<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04445727</url>
  </required_header>
  <id_info>
    <org_study_id>PScillone</org_study_id>
    <nct_id>NCT04445727</nct_id>
  </id_info>
  <brief_title>Efficacy of Vitamin C Supplement vs Spinal Manipulation to Treatment in Lateral Epicondylitis</brief_title>
  <official_title>Efficacy of Vitamin C Supplement Addiction vs. High-speed Spinal Manipulation to Routine Physiotherapy Treatment in Lateral Epicondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Rey Juan Carlos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized clinical trial will be conducted. 130 subjects diagnosed with lateral&#xD;
      epicondylitis will be studied. 3 intervention groups will be formed. Experimental group 1&#xD;
      will receive a 1000mg daily vitamin C supplement along with the usual practice of manual&#xD;
      therapy and TENS. Group 2 will undergo high-speed vertebral manipulations along with manual&#xD;
      therapy and TENS. In group 3 or control, manual therapy and transcutaneous electrotherapy&#xD;
      (TENS) will be applied. All groups will receive the same manual therapy program and TENS, one&#xD;
      session per week for 6 consecutive weeks. Data analysis: The data will be entered in the SPSS&#xD;
      statistical package (version 21.0) for analysis). Statistical analysis will be performed with&#xD;
      a 95% confidence interval, meaning that those whose P is &lt;0.05 will be considered significant&#xD;
      values.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 130 subjects will be randomized into 3 groups: Experimental group 1 will receive a&#xD;
      supplement of vitamin C (ascorbic complex) of the Bonusan brand, a daily dose of 1000mg&#xD;
      should be consumed along with the usual practice of manual therapy and TENS. This group will&#xD;
      maintain the daily intake of vitamin C for the 6 weeks that the treatment lasts, they will be&#xD;
      informed of the possible side effects of adaptation to the supplement, such as, for example,&#xD;
      diarrhea since excess vitamin C, in the case if there is, it lodges in the large intestine,&#xD;
      which attracts fluid and produces osmotic diarrhea. This group will have direct communication&#xD;
      with the doctor who collaborates in this investigation for any situation, query or unwanted&#xD;
      symptom. Vitamin C has been used in other degenerative-type pathologies of collagen tissue&#xD;
      such as Achilles tendinopathies and supraspinatus musculature. The investigators have also&#xD;
      found references to the effect of vitamin C as pain treatment. Group 2 will undergo&#xD;
      high-speed vertebral manipulations along with manual therapy and TENS. Vertebral&#xD;
      manipulations would seek a reflexogenic effect through the sympathetic nerve pathway of the&#xD;
      lower cervical ganglion. The transcutaneous TENS-type stimulation is evidenced to have an&#xD;
      analgesic effect using self-adhesive patches placed longitudinally at the myo-junction.&#xD;
      tendon with a size of 50X50 mm, a frequency of 100 Hz and a pulse duration of 200μs for 25&#xD;
      minutes. Both the vertebral manipulation intervention and the TENS placement will be&#xD;
      performed by a professional health physiotherapist with 27 years of clinical experience in&#xD;
      the application of the aforementioned techniques.&#xD;
&#xD;
      In group 3 or control, manual therapy and transcutaneous electrotherapy (TENS) will be&#xD;
      applied. All groups will receive the same manual therapy program and TENS, one session per&#xD;
      week for 6 consecutive weeks.&#xD;
&#xD;
      All the aforementioned interventions will be included in a 45 minute session for the 3 groups&#xD;
      alike. They will be in charge of a highly qualified physiotherapist for all the therapies&#xD;
      when carrying out which expresses his consent for the study in. Said professional uses all&#xD;
      these therapies in consultation daily.&#xD;
&#xD;
      8 The aforementioned therapies can generate some adverse effects that the participants should&#xD;
      be aware of and that is reflected in the informed consent that they must complete before the&#xD;
      start of the evaluation and the interventions. In the first place, in the TENS, no&#xD;
      bibliography has been found that warns of any unwanted effect, which it can refer to is an&#xD;
      increase in skin tone under the patch due to the local effect and heat conduction of the&#xD;
      same. which should disappear within 30 minutes after application.&#xD;
&#xD;
      In high-speed vertebral manipulation in the cervical region, in 6% of cases,&#xD;
      post-manipulation dizziness may occur due to the local vascular change that occurs . The&#xD;
      vitamin C supplement can produce some type of heartburn diarrhea, especially in the first&#xD;
      days of taking, since this vitamin is absorbed in the intestine .&#xD;
&#xD;
      Alterations at the elbow can cause pain and functional limitation. To quantify these effects,&#xD;
