Fu's Subcutaneous Needling Treatment for Biceps Tendinopathy

Not Applicable

Completed

• Conditions: Bicep Tendinitis
• Interventions: Procedure: Fu's subcutaneous needling(FSN); Procedure: Transcutaneous Electric Nerve Stimulation

• Registration Number: NCT04387591
• Lead Sponsor: China Medical University Hospital

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, 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 Timeline

• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-10
• Study First Posted: 2020-05-14
• Study Start: 2020-05-20
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fu's subcutaneous needling(FSN)	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	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scales	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.

Secondary Outcome Measures

Name	Time	Method
Pressure Pain Threshold	before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately	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.
Ultrasonographic evaluaton of biceps peritendinous effusion	before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately	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.
Muscle tension	before and after Day1, Day2, Day4 treatment ; on Day8 and Day 15 separately	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.
Shoulder pain and disability index (SPADI)	before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately	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.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan