Efficacy of Vitamin C Supplement vs Spinal Manipulation to Treatment in Lateral Epicondylitis
1 other identifier
interventional
130
1 country
1
Brief Summary
A randomized clinical trial will be conducted. 130 subjects diagnosed with lateral epicondylitis will be studied. 3 intervention groups will be formed. Experimental group 1 will receive a 1000mg daily vitamin C supplement along with the usual practice of manual therapy and TENS. Group 2 will undergo high-speed vertebral manipulations along with manual therapy and TENS. In group 3 or control, manual therapy and transcutaneous electrotherapy (TENS) will be applied. All groups will receive the same manual therapy program and TENS, one session per week for 6 consecutive weeks. Data analysis: The data will be entered in the SPSS statistical package (version 21.0) for analysis). Statistical analysis will be performed with a 95% confidence interval, meaning that those whose P is \<0.05 will be considered significant values.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2020
CompletedFirst Submitted
Initial submission to the registry
June 14, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2021
CompletedJune 26, 2020
June 1, 2020
8 months
June 14, 2020
June 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain will be measured using an analog visual Scale
For this, patients will be indicated how they should complete the scale, providing a numerical value from 0 to 10, being 10 0 no pain, and 10 the most severe or intense pain. The numerical pain scale is a simple, solid, sensitive and reproducible instrument, useful for reassessing patient pain
6 weeks
Secondary Outcomes (1)
Disabilities of the Arm, Shoulder and Hand Scale
6 weeks
Other Outcomes (2)
Global Rating of Change Scale
6 weeks
Algometry
6 weeks
Study Arms (4)
vitamin c
EXPERIMENTALdaily dose of 1000 mg vitamin c in order to regenerate collagen
spinal manipulation
EXPERIMENTALSpinal manipulation in cervical and dorsal with high speed and short amplitude techniques
Transcutaneous electrical nerve stimulation (TENS)
EXPERIMENTALelectrotherapy for an analgesic purpose
manual therapy
EXPERIMENTALmanual muscle treatment for epicondyl musculature
Interventions
Will apply 1000mg of vitamin C, TENS and manual therapy. One session will be held per week for 6 weeks.
Applied spinal manipulations, tens and manual therapy.One session will be held per week for 6 weeks.
Received a manual therapy intervention and Tens. one session will be held per week for 6 weeks.
Eligibility Criteria
You may qualify if:
- Elbow pain patients medically diagnosed with epicondylitis by ultrasound of more than 4 weeks of evolution.
- Age between 35 and 55 years (both inclusive).
- Have signed the informed consent.
You may not qualify if:
- Have received corticosteroid infiltrations in the previous 3 months. Having received physical therapy treatment for the same reason in last 3 months.
- Bilateral symptoms.
- Fibromyalgia syndrome.
- Previous trauma to the upper limb.
- Fractures or prior dislocation of the shoulder or elbow.
- Previous surgeries on the shoulder or elbow.
- Psychiatric treatment.
- Cognitive deficit.
- Owning defibrillator or pacemaker.
- Acute infectious diseases.
- Uncontrolled systemic pathologies (heart disease, pacemaker, coagulation disorders).
- Pregnant women.
- History of rheumatic disease affecting the elbow such as rheumatoid arthritis, gout, reflex sympathetic dystrophy, plaque psoriasis. • Oncological processes.
- Aversion or fear of the application of currents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pablo Federico Scillone Tessore
San Sebastián de los Reyes, Madrid, 28702, Spain
Related Publications (7)
Notarnicola A, Pesce V, Vicenti G, Tafuri S, Forcignano M, Moretti B. SWAAT study: extracorporeal shock wave therapy and arginine supplementation and other nutraceuticals for insertional Achilles tendinopathy. Adv Ther. 2012 Sep;29(9):799-814. doi: 10.1007/s12325-012-0046-4. Epub 2012 Aug 24.
PMID: 22923162RESULTLeijn E, Monnens LA, Cornelissen EA. Intravenous iron supplementation in children on hemodialysis. J Nephrol. 2004 May-Jun;17(3):423-6.
PMID: 15365964RESULTPasserieux E, Hayot M, Jaussent A, Carnac G, Gouzi F, Pillard F, Picot MC, Bocker K, Hugon G, Pincemail J, Defraigne JO, Verrips T, Mercier J, Laoudj-Chenivesse D. Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: a double-blind randomized controlled clinical trial. Free Radic Biol Med. 2015 Apr;81:158-69. doi: 10.1016/j.freeradbiomed.2014.09.014. Epub 2014 Sep 20.
PMID: 25246239RESULTMalek Mahdavi A, Mahdavi R, Kolahi S, Zemestani M, Vatankhah AM. L-Carnitine supplementation improved clinical status without changing oxidative stress and lipid profile in women with knee osteoarthritis. Nutr Res. 2015 Aug;35(8):707-15. doi: 10.1016/j.nutres.2015.06.003. Epub 2015 Jun 16.
PMID: 26149189RESULTLee GW, Yang HS, Yeom JS, Ahn MW. The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial. Clin Orthop Surg. 2017 Sep;9(3):317-324. doi: 10.4055/cios.2017.9.3.317. Epub 2017 Aug 4.
PMID: 28861199RESULTCoombes BK, Bisset L, Vicenzino B. Bilateral cervical dysfunction in patients with unilateral lateral epicondylalgia without concomitant cervical or upper limb symptoms: a cross-sectional case-control study. J Manipulative Physiol Ther. 2014 Feb;37(2):79-86. doi: 10.1016/j.jmpt.2013.12.005. Epub 2013 Dec 28.
PMID: 24378321RESULTFernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.
PMID: 19028251RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ana I de la Llave Rincón
Universidad Rey Juan Carlos
- STUDY DIRECTOR
José J Arias Buría
Universidad Rey Juan Carlos
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 14, 2020
First Posted
June 24, 2020
Study Start
May 21, 2020
Primary Completion
January 22, 2021
Study Completion
March 11, 2021
Last Updated
June 26, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share