Comparison of the Additional Effects of Using TENS and Interferential Currents for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Functional disability
研究概览
简要总结
In the current clinical and scientific reality, conservative treatment is the most coherent clinical management with a view to the proper rehabilitation of patients with chronic neck pain, with a trend towards the use of therapeutic exercise. However, some uncertainty about the effectiveness of therapeutic exercises still remains, requiring further studies with high methodological rigor, especially with regard to multimodal treatment, such as the combination of therapeutic exercises with photobiomodulation. Thus, the objective of this project is to evaluate the effects of adding photobiomodulation to a program of specific therapeutic exercises for the treatment of individuals with chronic non-specific neck pain. To this end, 60 participants will be randomized into three groups: therapeutic exercise group + photobiomodulation (n = 20), and therapeutic exercise group. There will be 8 treatment sessions and participants will be evaluated before, after the 8 sessions, and 4 weeks after the end of treatment using the Numerical Pain Scale, Neck Disability Index, Catastrophic Thoughts about Pain Scale, and Tampa Kinesiophobia Scale. In the statistical analysis, a linear mixed model will be applied, considering the interaction between the time and group factors. Finally, the addition of photobiomodulation to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic neck pain.
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 (Investigator, Outcomes Assessor)
盲法说明
The principal investigator will not be part of any assessment or treatment process.
Two researchers will be solely responsible for evaluating the outcomes. These will not participate in any other process. And they did not know the allocation of participants in their respective groups.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With chronic neck pain (for more than 90 days)
- •Identified according to the following criteria: NDI score ≥ 5
- •Numerical Pain Scale (END) score ≥ 3 at rest or during active neck movement
排除标准
- •Individuals who had a history of cervical trauma; head, face, or cervical surgery
- •Degenerative diseases of the spine
- •Pain radiating to the upper limbs
- •Having been submitted to physiotherapeutic treatment for the cervical region in the last three months
- •Use of analgesics, anti-inflammatory drugs, or muscle relaxants in the last week; the presence of systemic diseases
- •medical diagnosis of fibromyalgia.
研究组 & 干预措施
Therapeutic exercise group
1.Movements of flexion, extension, inclinations, and rotations of the cervical region at maximum amplitude and without load. 2.Neural mobilization of the cervical nerve roots. 3.Contraction of the deep muscles of the flexors, extensors, and rotators of the cervical region without performing spinal movements, using the movement of the eyes to aid in the accomplishment of these exercises. 4.Isometric contraction of the flexor muscles, inclinators, and rotators against manual resistance of the physiotherapist. 5.Isometric contraction of the cervical extensors of the cervical region against gravity. 6.Contraction of the flexor muscles, extensors, and incliners of the cervical region against the resistance of elastic bands.
干预措施: Therapeutic exercise (Other)
Therapeutic exercise group + high frequency TENS
This group will consist of 25 participants. Initially, TENS (Endophasys® - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda) will be applied to the cervical region through 4 silicon-carbon electrodes measuring 4 x 4 cm, with a water-based gel to reduce impedance at the skin-electrode interface. Thus, TENS will be applied with a rectangular, biphasic, and symmetrical pulse, with a pulse width of 100 µm, a frequency of 100 Hz, at the maximum tolerated sensitive threshold, for 30 minutes (VANCE et al., 2012). After the application of TENS, the same program of therapeutic exercises applied in the first group will be applied, in the same sequence, evolution, times, and repetitions.
干预措施: Therapeutic exercise (Other)
Therapeutic exercise group + high frequency TENS
This group will consist of 25 participants. Initially, TENS (Endophasys® - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda) will be applied to the cervical region through 4 silicon-carbon electrodes measuring 4 x 4 cm, with a water-based gel to reduce impedance at the skin-electrode interface. Thus, TENS will be applied with a rectangular, biphasic, and symmetrical pulse, with a pulse width of 100 µm, a frequency of 100 Hz, at the maximum tolerated sensitive threshold, for 30 minutes (VANCE et al., 2012). After the application of TENS, the same program of therapeutic exercises applied in the first group will be applied, in the same sequence, evolution, times, and repetitions.
干预措施: Therapeutic exercise group + high frequency TENS (Other)
Therapeutic exercise group + Interferential
This group will consist of 25 participants. Initially, the protocol of exercises performed in the therapeutic exercise group will be applied. In sequence, the interferential current will be applied. Through the Endophasys® device - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda). Four electrodes (8x5 cm), two upper and two lower (forming a square) will be positioned around the center of the neck. The electrodes will be positioned crosswise, following the parameters: 4KHz (carrier frequency), 1/1 second (Sweep Mode), 60 Hz Amplitude of frequency modulation (AMF), 30 Hz (Delta AMF), automatic vector mode, with intensity at the motor threshold of sensation, lasting 30 minutes (Albornoz-Cabello et al., 2019).
干预措施: Therapeutic exercise (Other)
Therapeutic exercise group + Interferential
This group will consist of 25 participants. Initially, the protocol of exercises performed in the therapeutic exercise group will be applied. In sequence, the interferential current will be applied. Through the Endophasys® device - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda). Four electrodes (8x5 cm), two upper and two lower (forming a square) will be positioned around the center of the neck. The electrodes will be positioned crosswise, following the parameters: 4KHz (carrier frequency), 1/1 second (Sweep Mode), 60 Hz Amplitude of frequency modulation (AMF), 30 Hz (Delta AMF), automatic vector mode, with intensity at the motor threshold of sensation, lasting 30 minutes (Albornoz-Cabello et al., 2019).
干预措施: Therapeutic exercise group + Interferential (Other)
结局指标
主要结局
Functional disability
时间窗: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.]
The NDI will be used to verify the degree of disability due to neck pain.
Numerical Pain Scale
时间窗: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.]
The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
次要结局
- Catastrophic Thoughts about Pain Scale(Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.])
- Kinesiophobia Tampa Scale(Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.])
- The Copenhagen Neck Functional Disability Scale (CNFDS)(Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.])
- Global Perception of Change Scale(Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.])
研究者
Cid André Fidelis de Paula Gomes
Phd, professor
University of Nove de Julho