Myofascial Pain Syndrome and Dextrose Prolotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome

Intervention / Treatment
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* Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger point
* Drug: Local anesthetic and saline injection to the myofascial trigger point


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial pain, dextrose prolotherapy, neck disability