The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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This experiment is designed to evaluate the therapeutic effects of dextrose injection on an myofascial trigger point (MTrP). Patients with an MTrP in their upper trapezius will be recruited and 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 (visual analog scale, pressure pain threshold, range of motion, neck disability index) will be measured before the injection, one hour after, one week after, two weeks after, and one month after the injection. Morphological changes of an MTrP before, and after the injection will also be evaluated by sonography. Through this study, the definite therapeutic effects, and the better osmolality of dextrose injection for the treatment of an MTrP will be delineated.

Official Title
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The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

Conditions
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Myofascial Trigger Point Pain

Intervention / Treatment
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* Other: normal saline
* Drug: Dextrose 5% in water
* Drug: Dextrose 15% in water


Participation Criteria
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Eligibility Criteria
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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 identiﬁed 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 ﬁbers, (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 immunodeﬁciency syndrome; (7). malignancy; (8). pregnant or likely to be pregnant. (9). diabetes mellitus

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline<br>Injection of 2 ml normal saline into a myofascial trigger point. | Other: normal saline<br>* Inject 2 ml normal saline into a myofascial trigger point and evaluate the clinical effects before and after the injection.<br>|
| Experimental: hypo-osmolar dextrose solution<br>Injection of 2 ml 5% dextrose into a myofascial trigger point. | Drug: Dextrose 5% in water<br>* Inject 2 ml 5% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.<br>|
| Experimental: hyper-osmolar dextrose solution<br>Injection of 2 ml 15% dextrose into a myofascial trigger point. | Drug: Dextrose 15% in water<br>* Inject 2 ml 15% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myofascial trigger point, endplate noise, dextrose.