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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.
1. Time interval of the study: from 2014-11-1 to 2016-10-31 2. Participants and sample size:
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:
V. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Intravascular laser irradiation of blood (ILIB, output power 0.3mW), Transcutaneous electrical nerve stimulation (TENS), stretching exercise. |
|
| Control Group | Sham Comparator | Intravascular laser irradiation of blood (ILIB, output power 0mW), Transcutaneous electrical nerve stimulation (TENS), stretching exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin-Yi Wang, MD | Contact | 886-7-7317123 | 6286 | s801121@cgmh.org.tw |
| Lin-Yi Wang, MD | Contact | 886-7-7317123 | 6286 | s801121.s801121@msa.hinet.net |
| Name | Affiliation | Role |
|---|---|---|
| Lin-Yi Wang, MD | Rehabilitation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lin-Yi Wang | Recruiting | Kaohsiung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20607458 | Background | 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. | |
| 11154541 | 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. |
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|
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| Transcutaneous electrical nerve stimulation | Device | TENS over neck for 15 minutes. |
|
|
| Stretching exercise | Other | stretching exercise to the involved muscle for 15 minutes. |
|
| 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. | 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. | week 0, week 2, week 14 |
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| ID | Term |
|---|---|
| D005156 | Facial Neuralgia |
| ID | Term |
|---|---|
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D005081 | Exercise Therapy |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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