Neuro-reflexotherapy for the management of myofascial temporomandibular joint pain: a double-blind, placebo-controlled, randomized clinical trial.
OBJECTIVE
To assess the efficacy of neuro-reflexotherapy intervention (NRT) for treating temporomandibular joint dysfunction attributed to myofascial pain. Neuro-reflexotherapy intervention consists of the temporary implantation of epidermal devices in trigger points in the back and ear. It has shown efficacy, effectiveness, and cost-effectiveness in treating subacute and chronic common back pain. No study, however, has explored its efficacy in treating myofascial temporomandibular joint pain (MF/TMJP).


METHODS
This was a randomized, double-blind, placebo-controlled trial. Patients with MF/TMJP for more than 3 months in spite of conservative treatment, and with no evidence of major structural damage in the joint, were recruited at the Maxillofacial Department of the Hospital Clínico Universitario, a teaching hospital in Madrid, Spain. Patients were randomly assigned to an intervention group and to a control group. Patients in the treated group underwent 2 NRTs, immediately after baseline assessment and 45 days later. Sham interventions in the control group consisted of placement of the same number of epidermal devices within a 5-cm radius of the target zones. In both groups, conservative treatment during follow-up was allowed and recorded. Patients underwent clinical evaluations on 4 occasions: 5 minutes before intervention, 5 minutes after intervention, and 45 and 90 days later. The preintervention assessment was performed by the physician at the hospital service who included the patient in the study. The 3 follow-up assessments were performed independently by 1 of 2 physicians who had no connection with the research team, and who were blinded to patients' assignments. The primary outcome variable was level of pain severity during jaw movements at the last assessment (90 days), and the key comparison of interest was change in pain over time (pain levels at baseline and at 90 days). Level of pain was measured using a visual analog scale (VAS).


RESULTS
Fifty-one patients with MF/TMJP were recruited into the study. Random assignment allocated 27 patients to the intervention group, and 24 to the control group. Differences in pain severity in favor of the intervention group appeared immediately after the intervention, persisted for 45 days, and increased after the second intervention. Differences at last follow-up were highly clinically and statistically significant (4 to 5 points on the VAS, P = .000), allowing for patients in the intervention group to cease drug treatment (P = .005). There were no differences in the evolution of crepitus or clicking in the joint. There were no clinically relevant side effects associated with the intervention.


CONCLUSIONS
For patients in whom conservative treatment has failed, NRT improves the chronic pain associated with MF/TMJP syndrome.
Berguer
Alberto
A
Servicio de Cirugía Maxilo-Facial, Hospital Clínico Universitario San Carlos, Madrid, Spain.
Kovacs
Francisco
F
Abraira
Víctor
V
Mufraggi
Nicole
N
Royuela
Ana
A
Muriel
Alfonso
A
Gestoso
Mario
M
Falahat
Farzin
F
Martín-Granizo
Rafael
R
Zamora
Javier
J
D000328:Adult; D000700:Analgesics / Q000627:therapeutic use; D014151:Anti-Anxiety Agents / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001415:Back / Q000601:surgery; D062109:Dermatologic Surgical Procedures; D004311:Double-Blind Method; D054644:Ear Auricle / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000627:therapeutic use; D017090:Occlusal Splints; D010147:Pain Measurement; D010919:Placebos; D019736:Prostheses and Implants; D016059:Range of Motion, Articular / Q000502:physiology; D012028:Reflexotherapy / Q000295:instrumentation / Q000379:methods*; D013537:Sutures; D013706:Temporomandibular Joint Dysfunction Syndrome / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome
D000700:Analgesics; D014151:Anti-Anxiety Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D009465:Neuromuscular Agents; D010919:Placebos