NCT03743818

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 11, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

November 11, 2018

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    Pain 0 maximum pain score---------10 minimum pain score

    1 month

Secondary Outcomes (2)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)

    1 month

  • International Physical Activity Questionnaire scale

    1 month

Study Arms (3)

dry needling

EXPERIMENTAL

dry needling in trigger point in vastus medialis of quadriceps

Device: dry needling

standardized treatment protocol

ACTIVE COMPARATOR

in the standardized treatment protocol the investigators including ultrasound, tens, and isometric quadriceps contractions

Other: ultrasound

hialuronic acid

ACTIVE COMPARATOR

infiltration of hyaluronic acid in the affected knee

Device: hyauluronic acid

Interventions

dry needling on the trigger point of the vastus medialis of the quadriceps

dry needling

aply ultrasound on the knee

standardized treatment protocol

aply hyaluronic acid on the knee

hialuronic acid

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisiosalud Avila

Ávila, 05003, Spain

Location

Related Publications (4)

  • Velazquez-Saornil J, Ruiz-Ruiz B, Rodriguez-Sanz D, Romero-Morales C, Lopez-Lopez D, Calvo-Lobo C. Efficacy of quadriceps vastus medialis dry needling in a rehabilitation protocol after surgical reconstruction of complete anterior cruciate ligament rupture. Medicine (Baltimore). 2017 Apr;96(17):e6726. doi: 10.1097/MD.0000000000006726.

  • Sanchez-Romero EA, Pecos-Martin D, Calvo-Lobo C, Ochoa-Saez V, Burgos-Caballero V, Fernandez-Carnero J. Effects of dry needling in an exercise program for older adults with knee osteoarthritis: A pilot clinical trial. Medicine (Baltimore). 2018 Jun;97(26):e11255. doi: 10.1097/MD.0000000000011255.

  • Espi-Lopez GV, Serra-Ano P, Vicent-Ferrando J, Sanchez-Moreno-Giner M, Arias-Buria JL, Cleland J, Fernandez-de-Las-Penas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial. J Orthop Sports Phys Ther. 2017 Jun;47(6):392-401. doi: 10.2519/jospt.2017.7389. Epub 2017 May 13.

  • Mayoral O, Salvat I, Martin MT, Martin S, Santiago J, Cotarelo J, Rodriguez C. Efficacy of myofascial trigger point dry needling in the prevention of pain after total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Evid Based Complement Alternat Med. 2013;2013:694941. doi: 10.1155/2013/694941. Epub 2013 Mar 27.

MeSH Terms

Conditions

Osteoarthritis

Interventions

Dry NeedlingHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 11, 2018

First Posted

November 16, 2018

Study Start

July 8, 2020

Primary Completion

December 15, 2020

Study Completion

April 20, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations