<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/NCT03820856</url>
  </required_header>
  <id_info>
    <org_study_id>98-3818A3</org_study_id>
    <nct_id>NCT03820856</nct_id>
  </id_info>
  <brief_title>Acupuncture Plus Fire Needle and Acupuncture on Lateral Epicondylitis</brief_title>
  <official_title>Therapeutic Effects of Acupuncture Plus Fire Needle Versus Acupuncture on Lateral Epicondylitis: A Randomized Case-control Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate whether or not the outcomes of acupuncture used in&#xD;
      combination with fire needle treatment are better than those of acupuncture alone in patients&#xD;
      with lateral epicondylitis.&#xD;
&#xD;
      The primary outcome was the visual analog scale pain score for the previous 24 hours and the&#xD;
      secondary outcomes were the maximum grip strength, Patient-rated Forearm Evaluation&#xD;
      Questionnaire score, and Medical Outcomes Study 36-Item Short-form Health Survey score. The&#xD;
      values at baseline (pretreatment), at the end of treatment, and at three months after&#xD;
      treatment were used to assess the short-term and intermediate-term effects of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lateral epicondylitis (LE) is the most common diagnosis in patients with elbow pain.&#xD;
&#xD;
      Although many management strategies have been used in patients with LE, including&#xD;
      pain-relieving drugs, corticosteroid injections, physiotherapy, elbow supports, shock-wave&#xD;
      therapy, platelet-rich plasma injections, and surgery, the optimal treatment is still&#xD;
      unclear. When conservative treatments are unsuccessful or not accessible because for cost&#xD;
      reasons, an increasing number of patients consider complementary medicine, particularly&#xD;
      acupuncture.&#xD;
&#xD;
      In a systematic review by Trinh et al., acupuncture was found to relieve the pain of LE&#xD;
      effectively but its long-term efficacy could not be established. Another technique commonly&#xD;
      used to treat chronic pain in patients with LE is fire needle therapy, which combines&#xD;
      acupuncture and moxibustion. A case report demonstrated a significant short-term effect of&#xD;
      fire needle therapy in a patient with LE. Moreover, it has been shown that a combination of&#xD;
      rehabilitation and fire needle therapy is effective for at least 4 weeks in patients with LE.&#xD;
      However, although the early case report demonstrated effects lasting for 4 months, there was&#xD;
      insufficient evidence for the intermediate-term or long-term therapeutic effects of&#xD;
      acupuncture or fire needle therapy in terms of reducing the pain associated with LE.&#xD;
&#xD;
      The aim of this study was to investigate whether or not the outcomes of acupuncture used in&#xD;
      combination with fire needle treatment are better than those of acupuncture alone in patients&#xD;
      with LE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2010</start_date>
  <completion_date type="Actual">March 18, 2011</completion_date>
  <primary_completion_date type="Actual">March 18, 2011</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in severity of elbow pain (VAS score)</measure>
    <time_frame>baseline, 6 weeks, 18 weeks</time_frame>
    <description>The severity of the patient's elbow pain was evaluated using a 10-point VAS (0, no pain; 10, most severe pain imaginable) at rest, during motion, and on exertion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in maximum grip strength</measure>
    <time_frame>baseline, 6 weeks, 18 weeks</time_frame>
    <description>The patient is required to stand with his or her arm alongside the body with the forearm pronated and the elbow extended while holding the dynamometer. The patient is then instructed to squeeze once with maximum pressure, and the measurement is recorded. The maximum grip strength is measured three times with a 30-second rest interval between each measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in Patient-rated Forearm Evaluation Questionnaire score</measure>
    <time_frame>baseline, 6 weeks, 18 weeks</time_frame>
    <description>The Patient-rated Forearm Evaluation Questionnaire is useful for assessment of the outcome of treatment for lateral epicondylitis. The Patient-rated Forearm Evaluation Questionnaire is divided into two sections, ie., pain and function at the elbow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in Medical Outcomes Study 36-Item Short-form Health Survey score</measure>
    <time_frame>baseline, 6 weeks, 18 weeks</time_frame>
