Clinical trial
The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome
Name
B-BR-110-078
Description
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.
Trial arms
Trial start
2022-11-18
Estimated PCD
2024-12-20
Trial end
2024-12-31
Status
Recruiting
Treatment
normal saline
Inject 2 ml normal saline into a myofascial trigger point and evaluate the clinical effects before and after the injection.
Arms:
Normal saline
Dextrose 5% in water
Inject 2 ml 5% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.
Arms:
hypo-osmolar dextrose solution
Dextrose 15% in water
Inject 2 ml 15% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.
Arms:
hyper-osmolar dextrose solution
Size
30
Primary endpoint
visual analog scale (VAS)
Change from Baseline visual analog scale at one hour after intervention.
visual analog scale (VAS)
Change from Baseline visual analog scale at one week after intervention.
visual analog scale (VAS)
Change from Baseline visual analog scale at two weeks after intervention.
visual analog scale (VAS)
Change from Baseline visual analog scale at one month after intervention.
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-04-11
1 organization
2 products
1 indication
Organization
National Cheng-Kung University HospitalProduct
Dextrose 5%Indication
Myofascial Trigger Point PainProduct
Dextrose