos Laita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
• Fear of needles

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dry needling; Dry needling technique in each active myofascial trigger point once per week for 3 weeks.	Other: Dry needling; 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.
SHAM_COMPARATOR: Sham Dry needling; Sham Dry needling technique in each active myofascial trigger point once per week for 3 weeks.	Other: Sham Dry needling; Sham Dry needling use a non-penetrating acupuncture needle
NO_INTERVENTION: Control; Control group. No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip Range of motion	The investigators measure the hip range of motion with an inclinometer at baseline	Baseline
Hip Range of motion	The investigators measure the hip range of motion with an inclinometer at the end of the intervention (through study completion, an average 21 days)	through study completion, an average 21 days
Muscular strength	The investigators measure the hip strength with a hand held dynamometer (Lafayette) at baseline	Baseline
Muscular strength	The investigators measure the hip strength with a hand held dynamometer (Lafayette) at the end of the intervention (through study completion, an average 21 days)	through study completion, an average 21 days
Muscular length	The investigators measure the muscular length with Passive Knee Extension test, ELY test, and modified Ober test at baseline	Baseline
Muscular length	The investigators measure the muscular length with Passive Knee Extension test, ELY test, and modified Ober test at the end of the intervention (through study completion, an average 21 days)	through study completion, an average 21 days
Pain threshold	The investigators measure the pain threshold with a digital algometer in myofascial trigger points of the hip muscles, and also other bone areas to discriminate a central sensitization at baseline	Baseline
Pain threshold	The investigators measure the pain threshold with a digital algometer in myofascial trigger points of the hip muscles, and also other bone areas to discriminate a central sensitization at the end of the intervention (through study completion, an average 21 days)	through study completion, an average 21 days
Anxiety and depression with a validated questionnaire (HADS)	The investigators measure the anxiety and depression with HADS questionnaire at baseline	Baseline
Anxiety and depression with a validated questionnaire (HADS)	The investigators measure the anxiety and depression with HADS questionnaire at the end of the intervention (through study completion, an average 21 days)	through study completion, an average 21 days
Functional capacity with a validated questionnaire (WOMAC)	The investigator measure the functional capacity with WOMAC questionnaire at baseline	Baseline
Functional capacity with a validated questionnaire (WOMAC)	The investigator measure the functional capacity with WOMAC questionnaire at the end of the intervention (through study completion, an average 21 days)	through study completion, an average 21 days
Gait in treadmill	The investigator measure gait pattern in treadmill using wearable inertial sensors to track body kinematics during gait	Baseline
Gait in treadmill	The investigator measure gait pattern in treadmill using wearable inertial sensors to track body kinematics during gait	through study completion

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): November 1, 2018
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 25, 2017
• First Posted (ACTUAL): June 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: manual therapy; physiotherapy; hip osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: C.I.PI17/0182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The patient data were confidential and were assigned a number to each patient to maintain confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No