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Efficacy of Vitamin C Supplement vs Spinal Manipulation to Treatment in Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis, Tennis Elbow

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vitamin C
spinal manipulation
Transcutaneous electrical nerve stimulation (TENS)
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Acid, Ascorbic, Transcutaneous Electric Nerve Stimulation, Spinal Manipulation, Musculoskeletal Manipulations

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Pablo Federico Scillone Tessore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

vitamin c

spinal manipulation

Transcutaneous electrical nerve stimulation (TENS)

manual therapy

Arm Description

daily dose of 1000 mg vitamin c in order to regenerate collagen

Spinal manipulation in cervical and dorsal with high speed and short amplitude techniques

electrotherapy for an analgesic purpose

manual muscle treatment for epicondyl musculature

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disabilities of the Arm, Shoulder and Hand Scale
The questionnaire will consist of 30 questions about their symptoms and the ability to carry out certain activities and has been validated in Spanish. The patient should answer the questions by circling the number that best describes their condition during the past week. Each item will be answered on a scale from 1 to 5, where 1 indicates that it has no difficulty executing, has no symptoms or impact, and 5 indicates that it cannot be performed, that it has very severe symptoms and a strong impact.

Full Information

First Posted
June 14, 2020
Last Updated
June 23, 2020
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT04445727
Brief Title
Efficacy of Vitamin C Supplement vs Spinal Manipulation to Treatment in Lateral Epicondylitis
Official Title
Efficacy of Vitamin C Supplement Addiction vs. High-speed Spinal Manipulation to Routine Physiotherapy Treatment in Lateral Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
January 22, 2021 (Anticipated)
Study Completion Date
March 11, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The 130 subjects will be randomized into 3 groups: Experimental group 1 will receive a supplement of vitamin C (ascorbic complex) of the Bonusan brand, a daily dose of 1000mg should be consumed along with the usual practice of manual therapy and TENS. This group will maintain the daily intake of vitamin C for the 6 weeks that the treatment lasts, they will be informed of the possible side effects of adaptation to the supplement, such as, for example, diarrhea since excess vitamin C, in the case if there is, it lodges in the large intestine, which attracts fluid and produces osmotic diarrhea. This group will have direct communication with the doctor who collaborates in this investigation for any situation, query or unwanted symptom. Vitamin C has been used in other degenerative-type pathologies of collagen tissue such as Achilles tendinopathies and supraspinatus musculature. The investigators have also found references to the effect of vitamin C as pain treatment. Group 2 will undergo high-speed vertebral manipulations along with manual therapy and TENS. Vertebral manipulations would seek a reflexogenic effect through the sympathetic nerve pathway of the lower cervical ganglion. The transcutaneous TENS-type stimulation is evidenced to have an analgesic effect using self-adhesive patches placed longitudinally at the myo-junction. tendon with a size of 50X50 mm, a frequency of 100 Hz and a pulse duration of 200μs for 25 minutes. Both the vertebral manipulation intervention and the TENS placement will be performed by a professional health physiotherapist with 27 years of clinical experience in the application of the aforementioned techniques. 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. All the aforementioned interventions will be included in a 45 minute session for the 3 groups alike. They will be in charge of a highly qualified physiotherapist for all the therapies when carrying out which expresses his consent for the study in. Said professional uses all these therapies in consultation daily. 8 The aforementioned therapies can generate some adverse effects that the participants should be aware of and that is reflected in the informed consent that they must complete before the start of the evaluation and the interventions. In the first place, in the TENS, no bibliography has been found that warns of any unwanted effect, which it can refer to is an increase in skin tone under the patch due to the local effect and heat conduction of the same. which should disappear within 30 minutes after application. In high-speed vertebral manipulation in the cervical region, in 6% of cases, post-manipulation dizziness may occur due to the local vascular change that occurs . The vitamin C supplement can produce some type of heartburn diarrhea, especially in the first days of taking, since this vitamin is absorbed in the intestine . Alterations at the elbow can cause pain and functional limitation. To quantify these effects, there are different measurement scales. The evaluation to quantify the pain will be carried out with the numerical pain scale (0-10). The Disabilities of the Arm Shoulder and Hand (DASH) questionnaire will be used to determine the functionality of the upper limb, the Shoulder Pain and Disability Index SPADI will be used to assess shoulder function, Global perception of change will also be evaluated, Global Rating of Change Scale (GROC) a 15-point scale where -7 indicates much worse than before, 0 the same as before and +7 much better than before . Finally, the pressure pain threshold (PDU) will be evaluated using a digital algometer . Measurement variables will be analyzed before treatment, after it, and at 3 and 6 months after the last treatment session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Tennis Elbow
