The Effectiveness of a Physiotherapeutic Re-education Based on the Pre-activation of the Transverse Abdominis in Patients With Non-specific Chronic Low Back Pain in Primary Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in pain intensity (from baseline)
研究概览
简要总结
Hypothesis: The hypothesis of the study is that the physiotherapeutic re-education of the pre-activation of the transverse abdominal muscle decreases pain intensity in patients with chronic non-specific low-back pain by at least 30% and is more effective than conventional treatment.
Aims: the principal aim is to determine the effectiveness of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on pain intensity in adult patients diagnosed with chronic non-specific low-back pain compared to conventional treatment in a primary care setting. The secondary aims of the study are to assess the effects of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on: (1) disability and limitations for the development of the activities of daily living associated with LBP, (2) transverse abdominal muscle muscle contraction, (3) to assess whether the resistance training parameters applied to older adults are valid for young adults and (4) to determine whether the training protocols used for the cervical spine could be extrapolated to the lumbar spine.
详细描述
This study will be a parallel randomized controlled trial. Participants between 18-65 years old, diagnosed with chronic nonspecific low-back pain, who will sign the informed consent, will be included in the study. Participants will be excluded if they are diagnosed with cognitive impairments, if the presence of any "Red Flag" is identified, women on pregnancy or postpartum less than three months and participants with difficulties understanding and/or speaking Spanish or Catalan.
Based upon the results of a systematic review about the effectiveness of physical therapy based treatment for low back pain, a reduction in 15 points of pain intensity assessed through Visual Analogue Scale will be considered for sample size calculation. Therefore, accepting an alfa risk of 0.05, a beta risk less than 0.2 and assuming a 15% of withdrawals a sample size of 108 participants has been estimated for this study.
Participants will be recruited from Primary Care Centers of the city of Lleida (Catalonia, Spain). They will be first contacted by telephone and the suitability of each participant will be assessed trough a brief interview. After participant selection via telephone, those who meet the inclusion criteria will be invited to have a personal interview with the researchers in order to solve any doubt and to read and sign the written informed consent. To ensure all participants understand the study, they will simply be asked about general study information (i.e. objectives, treatment and control conditions, etc.).
The included participants will be assigned either to the experimental or the control group using a simple randomization method. The allocation will be concealed to both, the physiotherapists who will make the assessments (pre- and post-treatment and follows-up) of the participants and the researcher who will manage the results data.
Participants in the experimental group will receive an individualized physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle. The intervention will last 4-weeks and will consist on two weekly sessions of 30-35 minutes each. Each session will be divided into two main parts (1) warm-up and (2) re-education of the pre-activation of the transverse abdominal muscle.
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
- •Being diagnosed of non-specific chronic low back pain of 3 or more months duration.
- •Patients between 18-65 years old.
- •To accept and sign the informed consent.
排除标准
- •Patients with diagnosed of cognitive problems that prevent understanding the procedure or participation in the study.
- •Any red flag condition:
- •Age of pain onset <20 or >55
- •Recent history of trauma
- •Pain not associated with movement and not relieved by lying down
- •Thoracic pain
- •Past history of malignancy, recurrent of prolonged use of corticosteroids, immunosuppression/HIV
- •Being systematically unwell
- •Unexplained weight loss
- •Neurological symptoms such as weakness of the limbs
- •Structural deformity of the spine
- •Women on pregnancy or postpartum less than three months.
- •Difficulty understanding and/or speaking Spanish or Catalan
结局指标
主要结局
Change in pain intensity (from baseline)
时间窗: 4 weeks, 3 months, 6 months, 12 months
The Visual Analogue Scale (VAS) is an unidimensional scale developed to measure pain intensity. This scale consists on a line of 100-mm with a description on both extremes. "No pain" appears on the left side, representing a value of 0, and "worst pain ever" appears on the right side of the scale, representing a value of 100. A higher score on the scale will be indicative of greater pain intensity. Although no normative values are available in regard of the distribution of VAS scores, the following cut-off scores have been recommended: no pain (0-4mm), slight pain (5-44mm), moderate pain (45-74mm) and severe pain (75-100mm)
次要结局
- Oswestry Disability Index(4 weeks, 3 months, 6 months, 12 months)
- Roland-Morris Scale(4 weeks, 3 months, 6 months, 12 months)
- Transverse abdominal muscle contraction with Pressure Biofeedback Unit(4 weeks, 3 months, 6 months, 12 months)
- Surface Electromyography(4 weeks, 3 months, 6 months, 12 months)
研究者
Francesc Josep Rubi Carnacea
Physiotherapist
Universitat de Lleida