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Trial record 53 of 110 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

Treatment of Chronic Myofascial Pain Syndrome Over Neck by Using Intravascular Laser Irradiation of Blood

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ClinicalTrials.gov Identifier: NCT02470000
Recruitment Status : Recruiting
First Posted : June 12, 2015
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

Myofascial pain syndrome (MPS) is characterized by single or multiple trigger points (TrP) in taut bands within the affected muscles. Chronic MPS over neck is prevalent and responsible for markedly loss of work-day and a reduction of quality of life.

Intravascular laser irradiation of blood (ILIB) involves in vivo illumination of the blood by low-level laser light through an optical fiber inserted in a vein. Researches disclosed that ILIB reduced blood viscosity, enhanced erythrocyte deformity, and increased oxygen saturation in blood. However, no research studies the effectiveness of ILIB to treat MPS.

Real-time sonoelastography (RTS) and shear wave velocity (SWV) are used to detect the stiffness of skeletal muscles. RTS is displayed as a color-coded graphic to represent the relative stiffness of structures. For a given material, faster SWV indicates the greater stiffness. To our knowledge, only one research using RTS and SWV to study MPS.

To elucidate the effectiveness of ILIB to treat chronic MPS over neck, and the validity of RTS and SWV for MPS, we conducted this study.


Condition or disease Intervention/treatment Phase
Myofacial Pain Syndromes Device: Intravascular laser irradiation of blood (ILIB) Device: Transcutaneous electrical nerve stimulation Other: Stretching exercise Not Applicable

  Show Detailed Description

Study Type : Interventional
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Myofascial Pain Syndrome Over Neck by Using Intravascular Laser Irradiation of Blood
Study Start Date : November 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental Group
Intravascular laser irradiation of blood (ILIB, output power 0.3mW), Transcutaneous electrical nerve stimulation (TENS), stretching exercise.
Device: Intravascular laser irradiation of blood (ILIB)
continuous-wave ILIB is performed using a 632.8nm (red light) laser beam from a He-Ne laser machine (Y-J ILIB-5, Bio Human Energy Cooperation, New Taipei City, Taiwan, R.O.C.).The participants sit on a sofa with their arms relax and supported on the table. A 24-gauge catheter is inserted to a superficial vein in upper extremity under sterile preparation, and an optic fiber channel is connected to the catheter for blood irradiation.
Other Name: ILIB
Device: Transcutaneous electrical nerve stimulation
TENS over neck for 15 minutes.
Other Name: TENS
Other: Stretching exercise
stretching exercise to the involved muscle for 15 minutes.
Sham Comparator: Control Group
Intravascular laser irradiation of blood (ILIB, output power 0mW), Transcutaneous electrical nerve stimulation (TENS), stretching exercise.
Device: Intravascular laser irradiation of blood (ILIB)
continuous-wave ILIB is performed using a 632.8nm (red light) laser beam from a He-Ne laser machine (Y-J ILIB-5, Bio Human Energy Cooperation, New Taipei City, Taiwan, R.O.C.).The participants sit on a sofa with their arms relax and supported on the table. A 24-gauge catheter is inserted to a superficial vein in upper extremity under sterile preparation, and an optic fiber channel is connected to the catheter for blood irradiation.
Other Name: ILIB
Device: Transcutaneous electrical nerve stimulation
TENS over neck for 15 minutes.
Other Name: TENS
Other: Stretching exercise
stretching exercise to the involved muscle for 15 minutes.



Primary Outcome Measures :
  1. Pain [ Time Frame: week 0, week 2, week 14 ]
    Pain as measured by using a 10-cm long visual analogue scale (0 indicates no pain while 10 indicates worst pain) at rest and at movement.


Secondary Outcome Measures :
  1. Pressure pain threshold (PPT) [ Time Frame: week 0, week 2, week 14 ]
    Pressure pain threshold (PPT) as measured by a pressure algometer, Force Dial FDK 20 with a scale ranging from 0 to 10 kg (Wagner Instruments, Greenwich, USA). The participant is in sitting position and relaxes, and the most painful TrPs in the taut band is measured. The investigators follow the procedures of measurement described by Fischer. The PPT is defined as the minimal pressure that results in the sensation change from pressure to pain. The investigators perform 3 repetitive measurements at an interval of 20 seconds, and the mean values will be analyzed.

