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The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

Primary Purpose

Myofascial Trigger Point Pain

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
normal saline
Dextrose 5% in water
Dextrose 15% in water
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring myofascial trigger point, endplate noise, dextrose.

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of physical Medicine and Rehabilitation, National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Normal saline

hypo-osmolar dextrose solution

hyper-osmolar dextrose solution

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

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).
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).
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).
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).
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.
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.
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.
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.
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).
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).
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).
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).

Full Information

First Posted
June 10, 2022
Last Updated
March 25, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05429827
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2022 (Actual)
Primary Completion Date
August 16, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain
Keywords
myofascial trigger point, endplate noise, dextrose.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Injection of 2 ml normal saline into a myofascial trigger point.
Arm Title
hypo-osmolar dextrose solution
Arm Type
Experimental
Arm Description
Injection of 2 ml 5% dextrose into a myofascial trigger point.
Arm Title
hyper-osmolar dextrose solution
Arm Type
Experimental
Arm Description
Injection of 2 ml 15% dextrose into a myofascial trigger point.
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
Inject 2 ml normal saline into a myofascial trigger point and evaluate the clinical effects before and after the injection.
Intervention Type
Drug
Intervention Name(s)
Dextrose 5% in water
Intervention Description
Inject 2 ml 5% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.
Intervention Type
Drug
Intervention Name(s)
Dextrose 15% in water
Intervention Description
Inject 2 ml 15% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.
Primary Outcome Measure Information:
Title
visual analog scale (VAS)
Description
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).
Time Frame
Change from Baseline visual analog scale at one hour after intervention.
Title
visual analog scale (VAS)
Description
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).
Time Frame
Change from Baseline visual analog scale at one week after intervention.
Title
visual analog scale (VAS)
Description
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).
Time Frame
Change from Baseline visual analog scale at two weeks after intervention.
Title
visual analog scale (VAS)
Description
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).
Time Frame
Change from Baseline visual analog scale at one month after intervention.
Secondary Outcome Measure Information:
Title
pressure pain threshold (PPT)
Description
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).
Time Frame
Change from Baseline pressure pain threshold at one hour after intervention.
Title
pressure pain threshold (PPT)
Description
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).
Time Frame
Change from Baseline pressure pain threshold at one week after intervention.
Title
pressure pain threshold (PPT)
Description
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).
Time Frame
Change from Baseline pressure pain threshold at two weeks after intervention.
Title
pressure pain threshold (PPT)
Description
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).
Time Frame
Change from Baseline pressure pain threshold at one month after intervention.
Title
Range of motion (ROM) of the neck
Description
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.
Time Frame
Change from Baseline range of motion (ROM) of the neck at one hour after intervention.
Title
Range of motion (ROM) of the neck
Description
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.
Time Frame
Change from Baseline range of motion (ROM) of the neck at one week after intervention.
Title
Range of motion (ROM) of the neck
Description
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.
Time Frame
Change from Baseline range of motion (ROM) of the neck at two weeks after intervention.
Title
Range of motion (ROM) of the neck
Description
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.
Time Frame
Change from Baseline range of motion (ROM) of the neck at one month after intervention.
Title
neck disability index (NDI)
Description
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).
Time Frame
Change from Baseline neck disability index (NDI) at one hour after intervention.
Title
neck disability index (NDI)
Description
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).
Time Frame
Change from Baseline neck disability index (NDI) at one week after intervention.
Title
neck disability index (NDI)
Description
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).
Time Frame
Change from Baseline neck disability index (NDI) at two weeks after intervention.
Title
neck disability index (NDI)
Description
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).
Time Frame
Change from Baseline neck disability index (NDI) at one month after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ta-Shen Kuan, M.D., M.S.
Phone
886-6-2353535
Ext
5242
Email
kuan@mail.ncku.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yao-Hong Guo, M.D., M.S.
Phone
886-6-2353535
Ext
5240
Email
n511478@mail.hosp.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ta-Shen Kuan, M.D., M.S.
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ta-Shen Kuan, M.D., M.S.
Phone
886-6-2353535
Ext
5242
Email
kuan@mail.ncku.edu.tw
First Name & Middle Initial & Last Name & Degree
Yao-Hong Guo, M.D., M.S.
Phone
886-6-2353535
Ext
5242
Email
n511478@mail.hosp.ncku.edu.tw
First Name & Middle Initial & Last Name & Degree
Ta-Shen Kuan, M.D., M.S.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32349034
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.
Results Reference
background
PubMed Identifier
27429562
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.
Results Reference
background
PubMed Identifier
16945250
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.
Results Reference
background
PubMed Identifier
9685106
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.
Results Reference
background
PubMed Identifier
12131178
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.
Results Reference
background

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The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

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