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.

Study Overview

• Status: Recruiting
• Conditions: Myofascial Trigger Point Pain
• Intervention / Treatment: Other: normal saline; Drug: Dextrose 5% in water; Drug: Dextrose 15% in water

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ta-Shen Kuan, M.D., M.S.; Phone Number: 5242 886-6-2353535; Email: kuan@mail.ncku.edu.tw
• Study Contact Backup: Name: Yao-Hong Guo, M.D., M.S.; Phone Number: 5240 886-6-2353535; Email: n511478@mail.hosp.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital
    • Contact: Ta-Shen Kuan, M.D., M.S.; Phone Number: 5242 886-6-2353535; Email: kuan@mail.ncku.edu.tw
    • Contact: Yao-Hong Guo, M.D., M.S.; Phone Number: 5242 886-6-2353535; Email: n511478@mail.hosp.ncku.edu.tw
    • Principal Investigator: Ta-Shen Kuan, M.D., M.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: Ta-Shen Kuan, M.D., M.S., National Cheng-Kung University Hospital

Publications and helpful links

General Publications

• 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.
• Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: myofascial trigger point; endplate noise; dextrose.
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: B-BR-110-078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No