      there are different measurement scales. The evaluation to quantify the pain will be carried&#xD;
      out with the numerical pain scale (0-10). The Disabilities of the Arm Shoulder and Hand&#xD;
      (DASH) questionnaire will be used to determine the functionality of the upper limb, the&#xD;
      Shoulder Pain and Disability Index SPADI will be used to assess shoulder function, Global&#xD;
      perception of change will also be evaluated, Global Rating of Change Scale (GROC) a 15-point&#xD;
      scale where -7 indicates much worse than before, 0 the same as before and +7 much better than&#xD;
      before . Finally, the pressure pain threshold (PDU) will be evaluated using a digital&#xD;
      algometer .&#xD;
&#xD;
      Measurement variables will be analyzed before treatment, after it, and at 3 and 6 months&#xD;
      after the last treatment session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Anticipated">March 11, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 22, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain will be measured using an analog visual Scale</measure>
    <time_frame>6 weeks</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand Scale</measure>
    <time_frame>6 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Global Rating of Change Scale</measure>
    <time_frame>6 weeks</time_frame>
    <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).&#xD;
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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Algometry</measure>
    <time_frame>6 weeks</time_frame>
    <description>Pressure pain threshold will be analyzed, defined as the minimum amount of pressure applied to produce pain</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Lateral Epicondylitis</condition>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>vitamin c</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>daily dose of 1000 mg vitamin c in order to regenerate collagen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>spinal manipulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal manipulation in cervical and dorsal with high speed and short amplitude techniques</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transcutaneous electrical nerve stimulation (TENS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>electrotherapy for an analgesic purpose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>manual therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>manual muscle treatment for epicondyl musculature</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Vitamin C</intervention_name>
    <description>Will apply 1000mg of vitamin C, TENS and manual therapy. One session will be held per week for 6 weeks.</description>
    <arm_group_label>Transcutaneous electrical nerve stimulation (TENS)</arm_group_label>
    <arm_group_label>manual therapy</arm_group_label>
    <other_name>tens</other_name>
    <other_name>manual therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>spinal manipulation</intervention_name>
    <description>Applied spinal manipulations, tens and manual therapy.One session will be held per week for 6 weeks.</description>
    <arm_group_label>Transcutaneous electrical nerve stimulation (TENS)</arm_group_label>
    <arm_group_label>manual therapy</arm_group_label>
    <other_name>tens</other_name>
    <other_name>manual therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Transcutaneous electrical nerve stimulation (TENS)</intervention_name>
    <description>Received a manual therapy intervention and Tens. one session will be held per week for 6 weeks.</description>
    <arm_group_label>manual therapy</arm_group_label>
    <arm_group_label>spinal manipulation</arm_group_label>
    <arm_group_label>vitamin c</arm_group_label>
    <other_name>manual therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elbow pain patients medically diagnosed with epicondylitis by ultrasound of more than&#xD;
             4 weeks of evolution.&#xD;
&#xD;
          -  Age between 35 and 55 years (both inclusive).&#xD;
&#xD;
          -  Have signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have received corticosteroid infiltrations in the previous 3 months. Having received&#xD;
             physical therapy treatment for the same reason in last 3 months.&#xD;
&#xD;
          -  Bilateral symptoms.&#xD;
&#xD;
          -  Fibromyalgia syndrome.&#xD;
&#xD;
          -  Previous trauma to the upper limb.&#xD;
&#xD;
          -  Fractures or prior dislocation of the shoulder or elbow.&#xD;
&#xD;
          -  Previous surgeries on the shoulder or elbow.&#xD;
&#xD;
          -  Psychiatric treatment.&#xD;
&#xD;
          -  Cognitive deficit.&#xD;
&#xD;
          -  Owning defibrillator or pacemaker.&#xD;
&#xD;
          -  Acute infectious diseases.&#xD;
&#xD;
          -  Uncontrolled systemic pathologies (heart disease, pacemaker, coagulation disorders).&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  History of rheumatic disease affecting the elbow such as rheumatoid arthritis, gout,&#xD;
