Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000412639
Ethics application status
Approved
Date submitted
6/04/2014
Date registered
15/04/2014
Date last updated
18/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate Effects of Combining Local Techniques in the Craniomandibular Area and Hamstring Muscle Stretching in Subjects with Temporomandibular Disorders: A Randomized Controlled Study.
Scientific title
Immediate effects on mouth opening, lumbar and suboccipital mobility, and orofacial mechanosensitivity after applying a combination of neuromuscular and myofascial techniques in the craniomandibular area and stretching of the hamstring muscles in 60 subjects with temporomandibular disorders: a randomized controlled trial
Secondary ID [1] 284398 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vertical mouth opening 291579 0
Muscular and neural mechanosensitivity 291580 0
Lumbar and suboccipital mobility 291581 0
Temporomandibular disorders 291652 0
Condition category
Condition code
Oral and Gastrointestinal 291957 291957 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 291958 291958 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291959 291959 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment protocol in the experimental group

Three techniques were performed in the following order.

(a) Neuromuscular technique of the masseter muscles. With the subject lying supine, the therapist sat at the head of the table and rotated the subject’s head. One therapist’s hand was placed on the zygomatic arch to fix the superior edge of the muscle, while the thumb of the other hand performed longitudinal myofascial strokes, of about 5-8 centimeters length (each of four to six seconds of duration). Tissue restrictions were respected during the gentle slide movement and no pain was provoked during the technique

(b)Passive stretching of the hamstring muscles. With the subject supine, the therapist performed a hip flexion keeping knee extension until the edge of flexibility of the posterior muscle chain, with no pain or discomfort. When this position was achieved, the therapist underwent a dorsal flexion of the ankle and kept the position for forty seconds. The stretching technique was performed in both lower limbs, avoiding any possible body compensation during the stretching.

c) The suboccipital muscle inhibition technique. With the participant lying supine, the therapist placed both hands under the head of the subject as a hammock. While contacting the inferior edge of the occipital bone, the therapist exerted a constant and painless pressure in cranial and ventral direction until suboccipital soft tissue was relaxed. The technique was performed for four minutes approximately.

The whole treatment protocol lasted about 10 minutes and involve a single treatment session
Intervention code [1] 289135 0
Rehabilitation
Comparator / control treatment
The treatment in the control group consisted of the same protocol used in the experimental group, but including only the first two techniques. Therefore the protocol included in this order:

(a) Neuromuscular technique of the masseter muscles. With the subject lying supine, the therapist sat at the head of the table and rotated the subject’s head. One therapist’s hand was placed on the zygomatic arch to fix the superior edge of the muscle, while the thumb of the other hand performed longitudinal myofascial strokes, of about 5-8 centimeters length (each of four to six seconds of duration). Tissue restrictions were respected during the gentle slide movement and no pain was provoked during the technique

(b)Passive stretching of the hamstring muscles. With the subject supine, the therapist performed a hip flexion keeping knee extension until the edge of flexibility of the posterior muscle chain, with no pain or discomfort. When this position was achieved, the therapist underwent a dorsal flexion of the ankle and kept the position for forty seconds. The stretching technique was performed in both lower limbs, avoiding any possible body compensation during the stretching.

The whole protocol was performed during a single session of about 6 minutes of duration
Control group
Active

Outcomes
Primary outcome [1] 291859 0
Improvement equal or superior to 14% in the vertical mouth opening in the experimental group compared to the control group

Vertical mouth opening was assessed with the subject in the supine position using an electronic digital caliper (Powerfix, London, United Kingdom). The subject was instructed to open the mouth as much as possible without there being any sensation of pain or discomfort. This procedure has proven to have high intra-tester reliability. The mean of three consecutive measurements, with a resting period of 30-45 seconds between them, was taken as the reference value for further analysis. The standard error of measurement for repeated evaluations in seated position in subjects with temporomandibular disorder has been observed to be between 2.1-2.9 mm.
Timepoint [1] 291859 0
Immediately after intervention
Primary outcome [2] 291860 0
Difference between-groups of at least 10% in pressure pain threshold after treatment

A digital algometer, model FDX 25 (Warner Instruments, Greenwich, CT, USA), with a 1cm2 contact area was used to measure pressure pain threshold (PPT). PPT is defined as the minimum pressure needed to provoke pain and/or disconfort in a certain site. With the subject lying supine, evaluations were made in the dominant and non-dominant sides on: (a) the anatomical site described for the location of tense bands in the masseter muscles, close to the mandibular angle; and (b) the three emerging branches of the trigeminal nerve, supraorbital, infraorbital and mental nerves.
Timepoint [2] 291860 0
Immediately after intervention
Secondary outcome [1] 307682 0
An increase of 10%-15% in suboccipital range of motion in flexion and extension in the experimental group compared to the control group

To measure suboccipital mobility, a digital inclinometer (DI), model ACU002 (Lafayette Instrument Company, Lafallette IN, USA) was used. The DI is an electronic device that displays absolute angular inclination with a resolution of 0.1 degrees. The DI has two different sensors. With the subject standing still and with the head and the back resting on the wall, one of the sensors was placed along the sagittal suture as a reference line perpendicular to the bridge of the nose, and the other was placed on the wall. The subject was asked to gently look upwards (to the ceiling) to measure suboccipital extension and then to look downwards (to the floor) to evaluate suboccipital flexion, without moving the back or head from the wall to ensure that suboccipital mobility was evaluated. In addition, any possible compensatory movements were prevented by the assessor. Participants were instructed to perform their maximal pain-free range of motion at a comfortable and self-selected pace and to keep the final position for at least 3 seconds. The DI has been previously validated and is considered to be an effective and easy to use tool to measure cervical mobility. When measuring neck range of motion in a seating position, the standard error of measurement is between 2.4 degrees and 2.6 degrees for cervical extension and flexion.
Timepoint [1] 307682 0
Immediately after intervention
Secondary outcome [2] 307683 0
A between-groups difference of 5%-10% in lumbar spine mobility

Lumbar mobility was evaluated using the “sit and reach” (SAR) test, and by means of measuring lumbar forward bending with a digital inclinometer.

- The SAR test is a common tool to measure maximum spinal mobility in flexion and hamstring muscles flexibility. The subject was sitting with knees extended and both feet against the edge of a standard sit-and-reach box. The participant was asked to bend slowly forward towards the toes as far as possible keeping knee extension and placing both hands on the box. The final position was kept for around 5 seconds. The SAR test has shown excellent intratester reliability, and a moderate to high criterion-related validity, ranging from 0.46 to 0.89. The typical percentage of measurement error has been observed around 3 cm.

- Lumbar foward bending evaluates spinal mobility in flexion and it is a possible indicator of functional limitation. Standard protocol requires the patient to be standing and to maintain knee extension, while bending forward. The digital inclinometer was positioned with one of the sensors on the lumbar spine (L3-L5 segment) as the dynamic region, and the other was placed on the wall, as the static stable position. The American Medical Association recommends using an inclinometer as the preferred tool to measure lumbar spine mobility. In the “worst case” scenario, the accuracy level of this measurement tool has been established between 3.4 – 3.8 cm for lumbar flexion and extension.
Timepoint [2] 307683 0
Immediately after intervention

Eligibility
Key inclusion criteria
(a) having myofascial pain, with or without limited opening and bilateral pain, for at least 6 months, according to the Research Diagnostic Criteria for Temporomandibular Disorders;
(b) presence of local and referred pain after manual pressure in the anatomical site described for location of trigger points in the masseter muscles;
(c) limitation to mobility in the anterior-posterior condilar mobility test; and
(d) restricted mobility of the first cervical vertebrae in the cervical flexion-rotation test
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) a previous cervical whiplash;
(b) previous severe traumatisms, surgery and/or fractures in the mandibular condyle, temporomandibular joint, cranial vault, craniofacial region and/or any spinal level;
(c) degenerative, systemic, rheumatic or tumoral disorders; (d) being under psychiatric treatment;
(e) having received soft tissue or manual therapy within eight weeks before data collection;
(f) being under orthodontic treatment; and
(g) consumption of analgesics or anti-inflammatory drugs within 48 hours prior to the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized number tables designed by an online company (www.randomized.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical processing of the data was performed with the PASW Statistics tool, version 18.0 plus (SPSS Inc., Chicago, USA). The Kolmogorov-Smirnov test was used to assess the normality of the data. The mean, standard deviation and 95 per cent of confidence intervals were calculated for quantitative variables, while categorical data was expressed in terms of percentage frequencies.

Baseline characteristics in both groups were evaluated with the chi-squared (X^2) test for qualitative variables and the Student´s t test for independent samples for quantitative variables. The inferential analysis of variance for repeated measures (ANOVA test), with the group as the between-subjects variable, and with the time (pre and post-intervention) as the within-subject variable, was used to evaluate the between groups differences and to observe the immediate effects of the protocol interventions.

The statistical analysis was conducted considering a p value inferior to 0.05 statistically significant.


Sample size estimation was made using the Granmo software, version 7.12 (Granmo, IMIM Hospital del Mar, Barcelona, Spain). For an unilateral contrast, taking into account an alpha value of 0.05, and in order to achieve a statistical power of 90 per cent, 25 subjects were needed in each study group to detect a difference equal or superior to 14 per cent in the vertical mouth opening, that was taken as the outcome measure that defines mandibular functionality. A common standard deviation of 16 per cent and a loss to follow-up rate of 8 per cent was assumed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2013
Actual
2/05/2013
Date of last participant enrolment
Anticipated
Actual
19/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 5966 0
Spain
State/province [1] 5966 0
Sevilla

Funding & Sponsors
Funding source category [1] 289045 0
University
Name [1] 289045 0
University of Sevilla, Spain
Country [1] 289045 0
Spain
Primary sponsor type
University
Name
University of Sevilla, Spain
Address
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.
C/ Avicena s/n 41009 Sevilla (Spain)
Country
Spain
Secondary sponsor category [1] 287714 0
None
Name [1] 287714 0
Address [1] 287714 0
Country [1] 287714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290842 0
COMITE ETICO DE EXPERIMENTACION DE LA UNIVERSIDAD DE SEVILLA
Ethics committee address [1] 290842 0
Ethics committee country [1] 290842 0
Spain
Date submitted for ethics approval [1] 290842 0
Approval date [1] 290842 0
05/04/2012
Ethics approval number [1] 290842 0
NONE

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47546 0
Dr Cleofas Rodriguez-Blanco
Address 47546 0
C/ Avicena s/n 41009, Sevilla, Spain, University of Sevilla, Spain
Country 47546 0
Spain
Phone 47546 0
(+34 954486528)
Fax 47546 0
(+34 954486527)
Email 47546 0
[email protected]
Contact person for public queries
Name 47547 0
Cleofas Rodriguez-Blanco
Address 47547 0
C/ Avicena s/n 41009, Sevilla, Spain, University of Sevilla, Spain
Country 47547 0
Spain
Phone 47547 0
(+34 954486528)
Fax 47547 0
(+34 954486527)
Email 47547 0
[email protected]
Contact person for scientific queries
Name 47548 0
Cleofas Rodriguez-Blanco
Address 47548 0
C/ Avicena s/n 41009, Sevilla, Spain, University of Sevilla, Spain
Country 47548 0
Spain
Phone 47548 0
(+34 954486528)
Fax 47548 0
(+34 954486527)
Email 47548 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.