Acute Effects of Spinal Manipulative Therapy, Exercise Therapy and Open-label Placebo on Movement Performance in Individuals With Chronic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Lifting performance
研究概览
简要总结
The goal of this laboratory-based cross-over randomized controlled study is to study the immediate effects Spinal manipulative therapy (SMT) and exercise therapy (ET) compared to open-label placebo (OLP) on movement performance, gait, active trunk mobility and pain-intensity in persons with chronic non-specific back pain.
The main question this study aims to answer is: What are the immediate and measurable effects of SMT and ET on work movements, gait, active trunk mobility and pain-intensity in people with chronic non-specific back pain, compared with and in combination with open-label placebo treatment (OP)?
The investigators hypothesize that the participants, after SMT and ET, will perform the lifting task faster, and use more range of motion in most of the joints. They also believe that a greater range of motion is used during gait and that the active ROM in the back is increased, while the pain intensity scores decrease after these interventions. The investigators hypothesize that the control intervention (OLP) could be effective as an add-on intervention, but not as a single intervention.
All participants will receive all three interventions SMT, ET and OLP and to study the immediate effects, the participants will be asked:
- to lift a box with two different weights
- to walk straight forward with and without a cognitive dual task
- perform two clinical tests of active range of motion (
- rate the intensity of their pain "right now"
- rank the treatment effects of these three treatment methods
详细描述
The occurrence of chronic non-specific back pain (CBP) is costly for Western society and most persons with CBP are functionally limited in their everyday movements. Studies show positive subjective short-term effects after a period of both spinal manipulative therapy (SMT) and exercise therapy (ET), but the immediate effects on of one session SMT/ET on movement performance are unknown. Open placebo is a relatively new field of research and a promising form of treatment for people with nonspecific pain conditions.
The goal of this laboratory-based cross-over randomized controlled study is to study the immediate effects Spinal manipulative therapy (SMT) and exercise therapy (ET) compared to open-label placebo (OLP) on movement performance, gait, active trunk mobility and pain-intensity in persons with chronic non-specific back pain.
Participants with long-term back pain will be recruited through primary care, such as health centers, private clinics and occupational health services.
All participants will receive all three interventions (around 5-8 minutes each)
- SMT: a doctor of chiropractic will perform HVLA spinal manipulation of areas with restricted range of motion.The areas of interest can be from the neck to the pelvis and hips.
- ET: The participants will be asked to perform mobility and motor control exercises of the trunk and pelvic muscles under supervision.
- OLP: The participant takes two pieces of orange gelatin capsules filled with the inactive substance microcrystalline cellulose, following the procedure described in Carvalho et al (2016). In short, participants will be informed that the pills are placebos and will be shown a news report featuring patients with non-specific complaints, such as migraines and irritable bowel syndrome, who describe their positive experiences with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons who have either experienced continuous or recurring back pain for a period longer than 3 months). Back pain is defined as problems/discomfort from the spine Th1-S1 with associated costovertebral joints and sacroiliac joints, thus including both the lumbar spine and the thoracic spine. The area of pain extends from Th1 to the inferior gluteal fold but does not include the shoulder blades
- •>18 years old,
- •those who can speak and understand Scandinavian or English.
排除标准
- •"red flags"
- •persons with specific back problems, rheumatic inflammatory joint- and/or back diseases, fractures, diagnosed hip osteoarthritis, fibromyalgia, or neurological co-morbidity.
结局指标
主要结局
Lifting performance
时间窗: Immediately after each intervention, the participants perform the lifting task. The results will be compared to the baseline measures.
Participants are asked to perform the movement at a comfortable self-selected speed. They perform two consecutive lifts and between the lifts, the test staff will the object to its original position. To standardize the test, the height of the table is adjusted to 50% of the participant's body height and the horizontal distance between the participant and the table to 75% of his/her arm length. The lift is performed in two situations: one "light" situation and one "moderate/heavy" situation. Kinematic and kinetic variables defining movement performance during the lifting task will be used to analyze the data. The lifts will be divided into two phases: a downward and an upward phase, and expressed in % movement-time. For each phase, we will study variables such as fixed time, speed of movement, ROM, intersegmental coordination.
次要结局
- Gait - 1) Temporal gait parameters(Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.)
- Gait - 2) Spatial gait parameters(Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.)
- Gait - 3) Joint angles during gait(Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.)
- m-FTF(Immediately after each intervention, the participants perform the test of active range of motion. The results will be compared to the baseline measures.)
- mm-Schober's test(Immediately after each intervention, the participants perform the test of active range of motion. The results will be compared to the baseline measures.)
- Pain-Intensity(Immediately after each intervention, the participants rate their pain-intensity ("pain right now"). The results will be compared to the baseline measures.)
- Preference(Immediately after all interventions, the participants evaluate the interventions.)
- Gait - 1) Temporal gait parameters(Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.)
- Gait - 2) Spatial gait parameters(Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.)
- Gait - 3) Joint angles during gait(Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.)
- m-FTF(Immediately after each intervention, the participants perform the test of active range of motion. The results will be compared to the baseline measures.)
- mm-Schober's test(Immediately after each intervention, the participants perform the test of active range of motion. The results will be compared to the baseline measures.)
- Pain-Intensity(Immediately after each intervention, the participants rate their pain-intensity ("pain right now"). The results will be compared to the baseline measures.)
- Preference(Immediately after all interventions, the participants evaluate the interventions.)
研究者
Wilhelmus Grooten
University lecturer
Karolinska Institutet