Dry Needling Treatment for Biceps Tendinopathy
Primary Purpose
Bicep Tendinitis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
dry needling
Transcutaneous electrical nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Bicep Tendinitis focused on measuring dry needling, myofascial trigger point, muscle tone
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- China Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dry needling
Transcutaneous Electric Nerve Stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03639454
First Posted
August 16, 2018
Last Updated
September 11, 2019
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03639454
Brief Title
Dry Needling Treatment for Biceps Tendinopathy
Official Title
Effect on Symptomatic Release of Dry Needling on Patients With Biceps Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
April 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bicep Tendinitis
Keywords
dry needling, myofascial trigger point, muscle tone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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.
Arm Title
Transcutaneous Electric Nerve Stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
dry needling
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scales
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
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.
Time Frame
1 day
Title
Muscle tension
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, PhD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
999079
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dry Needling Treatment for Biceps Tendinopathy
We'll reach out to this number within 24 hrs