The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

NCT05429827 | Recruiting

• 1 other identifier: B-BR-110-078
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Trigger Point Pain

Keywords

myofascial trigger point; endplate noise; dextrose.

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• pressure pain threshold (PPT)

  Change from Baseline pressure pain threshold at one hour after intervention.

• pressure pain threshold (PPT)

  Change from Baseline pressure pain threshold at one week after intervention.

• pressure pain threshold (PPT)

  Change from Baseline pressure pain threshold at two weeks after intervention.

• pressure pain threshold (PPT)

  Change from Baseline pressure pain threshold at one month after intervention.

• Range of motion (ROM) of the neck

  Change from Baseline range of motion (ROM) of the neck at one hour after intervention.

Study Arms (3)

Normal saline

PLACEBO COMPARATOR

Injection of 2 ml normal saline into a myofascial trigger point.

Other: normal saline

hypo-osmolar dextrose solution

EXPERIMENTAL

Injection of 2 ml 5% dextrose into a myofascial trigger point.

Drug: Dextrose 5% in water

hyper-osmolar dextrose solution

EXPERIMENTAL

Injection of 2 ml 15% dextrose into a myofascial trigger point.

Drug: Dextrose 15% in water

Interventions

normal saline OTHER

Inject 2 ml normal saline into a myofascial trigger point and evaluate the clinical effects before and after the injection.

Normal saline

Dextrose 5% in water DRUG

Inject 2 ml 5% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.

hypo-osmolar dextrose solution

Dextrose 15% in water DRUG

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

hyper-osmolar dextrose solution

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ). Patients should be 20 years of age or older;
• ). They are able to communicate freely;
• ). 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.
• ). Symptoms of MPS should be more than 3 weeks.

You may not qualify if:

• (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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Related 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.

  PMID: 32349034 BACKGROUND

• 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.

  PMID: 27429562 BACKGROUND

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

  PMID: 16945250 BACKGROUND

• 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.

  PMID: 9685106 BACKGROUND

• 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.

  PMID: 12131178 BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Saline Solution; Glucose; Water

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Ta-Shen Kuan, M.D., M.S.

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ta-Shen Kuan, M.D., M.S.

CONTACT

886-6-2353535; kuan@mail.ncku.edu.tw

Yao-Hong Guo, M.D., M.S.

CONTACT

886-6-2353535; n511478@mail.hosp.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor, M.D.

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 23, 2022
• Study Start: November 18, 2022
• Primary Completion: December 20, 2025
• Study Completion: December 31, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)