Lateral EpicondylitisNCT03605563
Fu's Subcutaneous Needling on the Myofascial Trigger Points: Lateral Epicondylitis
A study testing Fu's subcutaneous needling and Transcutaneous electrical nerve stimulation in people with Lateral Epicondylitis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The symptoms can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Fu's subcutaneous needling and Transcutaneous electrical nerve stimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2018to 28 Apr 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects older than 20 years of age who can cooperate with the experimental volunteers.
- 2. Suffering from epicondylitis of the humerus for more than one month, and subjective pain intensity (VAS) greater than 5 points.
- 3. There is a local tender point at the upper elbow of the elbow, and the isometric resistance test of the forearm to make a spin will induce pain.
- 4. Under soft tissue ultrasound, the thickness of the common tendon of the extensor carpi muscles is more than 0.15 mm greater than that of the healthy side.
Who cannot join
- 1. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
- 2. There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
- 3. Have received neck, upper back, or upper and lower limb surgery. 4. People with central or peripheral nerve disease. 5. Cognitive impairment, unable to cooperate with the experimenter. 6. Patients currently receiving other treatments for epicondylitis of the humerus.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 999079
Chou Li-Wei, PhD, +886-4-22052121 ext. 2381, chouliwe@mail.cmuh.org.tw
About this study
Official title: Changes in the Muscle Tone of Affected Muscle After Fu's Subcutaneous Needling on the Myofascial Trigger Points - a Sample of Lateral Epicondylitis
Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The symptoms can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag.
This is a randomized study, the investigators will evaluate the immediate, short-term, and long-term effect of Fu's subcutaneous needling on the patients suffering with lateral epicondylitis.
Read the detailed description
Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The major mechanism is overuse of the flexors, extensors and supination muscles in the wrist, causing micro-trauma in the muscles attachment to the lateral epicondyle of the elbow. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. Patients often describe pain at the lateral aspect of the elbow. Pain can be further elicited with passive wrist flexion and by resisting active wrist extension. Symptoms also include weakness in the grip strength and limitation of elbow motion. Therefore, it can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag.
Fu's subcutaneous needling (FSN), as one of the dry needle treatments, performed by swaying a disposable Fu's subcutaneous needle parallel to the underlying muscles after penetrating the skin to the subcutaneous fascia. With the reperfusion activities, myofascial pain and soft tissue pain caused by myofascial trigger points can be decreased effective simultaneously. So far, there is no solid research or clinical trial to evaluate the efficacy of the treatment yet.
The investigators will conduct the randomized experiment to evaluate the immediate, short-term, and long-term effect of FSN. The outcome measures include visual analog scale, patient-rated tennis elbow evaluation questionnaire, pressure pain threshold, pain-free grip test, muscle tone changes and ultrasonographic evaluaton of the common extensor tendon.
- Conditions
- Lateral Epicondylitis
- Being tested
- Fu's subcutaneous needling, Transcutaneous electrical nerve stimulation
- Keywords
- Fu's subcutaneous needling (FSN), Myofascial trigger point
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fu's subcutaneous needlingProcedure or surgery
Fu's Subcutaneous Needle (FSN), is an innovation for the treatment of myofascial pain and trigger points. The needle is a non-injection needle, and the fact that both needles are manipulated and act on soft connective tissue.
FSN abstains from the muscle and deep fascia layers and is confined to only the subcutaneous layer where collagen fibers are most abundant. As the subcutaneous layer is poorly innervated, pain is less than other needling therapies.
FSN is also currently being used successfully to treat non-musculoskeletal conditions.
Transcutaneous electrical nerve stimulationProcedure or surgery
Transcutaneous electrical nerve stimulation (TENS or TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.
TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical batteryoperated TENS unit is able to modulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10 Hz) with an intensity that produces motor contraction.
| Study group | Role | What they receive |
|---|---|---|
| FSN: Fu's subcutaneous needling | Experimental | In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately. Receives: Procedure: Fu's subcutaneous needling |
| TENS: Transcutaneous Electric Nerve Stimulation | Active comparator | In this arm, the subjects will receive the intervention of TENS on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately. Receives: Procedure: Transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scales
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Measured: 1 day
Secondary outcomes (3)
Pressure Pain Threshold
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom.
Measured: 1 day
Myotone of MTrPs
Muscle tone is the muscle's resistance to passive stretch during resting state. Myotone will help the investigators to get muscle parameters such as tone, elasticity and stiffness.
Measured: 1 day
Pain-free grip test
The pain-free grip (PFG) test is used to measure the amount of force that the patient generates to the onset of pain; when there is no pain the test result could be regarded as maximum grip strength. It is commonly performed in patients with lateral epicondylalgia (LE). LE is characterised by the presence of pain over the lateral humeral epicondyle which is provoked by at least two of: gripping, resisted wrist or middle finger extension, or palpation (Stratford et al 1993) in conjunction with reduced PFG over the affected side (Stratford et al 1993; Vicenzino et al 1996; Vicenzino et al 1998).
