Myofascial Pain Syndrome and Dextrose Prolotherapy

NCT ID: NCT04941118

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2021-12-31

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.

Detailed Description

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Conditions

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Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Only saline and local anesthetic (lidocaine)

Group Type SHAM_COMPARATOR

Local anesthetic and saline injection to the myofascial trigger point

Intervention Type DRUG

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.

Dextrose prolotherapy group

Dextrose, saline and local anesthetic (lidocaine)

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mustafa Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Halil Ogut

Assistant Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hatay Mustafa Kemal University, Tayfur Ata Sökmen Faculty of Medicine

Hatay, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Halil Ogut, M.D.

Role: CONTACT

+90 326 229 1000 ext. 5067

Facility Contacts

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Halil Ogut, M.D.

Role: primary

+90 326 229 1000 ext. 5067

References

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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.

Reference Type BACKGROUND
PMID: 29403602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23690322 (View on PubMed)

Other Identifiers

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MustafaKUPMR-MPS

Identifier Type: -

Identifier Source: org_study_id

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