Osteoarthritis Clinical Trial
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
| NCT number | NCT03743818 |
| Other study ID # | UCAvila |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 8, 2020 |
| Est. completion date | April 20, 2021 |
| Verified date | April 2021 |
| Source | Universidad Católica de Ávila |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | April 20, 2021 |
| Est. primary completion date | December 15, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Fisiosalud Avila | Avila |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Católica de Ávila | Ignacio Normand Farias, Raúl Vittori, Verónica Prieto Domínguez |
Spain,
Espí-López GV, Serra-Añó P, Vicent-Ferrando J, Sánchez-Moreno-Giner M, Arias-Buría JL, Cleland J, Fernández-de-Las-Peñas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Tri — View Citation
Mayoral O, Salvat I, Martín MT, Martín S, Santiago J, Cotarelo J, Rodríguez 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 Co — View Citation
Sánchez-Romero EA, Pecos-Martín D, Calvo-Lobo C, Ochoa-Sáez V, Burgos-Caballero V, Fernández-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) — View Citation
Velázquez-Saornil J, Ruíz-Ruíz B, Rodríguez-Sanz D, Romero-Morales C, López-López D, Calvo-Lobo C. Efficacy of quadriceps vastus medialis dry needling in a rehabilitation protocol after surgical reconstruction of complete anterior cruciate ligament ruptur — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual Analog Scale | Pain 0 maximum pain score---------10 minimum pain score | 1 month | |
| Secondary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale) | 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 | |
| Secondary | International Physical Activity Questionnaire scale | 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 |
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