Bicep TendinitisNCT04387591
Fu's Subcutaneous Needling Treatment for Biceps Tendinopathy
A study testing Fu's subcutaneous needling(FSN) and Transcutaneous Electric Nerve Stimulation in people with Bicep Tendinitis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Biceps tendinopathy is a common cause in shoulder-pain symptoms. The major mechanism is overuse of the biceps muscles. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles.We will conduct the randomized, open label experiment to evaluate the immediate, short-term… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bicep Tendinitis
- What is being tested?
- Fu's subcutaneous needling(FSN) and Transcutaneous Electric 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
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2020to 31 Dec 2020
- 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
- Subjects older than 20 years of age who can cooperate with the experimental volunteers.
- Suffering from biceps tendon lesions for more than one month, and subjective pain intensity (VAS) greater than 5 points.
- There is a local tender point in front of the shoulder, and the shoulder joint pronation test can induce pain.
- Under soft tissue ultrasound, the thickness of biceps peritendinous effusion (BPE) on the affected side of the biceps tendon is greater than1 mm.
Who cannot join
- There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
- There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
- Have received shoulder, neck or upper back surgery.
- People with central or peripheral nerve disease.
- Cognitive impairment, unable to cooperate with the experimenter.
- Patients currently receiving other treatments for biceps tendinopathy.
- Patients receiving shoulder injection treatments within the last 6 months.
- Patients with rheumatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Symptomatic Release of Remote Fu's Subcutaneous Needling on Patients With Biceps Tendinopathy
Biceps tendinopathy is a common cause in shoulder-pain symptoms. The major mechanism is overuse of the biceps muscles. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles.We will conduct the randomized, open label experiment to evaluate the immediate, short-term, and long-term effect of Fu's subcutaneous needling (FSN).
Read the detailed description
Biceps tendinopathy is a common cause in shoulder-pain symptoms. The major mechanism is overuse of the biceps muscles. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. Common symptoms are pain in the anterior shoulders and radiating pain in the biceps. Pain can be further elicited with lifting, pulling and repetitive overhead activity. Therefore, it can have a major impact on the patient's activity of daily life.
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.
We will conduct the randomized, open label experiment to evaluate the immediate, short-term, and long-term effect of FSN. Outcome measures include visual analog scale, shoulder pain and disability index, pressure pain threshold, muscle tone changes and ultrasonographic evaluaton of biceps peritendinous effusion.
- Conditions
- Bicep Tendinitis
- Being tested
- Fu's subcutaneous needling(FSN), Transcutaneous Electric Nerve Stimulation
- Keywords
- Fu's Subcutaneous Needling, myofascial trigger point, muscle tone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fu's subcutaneous needling(FSN)Procedure or surgery
In this study, the doctor will use a disposable Fu's subcutaneous needling(FSN) to penetrate the subject's skin of the middle of medial epicondyle and radial styloid process. Then the doctor will push forward the needle parallel to the skin surface (maintaining in the subcutaneous layer), towards the subject's medial epicondyle. The docotr will sway the needle 50 times in 30 seconds. After swaying the needle, the doctor will instruct the subject to do elbow flextion for 10 seconds resisting the doctor's opposite force, then the subject take a rest for 10 seconds. The above actions(elbow flexion and rest) are 3 repetitions. Then the subject do palmar flexion in the position of elbow flexion for 10 seconds resisting the doctor's opposite force, and take a rest for 10 seconds. These actions are also 3 repetitions. After the above reperfusion approach of muscles, the doctor will take out the needle to finish the treatment.
