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Myofascial Pain Syndrome and Dextrose Prolotherapy

Primary Purpose

Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Injection of dextrose, local anesthetic and saline to the myofascial trigger point
Local anesthetic and saline injection to the myofascial trigger point
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome focused on measuring Myofascial pain, dextrose prolotherapy, neck disability

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 60 women aged 20-50 years with a diagnosis of myofascial pain syndrome

Exclusion Criteria:

  • Cervical radiculopathy, cervical degeneration, neck surgery or trauma in the last year, injection history for myofascial pain syndrome in the last 6 months, cognitive impairment and fibromyalgia, rheumatoid arthritis, hypothyroidism, diabetes mellitus

Sites / Locations

  • Hatay Mustafa Kemal University, Tayfur Ata Sökmen Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Control group

Dextrose prolotherapy group

Arm Description

Only saline and local anesthetic (lidocaine)

Dextrose, saline and local anesthetic (lidocaine)

Outcomes

Primary Outcome Measures

Visual Analog Scale
0-10 cm visual scale (0: no pain, 10: most severe pain)
Neck Disability Index
It measures the functional state of the neck by scoring between 0-5 points according to the severity of pain, consisting of 20 questions.
Neck joint range of motion measurement
Active neck range of motion, which shows the movement of the neck in all directions, is evaluated by goniometric measurement.

Secondary Outcome Measures

Side effects
Edema, ecchymosis, hematoma, allergic reaction, exacerbation of pain, systemic or distant side effects

Full Information

First Posted
June 15, 2021
Last Updated
July 15, 2021
Sponsor
Mustafa Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT04941118
Brief Title
Myofascial Pain Syndrome and Dextrose Prolotherapy
Official Title
Evaluation of the Effect of Dextrose Prolotherapy on Pain and Function in Women With Myofascial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Myofascial pain syndrome is characterized by the presence of hypersensitive points called trigger points that cause pain, tenderness, spasm, stiffness, limitation of movement, weakness, taut band within the muscle, and pain reflected by pressing in a muscle group or a single muscle. Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces. In this study, it was aimed to examine the effect of prolotherapy application on pain, neck range of motion and neck disability in women with myofascial pain syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome
Keywords
Myofascial pain, dextrose prolotherapy, neck disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Only saline and local anesthetic (lidocaine)
Arm Title
Dextrose prolotherapy group
Arm Type
Active Comparator
Arm Description
Dextrose, saline and local anesthetic (lidocaine)
Intervention Type
Drug
Intervention Name(s)
Injection of dextrose, local anesthetic and saline to the myofascial trigger point
Intervention Description
An injection of 5 ml of 5% dextrose prolotherapy using 2.5 ml 10% dextrose, 1 ml 2% local anesthetic (lidocaine), 1.5 ml 0.9% saline will be administered to the active group from at least 10 trigger points.
Intervention Type
Drug
Intervention Name(s)
Local anesthetic and saline injection to the myofascial trigger point
Intervention Description
A total of 5 ml of solution created by using 4 ml of 0.9% saline and 1 ml of 2% local anesthetic (lidocaine) will be administered to the control group, with at least 10 trigger points.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
0-10 cm visual scale (0: no pain, 10: most severe pain)
Time Frame
First month post-treatment
Title
Neck Disability Index
Description
It measures the functional state of the neck by scoring between 0-5 points according to the severity of pain, consisting of 20 questions.
Time Frame
First month post-treatment
Title
Neck joint range of motion measurement
Description
Active neck range of motion, which shows the movement of the neck in all directions, is evaluated by goniometric measurement.
Time Frame
First month post-treatment
Secondary Outcome Measure Information:
Title
Side effects
Description
Edema, ecchymosis, hematoma, allergic reaction, exacerbation of pain, systemic or distant side effects
Time Frame
Through study completion, an average of 6 month.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 women aged 20-50 years with a diagnosis of myofascial pain syndrome Exclusion Criteria: Cervical radiculopathy, cervical degeneration, neck surgery or trauma in the last year, injection history for myofascial pain syndrome in the last 6 months, cognitive impairment and fibromyalgia, rheumatoid arthritis, hypothyroidism, diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halil Ogut, M.D.
Phone
+90 326 229 1000
Ext
5067
Email
oguthalil@gmail.com
Facility Information:
Facility Name
Hatay Mustafa Kemal University, Tayfur Ata Sökmen Faculty of Medicine
City
Hatay
ZIP/Postal Code
31060
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halil Ogut, M.D.
Phone
+90 326 229 1000
Ext
5067
Email
oguthalil@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
29403602
Citation
Farpour HR, Fereydooni F. Comparative effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis: A randomized clinical trial. Electron Physician. 2017 Nov 25;9(11):5663-5669. doi: 10.19082/5663. eCollection 2017 Nov.
Results Reference
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PubMed Identifier
23690322
Citation
Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504. Erratum In: Ann Fam Med. 2013 Sep-Oct;11(5):480.
Results Reference
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Myofascial Pain Syndrome and Dextrose Prolotherapy

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