Is the Combination of Manual Therapy and Movement Control Exercises More Effective Than Manual Therapy and Standard Exercises in a Population of Patients With Chronic Neck Pain to Reduce Neck Disability? A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
Chronic neck pain is a common and highly prevalent clinical entity among the population. It causes a high economic and financial burden. Commonly people with neck pain present temporomandibular disorders (TMD). These conditions are closely correlated with each other. Several studies have shown that patients with neck pain do have abnormalities in motor control, endurance capacities, and strength of the cervical and orofacial area.
Several treatment modalities are available for neck pain that can be divided into pharmaceutical and non-pharmaceutical approaches. Among the non-pharmaceutical interventions, physiotherapy, manual therapy and exercises are of interest. The effect of treatment modalities is heterogeneous. Passive modalities often lack positive long-term outcomes.
Therefore, our trial aims to measure the effects of a combined treatment, consisting in manual therapy and a movement control training for the neck region or for the temporomandibular region, respectively. The implementation of the temporomandibular movement control training is based on the assumption that there might be crossover effects between both regions, i.e., convergence of cervical and trigeminal sensory afferents between these two regions.
We designed a parallel randomized controlled trial (RCT) with three intervention arms and a blinded assessor for outcomes that are clinician performed. This study is a pilot trial, so each group is expected to consist of 15 subjects. Both female and male patients between the ages of 18 and 65 will be included. Participants must suffer from idiopathic chronic neck pain (at least 3 months) and may also have symptomatic TMD disorders. The Primary Outcome will be neck pain disability measured by the Neck Disability Index (NDI). Secondary Outcomes will be Diagnostic Criteria (DC)/TMD (Axis I and Axis II), range of motion (CROM, FRT), CVA, PPT, CCFT, and both cervical and orofacial test batteries to assess motor control in each region.
Patients are randomly assigned to one of the three intervention groups using a computer-generated sequence which is concealed. The three groups are: 1) clinical reasoning (CR) based physical therapy + cervical motor control training, 2) CR based physical therapy + orofacial motor control training, 3) CR based physical therapy + general coordination and strengthening exercises for the jaw and neck region.
Prior to the start of treatment, participants will undergo an eligibility assessment. If the participant meet the inclusion criteria, the baseline assessment is conducted, and the treatment is planned following the prescription for physiotherapy in Germany. Treatment will comprise six 30-minute treatment sessions, which take place once a week over a period of 6 weeks. Upon completion of the six treatment sessions, the final examination is conducted, which includes the same assessments as the initial examination.
详细描述
Considered from an epidemiologic perspective, musculoskeletal (MSK) disorders are highly burdensome and one of the most leading causes for illness especially in work life. Especially low back pain and neck pain are highly prevalent, even ranging among the top ten of health issues worldwide. Patients with neck pain (NP) often present headaches and orofacial pain (OFP) (including temporomandibular disorders). Most of these disorders can occur concomitantly and overlap to a greater extent. Therefore NP, headache and OFP are generally investigated together.
Since the causes for neck pain are multicausal, several treatment approaches exist, which can be divided into pharmaceutical and non-pharmaceutical modalities. The non-pharmaceutical approaches are further divided into surgical and non-surgical. However, in clinical practice, these different approaches are often combined.
In the domain of musculoskeletal therapy, the treatment modalities for chronic neck pain range from passive approaches, for example spinal manipulation (SMT) or myofascial trigger point therapy, to biopsychosocial approaches like pain neuroscience education (NPE). Exercise therapy is another treatment modality with good effect for this condition. Exercise therapy can further be divided into strength training, endurance training and coordination training. Motor control training (MCT) is an important treatment option.
However, clinical trials often analyze single approaches (stand-alone-modalities), while in clinical practice these approaches are frequently combined. Therefore, our trial aims to analyze the effects of manual therapy combined with a motor control training program. Our trial will respond several clinical/research questions.
