Fu's Subcutaneous Needling Treatment for Biceps Tendinopathy

NCT04387591 | Completed

• 1 other identifier: CMUH107-REC3-026
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Bicep Tendinitis

Keywords

Fu's Subcutaneous Needling; myofascial trigger point; muscle tone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pressure Pain Threshold

  before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately

• Muscle tension

  before and after Day1, Day2, Day4 treatment ; on Day8 and Day 15 separately

• Shoulder pain and disability index (SPADI)

  before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately

• Ultrasonographic evaluaton of biceps peritendinous effusion

  before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately

Study Arms (2)

Fu's subcutaneous needling(FSN)

EXPERIMENTAL

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)

Transcutaneous Electric Nerve Stimulation

ACTIVE COMPARATOR

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

Interventions

Fu's subcutaneous needling(FSN) 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.

Fu's subcutaneous needling(FSN)

Transcutaneous Electric Nerve Stimulation 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

Transcutaneous Electric Nerve Stimulation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
• There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
• Have received shoulder, neck or upper back surgery.
• People with central or peripheral nerve disease.
• Cognitive impairment, unable to cooperate with the experimenter.
• Patients currently receiving other treatments for biceps tendinopathy.
• Patients receiving shoulder injection treatments within the last 6 months.
• Patients with rheumatic diseases.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 999079, Taiwan

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Li-Wei Chou, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Minister of Rehabilitation

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 14, 2020
• Study Start: May 20, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

TW (1)