    <description>Quality of life was assessed using the Study 36-Item Short-form Health Survey.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Lateral Epicondylitis</condition>
  <condition>Tennis Elbow</condition>
  <condition>Acupuncture</condition>
  <arm_group>
    <arm_group_label>acupuncture plus fire needle group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>acupuncture group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acupuncture plus fire needle therapy</intervention_name>
    <description>The protocol used in this group was the same as that used in the acupuncture alone group except that fire needle therapy was added. The treatments were administered twice weekly for 6 weeks. Fire needle therapy was performed as follows: an acupuncture needle made of tungsten was heated until red-hot over a lighter and then inserted into the two Ah shi points (the tender points on the common extensor tendon, specifically extensor carpi radialis). The red-hot needle was inserted rapidly into the Ah shi point (approximately 5-8 fen deep, 1 cun = 10 fen) for approximately half a second and then removed. Pressure was then applied to the needle hole using a sterilized dry cotton ball.</description>
    <arm_group_label>acupuncture plus fire needle group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>We selected acupoints that have often been recommended for the treatment of lateral epicondylitis. Triple needling was performed at the Ah shi point, i.e., the 1-2-cm area encompassing the most painful spot on the humeral epicondyle. We also manipulated acupuncture needles in the following areas: LI10 (Shousanli), LI11 (Quchi), LI12 (Zhouliao) and LU5 (Chize). The treatments were administered twice weekly for 6 weeks.</description>
    <arm_group_label>acupuncture group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients were selected for inclusion if two or more of the following criteria were&#xD;
             noted on the physical examination form: pain over the lateral aspect of the elbow;&#xD;
             pain on palpation over the lateral epicondyle or the associated myotendinous junction&#xD;
             of the common extensor tendon; pain on hand gripping; and pain with either resisted&#xD;
             static contraction or stretching of the wrist extensor muscles.&#xD;
&#xD;
          2. symptoms have persisted for at least 2 months&#xD;
&#xD;
          3. symptoms are unilateral&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. signs and symptoms suggesting a cause other than overuse (e.g., cervical&#xD;
             radiculopathy)&#xD;
&#xD;
          2. osteoarthritis of the elbow joints&#xD;
&#xD;
          3. pathologic, neurologic, and/or vascular findings in the arms&#xD;
&#xD;
          4. arthritis (local/generalized polyarthritis)&#xD;
&#xD;
          5. radiohumeral bursitis&#xD;
&#xD;
          6. ligamentous sprain&#xD;
&#xD;
          7. bilateral tennis elbow&#xD;
&#xD;
          8. painful shoulder&#xD;
&#xD;
          9. surgery or dislocation of the elbow&#xD;
&#xD;
         10. coagulopathy&#xD;
&#xD;
         11. pregnancy&#xD;
&#xD;
         12. infection&#xD;
&#xD;
         13. malignancy&#xD;
&#xD;
         14. Patients who had been treated with other therapies or drugs for lateral epicondylitis&#xD;
             in the 2 weeks before the start of the trial, those who had received corticosteroid&#xD;
             injections in the previous 6 months, and those who had received acupuncture and fire&#xD;
             needle therapy for lateral epicondylitis were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2010</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 27, 2019</last_update_submitted>
  <last_update_submitted_qc>January 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lateral Epicondylitis</keyword>
  <keyword>Tennis Elbow</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Fire needle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <!-- 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/NCT03820856
org study id: 98-3818A3
nct id: NCT03820856
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate whether or not the outcomes of acupuncture used in
      combination with fire needle treatment are better than those of acupuncture alone in patients
      with lateral epicondylitis.

      The primary outcome was the visual analog scale pain score for the previous 24 hours and the
      secondary outcomes were the maximum grip strength, Patient-rated Forearm Evaluation
      Questionnaire score, and Medical Outcomes Study 36-Item Short-form Health Survey score. The
      values at baseline (pretreatment), at the end of treatment, and at three months after
      treatment were used to assess the short-term and intermediate-term effects of treatment.
