Clinical trial NCT03820856: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Tennis Elbow
Acupuncture
Keywords: Lateral Epicondylitis
Tennis Elbow
Acupuncture
Fire needle
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: changes in severity of elbow pain (VAS score)
timeFrame: baseline, 6 weeks, 18 weeks
Secondary outcomes:
measure: changes in maximum grip strength
timeFrame: baseline, 6 weeks, 18 weeks
measure: changes in Patient-rated Forearm Evaluation Questionnaire score
timeFrame: baseline, 6 weeks, 18 weeks
measure: changes in Medical Outcomes Study 36-Item Short-form Health Survey score
timeFrame: baseline, 6 weeks, 18 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References: