About this trial
Musculoskeletal (MSK) disorders are some of the most burdensome health issues in the world and the leading causes of years living with a disability. Between them, jaw pain and neck have been very prevalent among the general population. Subjects with chronic neck and jaw pain present with persistent pain, allodynia, and hyperalgesia, sometimes extending to regions distant from the neck, head, or face, as well as cognitive and motor dysfunction. In addition, both conditions are commonly related to pain in other anatomical regions, and they also might also exhibit a greater risk for pain-associated somatic symptom burden.
The treatment for patients with neck and jaw could involve different techniques in the rehabilitation area. Between them, therapeutic exercise is a cornerstone of MSK disease rehabilitation. Although mechanisms of action for exercise in subjects with pain are not yet understood, therapeutic exercise is widely applied in a variety of painful MSK conditions, such as low back pain, shoulder pain, knee pain, osteoarthritis, and disorders of the cervical and craniofacial regions such as temporomandibular disorders, headaches, and neck pain. Besides its effects on function and health, therapeutic exercise is known to have some pain-relieving effects and specific motor control exercises targeted to the neck can enhance the neural control of the cervical spine in patients with neck involvement such as patients with jaw and neck pain.
Previous studies have demonstrated that treatment directed to the neck may be beneficial in decreasing pain intensity in the masticatory muscles, increasing pain-free mouth opening, and decreasing pain in the head and neck regions in people with jaw pain. In addition, neck motor control exercises have been successful to manage chronic neck pain and cervicogenic headache. Subjects with neck pain and associated disorders receiving neck motor control exercises had a reduction of pain and improved quality of life. Another option that has been explored to relieve MSK pain is aerobic exercise. Aerobic exercise has been used to stimulate the release of pain-relieving peptides in healthy human beings; however, little is known about the analgesic effect of exercise in people suffering from actual musculoskeletal pain. Previous literature found positive results in favor of aerobic exercise for pain relief. However, none of them included patients with jaw and neck-related disorders. Therefore, the aim of the present pilot randomized controlled trial (RCT) is to test the effectiveness of local craniocervical motor control exercises when compared with aerobic exercise on pain-disability related outcomes such as pain intensity, pain pressure thresholds (PPTs), jaw and neck disabilities and to restore normal muscular performance and fatigability of the cervical muscles in people with jaw and neck pain. Also, an important objective for performing this pilot study is to test the feasibility of these protocols and gather data that will be the basis for applying to external funding.
This study will be a randomized controlled trial, blinded, two-armed parallel group. It will include women between 18-60 years of age; diagnosed with temporomandibular disorders (i.e., jaw pain) classified by the new Diagnostic Criteria for Temporomandibular Disorders (DC/TMD); or diagnosed with idiopathic chronic neck pain associated or not with TMD. Because this is an exploratory (pilot) study it will include at least 21 subjects per treatment group. The primary outcome will be pain intensity evaluated by the Visual Analogue Scale (VAS), and the secondary outcomes will be Neck Disability Index; Jaw Function; Pressure Pain Threshold; Psychological functioning; Global Rating Scale; and Muscular performance and fatigability of the cervical muscles. The patients will be randomized into two groups: local craniocervical motor control exercises and aerobic exercise. The local craniocervical motor control exercises program will be focused on training the deep and superficial flexors and extensors neck muscles. The treatment will consist of a 12-week progressive training program with a total duration of 30-45 min per session. Individuals assigned to the aerobic exercise will receive cycling exercise, with a total duration of 60 minutes. Both groups will be evaluated before the treatment starts (baseline); after two and six weeks from the beginning of treatment (1st and 2nd partial evaluation); at the end of the treatment (final evaluation - 12 weeks); and after three and six months of the end of the treatment (1st and 2nd follow-up).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be between 18-60 years of age
Be diagnosed with idiopathic chronic neck pain as described the IASP and/or presence of temporomandibular disorders identified by DC/TMD screening
Have pain in the neck or jaw area for at least 3 months (chronic pain)
Have pain not attributable to recent acute trauma, previous infection, or to an active inflammatory cause in the last month
Disqualifiers
Present red flags for serious pathologies related to neck pain or jaw pain
Report comorbidity functional chronic pain disorders (e.g., fibromyalgia)
Have been diagnosed with psychiatric disorders (e.g., depression, schizophrenia)
Have received therapy within 3 months prior to entry into the study
Trial design
Parallel
Treatments tested in this trial
Aerobic exercise
Other intervention30-45 minutes of aerobic exercise in a cycle ergometer will be applied in three different intensities (low, moderate and high) along 12 weeks of treatment.