Transcutaneous Electric Nerve StimulationProcedure or surgery
Transcutaneous electrical nerve stimulation (TENSor TNS) is the use of electric current produced bya device to stimulate the nerves for therapeuticpurposes. TENS, by definition, covers the completerange of transcutaneously applied currents usedfor nerve excitation although the term is often usedwith a more restrictive intent, namely to describe thekind of pulses produced by portable stimulators usedto treat pain. The unit is usually connected to theskin using two or more electrodes. A typical batteryoperated TENS unit is able to modulate pulse width,frequency and intensity. Generally TENS is applied athigh frequency (>50 Hz) with an intensity below motorcontraction (sensory intensity) or low frequency (<10Hz) with an intensity that produces motor contraction
| Study group | Role | What they receive |
|---|---|---|
| Fu's subcutaneous needling(FSN) | Experimental | In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments on Day8 and Day15, separately. Receives: Procedure: Fu's subcutaneous needling(FSN) |
| Transcutaneous Electric Nerve Stimulation | Active comparator | In this arm, the subjects will receive the intervention of Transcutaneous Electric Nerve Stimulation on Day1, Day2 and Day4, in the total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments on Day8 and Day15, separately. Receives: Procedure: Transcutaneous Electric 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 is a psychometric response scale which can be used in questionnaires. This tool used to help a person rate the intensity of certain sensations and feelings, such as pain. A straight line of 100mm is actually marked with 0 mm on the far left and 100mm on the far right. Two faces are drawn on both ends. Explain to the patient that 0 mm means no pain and 100 mm means very painful. From the left end, the right shift indicates more and more pain. The evaluator will let the patient draw a short line vertically on the line,representing his painful position, and record the measured cm value. In this test, if the score of the subject decreases,it can represent the treatment is helpful for the improvement of the patient's pain.
Measured: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
Secondary outcomes (4)
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: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
Muscle tension
Muscle tension is the muscle's resistance to passive stretch during resting state. The measuring tool called Myotone will calculate three parameters such as tone, elasticity and stiffness and get a value to represent the muscle tension. If the value decrease, it can represent the treatment is helpful for the subjective muscle relax.
Measured: before and after Day1, Day2, Day4 treatment ; on Day8 and Day 15 separately
Shoulder pain and disability index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a patient-reported outcome measure. All question items in the survey are presented on a 10cm visual analog scale (VAS). The verbal anchors for the pain dimension are "no pain at all" and "worst pain imaginable." And the verbal anchors for the functional activities are "no difficulty" and "so difficult it requires help". The scores from both dimensions are averaged to derive a total score with 0 being the best outcome (less disability) and 100 the worst (greater disability). If the value decrease, it can represent the treatment is helpful for shoulder pain relief and functional activities.
Measured: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
Ultrasonographic evaluaton of biceps peritendinous effusion
The biceps tendon is evaluated in the bicipital groove with the arm in a neutral position and the hand resting palm up on the patient's thigh. If the biceps peritendinous effusion decrease, it can represent the treatment is helpful.
Measured: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start20 May 2020
- Primary completion30 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicep TendinitisStudies of the same condition, open and under way.
- More trials run by China Medical University 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
- None (open label)
- Enrolment
- 32 participants (actual)
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
- NCT04387591
- Sponsor's protocol ID
- CMUH107-REC3-026
- Status last verified
- Mar 2021
- First submitted
- 10 May 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Symptomatic Release of Remote Fu's Subcutaneous Needling on Patients With Biceps Tendinopathy
- ClinicalTrials.gov ID
- NCT04387591
- Acronym / sponsor ID
- CMUH107-REC3-026
- Conditions
- Bicep Tendinitis
- Keywords
- Fu's Subcutaneous Needling, myofascial trigger point, muscle tone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 May 2020 (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.
Biceps tendinopathy is a common cause in shoulder-pain symptoms. The major mechanism is overuse of the biceps muscles. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles.We will conduct the randomized, open label experiment to evaluate the immediate, short-term, and long-term effect of Fu's subcutaneous needling (FSN).
Detailed description
Biceps tendinopathy is a common cause in shoulder-pain symptoms. The major mechanism is overuse of the biceps muscles. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. Common symptoms are pain in the anterior shoulders and radiating pain in the biceps. Pain can be further elicited with lifting, pulling and repetitive overhead activity. Therefore, it can have a major impact on the patient's activity of daily life.
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.
