Lateral EpicondylitisNCT03820856
Acupuncture Plus Fire Needle and Acupuncture on Lateral Epicondylitis
A study testing acupuncture plus fire needle therapy and acupuncture in people with Lateral Epicondylitis and Tennis Elbow, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow, Acupuncture
- What is being tested?
- acupuncture plus fire needle therapy and acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Aug 2010to 18 Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Acupuncture Plus Fire Needle Versus Acupuncture on Lateral Epicondylitis: A Randomized Case-control Pilot Study
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.
Read the 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.
- Conditions
- Lateral Epicondylitis, Tennis Elbow, Acupuncture
- Being tested
- acupuncture plus fire needle therapy, acupuncture
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Acupuncture, Fire needle
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture plus fire needle therapyProcedure or surgery
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.
acupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture plus fire needle group | Experimental | Not described Receives: Procedure: acupuncture plus fire needle therapy |
| acupuncture group | Active comparator | Not described Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks, 18 weeks
Secondary outcomes (3)
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.
Measured: baseline, 6 weeks, 18 weeks
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.
Measured: baseline, 6 weeks, 18 weeks
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.
Measured: baseline, 6 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start5 Aug 2010
- Primary completion18 Mar 2011
- Study completion18 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820856
- Sponsor's protocol ID
- 98-3818A3
- Status last verified
- Mar 2010
- First submitted
- 24 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Acupuncture Plus Fire Needle Versus Acupuncture on Lateral Epicondylitis: A Randomized Case-control Pilot Study
- ClinicalTrials.gov ID
- NCT03820856
- Acronym / sponsor ID
- 98-3818A3
- Conditions
- Lateral Epicondylitis, Tennis Elbow, Acupuncture
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Acupuncture, Fire needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Aug 2010 (actual)
- Primary completion
- 18 Mar 2011 (actual)
- Study completion
- 18 Mar 2011 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture plus fire needle group | Experimental | Procedure: acupuncture plus fire needle therapy |
| acupuncture group | Active comparator | Procedure: acupuncture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture plus fire needle therapyThe 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. | Procedure or surgery | acupuncture plus fire needle group |
| acupunctureWe 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. | Procedure or surgery | acupuncture group |
Primary outcome
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.
3 secondary outcomes
changes in maximum grip strength
Time frame: baseline, 6 weeks, 18 weeks
changes in Patient-rated Forearm Evaluation Questionnaire score
Time frame: baseline, 6 weeks, 18 weeks
changes in Medical Outcomes Study 36-Item Short-form Health Survey score
Time frame: baseline, 6 weeks, 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture plus fire needle therapy and acupuncture in people with Lateral Epicondylitis and Tennis Elbow, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in severity of elbow pain (VAS score) (time frame: baseline, 6 weeks, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.