  2. Shear wave velocity (SWV) [ Time Frame: week 0, week 2, week 14 ]
    SWV is undertaken by using a US system with 4-9 MHz multifrequency linear transducer. The investigators minimize probe pressure on muscles to avoid affect muscle stiffness. SWV of bilateral upper trapezius (TPZ), levator scapulae (LS), sternocleidomastoid (SCM) and the most painful TrP in taut band are measured longitudinally while their B-mode image qualities are optimal. When measuring TPZ, the probe was located at the midpoint of occipital protuberance and acromion and the ROI was placed inside the muscle belly. The SWV of LS is measured at the midpoint of superior-medial border of scapulae and the C1 transverse process. For the measurement of SCM, the probe is positioned at the midpoint of sternum and mastoid process. The most painful TrP in taut band is recognized by the participants and then marked and recorded its position related to bony landmarks with a measuring tape. SWV of each muscle is measured 10 times, and the median of the 10 valid measurements will be analyzed.

  3. Real-time sonoelastography (RTS) [ Time Frame: week 0, week 2, week 14 ]
    RTS is accessed by the aforementioned physiatrist by using the US system. RTS is depicted on the right side of the screen, while the longitudinal 2D image on the most painful TrP in taut band is displayed on the left side. The compression force applied is adjusted according to a quality factor set on the machine, which is displayed on the screen. A quality factor ≧ 60 indicates optimal compression force. The investigator stores the representative image with a quality factor ≧ 60, and determines the RTS score. Later, the stored images are analyzed with ImageJ software (National Institutes of Health,Bethesda, USA). The area of taut band on image is selected, and color histograms are made and the means of the blue pixel and the red pixel are recorded. The color pixels range from 0 to 255. Intrarater and interrater reliability tests for RTS and SWV are undertaken in the first 10 participants.

  4. World Health Organization Quality of Life Questionnaire Short Form Taiwan Version: WHOQOL - BREF Taiwan Version [ Time Frame: week 0, week 2, week 14 ]
    WHOQOL - BREF Taiwan Version consists of 4 domains (physical health, psychological, social relationship, and environment) and a total 28 items. Each item has a five-point Likert-type response scale, and four types of scale descriptors (capacity, frequency, intensity and evaluation) are used.37 Individual domain score and total QOL score can be calculated through straightforward summative scaling. A higher score indicates a better QOL. This questionnaire was proved to be reliable and valid for many diseases.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) age ≧ 18 years old; (2) willing to sign an inform consent; (3) having a chronic MPS over neck at least 6 months. The diagnosis of MPS was made while the following criteria are met: (a) recognized pain with exquisite spot tenderness on a palpable taut band over the pain area; (b) presence of one of the two confirmatory signs: referred pain and local twitch response

Exclusion Criteria:

  • (1) pregnancy; (2) bleeding tendency; (3) active systemic infective or inflammatory disease; (4) major surgery or trauma in the recent 3 months; (5) unstable cervical spine; (6) rheumatoid arthritis34; (7) open wound over neck; (8) pace-maker or defibrillator implantation; (9) overt neuropathic pain or radiation pain; (10) inability to express pain or quality of life.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470000


Contacts
Contact: Lin-Yi Wang, MD 886-7-7317123 ext 6286 s801121@cgmh.org.tw
Contact: Lin-Yi Wang, MD 886-7-7317123 ext 6286 s801121.s801121@msa.hinet.net

Locations
Taiwan
Lin-Yi Wang Recruiting
Kaohsiung, Taiwan
Contact: Lin-Yi Wang, MD    07-7317123 ext 6286    s801121@cgmh.org.tw   
Contact: Tsung-hsun Yang, MD    07-7317123 ext 6286    8902077@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Lin-Yi Wang, MD Rehabilitation

Publications:
Lin MY, KP; Hwang, JS; Wang, JD. Scale descriptor selection for Taiwan-version of questionnaire of World Health Organization quality of life. Chinese J Public Health (Taipei). 1999;18:262-270.

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02470000     History of Changes
Other Study ID Numbers: CMRPG8D0921
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chang Gung Memorial Hospital:
myofascial pain
neck
laser
elastography
shear wave velocity
randomized control trial
Intravascular Laser Irradiation of Blood

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Syndrome
Somatoform Disorders
Facial Pain
Facial Neuralgia
Disease
Pathologic Processes
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases