The Effectiveness of the Feldenkrais Method in Reducing Pain and Improving Functionality in Patients With Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
研究概览
简要总结
This doctoral thesis is a single blind randomized controlled clinical trial with an active control element. The intervention examined in this trial is the Awareness Through Movement (ATM) technique of the Feldenkrais Method (FM), while the standard treatment given to the control group is the combination of acupuncture and stretching.
The study was designed to examine the extend of the effect of ATM, as a means of reduction of pain, improvement of functionality and psychosomatic parameters of patients with chronic neck pain, in comparison to biomedical acupuncture protocol in combination with stretching.
The effectiveness of the intervention will be compared to the effect of the standard treatment, a combination of acupuncture and stretching, in relation to parameters of pain, range of motion of rotation, flexion-extension and lateral flexion of the cervical spine and the sense of position (kinesthesia), the endurance of the cervical deep flexor muscles, respiratory function and psychometric characteristics, which are evaluated at specific times (before and after the intervention-five weeks).
During the discussion, the results of this study, in combination with the degree of validity of the observation, will be compared to those of the literature review. This comparison could contribute to the more effective clinical application of ATM in the treatment of chronic neck pain, either as part of physiotherapeutic rehabilitation, or as a unique approach.
详细描述
Chronic neck pain is a common phenomenon in the adult population with a prevalence of about 15%, while it is indicative that 2/3 of the population will develop neck pain during their lifetime with slight predominance in women. In physiotherapy, a number of therapeutic techniques are available to treat chronic neck pain. Although no obvious, single treatment option has been shown to be the most effective, systematic reviews show that rehabilitation in a variety of forms has the strongest evidence for the effectiveness of relieving chronic neck pain. In these forms, complementary therapies such as acupuncture, chiropractic, yoga, Tai Chi as well as sensory-motor approaches such as the Feldenkrais method are incorporated.
Contemporary articles, found in 6 studies, investigate the effect of the Feldenkrais method (Feldenkrais Method/FM) in chronic neck pain and date between the years 1999-2014. Primary outcome measure was pain, while secondary assessed disability, functional status and quality of life. The findings in the majority showed initial positive indications for the application of FM in the management of chronic neck pain. However, further high-quality methodological studies are required in order to draw reliable conclusions.
This doctoral thesis is a single blind randomized controlled clinical trial with an active control element, where the intervention is the Feldenkrais Awareness Through Movement (ATM) technique and the standard treatment given to the control group is the combination of acupuncture and stretching, due to its scientifically proven efficacy and widespread use as the treatment of choice in this pathology.
The study was designed to examine whether and to what extent ATM application will reduce pain, improve functionality in patients with chronic neck pain and have a positive effect on the psychosomatic parameters of pain, firstly as an individual intervention and in comparison with biomedical acupuncture protocol in combination with stretching secondly.
The purpose of the study is twofold:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic non-specific neck pain
- •The duration of the symptoms should be at least three months before the initial evaluation and their participation in the study.
- •Existence of reported symptoms of non-rheumatic etiology on the shoulder or upper extremity.
- •Age range 19-70 years.
排除标准
- •History of surgery in Cervical Spine (Dibai-Fihlo et al. 2017)
- •Patients with a history of neck fracture or injury (Campa-Moran et al. 2015, Dibai-Fihlo et al. 2017) in the last year
- •Surgery on the head, face or neck (Dibai-Fihlo et al. 2017)
- •Active cervical hernia with radical symptoms or severe degenerative diseases in Cervical Spine (Dibai-Fihlo et al. 2017)
- •Systemic diseases (diagnosed rheumatic, metabolic and immune diseases), (Edward & Knowles 2003, Wilke et al. 2014, Campa-Moran et al. 2015, Cerezo-Téllez et al. 2016 Dibai-Fihlo et al. 2017, Cerezo -Téllez et al. 2018)
- •Myelopathy with severe disc or bone damage (Ma et al., 2010, Campa-Moran et al. 2015)
- •Cervical rhizitis / rhizopathy (Ma et al. 2010, Wilke et al. 2014, Campa-Moran et al. 2015)
- •Arterial dysfunction (Kerry et al. 2008)
- •Tumors active during the last five years
- •Lymphadenopathy (Tsakitzidis et al. 2013)
- •History of inflammatory arthritis (Tsakitzidis et al. 2013)
- •Diagnosed psychiatric illness (Wilke et al. 2014, Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
- •Severe neurological disorder (Edward & Knowles 2003, Wilke et al. 2014) or mental retardation (Ma et al. 2010)
- •Signs, Symptoms or History of Mouth Pain and Temporomandibular Disorders Based on the Research Diagnostic Criteria of Temporomandibular Disorders (RDC / TMD) (Campa-Moran et al. 2015)
- •Fibromyalgia syndrome diagnosed (Ma et al. 2010, Wilke et al. 2014, Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018) Infection or inflammatory swelling in the treated area
- •Skin damage (Edwards & Knowles 2003) or wounds in the area of the piercing (Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
- •Systematic intake of medications that may affect the patient's judgment (eg neuromodulators, antidepressants)
- •Taking systemic treatment for the same problem (Wilke et al. 2014) up to three months before the study
- •Pregnancy (Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
- •Previous Adverse Acupuncture Reaction (Edwards & Knowles 2003)
- •Allergy to metal (Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
- •Fear of the needle (Edwards & Knowles 2003, Campa-Moran et al. 2015, Cerezo-Téllez et al. 2016, Cerezo-Téllez et al. 2018)
- •Inability to express speech and writing in the Greek language
结局指标
主要结局
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
时间窗: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
The selected algometer (Commander Algometer, JTECH Medical, Midvale, Utah) was used to measure pain sensitivity through the application of pressure. This device can identify the pressure eliciting a pressure-pain threshold. The pain sensitivity recording was performed at specific points with 3 measurements taken at each. The first measurement was considered tentative and was rejected and the final value was the result from the average of the two remaining measurements. The sites that were selected for the pain pressure threshold measurements were the Mastoid Process, the Bladder 10 (BL 10), the C5-C6 Zygapophyseal Joint, the Upper Trapezius Muscle, the Levator Scapula Muscle, the Deltoid Muscle and the Tibialis Anterior Muscle, bilaterally (left and right).
次要结局
- Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Endurance of Deep Cervical Flexor Muscles of the Spine Measured by Chattanooga Stabilizer Pressure Biofeedback (PRESSURE BIOREACTION STABILIZER )(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Forced Vital Capacity (FVC) Measured by the Spirometer MIR Spirodoc(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Vital Capacity (VC) Measured by the Spirometer MIR Spirodoc(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Maximum Voluntary Ventilation (MVV) Measured by the Spirometer MIR Spirodoc(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Pain Intensity Measured by the Visual Analogue Scale(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Present Pain Intesity Measured by the Present Pain Intensity Index.(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Neck Disability Measured by the Neck Disability Index(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Anxiety and Depression Measured by the Hospital Anxiety and Depression Scale(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Kinesiophobia Measured by the Tampa Scale Kinesiophobia(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Perception of Fear and Trying to Avoid Pain in Relation to Physical and Work Activities Measured by the Fear Avoidance Beliefs Questionnaire.(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Quality of Life Measured by the Short Form 12 Health Survey.(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Pain Catastrophizing Measured by the Pain Catastrophizing Scale.(Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.)
- Global Perceived Effect Measured by the Global Perceived Effect Scale(Participants were assessed after the completion of the interventions (five weeks).)
研究者
Skordis Charalampos
Principal Investigator
University of West Attica