Fu's Subcutaneous Needling Treatment for Biceps Tendinopathy

China Medical University

Status: Completed

Conditions: Bicep Tendinitis

Treatments: Procedure: Transcutaneous Electric Nerve Stimulation; Procedure: Fu's subcutaneous needling(FSN)

Study type: Interventional

Funder types: Other

Identifiers

NCT04387591

CMUH107-REC3-026

Details and patient eligibility

About

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).

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Fu's subcutaneous needling(FSN)

Experimental group

Description:

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.

Treatment:

Procedure: Fu's subcutaneous needling(FSN)

Transcutaneous Electric Nerve Stimulation

Active Comparator group

Description:

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.

Treatment:

Procedure: Transcutaneous Electric Nerve Stimulation