Effects of Functional Taping Compared to Sham and Minimal Intervention Strategy on Pain Intensity and Static Postural Control in Patients With Non-specific Chronic Low Back Pain: a Protocol for a Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Postural control on force platform - Static Posturography with and without a secondary task
研究概览
简要总结
Background: Low back pain is a major public health problem that affects most people at some point in life, and results in major psychosocial, economic, functional and physical consequences that can last for days and months. Most cases are undiagnosed and become chronic non-specific low back pain. Studies showed that these patients presented changes in postural control, yet the information is inconsistent, as well as the effects of Functional Taping (FT).
Objectives: The aim of this study will be to investigate the immediate and one-month follow-up effects of the use of Functional Taping to lumbar spine on pain intensity and postural control in patients with chronic nonspecific low back pain (CLBP).
Methods: This study will be a sham-controlled and randomized clinical trial. Participants: One hundred and twenty participants (18 and 50 years) both genders. Interventions: Participants will be randomly allocated to receive three possible interventions: Functional Star-shape Taping, Sham Functional Taping (both interventions during seven days) and a Minimal Intervention (MI) (one session). Main outcome measures: Primary outcomes will be pain intensity and posturography to assess balance parameters. Low back pain related disability, global perceived effect of treatment and fear avoidance beliefs will be considered as secondary outcomes. Four measurements of static posturography will be conducted: pre-intervention, immediately after application of the tape, after seven days post-intervention (after removal of the tape) and after one month follow-up period. Secondary and primary outcomes will be assessed on three occasions: pre-intervention, seven days post-intervention and after one month follow-up period. All statistical analysis will be conducted following the principles of intention to treat, and the effects of treatment will be calculated using linear mixed models.
详细描述
BACKGROUND
Considering that evidence suggests that patients with CLBP have changes in postural control, we highlight the importance of conduct studies to identify treatment strategies that can influence postural control like as FT. In this way, the objective of the present study is to compare the effects of Functional Star-shape Taping (FST) vs. Sham-FT vs. MI on pain intensity and postural control (primary outcomes) in CLBP patients. The secondary outcomes will be low back pain related disability, global perceived effect of treatment and fear avoidance beliefs.
METHODS
Study design
This study will be a sham-controlled, randomized, three-arm parallel-group clinical Study participants
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged between 18 and 50 years;
- •(2) medical diagnosis of chronic non-specific low back pain in the last 3 months and/or pain during at least half of the days in the past 6 months (Deyo et al. 2014), that is located between T12 and the gluteal folds;
- •(3) pain intensity equal to or greater than three;
- •(4) pain caused by certain postures, activities and movements; and
- •(5) score greater than 14% on the Oswestry Lumbar Disability Index (Vibe Fersum et al. 2013).
排除标准
- •(1) red flags (neoplastic diseases or tumors in the spine, inflammatory diseases, infections and fractures);
- •(2) serious neurological (or central and peripheral neurological) symptoms, psychiatric, rheumatologic and cardiac diseases;
- •(3) disc herniation;
- •(4) lumbar stenosis;
- •(5) spondylolisthesis;
- •(6) history of spinal surgeries;
- •(7) pregnancy;
- •(8) menstrual period;
- •(9) underwent physical therapy treatments (less than 6 months before the evaluation period);
- •(10) participants with previously diagnosed balance disorders or with disorders that may interfere with balance (vestibular diseases, whiplash injuries, functional ankle instability or report of "giving" way sensation in ankle during the past 6 months); and
- •(11) using medications that alter or cause suppression of sensory perception.
研究组 & 干预措施
Functional Star-shape taping (FST)
For the Functional Star-shape taping (FST) procedure, four tapes will be applied in the form of an elastic ''I'' with the aim of facilitating muscle activation. The taping will be applied when the participant is in a seated position. The taping will be positioned covering the entire lumbar region and lower part of the thoracic region (T11, T12), and placed first at the center and then on the ends (Castro-Sanchez et al. 2012).The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.
干预措施: Functional Star-shape taping (SFT) (Procedure)
Sham Functional Taping (Sham-FT)
For the Sham-FT procedure, a single bandage 20 cm in length was positioned horizontally, passing through the spinous process of the second lumbar vertebra (Castro-Sanchez et al. 2012). The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.
干预措施: Sham Functional Taping (Sham-FT) (Procedure)
Minimal Intervention Strategy (MIS)
The MIS group will receive an educational and counseling booklet (The Back Book) as recommend by Dupeyron et al. (2011) containing information about the low back pain clinical features, risk factors and prognosis, fear avoidance beliefs, how to deal with an acute pain crisis, the early resumption of normal or vocational activities, even when still experiencing pain, and the importance of improvement in functional activity levels and posture, not just pain relief (Delitto et al. 2012). Participants from this group will not receive FT intervention and the investigator will encourage participants to not receive any kind of treatment during the one month epoch after the initial assessment. They will be followed by one of the investigators that will make phone calls to clarify doubts and reinforce the counseling.
干预措施: Minimal Intervention Strategy (MIS) (Behavioral)
结局指标
主要结局
Postural control on force platform - Static Posturography with and without a secondary task
时间窗: one month
For evaluation on the force platform, a modified clinical test of sensory interaction for balance (CTSIBm) (Boulgarides et al. 2003) will be used by measuring the static balance in four sensory conditions: (1) eyes open on stable surface; (2) eyes closed on stable surface; (3) eyes open on unstable surface; (4) eyes closed on unstable surface. For each condition, the participant will be evaluated three times for a period of 40 seconds with a 30 second interval between each evaluation (Ruhe et al. 2011). For an unstable surface, a 13 cm-thick cushion with a density of 5kg/m3 will be used Caffaro et al. (2014). For the assessment of static posturography with a secondary task, participant will be requested to perform fast movement of shoulder flexion (bilateral). Participants will perform five movements (open and closed eyes) (Mok et al. 2011).
Pain intensity
时间窗: one month
Measurement of pain intensity was accomplished by means of the application of the Numerical Pain Rating Scale (NPRS), which consists of a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable." The volunteers will rate their pain based on these parameters.
次要结局
- Disability(one month)
- Fear avoidance beliefs questionnaire (FABQ)(one month)
- Participant ratings of global improvement and satisfaction with treatment - Patient Global Impression of Change (PGIC)(one month)
研究者
Thais Cristina Chaves
Professor, Department of Neuroscience and Behavioral Science at the Ribeirão Preto Medical School at the University of Sao Paulo. Coordinator, Laboratory of Interdisciplinary Research on Musculoskeletal Pain.
University of Sao Paulo