We will conduct the randomized, open label experiment to evaluate the immediate, short-term, and long-term effect of FSN. Outcome measures include visual analog scale, shoulder pain and disability index, pressure pain threshold, muscle tone changes and ultrasonographic evaluaton of biceps peritendinous effusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fu's subcutaneous needling(FSN) | Experimental | Procedure: Fu's subcutaneous needling(FSN)In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments on Day8 and Day15, separately. |
| Transcutaneous Electric Nerve Stimulation | Active comparator | Procedure: Transcutaneous Electric Nerve StimulationIn this arm, the subjects will receive the intervention of Transcutaneous Electric Nerve Stimulation on Day1, Day2 and Day4, in the total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments 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)
- Subjects older than 20 years of age who can cooperate with the experimental volunteers.
- Suffering from biceps tendon lesions for more than one month, and subjective pain intensity (VAS) greater than 5 points.
- There is a local tender point in front of the shoulder, and the shoulder joint pronation test can induce pain.
- Under soft tissue ultrasound, the thickness of biceps peritendinous effusion (BPE) on the affected side of the biceps tendon is greater than1 mm.
Key exclusion criteria (8 listed)
- There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
- There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
- Have received shoulder, neck or upper back surgery.
- People with central or peripheral nerve disease.
- Cognitive impairment, unable to cooperate with the experimenter.
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 needling(FSN)In this study, the doctor will use a disposable Fu's subcutaneous needling(FSN) to penetrate the subject's skin of the middle of medial epicondyle and radial styloid process. Then the doctor will push forward the needle parallel to the skin surface (maintaining in the subcutaneous layer), towards the subject's medial epicondyle. The docotr will sway the needle 50 times in 30 seconds. After swaying the needle, the doctor will instruct the subject to do elbow flextion for 10 seconds resisting the doctor's opposite force, then the subject take a rest for 10 seconds. The above actions(elbow flexion and rest) are 3 repetitions. Then the subject do palmar flexion in the position of elbow flexion for 10 seconds resisting the doctor's opposite force, and take a rest for 10 seconds. These actions are also 3 repetitions. After the above reperfusion approach of muscles, the doctor will take out the needle to finish the treatment. | Procedure or surgery | Fu's subcutaneous needling(FSN) |
| Transcutaneous Electric Nerve StimulationTranscutaneous electrical nerve stimulation (TENSor TNS) is the use of electric current produced bya device to stimulate the nerves for therapeuticpurposes. TENS, by definition, covers the completerange of transcutaneously applied currents usedfor nerve excitation although the term is often usedwith a more restrictive intent, namely to describe thekind of pulses produced by portable stimulators usedto treat pain. The unit is usually connected to theskin using two or more electrodes. A typical batteryoperated TENS unit is able to modulate pulse width,frequency and intensity. Generally TENS is applied athigh frequency (>50 Hz) with an intensity below motorcontraction (sensory intensity) or low frequency (<10Hz) with an intensity that produces motor contraction | Procedure or surgery | Transcutaneous Electric Nerve Stimulation |
Primary outcome
Visual Analog Scales
Time frame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
The visual analogue scale or visual analog scale is a psychometric response scale which can be used in questionnaires. This tool used to help a person rate the intensity of certain sensations and feelings, such as pain. A straight line of 100mm is actually marked with 0 mm on the far left and 100mm on the far right. Two faces are drawn on both ends. Explain to the patient that 0 mm means no pain and 100 mm means very painful. From the left end, the right shift indicates more and more pain. The evaluator will let the patient draw a short line vertically on the line,representing his painful position, and record the measured cm value. In this test, if the score of the subject decreases,it can represent the treatment is helpful for the improvement of the patient's pain.
4 secondary outcomes
Pressure Pain Threshold
Time frame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
Muscle tension
Time frame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day 15 separately
Shoulder pain and disability index (SPADI)
Time frame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
Ultrasonographic evaluaton of biceps peritendinous effusion
Time frame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
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 3 Mar 2021.
- 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(FSN) and Transcutaneous Electric Nerve Stimulation in people with Bicep Tendinitis, 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 8 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 3 Mar 2021. 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?
Visual Analog Scales (time frame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately). 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 3 Mar 2021.