Myofacial Pain SyndromesNCT02470000

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

A study testing Intravascular laser irradiation of blood (ILIB), Transcutaneous electrical nerve stimulation and Stretching exercise in people with Myofacial Pain Syndromes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myofacial Pain Syndromes
What is being tested?: Intravascular laser irradiation of blood (ILIB), Transcutaneous electrical nerve stimulation and Stretching exercise
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteTaiwan
Study dates: Nov 2014to Oct 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(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

Who cannot join

(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.

Trial locations and contacts

1 site in 1 country.

Lin-Yi Wang, MD contact

886-7-7317123 ext. 6286

s801121@cgmh.org.tw

Lin-Yi Wang, MD contact

886-7-7317123 ext. 6286

s801121.s801121@msa.hinet.net

Taiwan1 site, 1 recruiting

Lin-Yi Wang
Kaohsiung City
Lin-Yi Wang, MD, 07-7317123 ext. 6286, s801121@cgmh.org.tw
Tsung-hsun Yang, MD, 07-7317123 ext. 6286, 8902077@cgmh.org.tw
Recruiting

Other trials in Taiwan

About this study

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.

Read the detailed description

Time interval of the study: from 2014-11-1 to 2016-10-31 2. Participants and sample size:
Participants: Patients having chronic MPS over neck were randomized allocated to experimental group or control group. Participants in both groups are evaluated before and after the interventions (week 0 and week 2 respectively), and 12 week after the intervention (week 14). Both participants and evaluators don't know the allocation.
Sample size: thirty-six participants. The investigators plan to recruit 18 participants in each year.

III. Intervention:

Participants in experimental group receive ILIB (He-Ne laser, wavelength 632.8nm) with output power 0.3mW for 60minutes and following transcutaneous electric nerve stimulation (TENS) and stretching exercise every day except weekend for 2 weeks. Participants in control group receive sham therapies with the same protocol but no laser energy output

IV.Outcome Measures:

1.Primary outcome: 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.

2.Secondary outcomes:

.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.
.Shear wave velocity (SWV): SWV is undertaken by a physiatrist specialized in musculoskeletal US using a US system with 4-9 MHz multifrequency linear transducer (S2000; Siemens Healthcare, Erlangen, Germany). The posture of participant is the same with which when testing PPT. 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.
.Real-time sonoelastography (RTS): 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.
. World Health Organization Quality of Life Questionnaire Short Form (WHOQOL - BREF) Taiwan Version: 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.
Analysis and Statistics: Reliability of RTS and SWV are tested by using intraclass correlation coefficients. Within-group and between-group comparisons are made by using a repeated-measure ANOVA. Correlation coefficients among outcomes are calculated.

Conditions: Myofacial Pain Syndromes
Being tested: Intravascular laser irradiation of blood (ILIB), Transcutaneous electrical nerve stimulation, Stretching exercise
Keywords: myofascial pain, neck, laser, elastography, shear wave velocity, randomized control trial, Intravascular Laser Irradiation of Blood
Medical subject headings: Facial Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravascular laser irradiation of blood (ILIB)Device
Also called 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.
Transcutaneous electrical nerve stimulationDevice
Also called TENS
TENS over neck for 15 minutes.
Stretching exerciseOther
stretching exercise to the involved muscle for 15 minutes.

Study groups in NCT02470000
Study group	Role	What they receive
Experimental Group	Experimental	Intravascular laser irradiation of blood (ILIB, output power 0.3mW), Transcutaneous electrical nerve stimulation (TENS), stretching exercise. Receives: Device: Intravascular laser irradiation of blood (ILIB); Device: Transcutaneous electrical nerve stimulation; Other: Stretching exercise
Control Group	Sham comparator	Intravascular laser irradiation of blood (ILIB, output power 0mW), Transcutaneous electrical nerve stimulation (TENS), stretching exercise. Receives: Device: Intravascular laser irradiation of blood (ILIB); Device: Transcutaneous electrical nerve stimulation; Other: Stretching exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain
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.
Measured: week 0, week 2, week 14