Neck motor control exercise
Other interventionAn specific neck motor control exercise targeted to the neck flexor and extensor muscles supervised by a physical therapist will be applied during 12 weeks of treatment.
Treatment groups
Trial outcomes
Primary outcomes
Pain - Visual Analog Scale (mean change at 12 weeks)
A change in pain intensity (measured with the VAS) from baseline to end of treatment (12 weeks) for both groups. The pain evaluated will be the pain related to the patient's main complaint, i.e. jaw pain or neck pain. The VAS is a 100 mm linear scale, labeled with the two extreme boundaries of pain sensation: "no pain" at one end (0 mm) and "worst pain imaginable" at the other end (100 mm). The VAS has demonstrated validity and reliability to measure the intensity of pain and it is heavily used in people with neck pain as well as jaw pain research. The VAS varies from 0 to 100 mm, and the higher values means worse results.
Secondary outcomes
Neck Disability Index
It is a 10-item questionnaire that measures how much neck pain affects activities of daily living. The Neck Disability Index (NDI) is a validated, reliable and responsive tool. The scores varies from 0 to 50 points, and the higher values means a worse result.
Jaw function scale
It will be measured using a self-reported questionnaire called Jaw functional limitation scale form the DC/TMD instruments. This tool has been shown to be valid and has excellent psychometric properties. The total score will be used for statistical purposes. The scores varies from 0 to 50 points, and the higher values means a worse result. The scores varies from 0 to1 points, and the higher values means a worse result.
Other outcomes
Mouth range of motion
All mouth range of motion will be measured: maximal mouth opening (MMO), lateral excursion to the right and left, and protrusion with a digital caliper tool. There is no specific range of values to be obtained, but all measures will be measure in millimetres (mm), and higher values means a better result.
Upper and global Neck range of motion
Upper neck range of motion (ROM) will be measured by performing the Flexion Rotation test to the right and left. All global neck range of motion will be measured: flexion, extension, lateral-flexion and rotation. All measures will be done with a Neck care device. There is no specific range of values to be obtained, but all measures will be measure in degrees, and higher values means a better result.
Pressure pain threshold
Pressure pain sensitivity will be evaluated via pressure pain threshold (PPT), or the minimum pressure that induces pain or discomfort. This will be done in the masticatory muscles and neck muscles using a calibrated mechanical algometer following the protocol described in Silveira et al. PPT measurements have been shown to have good or excellent inter-rater and intra-rater reliability (0.74 to 0.99). There is no specific range of values to be obtained, but all measures will be measure in Newtons (N), and higher values means a better result.
Heart Rate
The maximal heart rate (HRmax) will be calculated through the modified Bruce´s Protocol or by the ramp protocol for cycle ergometer. The modified Bruce´s Protocol is a treadmill test where the speed and the slope of the treadmill are increased systematically every three minutes. The first stage starts with 1.7 mph or 2.7 km/h without inclination of the treadmill for three minutes. Then, the second stage is done with a speed of 2.7 km/h with a slope of 5%. The test ends when the patient reports fatigue. Usually, the ramp protocol for cycle ergometer uses increments of the intensity of 5 to 50 w/minute to measure the HRmax, depending on the functional capacity of the participant. These increments could be determined for women by the formula proposed by Wasserman et al: \[(height in cm - age) x 20\] - \[150 + (6 x weight in kg)\]/ 100. There is no specific range of values to be obtained with this test.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.