Physiotherapy and Deontology in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.

NCT01800279 | Completed

• 1 other identifier: UAL-12
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether kinesitherapy techniques and a myofascial therapy protocol are effective in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Keywords

Fibromyalgia Syndrome, Temporomandibular Joint, Pain.

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  The visual analog scale (VAS), designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 for pain-free and 100 for maximum pain.

  At baseline and 12 weeks

Secondary Outcomes (7)

• Temporomandibular Dysfunction.

  At baseline and 12 weeks

• Quality of Life (SF-36)

  At baseline and 12 weeks

• Index of Widespread Pain and Symptom Severity

  At baseline and 12 weeks

• Physical Function.

  At baseline and 12 weeks

• Quality of Sleep.

  At baseline and 12 weeks

Other Outcomes (2)

• Clinical Impression of Severity.

  At baseline and 12 weeks

• Clinical Global Impression Improvement.

  At baseline and 12 weeks

Study Arms (2)

Deontology Therapy

ACTIVE COMPARATOR

The patients in the control group will port a deprogramming occlusal splint to sleep every night, an average of 8 hours per day, for 12 weeks of the treatment.

Other: Deontology Therapy

Physiotherapy Protocol

EXPERIMENTAL

The physiotherapy protocol involves the application of kinesitherapy techniques and a myofascial therapy protocol. This protocol will be administered twice a week for 12 weeks.

Other: Physiotherapy Protocol

Interventions

Physiotherapy Protocol OTHER

Kinesitherapy * Patient: supine position on the stretcher with a loop of 6 cm in the cervical area. * Tongue in the palate for all applied exercises. * Repetitions of each exercise: 8. Cervical traction. Cranium fore flexion 15 °. Open-close mouth dental contactless (10mm). 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 TMJ (Temporomandibular Joint). Horizontal Induction TMJ. Deep fascia induction in the temporal region. Deep Induction of the masseter fascia. Deep Induction of the external pterygoid. Induction of intraoral pterygoid.

Physiotherapy Protocol

Deontology Therapy OTHER

For the realization of the splint, the following protocol will be developed at the Faculty of Dentistry of Granada (Spain): * Impression of the maxilla with chromatic alginate "Phase plus" (Zhermack ©, Rovigo, Italy). * Emptying working models in plaster-stone type IV "Elite Rock" (Zhermack ©, Rovigo, Italy). * Deprogramming occlusal splints were made of polyester plates with terephthalic acid of 3 mm thick Clear 120 model (Dentaflux ©, Ripoll, Madrid). We used a molding machine of thermoplastic vacuum plate "The Machine" Dentaflux ©, Ripoll, Madrid.

Deontology Therapy

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
• Andaluz Health Service: collaborator

Study Sites (1)

Fibromyalgia Association (AGRAFIM)

Granada, Almeria, 04120, Spain

Location

Related Publications (20)

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  PMID: 21985440 BACKGROUND

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  PMID: 21659465 BACKGROUND

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome; Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Adelaida M Castro-Sánchez, PhD

  Universidad de Almeria

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 27, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

ES (1)