Secondary outcomes (4)

Pressure pain threshold (PPT)
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.
Measured: week 0, week 2, week 14
Shear wave velocity (SWV)
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.
Measured: week 0, week 2, week 14
Real-time sonoelastography (RTS)
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.
Measured: week 0, week 2, week 14
World Health Organization Quality of Life Questionnaire Short Form Taiwan Version: WHOQOL - BREF Taiwan Version
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.
Measured: week 0, week 2, week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Oct 2016

First posted12 Jun 2015 (estimated)
Study startNov 2014
Primary completionOct 2016 (estimated)
Study completionOct 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Myofacial Pain SyndromesStudies of the same condition, open and under way.
More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02470000
Sponsor's protocol ID: CMRPG8D0921
Status last verified: Jul 2016
First submitted: 9 Feb 2015
Last updated: 2 Aug 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Srbely JZ. New trends in the treatment and management of myofascial pain syndrome. Curr Pain Headache Rep. 2010 Oct;14(5):346-52. doi: 10.1007/s11916-010-0128-4.
PubMed 20607458
Hoving JL, Gross AR, Gasner D, Kay T, Kennedy C, Hondras MA, Haines T, Bouter LM. A critical appraisal of review articles on the effectiveness of conservative treatment for neck pain. Spine (Phila Pa 1976). 2001 Jan 15;26(2):196-205. doi: 10.1097/00007632-200101150-00015.
PubMed 11154541
Gur A, Sarac AJ, Cevik R, Altindag O, Sarac S. Efficacy of 904 nm gallium arsenide low level laser therapy in the management of chronic myofascial pain in the neck: a double-blind and randomize-controlled trial. Lasers Surg Med. 2004;35(3):229-35. doi: 10.1002/lsm.20082.
PubMed 15389743
Bron C, Dommerholt JD. Etiology of myofascial trigger points. Curr Pain Headache Rep. 2012 Oct;16(5):439-44. doi: 10.1007/s11916-012-0289-4.
PubMed 22836591
Yap EC. Myofascial pain--an overview. Ann Acad Med Singap. 2007 Jan;36(1):43-8.
PubMed 17285185
Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.
PubMed 22045511
Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006 Sep;124(1-2):201-10. doi: 10.1016/j.pain.2006.05.018. Epub 2006 Jun 27.
PubMed 16806710
Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13.
PubMed 19913903
Altan L, Bingol U, Aykac M, Yurtkuran M. Investigation of the effect of GaAs laser therapy on cervical myofascial pain syndrome. Rheumatol Int. 2005 Jan;25(1):23-7. doi: 10.1007/s00296-003-0396-y. Epub 2003 Dec 12.
PubMed 14673617
Dundar U, Evcik D, Samli F, Pusak H, Kavuncu V. The effect of gallium arsenide aluminum laser therapy in the management of cervical myofascial pain syndrome: a double blind, placebo-controlled study. Clin Rheumatol. 2007 Jun;26(6):930-4. doi: 10.1007/s10067-006-0438-4. Epub 2006 Oct 5.
PubMed 17021664
Huang SF, Tsai YA, Wu SB, Wei YH, Tsai PY, Chuang TY. Effects of intravascular laser irradiation of blood in mitochondria dysfunction and oxidative stress in adults with chronic spinal cord injury. Photomed Laser Surg. 2012 Oct;30(10):579-86. doi: 10.1089/pho.2012.3228. Epub 2012 Aug 14.
PubMed 22891782
Wasik M, Gorska E, Modzelewska M, Nowicki K, Jakubczak B, Demkow U. The influence of low-power helium-neon laser irradiation on function of selected peripheral blood cells. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):729-37.
PubMed 18204188
Mi XQ, Chen JY, Zhou LW. Effect of low power laser irradiation on disconnecting the membrane-attached hemoglobin from erythrocyte membrane. J Photochem Photobiol B. 2006 May 1;83(2):146-50. doi: 10.1016/j.jphotobiol.2005.12.018. Epub 2006 Feb 14.
PubMed 16481193
Mi XQ, Chen JY, Liang ZJ, Zhou LW. In vitro effects of helium-neon laser irradiation on human blood: blood viscosity and deformability of erythrocytes. Photomed Laser Surg. 2004 Dec;22(6):477-82. doi: 10.1089/pho.2004.22.477.
PubMed 15684746
Kwon DR, Park GY, Lee SU, Chung I. Spastic cerebral palsy in children: dynamic sonoelastographic findings of medial gastrocnemius. Radiology. 2012 Jun;263(3):794-801. doi: 10.1148/radiol.12102478. Epub 2012 Apr 10.
PubMed 22495685

