NCT03639454

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, single blind experiment to evaluate the immediate, short-term, and long-term effect of DN.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

September 18, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2019

Completed
Last Updated

September 12, 2019

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

August 16, 2018

Last Update Submit

September 11, 2019

Conditions

Keywords

dry needlingmyofascial trigger pointmuscle 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. Take a pen and 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.

    1 day

Secondary Outcomes (2)

  • Pressure Pain Threshold

    1 day

  • Muscle tension

    1 day

Study Arms (2)

Dry needling

EXPERIMENTAL

In this arm, the subjects will receive the intervention of DN on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.

Procedure: dry needling

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 total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.

Procedure: Transcutaneous electrical nerve stimulation

Interventions

dry needlingPROCEDURE

Dry needling, also known as myofascial trigger point dry needling, is an well-proved technique in alternative medicine similar to acupuncture. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. Dry needling is sometimes also known as intramuscular stimulation (IMS).

Dry needling

Transcutaneous electrical nerve stimulation (TENS or TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical battery operated TENS unit is able to modulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (\>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (\<10 Hz) with an intensity that produces motor contraction.

Transcutaneous Electric Nerve Stimulation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 than 1 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 999079, Taiwan

Location

Related Publications (1)

  • Chen IW, Liao YT, Tseng H, Lin HC, Chou LW. Pain, function and peritendinous effusion improvement after dry needling in patients with long head of biceps brachii tendinopathy: a single-blind randomized clinical trial. Ann Med. 2024 Dec;56(1):2391528. doi: 10.1080/07853890.2024.2391528. Epub 2024 Aug 14.

MeSH Terms

Interventions

Dry NeedlingTranscutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesElectric Stimulation TherapyRehabilitationAnalgesiaAnesthesia 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

August 16, 2018

First Posted

August 21, 2018

Study Start

September 18, 2018

Primary Completion

February 28, 2019

Study Completion

April 22, 2019

Last Updated

September 12, 2019

Record last verified: 2018-08

Locations