Bicep TendinitisNCT03639454
Dry Needling Treatment for Biceps Tendinopathy
A study testing dry needling and Transcutaneous electrical 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. 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?
- dry 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
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Sep 2018to 22 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
- 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 than 1 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Symptomatic Release of Dry 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, single blind experiment to evaluate the immediate, short-term, and long-term effect of DN.
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.
The investigator performed dry needle (DN) treatments with acupuncture needles. Stimulating the effected muscle , the investigator move the needle forward and backward several times. Muscle twitch may occur by our procedure. The 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 investigator will conduct the randomized, single blind experiment to evaluate the immediate, short-term, and long-term effect of DN. Outcome measures include visual analog scale, shoulder pain and disability index, pressure pain threshold, pain-free grip test, muscle tone changes and ultrasonographic evaluation of biceps peritendinous effusion.
- Conditions
- Bicep Tendinitis
- Being tested
- dry needling, Transcutaneous electrical nerve stimulation
- Keywords
- dry 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.
dry needlingProcedure or surgery
Dry needling, also known as myofascial trigger point dry needling, is an well-proved technique in alternative medicine similar to acupuncture. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. Dry needling is sometimes also known as intramuscular stimulation (IMS).
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 battery operated 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 |
|---|---|---|
| Dry needling | Experimental | In this arm, the subjects will receive the intervention of DN 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: dry needling |
| 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 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 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. Take a pen and 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: 1 day
Secondary outcomes (2)
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
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: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start18 Sep 2018
- Primary completion28 Feb 2019
- Study completion22 Apr 2019
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 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
- 30 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
- NCT03639454
- Sponsor's protocol ID
- CMUH107-REC2-101
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen IW, Liao YT, Tseng H, Lin HC, Chou LW. Pain, function and peritendinous effusion improvement after dry needling in patients with long head of biceps brachii tendinopathy: a single-blind randomized clinical trial. Ann Med. 2024 Dec;56(1):2391528. doi: 10.1080/07853890.2024.2391528. Epub 2024 Aug 14.
PubMed 39140690
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Symptomatic Release of Dry Needling on Patients With Biceps Tendinopathy
- ClinicalTrials.gov ID
- NCT03639454
- Acronym / sponsor ID
- CMUH107-REC2-101
- Conditions
- Bicep Tendinitis
- Keywords
- dry needling, myofascial trigger point, muscle tone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 21 Aug 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.
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, single blind experiment to evaluate the immediate, short-term, and long-term effect of DN.
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.
The investigator performed dry needle (DN) treatments with acupuncture needles. Stimulating the effected muscle , the investigator move the needle forward and backward several times. Muscle twitch may occur by our procedure. The 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 investigator will conduct the randomized, single blind experiment to evaluate the immediate, short-term, and long-term effect of DN. Outcome measures include visual analog scale, shoulder pain and disability index, pressure pain threshold, pain-free grip test, muscle tone changes and ultrasonographic evaluation 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 |
|---|---|---|
| Dry needling | Experimental | Procedure: dry needlingIn this arm, the subjects will receive the intervention of DN on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately. |
| Transcutaneous Electric Nerve Stimulation | Active comparator | Procedure: Transcutaneous electrical nerve stimulationIn this arm, the subjects will receive the intervention of Transcutaneous Electric Nerve Stimulation 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)
- 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 than 1 mm.
Key exclusion criteria (6 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 |
|---|---|---|
| dry needlingDry needling, also known as myofascial trigger point dry needling, is an well-proved technique in alternative medicine similar to acupuncture. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. Dry needling is sometimes also known as intramuscular stimulation (IMS). | Procedure or surgery | Dry 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 battery operated 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 | Transcutaneous Electric Nerve Stimulation |
Primary outcome
Visual Analog Scales
Time frame: 1 day
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. Take a pen and 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.
2 secondary outcomes
Pressure Pain Threshold
Time frame: 1 day
Muscle tension
Time frame: 1 day
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 12 Sep 2019.
- Derived from this study: PubMed 39140690Chen IW, Liao YT, Tseng H, Lin HC, Chou LW. Pain, function and peritendinous effusion improvement after dry needling in patients with long head of biceps brachii tendinopathy: a single-blind randomized clinical trial. Ann Med. 2024 Dec;56(1):2391528. doi: 10.1080/07853890.2024.2391528. Epub 2024 Aug 14.
- Individual participant dataSharing planned: Undecided
Related trials for Bicep Tendinitis
Recruiting
Electroacupuncture and Cupping for Shoulder Tendinitis
Shoulder Tendinopathy, Shoulder Tendinitis
Recruiting
Functional Results of Infiltration for Biceps Tendonitis Guided by Ultrasound vs Anatomical Repairs: Variation in Technique
Bíceps Tendinitis
Not yet recruiting
Comparison of the Effectiveness Heavy Slow Resistance and Eccentric Training in Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy, Subacromial Impingement Syndrome
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 dry needling and Transcutaneous electrical 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 6 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 12 Sep 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?
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 NCT03639454, 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 12 Sep 2019.