Want to know more?

Lin-Yi Wang, MD

886-7-7317123 ext. 6286

s801121@cgmh.org.tw

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome
Myofacial Pain Syndrome
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Artificial Intelligence Clinical Decision
Myofacial Pain Syndrome, Clinical Decision Support
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Efficacy of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients With Neck Pain
Neck Pain, Myofacial Pain Syndrome

All Myofacial Pain Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Chronic Myofascial Pain Syndrome Over Neck by Using Intravascular Laser Irradiation of Blood
ClinicalTrials.gov ID: NCT02470000
Acronym / sponsor ID: CMRPG8D0921
Conditions: Myofacial Pain Syndromes
Keywords: myofascial pain, neck, laser, elastography, shear wave velocity, randomized control trial, Intravascular Laser Irradiation of Blood
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 36 participants (estimated)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: Nov 2014
Primary completion: Oct 2016 (estimated)
Study completion: Oct 2016 (estimated)
First posted: 12 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Time interval of the study: from 2014-11-1 to 2016-10-31 2. Participants and sample size:
Participants: Patients having chronic MPS over neck were randomized allocated to experimental group or control group. Participants in both groups are evaluated before and after the interventions (week 0 and week 2 respectively), and 12 week after the intervention (week 14). Both participants and evaluators don't know the allocation.
Sample size: thirty-six participants. The investigators plan to recruit 18 participants in each year.

III. Intervention:

IV.Outcome Measures:

1.Primary outcome: 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.

2.Secondary outcomes:

.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.
.Shear wave velocity (SWV): SWV is undertaken by a physiatrist specialized in musculoskeletal US using a US system with 4-9 MHz multifrequency linear transducer (S2000; Siemens Healthcare, Erlangen, Germany). The posture of participant is the same with which when testing PPT. 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.
.Real-time sonoelastography (RTS): 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.
. World Health Organization Quality of Life Questionnaire Short Form (WHOQOL - BREF) Taiwan Version: 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.
Analysis and Statistics: Reliability of RTS and SWV are tested by using intraclass correlation coefficients. Within-group and between-group comparisons are made by using a repeated-measure ANOVA. Correlation coefficients among outcomes are calculated.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Experimental Group	Experimental	Device: Intravascular laser irradiation of blood (ILIB), Device: Transcutaneous electrical nerve stimulation, Other: Stretching exerciseIntravascular laser irradiation of blood (ILIB, output power 0.3mW), Transcutaneous electrical nerve stimulation (TENS), stretching exercise.
Control Group	Sham comparator	Device: Intravascular laser irradiation of blood (ILIB), Device: Transcutaneous electrical nerve stimulation, Other: Stretching exerciseIntravascular laser irradiation of blood (ILIB, output power 0mW), Transcutaneous electrical nerve stimulation (TENS), stretching exercise.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

(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

Key exclusion criteria (1 listed)

(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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravascular laser irradiation of blood (ILIB)Also: ILIBcontinuous-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.	Device	Control Group, Experimental Group
Transcutaneous electrical nerve stimulationAlso: TENSTENS over neck for 15 minutes.	Device	Control Group, Experimental Group
Stretching exercisestretching exercise to the involved muscle for 15 minutes.	Other	Control Group, Experimental Group

Primary outcome

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.

