Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain and Upper Cervical Spine Dysfunction. Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Active range of motion mobility in the inferior cervical region (º)
研究概览
简要总结
Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year.
The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction.
The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience.
The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention.
Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.
In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions.
The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will be mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. Also, no pain will be allowed in the positions. Exercises were always carried out without pain, because pain can be an inhibitor of muscle contraction.
The Exercise (E) group will carried out one 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks.
Manual Therapy + Exercise Group The MT + E group will carried out 20-minute sessions led by an experienced physical therapist. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation (high velocity low amplitude) and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise. The MT techniques were applied depending on the clinical findings in each patient.
详细描述
Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year.
The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction.
The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience.
The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention.
Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with chronic neck pain
- •More than 18 years old
- •Loss of mobility in one or more upper cervical spine segments found through manual assessment according to Zito et al. (2006) and Kaltenborn (2012).
- •A positive result in the Flexion rotation-test in the upper cervical spine (less than 32º or a difference of 10º or more between the two rotations.
- •Not being able to exceed 24 mmHg in the cranio-cervical flexion test.
- •Signing the informed consent.
排除标准
- •Contraindication to manual therapy or exercise (pathological changes due to neoplasm, inflammation infections, osteopenia, congenital collagenous compromise syndromes "Down´s, Ehlers-Danlos, Grisel, Morquio"
- •Marked degeneration of the cervical spine that may affect cervical spine ligament integrity.
- •History of trauma to cervical vessels.
- •Anticoagulant therapy or blood clotting disorders or to have participated in any program of exercises or manual therapy treatments designed to improve the performance of the cervical region in the previous 3 months.
- •Post-traumatic neck pain or red flags according to Rushton et al.
- •Inability to maintain the supine position, use of pacemakers, an inability to perform the flexion rotation-test
- •Language difficulties that hinder understanding of informed consent or completion of the questionnaires necessary for this study.
- •Subjects with litigation or lawsuits pending
结局指标
主要结局
Active range of motion mobility in the inferior cervical region (º)
时间窗: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Mobility in the inferior cervical region will be evaluated in a sitting position with the back vertical and resting on the backrest of the chair with a CROM device (floating compass; Plastimo Airguide, Inc, Buffalo Groove,IL). Flexion, extension, right and left side-bending and right and left rotation will be measured. Three measurements will be made for each movement, and the result will be the mean of the three measurements.
Active range of motion mobility in the upper cervical region (º)
时间窗: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Flexion rotation-test will be used to measure the upper rotation, predominantly at C1-2. To perform this test, the subjects position themselves in the supine position and the evaluator passively will take the patients cervical spine to its maximum flexion and then will rotated the head to the right and left side with the occiput resting against the evaluator's abdomen. The movement will stopped at whichever situation occurs first, either the subject presents symptoms, or the evaluator reaches the end of the range of motion and finds a firm end feel. A CROM device will be used too, and three measurements will be performed for each movement, with the result being the mean of the three measurements
Pressure Pain Threshold (Kpa)
时间窗: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Cervical pressure pain threshold (PPT) will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2, and pressure will be applied at the rate of 1 kg/cm2/s perpendicular to the skin. With the subject supine, PPT will be assessed over 6 points bilaterally with a 10-second rest between each measurement: first metacarpal joint, upper trapezius muscle, elevator of scapula, C5-6 zygapophyseal joint, C2-3 zygapophyseal joint, and suboccipital muscles. Patients will be instructed to press the button of the digital algometer at the precise moment that pressure sensation changed to pain. The mean of 3 trials will be calculated over each point and used for analysis.
次要结局
- Pain Intensity (Visual analogue scale 0-100 mm)(Change between baseline(immediately before intervention) and post intervention (immediately after intervention))
研究者
Jacobo Rodríguez Sanz
Principal Investigator
Universitat Internacional de Catalunya