Myofascial Pain Syndrome and Dextrose Prolotherapy

Phase 4

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

• Registration Number: NCT04941118
• Lead Sponsor: Mustafa Kemal University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-28
• Status Verified: 2021-07
• Study Start: 2021-07-15
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-21
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Local anesthetic and saline injection to the myofascial trigger point	Only saline and local anesthetic (lidocaine)
Dextrose prolotherapy group	Injection of dextrose, local anesthetic and saline to the myofascial trigger point	Dextrose, saline and local anesthetic (lidocaine)

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	First month post-treatment	0-10 cm visual scale (0: no pain, 10: most severe pain)
Neck Disability Index	First month post-treatment	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	First month post-treatment	Active neck range of motion, which shows the movement of the neck in all directions, is evaluated by goniometric measurement.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hatay Mustafa Kemal University, Tayfur Ata Sökmen Faculty of Medicine; 🇹🇷 Hatay, Turkey