Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 78 of 1203 for:    acupuncture

Acupuncture Plus Fire Needle and Acupuncture on Lateral Epicondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820856
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.


Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Tennis Elbow Acupuncture Procedure: acupuncture plus fire needle therapy Procedure: acupuncture Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Acupuncture Plus Fire Needle Versus Acupuncture on Lateral Epicondylitis: A Randomized Case-control Pilot Study
Actual Study Start Date : August 5, 2010
Actual Primary Completion Date : March 18, 2011
Actual Study Completion Date : March 18, 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: acupuncture plus fire needle group Procedure: acupuncture plus fire needle therapy
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.

Active Comparator: acupuncture group Procedure: acupuncture
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 Measures :
  1. changes in severity of elbow pain (VAS score) [ Time Frame: baseline, 6 weeks, 18 weeks ]
    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 :
  1. changes in maximum grip strength [ Time Frame: baseline, 6 weeks, 18 weeks ]
    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.

  2. changes in Patient-rated Forearm Evaluation Questionnaire score [ Time Frame: baseline, 6 weeks, 18 weeks ]
    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.

  3. changes in Medical Outcomes Study 36-Item Short-form Health Survey score [ Time Frame: baseline, 6 weeks, 18 weeks ]
    Quality of life was assessed using the Study 36-Item Short-form Health Survey.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820856


Locations
Layout table for location information
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital

Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03820856     History of Changes
Other Study ID Numbers: 98-3818A3
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: March 2010

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Lateral Epicondylitis
Tennis Elbow
Acupuncture
Fire needle
Additional relevant MeSH terms:
Layout table for MeSH terms
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries