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

April 26, 2021 updated by: JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila

COMPARATIVE STUDY OF THE EFFICACY OF HYALURONIC ACID, DRY NEEDLING AND COMBINED TREATMENT IN PATELLAR OSTEOARTHRITIS: NON-CONTROLLED RANDOMIZED CLINICAL TRIAL WITH BLINDED EVALUATOR

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Avila, Spain, 05003
        • Fisiosalud Avila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 1 month
Pain 0 maximum pain score---------10 minimum pain score
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month
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).
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica de Ávila

Collaborators

Verónica Prieto Domínguez
Raúl Vittori
Ignacio Normand Farias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2020

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

April 20, 2021

Study Registration Dates

First Submitted

November 11, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCAvila

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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