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

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ClinicalTrials.gov Identifier: NCT03202056
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Luis Ceballos Laita, Universidad de Zaragoza

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.


Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Other: Dry needling Other: Sham Dry needling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Functional Capacity with functional tests [ Time Frame: Baseline ]
    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

  2. Intensity symptoms [ Time Frame: Baseline ]
    The investigators measure the intensity of with a visual analogic scale pre-intervention at baseline

  3. Intensity symptoms [ Time Frame: through study completion, an average 21 days ]
    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)

  4. Functional Capacity with functional tests [ Time Frame: through study completion, an average 21 days ]
    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).


Secondary Outcome Measures :
  1. Hip Range of motion [ Time Frame: Baseline ]
    The investigators measure the hip range of motion with an inclinometer at baseline

  2. Hip Range of motion [ Time Frame: through study completion, an average 21 days ]
    The investigators measure the hip range of motion with an inclinometer at the end of the intervention (through study completion, an average 21 days)

  3. Muscular strength [ Time Frame: Baseline ]
    The investigators measure the hip strength with a hand held dynamometer (Lafayette) at baseline

  4. Muscular strength [ Time Frame: through study completion, an average 21 days ]
    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)

  5. Muscular length [ Time Frame: Baseline ]
    The investigators measure the muscular length with Passive Knee Extension test, ELY test, and modified Ober test at baseline

  6. Muscular length [ Time Frame: through study completion, an average 21 days ]
    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)

  7. Pain threshold [ Time Frame: Baseline ]
    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

  8. Pain threshold [ Time Frame: through study completion, an average 21 days ]
    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)

  9. Anxiety and depression with a validated questionnaire (HADS) [ Time Frame: Baseline ]
    The investigators measure the anxiety and depression with HADS questionnaire at baseline

  10. Anxiety and depression with a validated questionnaire (HADS) [ Time Frame: through study completion, an average 21 days ]
    The investigators measure the anxiety and depression with HADS questionnaire at the end of the intervention (through study completion, an average 21 days)

  11. Functional capacity with a validated questionnaire (WOMAC) [ Time Frame: Baseline ]
    The investigator measure the functional capacity with WOMAC questionnaire at baseline

  12. Functional capacity with a validated questionnaire (WOMAC) [ Time Frame: through study completion, an average 21 days ]
    The investigator measure the functional capacity with WOMAC questionnaire at the end of the intervention (through study completion, an average 21 days)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Fear of needles

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202056


Contacts
Contact: Luis Ceballos Laita +34 677380938 lceballoslaita@gmail.com

Locations
Spain
Luis Ceballos Laita Recruiting
Zaragoza, Spain, 50008
Contact: Luis Ceballos Laita    677380938    lceballoslaita@gmail.com   
Sponsors and Collaborators
Universidad de Zaragoza

Responsible Party: Luis Ceballos Laita, Principal Investigator, Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT03202056     History of Changes
Other Study ID Numbers: C.I.PI17/0182
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The patient data were confidential and were assigned a number to each patient to maintain confidentiality

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

Keywords provided by Luis Ceballos Laita, Universidad de Zaragoza:
hip osteoarthritis
physiotherapy
manual therapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases