- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04941118
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
Study Type
Enrollment (Anticipated)
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
-
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Control group
Only saline and local anesthetic (lidocaine)
|
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)
|
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
Time Frame: First month post-treatment
|
0-10 cm visual scale (0: no pain, 10: most severe pain)
|
First month post-treatment
|
Neck Disability Index
Time Frame: 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.
|
First month post-treatment
|
Neck joint range of motion measurement
Time Frame: First month post-treatment
|
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
Time Frame: Through study completion, an average of 6 month.
|
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
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)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome
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Riphah International UniversityCompletedMyofascial Trigger Point Pain | Quadratus Lumborum Syndrome | Positional Fault of Pelvis | Myofascial Trigger Point in Quadratus LumborumPakistan
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Medical University of SilesiaCompletedMyofascial Trigger Point Pain | Myofascial Pain Syndrome of Neck | Myofascial Trigger Point SyndromePoland
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Riphah International UniversityCompletedMyofascial Pain Syndrome of NeckPakistan
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Istanbul UniversityCompletedMyofascial Pain Syndrome of NeckTurkey
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