4 secondary outcomes

Pressure pain threshold (PPT)
Time frame: week 0, week 2, week 14
Shear wave velocity (SWV)
Time frame: week 0, week 2, week 14
Real-time sonoelastography (RTS)
Time frame: week 0, week 2, week 14
World Health Organization Quality of Life Questionnaire Short Form Taiwan Version: WHOQOL - BREF Taiwan Version
Time frame: week 0, week 2, week 14

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
Background: PubMed 20607458Srbely JZ. New trends in the treatment and management of myofascial pain syndrome. Curr Pain Headache Rep. 2010 Oct;14(5):346-52. doi: 10.1007/s11916-010-0128-4.
Background: PubMed 11154541Hoving JL, Gross AR, Gasner D, Kay T, Kennedy C, Hondras MA, Haines T, Bouter LM. A critical appraisal of review articles on the effectiveness of conservative treatment for neck pain. Spine (Phila Pa 1976). 2001 Jan 15;26(2):196-205. doi: 10.1097/00007632-200101150-00015.
Background: PubMed 15389743Gur A, Sarac AJ, Cevik R, Altindag O, Sarac S. Efficacy of 904 nm gallium arsenide low level laser therapy in the management of chronic myofascial pain in the neck: a double-blind and randomize-controlled trial. Lasers Surg Med. 2004;35(3):229-35. doi: 10.1002/lsm.20082.
Background: PubMed 22836591Bron C, Dommerholt JD. Etiology of myofascial trigger points. Curr Pain Headache Rep. 2012 Oct;16(5):439-44. doi: 10.1007/s11916-012-0289-4.
Background: PubMed 17285185Yap EC. Myofascial pain--an overview. Ann Acad Med Singap. 2007 Jan;36(1):43-8.
Background: PubMed 22045511Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.
Background: PubMed 16806710Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006 Sep;124(1-2):201-10. doi: 10.1016/j.pain.2006.05.018. Epub 2006 Jun 27.
Background: PubMed 19913903Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13.
Background: PubMed 14673617Altan L, Bingol U, Aykac M, Yurtkuran M. Investigation of the effect of GaAs laser therapy on cervical myofascial pain syndrome. Rheumatol Int. 2005 Jan;25(1):23-7. doi: 10.1007/s00296-003-0396-y. Epub 2003 Dec 12.
Background: PubMed 17021664Dundar U, Evcik D, Samli F, Pusak H, Kavuncu V. The effect of gallium arsenide aluminum laser therapy in the management of cervical myofascial pain syndrome: a double blind, placebo-controlled study. Clin Rheumatol. 2007 Jun;26(6):930-4. doi: 10.1007/s10067-006-0438-4. Epub 2006 Oct 5.
Background: PubMed 22891782Huang SF, Tsai YA, Wu SB, Wei YH, Tsai PY, Chuang TY. Effects of intravascular laser irradiation of blood in mitochondria dysfunction and oxidative stress in adults with chronic spinal cord injury. Photomed Laser Surg. 2012 Oct;30(10):579-86. doi: 10.1089/pho.2012.3228. Epub 2012 Aug 14.
Background: PubMed 18204188Wasik M, Gorska E, Modzelewska M, Nowicki K, Jakubczak B, Demkow U. The influence of low-power helium-neon laser irradiation on function of selected peripheral blood cells. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):729-37.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lin-Yi Wang, MD contact

886-7-7317123 ext. 6286

s801121@cgmh.org.tw

Lin-Yi Wang, MD contact

886-7-7317123 ext. 6286

s801121.s801121@msa.hinet.net

Lin-Yi Wang, MD study chair

Rehabilitation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lin-Yi Wang, MD (886-7-7317123 ext. 6286, s801121@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: week 0, week 2, week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02470000, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.