Fu's Subcutaneous Needling Treatment for Biceps Tendinopathy

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).

Study Overview

• Status: Completed
• Conditions: Bicep Tendinitis
• Intervention / Treatment: Procedure: Fu's subcutaneous needling(FSN); Procedure: Transcutaneous Electric Nerve Stimulation

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 999079
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects older than 20 years of age who can cooperate with the experimental volunteers.
2. Suffering from biceps tendon lesions for more than one month, and subjective pain intensity (VAS) greater than 5 points.
3. There is a local tender point in front of the shoulder, and the shoulder joint pronation test can induce pain.
4. Under soft tissue ultrasound, the thickness of biceps peritendinous effusion (BPE) on the affected side of the biceps tendon is greater than1 mm.

Exclusion Criteria:

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 shoulder, neck or upper back 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 biceps tendinopathy.
7. Patients receiving shoulder injection treatments within the last 6 months.
8. Patients with rheumatic diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: Transcutaneous Electric Nerve Stimulation; 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.	Procedure: Transcutaneous Electric Nerve Stimulation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Li-Wei Chou, PhD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 10, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Fu's Subcutaneous Needling; myofascial trigger point; muscle tone
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: CMUH107-REC3-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No