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Acupuncture Plus Fire Needle and Acupuncture on Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis, Tennis Elbow, Acupuncture

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture plus fire needle therapy
acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Lateral Epicondylitis, Tennis Elbow, Acupuncture, Fire needle

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients were selected for inclusion if two or more of the following criteria were noted on the physical examination form: pain over the lateral aspect of the elbow; pain on palpation over the lateral epicondyle or the associated myotendinous junction of the common extensor tendon; pain on hand gripping; and pain with either resisted static contraction or stretching of the wrist extensor muscles.
  2. symptoms have persisted for at least 2 months
  3. symptoms are unilateral

Exclusion Criteria:

  1. signs and symptoms suggesting a cause other than overuse (e.g., cervical radiculopathy)
  2. osteoarthritis of the elbow joints
  3. pathologic, neurologic, and/or vascular findings in the arms
  4. arthritis (local/generalized polyarthritis)
  5. radiohumeral bursitis
  6. ligamentous sprain
  7. bilateral tennis elbow
  8. painful shoulder
  9. surgery or dislocation of the elbow
  10. coagulopathy
  11. pregnancy
  12. infection
  13. malignancy
  14. Patients who had been treated with other therapies or drugs for lateral epicondylitis in the 2 weeks before the start of the trial, those who had received corticosteroid injections in the previous 6 months, and those who had received acupuncture and fire needle therapy for lateral epicondylitis were also excluded.

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

acupuncture plus fire needle group

acupuncture group

Arm Description

Outcomes

Primary Outcome Measures

changes in severity of elbow pain (VAS score)
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.

Secondary Outcome Measures

changes in maximum grip strength
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.
changes in Patient-rated Forearm Evaluation Questionnaire score
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.
changes in Medical Outcomes Study 36-Item Short-form Health Survey score
Quality of life was assessed using the Study 36-Item Short-form Health Survey.

Full Information

First Posted
January 24, 2019
Last Updated
January 27, 2019
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03820856
Brief Title
Acupuncture Plus Fire Needle and Acupuncture on Lateral Epicondylitis
Official Title
Therapeutic Effects of Acupuncture Plus Fire Needle Versus Acupuncture on Lateral Epicondylitis: A Randomized Case-control Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 5, 2010 (Actual)
Primary Completion Date
March 18, 2011 (Actual)
Study Completion Date
March 18, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Tennis Elbow, Acupuncture
Keywords
Lateral Epicondylitis, Tennis Elbow, Acupuncture, Fire needle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture plus fire needle group
Arm Type
Experimental
Arm Title
acupuncture group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
acupuncture plus fire needle therapy
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention 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.
Primary Outcome Measure Information:
Title
changes in severity of elbow pain (VAS score)
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.
Time Frame
baseline, 6 weeks, 18 weeks
Secondary Outcome Measure Information:
Title
changes in maximum grip strength
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.
Time Frame
baseline, 6 weeks, 18 weeks
Title
changes in Patient-rated Forearm Evaluation Questionnaire score
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.
Time Frame
baseline, 6 weeks, 18 weeks
Title
changes in Medical Outcomes Study 36-Item Short-form Health Survey score
Description
Quality of life was assessed using the Study 36-Item Short-form Health Survey.
Time Frame
baseline, 6 weeks, 18 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients were selected for inclusion if two or more of the following criteria were noted on the physical examination form: pain over the lateral aspect of the elbow; pain on palpation over the lateral epicondyle or the associated myotendinous junction of the common extensor tendon; pain on hand gripping; and pain with either resisted static contraction or stretching of the wrist extensor muscles. symptoms have persisted for at least 2 months symptoms are unilateral Exclusion Criteria: signs and symptoms suggesting a cause other than overuse (e.g., cervical radiculopathy) osteoarthritis of the elbow joints pathologic, neurologic, and/or vascular findings in the arms arthritis (local/generalized polyarthritis) radiohumeral bursitis ligamentous sprain bilateral tennis elbow painful shoulder surgery or dislocation of the elbow coagulopathy pregnancy infection malignancy Patients who had been treated with other therapies or drugs for lateral epicondylitis in the 2 weeks before the start of the trial, those who had received corticosteroid injections in the previous 6 months, and those who had received acupuncture and fire needle therapy for lateral epicondylitis were also excluded.
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

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Acupuncture Plus Fire Needle and Acupuncture on Lateral Epicondylitis

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