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临床试验/NCT02759757
NCT02759757Unknown不适用

Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain? A Controlled Randomized Trial

Leandro Pires0 个研究点目标入组 63 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
63
主要终点
Median Force

研究概览

简要总结

Objectives: To test if the Kinesio Tex Gold ® is able to change the electromyographic signal of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain.

Study design: Three-arm, randomized controlled trial with a blinded assessor.

Location of study: Physical therapy Clinic of the Universidade Cidade de São Paulo (UNICID)

Patients: Sixty-three patients with chronic nonspecific low back pain.

Intervention: Patients allocated to the Kinesio Taping® group will receive the tape as described by the manufacturer's manual. The patients assigned to the placebo group will receive a Micropore tape and the control group will not receive any intervention. All groups will be assessed before and 30 minutes after intervention

Measures: The following outcomes will be measured: 1) Muscle activity and 2) pain intensity.

Limitations: Therapists will not be blinded.

详细描述

Patients who are seeking care for low back pain at the physiotherapy clinic from Universidade São Paulo will be invited to participate in the study and informed about the objectives of the study and evaluation procedures.

Patients who agree to participate will sign a consent form.

Patients will be assessed at baseline and immediately after the interventions.

Investigators will collect data with regards to personal and anthropometric data, as well as pain intensity (measured by a 0-10 numerical rating scale in all follow up points) and disability (measured by the 0-24 point Roland Morris Disability Questionnaire at baseline only).

Finally, muscle activation will be evaluated by surface electromyography and the maximum voluntary contraction of the trunk at 30 degrees position for a lumbar dynamometer that will be adjusted to the anthropometric profile of patients. The average and maximum values of muscular strength will be obtained by maximum voluntary contraction. The electromyography will capture the muscle activity in an integrated manner to electrogoniometers and will transmit the data via Bluetooth to a desktop with a MWX8 software (Biometrics) that will analyze the data. Before instrumentation patients will be instructed to perform the trunk extension movement the therapist's commands to become familiar with the equipment. Soon after will be held instrumentation (placement of electromyography electrodes and electrogoniometers and lumbar dynamometer) maximal voluntary contraction will be collected in trunk extension without Kinesio taping

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with chronic low back pain (with a duration of at least 3 months), with or without leg pain.

排除标准

  • •patients who have used the Kinesio Taping previously
  • •any contraindications to the use of Kinesio Tex Gold®, such as allergy or severe skin problems.
  • •patients with nerve root compromise
  • •patients with fracture, tumor, inflammatory and/or infectious diseases
  • •patients with severe cardiorespiratory and/or metabolic diseases
  • •previous spinal surgery

研究组 & 干预措施

Kinesio Taping

Experimental

Patients from this group will receive the kinesio Taping® Tex Gold tape according to the manufacturer's instructions. Kinesio Taping will be applied for the purpose of inhibiting the erector spinal muscle from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae with 10 to 15% tension (paper-OFF) in a "I" position bilaterally.

干预措施: Kinesio Taping (Other)

Placebo

Placebo Comparator

Patient from this group will receive a 5cm-wide Micropore® tape from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae bilaterally.

干预措施: Placebo (Other)

Control

No Intervention

Patients allocated will not receive any intervention.

结局指标

主要结局

Median Force

时间窗: thirty minutes after interventions

Median force (a measure of muscle activity) will be collected using surface electromyography.

Root Mean Square

时间窗: thirty minutes after interventions

Root Mean Square (a measure of muscle activity) will be collected using surface electromyography.

次要结局

  • Pain Intensity(thirty minutes after interventions)

研究者

发起方
Leandro Pires
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leandro Pires

PT, masters student

Universidade Cidade de Sao Paulo

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