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Fu's Subcutaneous Needling on the Myofascial Trigger Points: Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fu's subcutaneous needling
Transcutaneous electrical nerve stimulation
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Fu's subcutaneous needling (FSN), Myofascial trigger point

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Subjects older than 20 years of age who can cooperate with the experimental volunteers.

    2. Suffering from epicondylitis of the humerus for more than one month, and subjective pain intensity (VAS) greater than 5 points.

    3. There is a local tender point at the upper elbow of the elbow, and the isometric resistance test of the forearm to make a spin will induce pain.

    4. Under soft tissue ultrasound, the thickness of the common tendon of the extensor carpi muscles is more than 0.15 mm greater than that of the healthy side.

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 neck, upper back, or upper and lower limb 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 epicondylitis of the humerus.

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FSN: Fu's subcutaneous needling

TENS: Transcutaneous Electric Nerve Stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Analog Scales
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

Secondary Outcome Measures

Pressure Pain Threshold
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom.
Myotone of MTrPs
Muscle tone is the muscle's resistance to passive stretch during resting state. Myotone will help the investigators to get muscle parameters such as tone, elasticity and stiffness.
Pain-free grip test
The pain-free grip (PFG) test is used to measure the amount of force that the patient generates to the onset of pain; when there is no pain the test result could be regarded as maximum grip strength. It is commonly performed in patients with lateral epicondylalgia (LE). LE is characterised by the presence of pain over the lateral humeral epicondyle which is provoked by at least two of: gripping, resisted wrist or middle finger extension, or palpation (Stratford et al 1993) in conjunction with reduced PFG over the affected side (Stratford et al 1993; Vicenzino et al 1996; Vicenzino et al 1998).

Full Information

First Posted
July 18, 2018
Last Updated
July 26, 2018
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03605563
Brief Title
Fu's Subcutaneous Needling on the Myofascial Trigger Points: Lateral Epicondylitis
Official Title
Changes in the Muscle Tone of Affected Muscle After Fu's Subcutaneous Needling on the Myofascial Trigger Points - a Sample of Lateral Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
April 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The symptoms can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag. This is a randomized study, the investigators will evaluate the immediate, short-term, and long-term effect of Fu's subcutaneous needling on the patients suffering with lateral epicondylitis.
Detailed Description
Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The major mechanism is overuse of the flexors, extensors and supination muscles in the wrist, causing micro-trauma in the muscles attachment to the lateral epicondyle of the elbow. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. Patients often describe pain at the lateral aspect of the elbow. Pain can be further elicited with passive wrist flexion and by resisting active wrist extension. Symptoms also include weakness in the grip strength and limitation of elbow motion. Therefore, it can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag. 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. The investigators will conduct the randomized experiment to evaluate the immediate, short-term, and long-term effect of FSN. The outcome measures include visual analog scale, patient-rated tennis elbow evaluation questionnaire, pressure pain threshold, pain-free grip test, muscle tone changes and ultrasonographic evaluaton of the common extensor tendon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Fu's subcutaneous needling (FSN), Myofascial trigger point

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FSN: Fu's subcutaneous needling
Arm Type
Experimental
Arm Description
In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.
Arm Title
TENS: Transcutaneous Electric Nerve Stimulation
Arm Type
Active Comparator
Arm Description
In this arm, the subjects will receive the intervention of TENS on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.
Intervention Type
Procedure
Intervention Name(s)
Fu's subcutaneous needling
Intervention Description
Fu's Subcutaneous Needle (FSN), is an innovation for the treatment of myofascial pain and trigger points. The needle is a non-injection needle, and the fact that both needles are manipulated and act on soft connective tissue. FSN abstains from the muscle and deep fascia layers and is confined to only the subcutaneous layer where collagen fibers are most abundant. As the subcutaneous layer is poorly innervated, pain is less than other needling therapies. FSN is also currently being used successfully to treat non-musculoskeletal conditions.
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
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 batteryoperated 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.
Primary Outcome Measure Information:
Title
Visual Analog Scales
Description
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom.
Time Frame
1 day
Title
Myotone of MTrPs
Description
Muscle tone is the muscle's resistance to passive stretch during resting state. Myotone will help the investigators to get muscle parameters such as tone, elasticity and stiffness.
Time Frame
1 day
Title
Pain-free grip test
Description
The pain-free grip (PFG) test is used to measure the amount of force that the patient generates to the onset of pain; when there is no pain the test result could be regarded as maximum grip strength. It is commonly performed in patients with lateral epicondylalgia (LE). LE is characterised by the presence of pain over the lateral humeral epicondyle which is provoked by at least two of: gripping, resisted wrist or middle finger extension, or palpation (Stratford et al 1993) in conjunction with reduced PFG over the affected side (Stratford et al 1993; Vicenzino et al 1996; Vicenzino et al 1998).
Time Frame
1day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Subjects older than 20 years of age who can cooperate with the experimental volunteers. 2. Suffering from epicondylitis of the humerus for more than one month, and subjective pain intensity (VAS) greater than 5 points. 3. There is a local tender point at the upper elbow of the elbow, and the isometric resistance test of the forearm to make a spin will induce pain. 4. Under soft tissue ultrasound, the thickness of the common tendon of the extensor carpi muscles is more than 0.15 mm greater than that of the healthy side. 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 neck, upper back, or upper and lower limb 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 epicondylitis of the humerus.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Wei HuangChou, PhD
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@mail.cmuh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Hsuan Huang, MD
Phone
MD
Email
lauren8.huang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, PhD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
999079
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chou Li-Wei, PhD
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@mail.cmuh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35321501
Citation
Huang CH, Lin CY, Sun MF, Fu Z, Chou LW. Efficacy of Fu's Subcutaneous Needling on Myofascial Trigger Points for Lateral Epicondylalgia: A Randomized Control Trial. Evid Based Complement Alternat Med. 2022 Mar 14;2022:5951327. doi: 10.1155/2022/5951327. eCollection 2022.
Results Reference
derived

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Fu's Subcutaneous Needling on the Myofascial Trigger Points: Lateral Epicondylitis

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