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 May 2018
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Wei Chou, China Medical University Hospital
- Investigators
- Li-Wei Chou, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605563
- Sponsor's protocol ID
- CMUH107-REC2-019
- Status last verified
- Jul 2018
- First submitted
- 18 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang CH, Lin CY, Sun MF, Fu Z, Chou LW. Efficacy of Fu's Subcutaneous Needling on Myofascial Trigger Points for Lateral Epicondylalgia: A Randomized Control Trial. Evid Based Complement Alternat Med. 2022 Mar 14;2022:5951327. doi: 10.1155/2022/5951327. eCollection 2022.
PubMed 35321501
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Muscle Tone of Affected Muscle After Fu's Subcutaneous Needling on the Myofascial Trigger Points - a Sample of Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT03605563
- Acronym / sponsor ID
- CMUH107-REC2-019
- Conditions
- Lateral Epicondylitis
- Keywords
- Fu's subcutaneous needling (FSN), Myofascial trigger point
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Apr 2019 (estimated)
- First posted
- 30 Jul 2018 (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.
Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The symptoms can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag.
This is a randomized study, the investigators will evaluate the immediate, short-term, and long-term effect of Fu's subcutaneous needling on the patients suffering with lateral epicondylitis.
Detailed description
Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The major mechanism is overuse of the flexors, extensors and supination muscles in the wrist, causing micro-trauma in the muscles attachment to the lateral epicondyle of the elbow. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. Patients often describe pain at the lateral aspect of the elbow. Pain can be further elicited with passive wrist flexion and by resisting active wrist extension. Symptoms also include weakness in the grip strength and limitation of elbow motion. Therefore, it can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag.
Fu's subcutaneous needling (FSN), as one of the dry needle treatments, performed by swaying a disposable Fu's subcutaneous needle parallel to the underlying muscles after penetrating the skin to the subcutaneous fascia. With the reperfusion activities, myofascial pain and soft tissue pain caused by myofascial trigger points can be decreased effective simultaneously. So far, there is no solid research or clinical trial to evaluate the efficacy of the treatment yet.
The investigators will conduct the randomized experiment to evaluate the immediate, short-term, and long-term effect of FSN. The outcome measures include visual analog scale, patient-rated tennis elbow evaluation questionnaire, pressure pain threshold, pain-free grip test, muscle tone changes and ultrasonographic evaluaton of the common extensor tendon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSN: Fu's subcutaneous needling | Experimental | Procedure: Fu's subcutaneous needlingIn this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately. |
| TENS: Transcutaneous Electric Nerve Stimulation | Active comparator | Procedure: Transcutaneous electrical nerve stimulationIn this arm, the subjects will receive the intervention of TENS on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Subjects older than 20 years of age who can cooperate with the experimental volunteers.
- 2. Suffering from epicondylitis of the humerus for more than one month, and subjective pain intensity (VAS) greater than 5 points.
- 3. There is a local tender point at the upper elbow of the elbow, and the isometric resistance test of the forearm to make a spin will induce pain.
- 4. Under soft tissue ultrasound, the thickness of the common tendon of the extensor carpi muscles is more than 0.15 mm greater than that of the healthy side.
Key exclusion criteria (3 listed)
- 1. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
- 2. There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
- 3. Have received neck, upper back, or upper and lower limb surgery. 4. People with central or peripheral nerve disease. 5. Cognitive impairment, unable to cooperate with the experimenter. 6. Patients currently receiving other treatments for epicondylitis of the humerus.
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 |
|---|---|---|
| Fu's subcutaneous needlingFu's Subcutaneous Needle (FSN), is an innovation for the treatment of myofascial pain and trigger points. The needle is a non-injection needle, and the fact that both needles are manipulated and act on soft connective tissue. FSN abstains from the muscle and deep fascia layers and is confined to only the subcutaneous layer where collagen fibers are most abundant. As the subcutaneous layer is poorly innervated, pain is less than other needling therapies. FSN is also currently being used successfully to treat non-musculoskeletal conditions. | Procedure or surgery | FSN: Fu's subcutaneous needling |
| Transcutaneous electrical nerve stimulationTranscutaneous electrical nerve stimulation (TENS or TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical batteryoperated TENS unit is able to modulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10 Hz) with an intensity that produces motor contraction. | Procedure or surgery | TENS: Transcutaneous Electric Nerve Stimulation |
Primary outcome
Visual Analog Scales
Time frame: 1 day
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
3 secondary outcomes
Pressure Pain Threshold
Time frame: 1 day
Myotone of MTrPs
Time frame: 1 day
Pain-free grip test
Time frame: 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Derived from this study: PubMed 35321501Huang CH, Lin CY, Sun MF, Fu Z, Chou LW. Efficacy of Fu's Subcutaneous Needling on Myofascial Trigger Points for Lateral Epicondylalgia: A Randomized Control Trial. Evid Based Complement Alternat Med. 2022 Mar 14;2022:5951327. doi: 10.1155/2022/5951327. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Li-Wei Chou, PhD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fu's subcutaneous needling and Transcutaneous electrical nerve stimulation in people with Lateral Epicondylitis, run by China Medical University 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Wei HuangChou, PhD (+886-4-22052121 ext. 2381, chouliwe@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scales (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605563, which also lists 1 linked publication.
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 30 Jul 2018.