Clinical trial NCT04387591: Fu's Subcutaneous Needling Treatment for Biceps Tendinopathy
Official title: Effect on Symptomatic Release of Remote Fu's Subcutaneous Needling on Patients With Biceps Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bicep Tendinitis
Keywords: Fu's Subcutaneous Needling
myofascial trigger point
muscle tone
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scales
timeFrame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
measure: Muscle tension
timeFrame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day 15 separately
measure: Shoulder pain and disability index (SPADI)
timeFrame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
measure: Ultrasonographic evaluaton of biceps peritendinous effusion
timeFrame: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Li-Wei Chou, PhD
role: PRINCIPAL_INVESTIGATOR
References: