The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

Myofascial Trigger Point Pain Clinical Trial

Official title:

The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429827
• Other study ID #: B-BR-110-078
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: National Cheng-Kung University Hospital
• Contact: Ta-Shen Kuan, M.D., M.S.
• Phone: 886-6-2353535
• Email: kuan[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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 identi?ed 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 ?bers,
• (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 immunode?ciency syndrome;
• (7). malignancy;
• (8). pregnant or likely to be pregnant.
• (9). diabetes mellitus

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain

Intervention

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.
• Dextrose 15% in water
Inject 2 ml 15% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.

Locations

Country	Name	City	State
Taiwan	Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.