Myofascial Pain Syndrome and Dextrose Prolotherapy

Evaluation of the Effect of Dextrose Prolotherapy on Pain and Function in Women With Myofascial Pain Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome
• Intervention / Treatment: Drug: Local anesthetic and saline injection to the myofascial trigger point; Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger point

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Halil Ogut, M.D.; Phone Number: 5067 +90 326 229 1000; Email: oguthalil@gmail.com

Study Locations

• Turkey
  • Hatay, Turkey, 31060
    • Recruiting
    • Hatay Mustafa Kemal University, Tayfur Ata Sökmen Faculty of Medicine
    • Contact: Halil Ogut, M.D.; Phone Number: 5067 +90 326 229 1000; Email: oguthalil@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; Only saline and local anesthetic (lidocaine)	Drug: Local anesthetic and saline injection to the myofascial trigger point; 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.
Active Comparator: Dextrose prolotherapy group; Dextrose, saline and local anesthetic (lidocaine)	Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger point; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	0-10 cm visual scale (0: no pain, 10: most severe pain)	First month post-treatment
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.	First month post-treatment
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.	First month post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Edema, ecchymosis, hematoma, allergic reaction, exacerbation of pain, systemic or distant side effects	Through study completion, an average of 6 month.

Collaborators and Investigators

• Sponsor: Mustafa Kemal University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Myofascial pain, dextrose prolotherapy, neck disability
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: MustafaKUPMR-MPS

Drug and device information, study documents

• 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