             reflex sympathetic dystrophy, plaque psoriasis. • Oncological processes.&#xD;
&#xD;
          -  Aversion or fear of the application of currents.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana I de la Llave Rincón</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Rey Juan Carlos</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José J Arias Buría</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Rey Juan Carlos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pablo Federico Scillone Tessore</name>
      <address>
        <city>San Sebastián De Los Reyes</city>
        <state>Madrid</state>
        <zip>28702</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>22923162</PMID>
  </results_reference>
  <results_reference>
    <citation>Leijn E, Monnens LA, Cornelissen EA. Intravenous iron supplementation in children on hemodialysis. J Nephrol. 2004 May-Jun;17(3):423-6.</citation>
    <PMID>15365964</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>25246239</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>26149189</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>28861199</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>24378321</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>19028251</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>Pablo Federico Scillone Tessore</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Acid, Ascorbic</keyword>
  <keyword>Transcutaneous Electric Nerve Stimulation</keyword>
  <keyword>Spinal Manipulation</keyword>
  <keyword>Musculoskeletal Manipulations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>vitamin c</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>http://www.bonusan.es/vademecum/vitamina_c1000_complejo_de_ascorbatos.html</doc_url>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04445727
org study id: PScillone
nct id: NCT04445727
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Pain will be measured using an analog visual Scale
time frame: 6 weeks
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
measure: Disabilities of the Arm, Shoulder and Hand Scale
time frame: 6 weeks
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.
measure: Global Rating of Change Scale
time frame: 6 weeks
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.
measure: Algometry
time frame: 6 weeks
description: Pressure pain threshold will be analyzed, defined as the minimum amount of pressure applied to produce pain
arm group label: vitamin c
arm group type: Experimental
description: daily dose of 1000 mg vitamin c in order to regenerate collagen
arm group label: spinal manipulation
arm group type: Experimental
description: Spinal manipulation in cervical and dorsal with high speed and short amplitude techniques
arm group label: Transcutaneous electrical nerve stimulation (TENS)
arm group type: Experimental
description: electrotherapy for an analgesic purpose
arm group label: manual therapy
arm group type: Experimental
description: manual muscle treatment for epicondyl musculature
intervention type: Combination Product
intervention name: Vitamin C
description: Will apply 1000mg of vitamin C, TENS and manual therapy. One session will be held per week for 6 weeks.
arm group label: Transcutaneous electrical nerve stimulation (TENS)
arm group label: manual therapy
other name: tens
other name: manual therapy
intervention type: Combination Product
intervention name: spinal manipulation
description: Applied spinal manipulations, tens and manual therapy.One session will be held per week for 6 weeks.
arm group label: Transcutaneous electrical nerve stimulation (TENS)
arm group label: manual therapy
other name: tens
other name: manual therapy
intervention type: Combination Product
intervention name: Transcutaneous electrical nerve stimulation (TENS)
description: Received a manual therapy intervention and Tens. one session will be held per week for 6 weeks.
arm group label: manual therapy
arm group label: spinal manipulation
arm group label: vitamin c
other name: manual therapy
criteria: 
gender: All
minimum age: 35 Years
maximum age: 55 Years
healthy volunteers: No
last name: Ana I de la Llave Rincón
role: Study Director
affiliation: Universidad Rey Juan Carlos
last name: José J Arias Buría
role: Study Director
affiliation: Universidad Rey Juan Carlos
facility: 
country: Spain
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.
PMID: 22923162
citation: Leijn E, Monnens LA, Cornelissen EA. Intravenous iron supplementation in children on hemodialysis. J Nephrol. 2004 May-Jun;17(3):423-6.
PMID: 15365964
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.
PMID: 25246239
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.
PMID: 26149189
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.
PMID: 28861199
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.
PMID: 24378321
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.
PMID: 19028251
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: Pablo Federico Scillone Tessore
investigator title: Principal Investigator
mesh term: Tennis Elbow
sharing ipd: No
study doc: 