The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

Not Applicable

Recruiting

• Conditions: Myofascial Trigger Point Pain
• Interventions: Other: normal saline; Drug: Dextrose 5% in water; Drug: Dextrose 15% in water

• Registration Number: NCT05429827
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-23
• Study Start: 2022-11-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	normal saline	Injection of 2 ml normal saline into a myofascial trigger point.
hypo-osmolar dextrose solution	Dextrose 5% in water	Injection of 2 ml 5% dextrose into a myofascial trigger point.
hyper-osmolar dextrose solution	Dextrose 15% in water	Injection of 2 ml 15% dextrose into a myofascial trigger point.

Primary Outcome Measures

Name	Time	Method
visual analog scale (VAS)	Change from Baseline visual analog scale at one month after intervention.	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).

Secondary Outcome Measures

Name	Time	Method
pressure pain threshold (PPT)	Change from Baseline pressure pain threshold at one month after intervention.	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).
Range of motion (ROM) of the neck	Change from Baseline range of motion (ROM) of the neck at one month after intervention.	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.
neck disability index (NDI)	Change from Baseline neck disability index (NDI) at one month after intervention.	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).

Trial Locations

Locations (1)

Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan