Clinical trial NCT05429827: The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome
Official title: The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myofascial Trigger Point Pain
Keywords: myofascial trigger point
endplate noise
dextrose.
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: visual analog scale (VAS)
timeFrame: Change from Baseline visual analog scale at one hour after intervention.
measure: visual analog scale (VAS)
timeFrame: Change from Baseline visual analog scale at one week after intervention.
measure: visual analog scale (VAS)
timeFrame: Change from Baseline visual analog scale at two weeks after intervention.
measure: visual analog scale (VAS)
timeFrame: Change from Baseline visual analog scale at one month after intervention.
Secondary outcomes:
measure: pressure pain threshold (PPT)
timeFrame: Change from Baseline pressure pain threshold at one hour after intervention.
measure: pressure pain threshold (PPT)
timeFrame: Change from Baseline pressure pain threshold at one week after intervention.
measure: pressure pain threshold (PPT)
timeFrame: Change from Baseline pressure pain threshold at two weeks after intervention.
measure: pressure pain threshold (PPT)
timeFrame: Change from Baseline pressure pain threshold at one month after intervention.
measure: Range of motion (ROM) of the neck
timeFrame: Change from Baseline range of motion (ROM) of the neck at one hour after intervention.
measure: Range of motion (ROM) of the neck
timeFrame: Change from Baseline range of motion (ROM) of the neck at one week after intervention.
measure: Range of motion (ROM) of the neck
timeFrame: Change from Baseline range of motion (ROM) of the neck at two weeks after intervention.
measure: Range of motion (ROM) of the neck
timeFrame: Change from Baseline range of motion (ROM) of the neck at one month after intervention.
measure: neck disability index (NDI)
timeFrame: Change from Baseline neck disability index (NDI) at one hour after intervention.
measure: neck disability index (NDI)
timeFrame: Change from Baseline neck disability index (NDI) at one week after intervention.
measure: neck disability index (NDI)
timeFrame: Change from Baseline neck disability index (NDI) at two weeks after intervention.
measure: neck disability index (NDI)
timeFrame: Change from Baseline neck disability index (NDI) at one month after intervention.
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Ta-Shen Kuan, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.