How is Aerobic Exercise Compared to Localized Pain Relief Exercises in Patients With Jaw Pain and Neck Pain? Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Pain - Visual Analog Scale (mean change at 12 weeks)
研究概览
简要总结
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).
详细描述
Musculoskeletal (MSK) disorders are some of the most burdensome health issues in the world and the leading causes of years living with a disability.1 Low back pain, neck pain, and other MSK disorders are within the ten more burdensome conditions in the world. Chronic pain, including chronic MSK pain, is increasing in Europe, and almost one in five Europeans have reported having moderate or severe chronic pain, representing approximately 25-35% of the adult population. Thus, MSK pain is considered a major public health problem due to its high prevalence and considerable burden in terms of medical costs, work disability, and reduced quality of life. The most common MSK pain is located in the back and joints, followed by head and neck pain. Temporomandibular disorders (TMD) or commonly known as jaw pain are one of the chronic musculoskeletal disorders (MSKD) that are in close relationship with neck and head pain and are also considered to be a major public health problem as they are the main source of chronic orofacial pain and the most prevalent category of nondental chronic pain conditions in the orofacial region. These disorders affect the masticatory muscles, the temporomandibular joint, and related structures such as the neck and head.
MSK pain is related to poor individuals´ health status and poor quality of life, affecting the patient's family environment. Specifically, there is abundant evidence that has shown the great impact that neck pain and TMD pain have on the subject's quality of life. They interfere with daily activities, diminishing patient's capacity for work and/or ability to interact with their social environment. Across Europe, around 20% of patients with chronic pain have lost their job or have lost their productivity because of pain; this makes the cost of healthcare very high. In addition, neck pain and TMD have been considered to have a great economic impact due to direct care and have been shown to have similar individual impact and burden as back pain (BP) and severe headache. Therefore, chronic pain, especially musculoskeletal pain has been considered a priority in Europe.
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, demonstrating an abnormal function of the central nervous system similar to other chronic painful conditions. 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.
Subjects with neck and jaw pain commonly complain of pain in the neck, face and head region. In a population sample with almost 190000 participants, found that subjects with jaw pain presented generally other pains such as headache, low back pain, and neck pain. Neck pain was one of the most common comorbidities in these subjects. The close relationship between jaw and neck pain and dysfunction has been established by several studies. For example, it was concluded that symptoms of the stomatognathic system overlap in patients with TMD and cervical spine disorder (CSD), and symptoms of the cervical spine overlap in the same group of patients (TMD and CSD). Also, it was found that patients with chronic jaw pain more often suffered from cervical spine pain than those without this disorder. It was found that asymptomatic functional disorders of the cervical spine occurred more frequently in patients with internal derangement of the TMJ than in a control group. The presence of tender points in the cervical and shoulder girdle in patients with the same diagnosis was more common, especially in upper segments of the cervical spine, compared with healthy controls. Also, facial pain was associated with reported pain in the neck area and clinical pain resulting from palpation in the muscles of the neck-occiput area.
Furthermore, the literature has highlighted that people with jaw and neck pain have neck muscle impairments relative to healthy people, specifically abnormalities in endurance and performance of the cervical flexor and extensor muscles. People with jaw and neck pain also demonstrate poor performance in the Craniocervical Flexion Test, with the increased electromyographic activity of the superficial cervical flexor muscles. These results implicate the altered endurance capacity of the flexor and extensor cervical muscles that lead to neck-shoulder disturbances observed in people with jaw and neck pain. These physical impairments seem to be a common factor of subjects with neck pain involvement such as cervicogenic headache, and whiplash-associated disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Assessors (assessing clinician assessed outcomes) and the statistician will be blinded to group allocation. Participants will be unaware of the hypothesis of this study to decrease performance biases.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Have a moderate or severe baseline pain score of 30mm or greater using a 100mm VAS
排除标准
- •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
结局指标
主要结局
Pain - Visual Analog Scale (mean change at 12 weeks)
时间窗: Main Outcome is pain change at 12 weeks. Other time points will also be collected (baseline, 2, 6 weeks after the beginning of treatment, final evaluation (12 weeks after the beginning of treatment), three and six months after the end of treatment
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.
次要结局
- Neck Disability Index(baseline, 2, 6 weeks after the beginning of treatment, final evaluation (12 weeks after the beginning of treatment), three and six months after the end of treatment)
- Jaw function scale(baseline, 6 weeks after the beginning of treatment, final evaluation (12 weeks after the beginning of treatment), three and six months after the end of treatment)
