Myofascial Trigger Point Pain Clinical Trial
Official title:
The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome
Patients with an myofascial trigger point (MTrP) in their upper trapezius will be divided into three groups: Group A receiving MTrP injection with normal saline (control group), Group B with hypo-osmolar dextrose (5% dextrose), and Group C with hyper-osmolar dextrose (15% dextrose). Clinical outcomes and morphological changes will be measured before the injection, one hour after, one week after, two weeks after, and one month after the injection to delineate the therapeutic effects of dextrose injection for an MTrP.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - 1). Patients should be 20 years of age or older; - 2). They are able to communicate freely; - 3). Patients have the diagnosis of myofascial pain syndrome (MPS) with a definite myofascial trigger point (MTrP) in the neck base and upper back regions (the upper trapezius muscle). The MTrP is identi?ed based on the following criteria, as recommended by Simons [Simons et al., 1999]: - (a). a localized tender spot in a palpable taut band of muscle ?bers, - (b). recognized pain (as the usual clinical complaint) when the tender spot is compressed, - (c). characteristic and consistent referred pain. - 4). Symptoms of MPS should be more than 3 weeks. Exclusion Criteria: - (1). acute or serious medical problems; - (2). cognitive impairment or psychiatric disorder; - (3). coagulopathy or any other bleeding disorder; - (4). taking medication of anticoagulation or antithrombolytics; - (5). sensory deficiency over the body part where MTrPs located; - (6). serum hepatitis B or acquired immunode?ciency syndrome; - (7). malignancy; - (8). pregnant or likely to be pregnant. - (9). diabetes mellitus |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng-Kung University Hospital |
Taiwan,
Chou Y, Chiou HJ, Wang HK, Lai YC. Ultrasound-guided dextrose injection treatment for chronic myofascial pain syndrome: A retrospective case series. J Chin Med Assoc. 2020 Sep;83(9):876-879. doi: 10.1097/JCMA.0000000000000339. — View Citation
Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016. — View Citation
Hong CZ, Simons DG. Pathophysiologic and electrophysiologic mechanisms of myofascial trigger points. Arch Phys Med Rehabil. 1998 Jul;79(7):863-72. doi: 10.1016/s0003-9993(98)90371-9. — View Citation
Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3. — View Citation
Kuan TS, Chen JT, Chen SM, Chien CH, Hong CZ. Effect of botulinum toxin on endplate noise in myofascial trigger spots of rabbit skeletal muscle. Am J Phys Med Rehabil. 2002 Jul;81(7):512-20; quiz 521-3. doi: 10.1097/00002060-200207000-00008. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | visual analog scale (VAS) | To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful). | Change from Baseline visual analog scale at one hour after intervention. | |
Primary | visual analog scale (VAS) | To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful). | Change from Baseline visual analog scale at one week after intervention. | |
Primary | visual analog scale (VAS) | To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful). | Change from Baseline visual analog scale at two weeks after intervention. | |
Primary | visual analog scale (VAS) | To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful). | Change from Baseline visual analog scale at one month after intervention. | |
Secondary | pressure pain threshold (PPT) | To measure the change of pressure pain threshold of a myofascial trigger point. The minimum value is 0 Kg/cm2, the maximum value is 5 Kg/cm2, and higher scores mean better outcome (less painful). | Change from Baseline pressure pain threshold at one hour after intervention. | |
Secondary | pressure pain threshold (PPT) | To measure the change of pressure pain threshold of a myofascial trigger point. The minimum value is 0 Kg/cm2, the maximum value is 5 Kg/cm2, and higher scores mean better outcome (less painful). | Change from Baseline pressure pain threshold at one week after intervention. | |
Secondary | pressure pain threshold (PPT) | To measure the change of pressure pain threshold of a myofascial trigger point. The minimum value is 0 Kg/cm2, the maximum value is 5 Kg/cm2, and higher scores mean better outcome (less painful). | Change from Baseline pressure pain threshold at two weeks after intervention. | |
Secondary | pressure pain threshold (PPT) | To measure the change of pressure pain threshold of a myofascial trigger point. The minimum value is 0 Kg/cm2, the maximum value is 5 Kg/cm2, and higher scores mean better outcome (less painful). | Change from Baseline pressure pain threshold at one month after intervention. | |
Secondary | Range of motion (ROM) of the neck | To measure the change of the range of motion of cervical spine. The minimum value is 0 degree, the maximum value is 90 degree, and higher scores mean better outcome. | Change from Baseline range of motion (ROM) of the neck at one hour after intervention. | |
Secondary | Range of motion (ROM) of the neck | To measure the change of the range of motion of cervical spine. The minimum value is 0 degree, the maximum value is 90 degree, and higher scores mean better outcome. | Change from Baseline range of motion (ROM) of the neck at one week after intervention. | |
Secondary | Range of motion (ROM) of the neck | To measure the change of the range of motion of cervical spine. The minimum value is 0 degree, the maximum value is 90 degree, and higher scores mean better outcome. | Change from Baseline range of motion (ROM) of the neck at two weeks after intervention. | |
Secondary | Range of motion (ROM) of the neck | To measure the change of the range of motion of cervical spine. The minimum value is 0 degree, the maximum value is 90 degree, and higher scores mean better outcome. | Change from Baseline range of motion (ROM) of the neck at one month after intervention. | |
Secondary | neck disability index (NDI) | To measure the change of neck disability index (NDI) related to the myofascial trigger point. The minimum value is 0, the maximum value is 50, and higher scores mean worse outcome (increased functional disability). | Change from Baseline neck disability index (NDI) at one hour after intervention. | |
Secondary | neck disability index (NDI) | To measure the change of neck disability index (NDI) related to the myofascial trigger point. The minimum value is 0, the maximum value is 50, and higher scores mean worse outcome (increased functional disability). | Change from Baseline neck disability index (NDI) at one week after intervention. | |
Secondary | neck disability index (NDI) | To measure the change of neck disability index (NDI) related to the myofascial trigger point. The minimum value is 0, the maximum value is 50, and higher scores mean worse outcome (increased functional disability). | Change from Baseline neck disability index (NDI) at two weeks after intervention. | |
Secondary | neck disability index (NDI) | To measure the change of neck disability index (NDI) related to the myofascial trigger point. The minimum value is 0, the maximum value is 50, and higher scores mean worse outcome (increased functional disability). | Change from Baseline neck disability index (NDI) at one month after intervention. |
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