Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome

NCT01825629 | Completed

• 1 other identifier: UAL-321-15/03/2013
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of a multidisciplinary therapy with physical, manual and deontology therapies in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Keywords

Pain; Temporomandibular joint; Manual therapy; Physical therapy; Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (1)

• Change on pain intensity

  The visual analog scales designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 refers to the situation of no pain and score 100 refers to the situation of unbearable pain.

  At baseline, 15 weeks and 20 weeks

Secondary Outcomes (7)

• Change in temporomandibular dysfunction

  At baseline, 15 weeks and 20 weeks

• Change in quality of life SF-36

  At baseline, 15 weeks and 20 weeks

• Change on index of widespread pain and symptom severity

  At baseline, 15 weeks and 20 weeks

• Change in physical function

  At baseline, 15 weeks and 20 weeks

• Change on quality of sleep

  At baseline, 15 weeks and 20 weeks

Other Outcomes (2)

• Change in clinical impression of severity

  At baseline, 15 weeks and 20 weeks

• Change in clinical global impression of improvement

  15 weeks and 20 weeks after intervention

Study Arms (2)

Multidisplinary Therapy

EXPERIMENTAL

The multidisciplinary therapy involves the application of physical therapy, manual therapy and deontology therapy. This multidisciplinary therapy will be administered twice a week for 15 weeks.

Other: Multidisciplinary therapy

One technique of myofascial release

PLACEBO COMPARATOR

A physiotherapist administered 15 sessions of "induction occipital" once a week.

Other: Placebo

Interventions

Multidisciplinary therapy OTHER

Physical Therapy: Cervical traction, Cranium fore flexion 15 °, Open-close mouth dental contactless (10 mm), Opening movement with a small resistor (one finger on chin), Flexion of the head, without actually lifting, resisting in the front, Occipital extension, Cranium fore flexion 15 °, Cervical traction. Myofascial Therapy: Induction suboccipital, compression - decompression of the temporomandibular joint, horizontal induction of the temporomandibular joint, deep fascia induction in the temporal region, deep induction of the masseter fascia, deep induction of the external pterygoid, and induction of intraoral pterygoid. Deontology therapy: the patient are going to port a deprogramming occlusal splint every night, an average of 8 hours per day, for 15 weeks.

Multidisplinary Therapy

Placebo OTHER

One technique of myofascial release

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Fibromyalgia Syndrome
• Agreement to attend evening therapy sessions
• A chief complaint of acute pain (duration \< 6 months) in the temporomandibular joint on at least one side.
• The presence of joint clicking during jaw opening that was eliminated on protrusive opening.

You may not qualify if:

• History of recent trauma.
• Therapeutic co-interventions during treatment.
• Indication for surgical treatment of temporomandibular joint.
• Edentulism.
• Physical or mental illness that precludes attendance at therapy sessions.

Sponsors & Collaborators

• Universidad de Almeria: lead
• Universidad de Granada: collaborator

Study Sites (1)

Fibromyalgia Association (AGRAFIM)

Granada, Almeria, 04120, Spain

Location

Related Publications (20)

• Fernandez-Carnero J, La Touche R, Ortega-Santiago R, Galan-del-Rio F, Pesquera J, Ge HY, Fernandez-de-Las-Penas C. Short-term effects of dry needling of active myofascial trigger points in the masseter muscle in patients with temporomandibular disorders. J Orofac Pain. 2010 Winter;24(1):106-12.

  PMID: 20213036 BACKGROUND

• Fricton JR, Ouyang W, Nixdorf DR, Schiffman EL, Velly AM, Look JO. Critical appraisal of methods used in randomized controlled trials of treatments for temporomandibular disorders. J Orofac Pain. 2010 Spring;24(2):139-51.

  PMID: 20401352 BACKGROUND

• Oliveira-Campelo NM, Rubens-Rebelatto J, Marti N-Vallejo FJ, Alburquerque-Sendi N F, Fernandez-de-Las-Penas C. The immediate effects of atlanto-occipital joint manipulation and suboccipital muscle inhibition technique on active mouth opening and pressure pain sensitivity over latent myofascial trigger points in the masticatory muscles. J Orthop Sports Phys Ther. 2010 May;40(5):310-7. doi: 10.2519/jospt.2010.3257.

  PMID: 20436241 BACKGROUND

• Santos Tde S, Piva MR, Ribeiro MH, Antunes AA, Melo AR, Silva ED. Lasertherapy efficacy in temporomandibular disorders: control study. Braz J Otorhinolaryngol. 2010 May-Jun;76(3):294-9. doi: 10.1590/S1808-86942010000300004.

  PMID: 20658006 BACKGROUND

• La Touche R, Paris-Alemany A, von Piekartz H, Mannheimer JS, Fernandez-Carnero J, Rocabado M. The influence of cranio-cervical posture on maximal mouth opening and pressure pain threshold in patients with myofascial temporomandibular pain disorders. Clin J Pain. 2011 Jan;27(1):48-55. doi: 10.1097/AJP.0b013e3181edc157.