Lateral epicondylitis (LE) is the most common diagnosis in patients with elbow pain.

      Although many management strategies have been used in patients with LE, including
      pain-relieving drugs, corticosteroid injections, physiotherapy, elbow supports, shock-wave
      therapy, platelet-rich plasma injections, and surgery, the optimal treatment is still
      unclear. When conservative treatments are unsuccessful or not accessible because for cost
      reasons, an increasing number of patients consider complementary medicine, particularly
      acupuncture.

      In a systematic review by Trinh et al., acupuncture was found to relieve the pain of LE
      effectively but its long-term efficacy could not be established. Another technique commonly
      used to treat chronic pain in patients with LE is fire needle therapy, which combines
      acupuncture and moxibustion. A case report demonstrated a significant short-term effect of
      fire needle therapy in a patient with LE. Moreover, it has been shown that a combination of
      rehabilitation and fire needle therapy is effective for at least 4 weeks in patients with LE.
      However, although the early case report demonstrated effects lasting for 4 months, there was
      insufficient evidence for the intermediate-term or long-term therapeutic effects of
      acupuncture or fire needle therapy in terms of reducing the pain associated with LE.

      The aim of this study was to investigate whether or not the outcomes of acupuncture used in
      combination with fire needle treatment are better than those of acupuncture alone in patients
      with LE.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: changes in severity of elbow pain (VAS score)
time frame: baseline, 6 weeks, 18 weeks
description: The severity of the patient's elbow pain was evaluated using a 10-point VAS (0, no pain; 10, most severe pain imaginable) at rest, during motion, and on exertion.
measure: changes in maximum grip strength
time frame: baseline, 6 weeks, 18 weeks
description: The patient is required to stand with his or her arm alongside the body with the forearm pronated and the elbow extended while holding the dynamometer. The patient is then instructed to squeeze once with maximum pressure, and the measurement is recorded. The maximum grip strength is measured three times with a 30-second rest interval between each measurement.
measure: changes in Patient-rated Forearm Evaluation Questionnaire score
time frame: baseline, 6 weeks, 18 weeks
description: The Patient-rated Forearm Evaluation Questionnaire is useful for assessment of the outcome of treatment for lateral epicondylitis. The Patient-rated Forearm Evaluation Questionnaire is divided into two sections, ie., pain and function at the elbow.
measure: changes in Medical Outcomes Study 36-Item Short-form Health Survey score
time frame: baseline, 6 weeks, 18 weeks
description: Quality of life was assessed using the Study 36-Item Short-form Health Survey.
arm group label: acupuncture plus fire needle group
arm group type: Experimental
arm group label: acupuncture group
arm group type: Active Comparator
intervention type: Procedure
intervention name: acupuncture plus fire needle therapy
description: The protocol used in this group was the same as that used in the acupuncture alone group except that fire needle therapy was added. The treatments were administered twice weekly for 6 weeks. Fire needle therapy was performed as follows: an acupuncture needle made of tungsten was heated until red-hot over a lighter and then inserted into the two Ah shi points (the tender points on the common extensor tendon, specifically extensor carpi radialis). The red-hot needle was inserted rapidly into the Ah shi point (approximately 5-8 fen deep, 1 cun = 10 fen) for approximately half a second and then removed. Pressure was then applied to the needle hole using a sterilized dry cotton ball.
arm group label: acupuncture plus fire needle group
intervention type: Procedure
intervention name: acupuncture
description: We selected acupoints that have often been recommended for the treatment of lateral epicondylitis. Triple needling was performed at the Ah shi point, i.e., the 1-2-cm area encompassing the most painful spot on the humeral epicondyle. We also manipulated acupuncture needles in the following areas: LI10 (Shousanli), LI11 (Quchi), LI12 (Zhouliao) and LU5 (Chize). The treatments were administered twice weekly for 6 weeks.
arm group label: acupuncture group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Tennis Elbow