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

NCT02470000 | Unknown

• 1 other identifier: CMRPG8D0921
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofacial Pain Syndromes

Keywords

myofascial pain; neck; laser; elastography; shear wave velocity; randomized control trial; Intravascular Laser Irradiation of Blood

Outcome Measures

Primary Outcomes (1)

• 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.

  week 0, week 2, week 14

Secondary Outcomes (4)

• Pressure pain threshold (PPT)

  week 0, week 2, week 14

• Shear wave velocity (SWV)

  week 0, week 2, week 14

• Real-time sonoelastography (RTS)

  week 0, week 2, week 14

• World Health Organization Quality of Life Questionnaire Short Form Taiwan Version: WHOQOL - BREF Taiwan Version

  week 0, week 2, week 14

Study Arms (2)

Experimental Group

EXPERIMENTAL

Intravascular laser irradiation of blood (ILIB, output power 0.3mW), Transcutaneous electrical nerve stimulation (TENS), stretching exercise.

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.

Device: Intravascular laser irradiation of blood (ILIB); Device: Transcutaneous electrical nerve stimulation; Other: Stretching exercise

Interventions

Intravascular laser irradiation of blood (ILIB) DEVICE

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.

Also known as: ILIB

Control Group; Experimental Group

Transcutaneous electrical nerve stimulation DEVICE

TENS over neck for 15 minutes.

Also known as: TENS

Control Group; Experimental Group

Stretching exercise OTHER

stretching exercise to the involved muscle for 15 minutes.

Control Group; Experimental Group

Eligibility Criteria

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

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Lin-Yi Wang

Kaohsiung City, Taiwan

RECRUITING

Related Publications (28)

• 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.

  PMID: 20607458 BACKGROUND

• 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.

  PMID: 11154541 BACKGROUND

• 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.

  PMID: 15389743 BACKGROUND

• 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.

  PMID: 22836591 BACKGROUND

• Yap EC. Myofascial pain--an overview. Ann Acad Med Singap. 2007 Jan;36(1):43-8.

  PMID: 17285185 BACKGROUND

• 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.

  PMID: 22045511 BACKGROUND

• 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.

  PMID: 16806710 BACKGROUND

• 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.

  PMID: 19913903 BACKGROUND

• 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.

  PMID: 14673617 BACKGROUND

• 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.

  PMID: 17021664 BACKGROUND

• 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.

  PMID: 22891782 BACKGROUND

• 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.

  PMID: 18204188 BACKGROUND

• 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.

  PMID: 16481193 BACKGROUND

• 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.

  PMID: 15684746 BACKGROUND

• 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.

  PMID: 22495685 BACKGROUND

• Friedrich-Rust M, Romenski O, Meyer G, Dauth N, Holzer K, Grunwald F, Kriener S, Herrmann E, Zeuzem S, Bojunga J. Acoustic Radiation Force Impulse-Imaging for the evaluation of the thyroid gland: a limited patient feasibility study. Ultrasonics. 2012 Jan;52(1):69-74. doi: 10.1016/j.ultras.2011.06.012. Epub 2011 Jul 7.

  PMID: 21788057 BACKGROUND

• Kang J, Kwon H, Cho J, Oh J, Nam K, Yoon S, Kang M, Lee S, Han S. Comparative study of shear wave velocities using acoustic radiation force impulse technology in hepatocellular carcinoma: the extent of radiofrequency ablation. Gut Liver. 2012 Jul;6(3):362-7. doi: 10.5009/gnl.2012.6.3.362. Epub 2012 May 2.

  PMID: 22844566 BACKGROUND

• Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.

  PMID: 23684553 BACKGROUND

• Leong HT, Ng GY, Leung VY, Fu SN. Quantitative estimation of muscle shear elastic modulus of the upper trapezius with supersonic shear imaging during arm positioning. PLoS One. 2013 Jun 25;8(6):e67199. doi: 10.1371/journal.pone.0067199. Print 2013.

  PMID: 23825641 BACKGROUND

• Bai M, Du L, Gu J, Li F, Jia X. Virtual touch tissue quantification using acoustic radiation force impulse technology: initial clinical experience with solid breast masses. J Ultrasound Med. 2012 Feb;31(2):289-94. doi: 10.7863/jum.2012.31.2.289.

  PMID: 22298873 BACKGROUND

• Kuo WH, Jian DW, Wang TG, Wang YC. Neck muscle stiffness quantified by sonoelastography is correlated with body mass index and chronic neck pain symptoms. Ultrasound Med Biol. 2013 Aug;39(8):1356-61. doi: 10.1016/j.ultrasmedbio.2012.11.015. Epub 2013 May 15.

  PMID: 23683408 BACKGROUND

• Nightingale K. Acoustic Radiation Force Impulse (ARFI) Imaging: a Review. Curr Med Imaging Rev. 2011 Nov 1;7(4):328-339. doi: 10.2174/157340511798038657.

  PMID: 22545033 BACKGROUND

• Gerwin RD, Shannon S, Hong CZ, Hubbard D, Gevirtz R. Interrater reliability in myofascial trigger point examination. Pain. 1997 Jan;69(1-2):65-73. doi: 10.1016/s0304-3959(96)03248-4.

  PMID: 9060014 BACKGROUND

• Zvereva KV, Grunina EA. [The negative effects of low-intensity laser therapy in rheumatoid arthritis]. Ter Arkh. 1996;68(5):22-4. Russian.

  PMID: 9082591 BACKGROUND

• Yao G, Chung CW, Yu CF, Wang JD. Development and verification of validity and reliability of the WHOQOL-BREF Taiwan version. J Formos Med Assoc. 2002 May;101(5):342-51.

  PMID: 12101852 BACKGROUND

• 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.

  BACKGROUND

• Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.

  PMID: 16945250 BACKGROUND

• Eby SF, Song P, Chen S, Chen Q, Greenleaf JF, An KN. Validation of shear wave elastography in skeletal muscle. J Biomech. 2013 Sep 27;46(14):2381-7. doi: 10.1016/j.jbiomech.2013.07.033. Epub 2013 Jul 30.

  PMID: 23953670 BACKGROUND

MeSH Terms

Conditions

Facial Neuralgia

Interventions

Transcutaneous Electric Nerve Stimulation; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lin-Yi Wang, MD

  Rehabilitation

  STUDY CHAIR

Central Study Contacts

Lin-Yi Wang, MD

CONTACT

886-7-7317123; s801121@cgmh.org.tw

Lin-Yi Wang, MD

CONTACT

886-7-7317123; s801121.s801121@msa.hinet.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: June 12, 2015
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 2, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)