Q1) Does the combination of clinical reasoning-based manual therapy and movement control for the neck region (G1) or the orofacial region (G2), respectively, generate additional effects in terms of lowering the NDI score (main outcome) and improving CROM, FRT, CVA, PPT and CCFT (secondary outcomes) compared to manual therapy and standard exercises (usual care) (G3)?
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
Assessing clinician 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 18 - 65 years of age
- •being diagnosed with idiopathic chronic neck pain (>= 3 month)
- •scoring minimum >= 15 in the NDI
- •linguistic (german) and cognitive ability to fully understand the questionnaires and exercise instructions.
排除标准
- •presence of neurological symptoms of the upper limb
- •presence of elapsed fractures or surgeries in the past half year in the head, jaw or cervical region
- •medical interventions in these regions
- •systemic inflammatory conditions requiring systemic-acting drugs
- •Central Sensitization Index (CSI) score > 40 points
研究组 & 干预措施
Group 2: Clinical reasoning-based physiotherapy + orofacial movement control training
Physiotherapeutic treatment is carried out based on the results of a subjective and physical examination performed at the outset. It may thus include various manual therapy treatment approaches targeting the maxillary and/or cervical or thoracic regions and adapted individually to each patient. In addition, one third of each treatment time is used to gradually teach patients the abnormal (positive) tests of the test battery for assessing motor control of the orofacial region as a self-exercise for home use. To do this, patients are also given access via a QR code to a website where they can find videos and instructions for the exact exercises that are in their home program.
干预措施: Clinical reasoning based physiotherapy + orofacial movement control training (Other)
Group1: Clinical reasoning-based physiotherapy + cervical movement control training
Physiotherapeutic treatment is carried out based on the results of a subjective and physical examination performed at the outset. It may thus include various manual therapy treatment approaches targeting the maxillary and/or cervical or thoracic regions and adapted individually to each patient. In addition, one third of each treatment time is used to gradually teach patients the abnormal (positive) tests of the test battery for assessing motor control of the cervical region as a self-exercise for home use. To do this, patients are also given access via a quick response (QR) code to a website where they can find videos and instructions for the exact exercises that are in their home program.
干预措施: Clinical reasoning based physiotherapy + cervical movement control training (Other)
Group 3: Clinical reasoning-based physiotherapy + standard exercises
Physiotherapeutic treatment is carried out based on the results of a subjective and physical examination performed at the outset. It may thus include various manual therapy treatment approaches targeting the maxillary and/or cervical or thoracic regions and adapted individually to each patient. In addition, one third of each treatment time is used to gradually teach patients general coordination- and strength exercises for the jaw and the cervical region as a self-exercise for home use. To do this, patients are also given access via a QR code to a website where they can find videos and instructions for the exact exercises that are in their home program.
干预措施: Clinical reasoning based physiotherapy + standard exercises (Other)
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement)
This is a 10-item self-report questionnaire designed to assess the extent to which neck pain interferes with activities daily living. The Neck Disability Index is a validated, reliable and responsive tool. The score ranges from 0 and 50 points, the achieved value is divided by the maximum score of 50 and multiplied by 100. This is how the score of the NDI is calculated. A higher value equals higher disability.
次要结局
- Orofacial test battery to assess movement control in the orofacial region(baseline, final evaluation ( (6 treatments (6-8 weeks) after the baseline measurement))
- Diagnostic criteria for temporomandibular disorders DC/TMD (Axis I and Axis II)(baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement))
- Craniovertebral angle(Time Frame: baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement))
- Pressure Pain Threshold(baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement))
- Craniocervical flexion test(baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement))
- Cervical test battery to assess movement control in the cervical region(baseline, final evaluation ( (6 treatments (6-8 weeks) after the baseline measurement))
- Upper and global cervical range of motion(baseline, final evaluation (6 treatments (6-8 weeks) after the baseline measurement))