  PMID: 20733480 BACKGROUND

• Silant'eva EN. [The role of therapeutic exercises in the combined treatment and rehabilitation of patients with pain syndrome associated with the dysfunction of temporomandibular joint]. Vopr Kurortol Fizioter Lech Fiz Kult. 2010 May-Jun;(3):22-6. Russian.

  PMID: 20737707 BACKGROUND

• Ariji Y, Katsumata A, Hiraiwa Y, Izumi M, Sakuma S, Shimizu M, Kurita K, Ariji E. Masseter muscle sonographic features as indices for evaluating efficacy of massage treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Oct;110(4):517-26. doi: 10.1016/j.tripleo.2010.05.003.

  PMID: 20868996 BACKGROUND

• Miernik M, Wieckiewicz M, Paradowska A, Wieckiewicz W. Massage therapy in myofascial TMD pain management. Adv Clin Exp Med. 2012 Sep-Oct;21(5):681-5.

  PMID: 23356206 BACKGROUND

• de Felicio CM, Medeiros AP, de Oliveira Melchior M. Validity of the 'protocol of oro-facial myofunctional evaluation with scores' for young and adult subjects. J Oral Rehabil. 2012 Oct;39(10):744-53. doi: 10.1111/j.1365-2842.2012.02336.x. Epub 2012 Aug 1.

  PMID: 22852833 BACKGROUND

• Guarda-Nardini L, Stecco A, Stecco C, Masiero S, Manfredini D. Myofascial pain of the jaw muscles: comparison of short-term effectiveness of botulinum toxin injections and fascial manipulation technique. Cranio. 2012 Apr;30(2):95-102. doi: 10.1179/crn.2012.014.

  PMID: 22606852 BACKGROUND

• Richardson K, Gonzalez Y, Crow H, Sussman J. The effect of oral motor exercises on patients with myofascial pain of masticatory system. Case series report. N Y State Dent J. 2012 Jan;78(1):32-7.

  PMID: 22474795 BACKGROUND

• Manfredini D, Castroflorio T, Perinetti G, Guarda-Nardini L. Dental occlusion, body posture and temporomandibular disorders: where we are now and where we are heading for. J Oral Rehabil. 2012 Jun;39(6):463-71. doi: 10.1111/j.1365-2842.2012.02291.x. Epub 2012 Mar 21.

  PMID: 22435603 BACKGROUND

• Aggarwal A, Keluskar V. Physiotherapy as an adjuvant therapy for treatment of TMJ disorders. Gen Dent. 2012 Mar-Apr;60(2):e119-22.

  PMID: 22414516 BACKGROUND

• Walczynska-Dragon K, Baron S. The biomechanical and functional relationship between temporomandibular dysfunction and cervical spine pain. Acta Bioeng Biomech. 2011;13(4):93-8.

  PMID: 22339095 BACKGROUND

• Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.

  PMID: 22318373 BACKGROUND

• Dym H, Israel H. Diagnosis and treatment of temporomandibular disorders. Dent Clin North Am. 2012 Jan;56(1):149-61, ix. doi: 10.1016/j.cden.2011.08.002.

  PMID: 22117948 BACKGROUND

• Doepel M, Nilner M, Ekberg E, LE Bell Y. Long-term effectiveness of a prefabricated oral appliance for myofascial pain. J Oral Rehabil. 2012 Apr;39(4):252-60. doi: 10.1111/j.1365-2842.2011.02261.x. Epub 2011 Oct 11.

  PMID: 21985440 BACKGROUND

• Hunter EK. Integration of rehabilitation and acupuncture in the treatment of a professional musician with temporomandibular joint dysfunction. Acupunct Med. 2011 Dec;29(4):298-301. doi: 10.1136/aim.2010.003889. Epub 2011 Jun 16.

  PMID: 21685109 BACKGROUND

• Armijo-Olivo S, Silvestre R, Fuentes J, da Costa BR, Gadotti IC, Warren S, Major PW, Thie NM, Magee DJ. Electromyographic activity of the cervical flexor muscles in patients with temporomandibular disorders while performing the craniocervical flexion test: a cross-sectional study. Phys Ther. 2011 Aug;91(8):1184-97. doi: 10.2522/ptj.20100233. Epub 2011 Jun 9.

  PMID: 21659465 BACKGROUND

• Cuccia AM, Caradonna C, Caradonna D. Manual therapy of the mandibular accessory ligaments for the management of temporomandibular joint disorders. J Am Osteopath Assoc. 2011 Feb;111(2):102-12.

  PMID: 21357496 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome; Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Adelaida M Castro-Sánchez, PhD

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD (Lecturer)

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 5, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

ES (1)