Chronic Masticatory Myofascial Pain
Conditions
Brief summary
This study examined whether adding an oral magnesium supplement to behavioral counseling reduced pain in adults with chronic jaw muscle pain. Fifty adults were randomly assigned to two groups. One group received magnesium citrate providing 200 mg of elemental magnesium daily for 30 days and behavioral counseling. The other group received behavioral counseling alone. Pain, jaw movement, jaw function, pain-related disability, and anxiety were assessed before treatment and at 1 and 3 months. The main outcome was jaw muscle pain intensity at 3 months. Adverse events were also recorded. The study was completed before registration.
Detailed description
This single-center, parallel-group randomized trial evaluated oral magnesium citrate as an adjunct to behavioral counseling in adults with chronic masticatory myofascial pain diagnosed using the DC/TMD Axis I examination. Fifty participants were assigned in a 1:1 ratio to magnesium citrate plus behavioral counseling or behavioral counseling alone. An independent statistician generated the allocation sequence using simple randomization and prepared sequentially numbered, sealed, opaque envelopes. Participants and the treating clinician knew the assigned treatment. Clinical outcome assessments were performed by a trained examiner who was not involved in treatment delivery and was blinded to group allocation. Assessments were performed at baseline and 1 and 3 months after randomization. The study protocol was approved by the Afyonkarahisar Health Sciences University Clinical Research Ethics Committee on 13 May 2022 (approval number 2022/245; meeting number 2022/6; decision number 245). Regulatory authorization was obtained from the Turkish Medicines and Medical Devices Agency on 29 March 2023 (Clinical Trial Reference 22-AKD-151). All participants provided written informed consent before enrollment.
Interventions
DIETARY_SUPPLEMENTMagnesium citrate
A commercially available magnesium citrate preparation (VeNatura, Türkiye) providing 200 mg of elemental magnesium, taken orally as one tablet daily with food for 30 days. Participants purchased the product themselves.
BEHAVIORALBehavioral counseling
A single standardized 30-minute session covering education about temporomandibular disorders, self-management, avoidance of parafunctional habits, self-massage, thermal therapy, and dietary recommendations to reduce jaw strain. The same orofacial pain specialist delivered counseling in both groups using a written protocol and checklist. Participants received written instructions for home practice.
Sponsors
Muhammet Yasin Pektaş
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and the treating clinician knew the assigned intervention. Clinical outcomes were assessed by an examiner who was not involved in treatment delivery and was blinded to group allocation. Participants were asked not to disclose their allocation during follow-up visits.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 65 years. * DC/TMD Axis I diagnosis of myalgia/myofascial pain. * Pain persisting or recurring for at least 3 months. * Palpable trigger points in the masseter or temporalis muscles.
Exclusion criteria
* Other TMD subtypes. * Systemic inflammatory or neurological disorders. * Current magnesium supplementation. * Contraindications to magnesium. * Renal impairment. * Pregnancy. * Severe psychiatric disorders. * Ongoing TMD-related litigation. * Inability to complete Turkish questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Masticatory Muscle Pain Intensity | 3 months after randomization | Masticatory muscle pain intensity measured on a 10-cm visual analogue scale (VAS), reflecting average pain over the preceding 7 days. VAS was assessed at baseline and 1 and 3 months after randomization; the 3-month assessment was the primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Unassisted Mouth Opening | Baseline, 1 month, and 3 months after randomization | Maximum unassisted mouth opening measured in millimeters with a digital caliper. Measurements were obtained in triplicate and averaged for analysis. |
| Contralateral Mandibular Excursion | Baseline, 1 month, and 3 months after randomization | Contralateral mandibular excursion measured in millimeters with a digital caliper. Measurements were obtained in triplicate and averaged for analysis. |
| Ipsilateral Mandibular Excursion | Baseline, 1 month, and 3 months after randomization | Ipsilateral mandibular excursion measured in millimeters with a digital caliper. Measurements were obtained in triplicate and averaged for analysis. |
| Mandibular Protrusion | Baseline, 1 month, and 3 months after randomization | Protrusive mandibular excursion measured in millimeters with a digital caliper. Measurements were obtained in triplicate and averaged for analysis. |
| Jaw Functional Limitation Scale-20 Global Score | Baseline, 1 month, and 3 months after randomization | The JFLS-20 global score was calculated as the mean of all 20 items, with scores ranging from 0 to 10. |
| Jaw Functional Limitation Scale-20 Subscale Scores | Baseline, 1 month, and 3 months after randomization | JFLS-20 mastication (items 1-6), mobility (items 7-10), and verbal and emotional expression (items 13-20) subscale scores were calculated as the means of their items, with scores ranging from 0 to 10. |
| TMD Pain Screener Positive Status | Baseline, 1 month, and 3 months after randomization | TMD Pain Screener scores range from 0 to 7. A score of 3 or higher was considered positive. The proportion of participants with a positive result was assessed. |
| Graded Chronic Pain Scale Version 2 Grade | Baseline, 1 month, and 3 months after randomization | The GCPS-2, with a 30-day recall, was used to characterize pain intensity and pain-related disability. Participants were classified into grades 0-IV. Grade II indicates high-intensity pain with low disability; grades III-IV indicate high pain-related disability. |
| Generalized Anxiety Disorder-7 Category | Baseline, 1 month, and 3 months after randomization | GAD-7 total scores were categorized as minimal (0-4), mild (5-9), moderate (10-14), or severe (15-21) anxiety. |
| Adverse Events | At the 1-month and 3-month follow-up visits | Adverse events were recorded through open-ended questioning by the blinded assessor at each follow-up visit. Reported events were documented and categorized according to severity and relationship to the intervention. No structured symptom checklist was used. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOROlgun Topal, DDS, PhD
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Afyonkarahisar Health Sciences University
Outcome results
None listed