Keywords
Acid, Ascorbic, Transcutaneous Electric Nerve Stimulation, Spinal Manipulation, Musculoskeletal Manipulations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin c
Arm Type
Experimental
Arm Description
daily dose of 1000 mg vitamin c in order to regenerate collagen
Arm Title
spinal manipulation
Arm Type
Experimental
Arm Description
Spinal manipulation in cervical and dorsal with high speed and short amplitude techniques
Arm Title
Transcutaneous electrical nerve stimulation (TENS)
Arm Type
Experimental
Arm Description
electrotherapy for an analgesic purpose
Arm Title
manual therapy
Arm Type
Experimental
Arm Description
manual muscle treatment for epicondyl musculature
Intervention Type
Combination Product
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
tens, manual therapy
Intervention Description
Will apply 1000mg of vitamin C, TENS and manual therapy. One session will be held per week for 6 weeks.
Intervention Type
Combination Product
Intervention Name(s)
spinal manipulation
Other Intervention Name(s)
tens, manual therapy
Intervention Description
Applied spinal manipulations, tens and manual therapy.One session will be held per week for 6 weeks.
Intervention Type
Combination Product
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Other Intervention Name(s)
manual therapy
Intervention Description
Received a manual therapy intervention and Tens. one session will be held per week for 6 weeks.
Primary Outcome Measure Information:
Title
Pain will be measured using an analog visual Scale
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand Scale
Description
The questionnaire will consist of 30 questions about their symptoms and the ability to carry out certain activities and has been validated in Spanish. The patient should answer the questions by circling the number that best describes their condition during the past week. Each item will be answered on a scale from 1 to 5, where 1 indicates that it has no difficulty executing, has no symptoms or impact, and 5 indicates that it cannot be performed, that it has very severe symptoms and a strong impact.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Global Rating of Change Scale
Description
The 15-point improvement self-perception scale (GROC) will be used, consisting of a 15-point Likert scale ranging from a rating of 0 to +7 (I am much better) or -7 (I am much worse). eleven The descriptors of improvement range from +1 to +7, and those of worsening from -1 to -7. A value of +5 has been shown to be indicative of moderate clinical improvement, while a value of +6 or +7 suggests high clinical improvement.
Time Frame
6 weeks
Title
Algometry
Description
Pressure pain threshold will be analyzed, defined as the minimum amount of pressure applied to produce pain
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana I de la Llave Rincón
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
José J Arias Buría
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Director
Facility Information:
Facility Name
Pablo Federico Scillone Tessore
City
San Sebastián De Los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22923162
Citation
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. Erratum In: Adv Ther. 2012 Nov;29(11):992.
Results Reference
result
PubMed Identifier
15365964
Citation
Leijn E, Monnens LA, Cornelissen EA. Intravenous iron supplementation in children on hemodialysis. J Nephrol. 2004 May-Jun;17(3):423-6.
Results Reference
result
PubMed Identifier
25246239
Citation
Passerieux 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.
Results Reference
result
PubMed Identifier
26149189
Citation
Malek 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.
Results Reference
result
PubMed Identifier
28861199
Citation
Lee 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.
Results Reference
result
PubMed Identifier
24378321
Citation
Coombes 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.
Results Reference
result
PubMed Identifier
19028251
Citation
Fernandez-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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.bonusan.es/vademecum/vitamina_c1000_complejo_de_ascorbatos.html
Available IPD/Information Identifier
vitamin c

Learn more about this trial

Efficacy of Vitamin C Supplement vs Spinal Manipulation to Treatment in Lateral Epicondylitis

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