The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

NCT ID: NCT05429827

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-18

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Myofascial Trigger Point Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Normal saline

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

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

hypo-osmolar dextrose solution

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

Group Type EXPERIMENTAL

Dextrose 5% in water

Intervention Type DRUG

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

hyper-osmolar dextrose solution

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

Group Type EXPERIMENTAL

Dextrose 15% in water

Intervention Type DRUG

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

Interventions

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normal saline

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

Intervention Type OTHER

Dextrose 5% in water

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ta-Shen Kuan, MD

associate professor, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

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

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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

Role: CONTACT

886-6-2353535 ext. 5242

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

Role: CONTACT

886-6-2353535 ext. 5240

Facility Contacts

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

Role: primary

886-6-2353535 ext. 5242

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

Role: backup

886-6-2353535 ext. 5242

References

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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.

Reference Type BACKGROUND
PMID: 32349034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27429562 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16945250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9685106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12131178 (View on PubMed)

Other Identifiers

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B-BR-110-078

Identifier Type: -

Identifier Source: org_study_id

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