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Status unknownNCT04941118Updated Jul 21, 2021

Myofascial Pain Syndrome and Dextrose Prolotherapy

A Phase 4 interventional study of Injection of dextrose, local anesthetic and saline to the myofascial trigger point and Local anesthetic and saline injection to the myofascial trigger point in Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome, sponsored by Mustafa Kemal University. Status unknown at 1 site in Turkey. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-07-21.

Sponsored by Mustafa Kemal University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Female
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Study 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.

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Conditions studied

  • Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome

Keywords

  • Myofascial pain, dextrose prolotherapy, neck disability
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In context

Myofascial Pain Syndromes

1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

Mustafa Kemal University is the lead sponsor of 71 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Sham comparator
    Control group

    Only saline and local anesthetic (lidocaine)

    Drug: Local anesthetic and saline injection to the myofascial trigger point

  • Active comparator
    Dextrose prolotherapy group

    Dextrose, saline and local anesthetic (lidocaine)

    Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger point

Interventions

  • DrugInjection 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.

  • DrugLocal 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.

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What researchers measure

Primary outcomes

  1. Visual Analog Scale

    0-10 cm visual scale (0: no pain, 10: most severe pain)

    Time frame: First month post-treatment

  2. 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.

    Time frame: First month post-treatment

  3. 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.

    Time frame: First month post-treatment

Secondary outcomes

  1. Side effects

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

    Time frame: Through study completion, an average of 6 month.

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Study locations

1 of 1 sites recruiting
  • Hatay Mustafa Kemal University, Tayfur Ata Sökmen Faculty of Medicine
    Hatay, 31060, Turkey
    Recruiting
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References and documents

Publications

  • 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. PubMed 29403602 ↗
  • 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. PubMed 23690322 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04941118
Lead sponsor
Mustafa Kemal University
Responsible party
Halil Ogut (Assistant Professor Doctor, Mustafa Kemal University) — Principal investigator
First posted
Jun 28, 2021
Start date
Jul 15, 2021
Primary completion
Dec 30, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jul 21, 2021

Study contacts

Halil Ogut, M.D.
Contact
oguthalil@gmail.com
+90 326 229 1000 ext. 5067

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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