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COMPARATIVE STUDY OF THE EFFICACY OF HYALURONIC ACID, DRY NEEDLING AND COMBINED TREATMENT IN PATELLAR OSTEOARTHRITIS

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ClinicalTrials.gov Identifier: NCT03743818
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : March 23, 2020
Sponsor:
Collaborators:
Verónica Prieto Domínguez
Raúl Vittori
Ignacio Normand Farias
Information provided by (Responsible Party):
JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila

Brief Summary:
Randomized clinical trial in patients with knee osteoarthritis. Sixty patients will be evaluated, divided in three groups (20 in each). One group A will be treated by dry needling in the vast internal, other group B will be treated with a standardized treatment protocol (electrotherapy and manual therapy), and group C will be treated with hialuronic acid. The investigators want to observe which technique is the most effective in osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: dry needling Other: ultrasound Device: hyauluronic acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: COMPARATIVE STUDY OF THE EFFICACY OF HYALURONIC ACID, DRY NEEDLING AND COMBINED TREATMENT IN PATELLAR OSTEOARTHRITIS: NON-CONTROLLED RANDOMIZED CLINICAL TRIAL WITH BLINDED EVALUATOR
Estimated Study Start Date : July 8, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : June 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: dry needling
dry needling in trigger point in vastus medialis of quadriceps
Device: dry needling
dry needling on the trigger point of the vastus medialis of the quadriceps

Active Comparator: standardized treatment protocol
in the standardized treatment protocol the investigators including ultrasound, tens, and isometric quadriceps contractions
Other: ultrasound
aply ultrasound on the knee

Active Comparator: hialuronic acid
infiltration of hyaluronic acid in the affected knee
Device: hyauluronic acid
aply hyaluronic acid on the knee




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 1 month ]
    Pain 0 maximum pain score---------10 minimum pain score


Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale) [ Time Frame: 1 month ]
    scale with questions to mesure pain,(5 questions), stiffness (2 questions) and physical function (17 questions). There are five answers in each questions: none, mild, moderate, severe and extreme.

  2. International Physical Activity Questionnaire scale [ Time Frame: 1 month ]
    questions to mesure physical activity. 7 questions about the time that employed the patients in activities physical ( hours/day, minutes/day, days/week or any activity).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with knee pain and diagnosed of osteoarthritis knee and confirm RNM
  • More 18 years.
  • Less 55 years

Exclusion Criteria:

  • More 55 years.
  • Less 18 years.
  • mental dysfunction
  • those who have any type of complication that can cause myofascial or neuropathic pain in the lower limb, such as lumbo-sacral radiculopathy, neuropraxia, neurothymesis, axonotmesis, or meralgia paraesthetica; who have any condition generally considered to be a factor in perpetuating TrPs, such as fibromyalgia, hypothyroidism, or iron deficiency; and patients who may have a fear of needles (belonephobia) will be excluded.

Patients with lower limb dysmetries of 0.50 cm or more were also excluded from this study.


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): NCT03743818


Contacts
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Contact: JORGE V VELAZQUEZ SAORNIL, PhD 655909940 jorge.velazquezsaornil@ucavila.es

Locations
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Spain
Fisiosalud Avila
Avila, Spain, 05003
Contact: JORGE V VELAZQUEZ SAORNIL, PhD    655909940    jorge.velazquezsaornil@ucavila.es   
Contact: PhD         
Sub-Investigator: SARA DELGADO ALVAREZ         
Sponsors and Collaborators
Universidad Católica de Ávila
Verónica Prieto Domínguez
Raúl Vittori
Ignacio Normand Farias
Publications of Results:
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Responsible Party: JORGE VELAZQUEZ SAORNIL, principal investigator, Universidad Católica de Ávila
ClinicalTrials.gov Identifier: NCT03743818    
Other Study ID Numbers: UCAvila
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases