Effects of Cervico-Mandibular Manual Therapy in Patients with Temporomandibular Pain Disorders and Associated Somatic Tinnitus: A Randomized Clinical Trial

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Abstract

Objective

This randomized clinical trial investigated the effects of adding cervico-mandibular manual therapies into an exercise and educational program on clinical outcomes in individuals with tinnitus associated with temporomandibular disorders (TMDs).

Methods

Sixty-one patients with tinnitus attributed to TMD were randomized into the physiotherapy and manual therapy group or physiotherapy alone group. All patients received six sessions of physiotherapy treatment including cranio-cervical and temporomandibular joint (TMJ) exercises, self-massage, and patient education for a period of one month. Patients allocated to the manual therapy group also received cervico-mandibular manual therapies targeting the TMJ and cervical and masticatory muscles. Primary outcomes included TMD pain intensity and tinnitus severity. Secondary outcomes included tinnitus-related handicap (Tinnitus Handicap Inventory [THI]), TMD-related disability (Craniofacial Pain and Disability Inventory [CF-PDI]), self-rated quality of life (12-item Short Form Health Survey [SF-12]), depressive symptoms (Beck Depression Inventory [BDI-II]), pressure pain thresholds (PPTs), and mandibular range of motion. Patients were assessed at baseline, one week, three months, and six months after intervention by a blinded assessor.

Results

The adjusted analyses showed better outcomes (all, P < 0.001) in the exercise/education plus manual therapy group (large effect sizes) for TMD pain (η 2 P = 0.153), tinnitus severity (η 2 P = 0.233), THI (η 2 P = 0.501), CF-PDI (η 2 P = 0.395), BDI-II (η 2 P = 0.194), PPTs (0.363 < η 2 P < 0.415), and range of motion (η 2 P = 0.350), but similar changes for the SF-12 (P = 0.622, η 2 P = 0.01) as the exercise/education alone group.

Conclusions

This clinical trial found that application of cervico-mandibular manual therapies in combination with exercise and education resulted in better outcomes than application of exercise/education alone in individuals with tinnitus attributed to TMD.

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Most cited references 45

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A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.

J. Ware, M Kosinski, S Keller (1996)

Regression methods were used to select and score 12 items from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to reproduce the Physical Component Summary and Mental Component Summary scales in the general US population (n=2,333). The resulting 12-item short-form (SF-12) achieved multiple R squares of 0.911 and 0.918 in predictions of the SF-36 Physical Component Summary and SF-36 Mental Component Summary scores, respectively. Scoring algorithms from the general population used to score 12-item versions of the two components (Physical Components Summary and Mental Component Summary) achieved R squares of 0.905 with the SF-36 Physical Component Summary and 0.938 with SF-36 Mental Component Summary when cross-validated in the Medical Outcomes Study. Test-retest (2-week)correlations of 0.89 and 0.76 were observed for the 12-item Physical Component Summary and the 12-item Mental Component Summary, respectively, in the general US population (n=232). Twenty cross-sectional and longitudinal tests of empirical validity previously published for the 36-item short-form scales and summary measures were replicated for the 12-item Physical Component Summary and the 12-item Mental Component Summary, including comparisons between patient groups known to differ or to change in terms of the presence and seriousness of physical and mental conditions, acute symptoms, age and aging, self-reported 1-year changes in health, and recovery for depression. In 14 validity tests involving physical criteria, relative validity estimates for the 12-item Physical Component Summary ranged from 0.43 to 0.93 (median=0.67) in comparison with the best 36-item short-form scale. Relative validity estimates for the 12-item Mental Component Summary in 6 tests involving mental criteria ranged from 0.60 to 107 (median=0.97) in relation to the best 36-item short-form scale. Average scores for the 2 summary measures, and those for most scales in the 8-scale profile based on the 12-item short-form, closely mirrored those for the 36-item short-form, although standard errors were nearly always larger for the 12-item short-form.

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Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale

John T Farrar, James P Young, Linda LaMoreaux … (2001)

Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.

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Development of the Tinnitus Handicap Inventory

C Newman, G Jacobson, J. B. Spitzer (1996)

To develop a self-report tinnitus handicap measure that is brief, easy to administer and interpret, broad in scope, and psychometrically robust.

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Author and article information

Journal

Title: Pain Medicine

Publisher: Oxford University Press (OUP)

ISSN (Print): 1526-2375

ISSN (Electronic): 1526-4637

Publication date Created: March 2020

Publication date Created: March 01 2020

Publication date Created: October 29 2019

Publication date Other: March 2020

Publication date (Print): March 01 2020

Publication date (Electronic): October 29 2019

Volume: 21

Issue: 3

Pages: 613-624

Affiliations

[1 ]Department of Physical Therapy, Universidad Francisco de Vitoria, Madrid, Spain

[2 ]Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain

[3 ]Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain

[4 ]Physical Therapist, Rehabilitation Services, Concord Hospital, Concord, New Hampshire

[5 ]Faculty, Manual Therapy Fellowship Program, Regis University, Denver, Colorado

[6 ]Department of Physical Therapy, Franklin Pierce University, Manchester, New Hampshire, USA

[7 ]Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain

[8 ]Cátedra de Investigación y Docencia en Fisioterapia: Terapia Manual y Punción Seca, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain

Article

DOI: 10.1093/pm/pnz278

PubMed ID: 31665507

SO-VID: ab955fc3-394a-4998-b0fd-5db7a144cea3

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https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model

Effects of Cervico-Mandibular Manual Therapy in Patients with Temporomandibular Pain Disorders and Associated Somatic Tinnitus: A Randomized Clinical Trial

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Abstract

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Most cited references 45

A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.

Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale

Development of the Tinnitus Handicap Inventory

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