Fu's Subcutaneous Needling Treatment for Biceps Tendinopathy

NCT ID: NCT04387591

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2020-12-31

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.

Conditions

Bicep Tendinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fu's subcutaneous needling(FSN)

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electric Nerve Stimulation

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li-Wei Chou

Minister of Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li-Wei Chou, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH107-REC3-026

Identifier Type: -

Identifier Source: org_study_id