The Efficacy of Kinesio Taping as an Adjunct Intervention to Traditional Physical Therapy in the Treatment of Nonspecific Acute Low Back Pain: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 主要终点
- Disability
研究概览
简要总结
The Purpose of the study was to examine the effect of KinesioTaping (KT) on disability, fear avoidance beliefs and pain intensity in patients with acute non-specific LBP. Materials and Methods: Seventy-eight patients were randomized to an experimental group that received traditional physical therapy plus KT and a control group that received traditional physical therapy alone. Interventions were administered twice a week for four weeks. Assessment tools used were; RMDQ for disability, FABQ for fear-avoidance beliefs and NPRS for pain intensity.
详细描述
This study followed a prospective experimental pretest-posttest control group randomized design with repeated measures. Two groups were included in this study, an experimental group and a control group. Both groups were tested with respect to three main outcomes which are disability, fear avoidance beliefs and pain intensity. Five points of measurements were used; at baseline, at the end of week 1, at the end of week 2, at the end of week 3 and at the end of week 4.
A total of 88 patients with a primary complaint of low back pain were enrolled and consented to participate in the study. Potential study participants were assessed for study eligibility based on the pre-defined inclusion and exclusion criteria. Study flow chart. Subjects were pre-screened for known contraindications and precautions to thrust joint manipulation and exercises. No individuals were excluded from participation in this study based on race, creed, color, gender, age, national or ethnic origin, sexual orientation, disability, or health status.
After obtaining the informed consent, participant's demographic information was collected including age, gender, ethnicity, contact information, emergency contact, employment status etc. History taking also included collecting information about patient's past medical history, family history, mechanism of injury, chief complaint, present history, number of days since onset, presence of previous episodes of low back pain, treatment for previous episodes, questions related to red flags, and review of systems and allergies. Patients were also checked for eligibility criteria. Pain characteristics were also documented including, pain intensity, location, duration, timing, character, aggravating and alleviating factors. History, review of systems and medical screening questionnaire were also used to identify red flags. Red flags are clinical features that may indicate a serious spinal pathology that warrant further investigation.
Each participant was examined by the PI who conducted a thorough physical exam that included observation, palpation, and assessment of vertebral mobility, range of motion testing, muscle tests, neurological screening and special tests. Neurological examination included sensation for dermatomes, muscle testing for myotomes and deep tendon reflexes (Knee jerk and Ankle jerk). The allergy test for Kinesio taping was performed for all participants by the PI. An I strip of KT was applied on either side of lumbar spine at around 25% tension and left in place for 24 hours. The patient was checked during the second visit for any signs of adverse reactions such as rash or excessive hotness or itching in the tested area.
The PI then opened a new file for the participant that included all the information obtained from history taking, physical examination and any other assessments. This process took between 30 minutes and 45 minutes. In the second visit, the tape was removed and the patient checked for any abnormal reactions. The participant was then randomized to either the experimental group or the control group using random number generator.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding the physical therapist (the principal investigator) who provided interventions to both groups in the study to the type of intervention was not feasible. Blinding the principal investigator to the assessment process was possible by using another physical therapist who conducted all measurements. Blinding the assessor to subject's group assignment was done to ensure unbiased ascertainment of outcomes. Randomization also served to reduce the risk of selection bias by the principal investigator.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders, age between 18 and
- •Primary complaint of pain in the lower back located between the costal margins and the gluteal folds, less than 4 weeks in duration with or without leg pain but symptoms not distal to the knee.
- •A new episode of low back pain. This is defined as an episode which was preceded by a period of at least one month without low back pain where the participant was not consulting a health care practitioner or taking medication for their low back pain.
- •Pain of sufficient intensity to interfere with patient's daily activities and function. A minimum pain intensity of 3 on the numerical pain rating scale to allow room for change, as the MCID for the NPRS is 2 points. A minimal score of 4 on the RMDQ will also be required as patients with scores under 4 and over 20 may not show meaningful change over time. NPRS and RMDQ were used to determine such criteria.
- •Ability to communicate with English language which is important to complete the questionnaires successfully.
- •Lumbar spine hypomobility. This was determined through palpation by applying postero-anterior pressure by the tips of the thumbs against the spinous processes of all segments of the lumbar spine. Three oscillatory postero-anterior movements were performed at each level. Through comparison of quality and range of movements at each level, the physical therapist can determine which segments are stiff or hypomobile and the quality of the end feel.
排除标准
- •Patients with a diagnosis of severe degenerative and stenotic conditions which make spinal manipulative therapy contraindicated.
- •known or suspected serious spinal pathology (metastatic tumors, inflammatory or infective diseases of the spine, cauda equina syndrome, spinal fracture, dislocations/sublaxations).
- •Nerve root compromise evidenced by at least two of the following (a) myotomal weakness, (b) dermatomal or widespread sensory loss, (c) hypo or hyper-reflexia of the lower limb reflexes. Examination of sensation, reflexes and motor power were used to identify such criteria.
- •Adverse skin reactions to Kinesio taping.
- •RMDQ score of less than 4 or more than
- •NPRS of less than
- •Patients taking NSAIDs.
- •Patients currently receiving physical therapy or any form of manual therapy.
- •Previous spinal surgery.
- •Patients with contraindications to manual therapy or therapeutic exercises.
结局指标
主要结局
Disability
时间窗: changes at five points of time, at baseline (W0, before interventions), at the end of the first week (W1), at the end of the second week (W2), at the end of the third week (W3) and at the end of the fourth week (W4).
Disability was evaluated with the Ronald-Morris Disability Questionnaire (RMDQ). RMDQ is a patient reported outcome measure that is composed of 24 yes/no questions to assess functional status and disability in patients with low back pain. RMDQ scores can range from 0, the highest functional status indicating no disability, to 24, the lowest functional status indicating maximum disability. Patients were asked to mark the sentences that describe them at the time of evaluation.
次要结局
- Fear avoidance beliefs questionnaire (FABQ)(changes at five points of time, at baseline (W0, before interventions), at the end of the first week (W1), at the end of the second week (W2), at the end of the third week (W3) and at the end of the fourth week (W4).)
- Assessment of Pain(changes at five points of time, at baseline (W0, before interventions), at the end of the first week (W1), at the end of the second week (W2), at the end of the third week (W3) and at the end of the fourth week (W4).)
研究者
Prof. Dr Mahmoud Ibrahim Ibrahim
Professor of orthopedic PT
Rocky Mountain University of Health Professions