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Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome

Comparison of the Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05318560
Enrollment
72
Registered
2022-04-08
Start date
2022-06-30
Completion date
2022-12-10
Last updated
2022-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndrome, Ozone

Keywords

Ozone, Pain

Brief summary

In this study, the investigators planned to compare local anesthetic injection added to stretching exercise, ozone injection treatment added to stretching exercise, and only stretching exercise in patients with upper trapezius muscle myofascial pain syndrome.

Detailed description

The investigators will recruit 72 patients with at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of myofascial pain syndrome (MAS) (according to Travell-Simons' criteria) admitted to the physical medicine and rehabilitation outpatient clinic. Age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain of these patients will be questioned. Patients will be randomly divided into three groups. A total of 3 consecutive weeks of treatment were planned.

Interventions

DRUGOzone

for MPS

OTHERstretching exercise

for MPS

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* With at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of MPS

Exclusion criteria

* Presence of any cervical radiculopathy or a history of degenerative conditions * Presence of any cervical surgery or trauma in the past year, * History of injection for the treatment of MAS in the last 6 months, * Cognitive disorder, * Rheumatological disease, fibromyalgia, * History of metabolic diseases such as hypothyroidism and diabetes mellitus

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS)Change from baseline VAS at the 1st week after the treatment.The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.

Secondary

MeasureTime frameDescription
Neck Disability Index (NDI)Change from baseline VAS at the 1st week after the treatment.NDI was assessed by the neck pain questionnaire that included 10 questions regarding the severity of neck pain, its impact on sleeping, driving, etc. Each question was scored from 0 to 5 and the total score was measured from 50 and was finally reported in percent (%). A higher percentage of NDI was an indicator of more disability and pain.
Range of motion (ROM)Change from baseline VAS at the 1st week after the treatment.Range of motion (ROM) in neck lateral flexion movement measured according to the maximum angle that the patient could laterally bend his or her neck to the right and left side, using three consecutive times of goniometry and recording maximum value of them. Mean of the highest values of both directions was recorded as the final amount.

Contacts

Primary ContactAyse Simsek, m.d.
draysesimsek2@gmail.com+905319698492
Backup ContactHakan Alkan, Prof.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026