The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 20, 2022

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.

Interventions

  • Other: normal saline
    • Inject 2 ml normal saline into a myofascial trigger point and evaluate the clinical effects before and after the injection.
  • Drug: Dextrose 5% in water
    • Inject 2 ml 5% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.
  • Drug: 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, Groups and Cohorts

  • Placebo Comparator: Normal saline
    • Injection of 2 ml normal saline into a myofascial trigger point.
  • Experimental: hypo-osmolar dextrose solution
    • Injection of 2 ml 5% dextrose into a myofascial trigger point.
  • Experimental: hyper-osmolar dextrose solution
    • Injection of 2 ml 15% dextrose into a myofascial trigger point.

Clinical Trial Outcome Measures

Primary Measures

  • visual analog scale (VAS)
    • Time Frame: Change from Baseline visual analog scale at one hour 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).
  • visual analog scale (VAS)
    • Time Frame: Change from Baseline visual analog scale at one week 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).
  • visual analog scale (VAS)
    • Time Frame: Change from Baseline visual analog scale at two weeks 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).
  • visual analog scale (VAS)
    • Time Frame: 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 Measures

  • pressure pain threshold (PPT)
    • Time Frame: Change from Baseline pressure pain threshold at one hour 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).
  • pressure pain threshold (PPT)
    • Time Frame: Change from Baseline pressure pain threshold at one week 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).
  • pressure pain threshold (PPT)
    • Time Frame: Change from Baseline pressure pain threshold at two weeks 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).
  • pressure pain threshold (PPT)
    • Time Frame: 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
    • Time Frame: Change from Baseline range of motion (ROM) of the neck at one hour 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.
  • Range of motion (ROM) of the neck
    • Time Frame: Change from Baseline range of motion (ROM) of the neck at one week 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.
  • Range of motion (ROM) of the neck
    • Time Frame: Change from Baseline range of motion (ROM) of the neck at two weeks 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.
  • Range of motion (ROM) of the neck
    • Time Frame: 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)
    • Time Frame: Change from Baseline neck disability index (NDI) at one hour 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).
  • neck disability index (NDI)
    • Time Frame: Change from Baseline neck disability index (NDI) at one week 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).
  • neck disability index (NDI)
    • Time Frame: Change from Baseline neck disability index (NDI) at two weeks 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).
  • neck disability index (NDI)
    • Time Frame: 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Cheng-Kung University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ta-Shen Kuan, MD, associate professor, M.D. – National Cheng-Kung University Hospital
  • Overall Official(s)
    • Ta-Shen Kuan, M.D., M.S., Principal Investigator, National Cheng-Kung University Hospital
  • Overall Contact(s)
    • Ta-Shen Kuan, M.D., M.S., 886-6-2353535, kuan@mail.ncku.edu.tw

References

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.

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. Review.

Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. Review.

Hong CZ, Simons DG. Pathophysiologic and electrophysiologic mechanisms of myofascial trigger points. Arch Phys Med Rehabil. 1998 Jul;79(7):863-72. Review.

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.

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