Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain: a Double-blinded, Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
Patients with chronic low back pain may have altered pain processing, making them vulnerable to pain or disability. It can be measured with test like pressure pain threshold, temporal summation or conditioned pain modulation. Manual therapy has shown improve this pain processing variables in other conditions (like knee osteoarthritis or lateral elbow pain), although the quality of the evidence is low in terms of temporal summation and controversial in terms of conditioned pain modulation. There are not studies that had investigated the impact of manual therapy techniques on pain processing in patients with chronic low back pain.
详细描述
Study Aims:
Aim #1: The main objective of this study is to determine the efficacy of two manual therapy approaches (passive joint mobilization and mobilization with movement) on pain (measured with Visual Analogue Scale) and pain processing (measured with pressure pain threshold, temporal summation and conditioned pain modulation) in patients with chronic low back pain and see its results on short, medium and long term.
Aim #2: The secondary objective is to compare the effect of both manual therapy techniques with an inactive control group in terms of pain and pain processing.
Aim #3: Determine the efficacy of manual therapy on intervention groups on psychological outcomes as catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale of Kinesiophobia) and depression (Beck Depressive Inventory) and compare them with control group.
Methodology Research Design: Randomized, longitudinal, experimental, prospective, parallel and double-blind study with patients with chronic low back pain.
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
- Double (Participant, 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
- •Non-specific chronic low back pain patients, without lower limb pain
- •Pain lasting 6 months or more
- •Pain measure of 2 or more on a 0 to 10 scale
- •Age between 18-65 years old
- •Haven't received physical therapy during last month
排除标准
- •Radiculopathy
- •Neurological signs, symptoms or deficit
- •Rheumatic/autoimmune/systemic disease
- •History of fracture, trauma or previous spinal surgery
- •Pregnancy
- •Disc herniation
- •Neuropathic pain
- •Active cancer
- •Spondylolysis/Spondylolisthesis
- •Cognitive impairment
- •Long-term opioid intake
结局指标
主要结局
Pain
时间窗: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Visual Analogue Scale (VAS) was used to measure pain. It consists of a 100mm length line and has written "no pain" and "worst pain imaginable" on its ends and measures pain intensity. The confidence and reliability of this scale has been approved and validated in different studies.
Temporal summation
时间窗: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Temporal summation was measured with Von Frey monofilaments. Patients lay down on prone position and measurements were taken 1cm lateral to spinous process of L4. First, a single stimulus was applied and the patient assessed the pain intensity on a 0-10 numeric rating scale. After that, 10 rhythmic stimuli were applied on the same spot (1 stimuli per second) and the patient assessed again the pain intensity. The temporal summation effect was calculated as the difference between the mean rating of the three repetitions of one stimulus and the mean rating of the three repetitions of 10 stimulus.
Pressure pain threshold
时间窗: Time Frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
A digital algometer was used to measure mechanical hyperalgesia. The model was de X® brand, consisting of a 1cm2 cylindrical rubber attached to a pressure gauge, calibrated in kilograms (kg). The scale expressed in kg/cm2 was used. Before the measurement, patients were trained in forearm muscles through a trial session. They were instructed to say STOP when the pressure sensation was painful. For the measurement, patients lay down on prone position on the stretcher and the algometer was placed perpendicular to skin on the measured points, who were marked prior to measurement (2cm lateral to L5 spinous process, C2 spinous process, ipsilateral anterior tibialis and contralateral epicondyle). A rest period of 30 seconds was established between the measurements. For each point, three measurements were done and their mean was calculated and recorded for analysis. The minimum detectable change (CMD) for considering the results as clinically relevant was established at 15% minimum.
Conditioned pain modulation
时间窗: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Conditioned pain modulation was measured with tourniquet test. A sphygmomanometer was used to induce ischemic muscle pain as conditioning stimulus (model X®). It was applied around the contralateral upper arm, 3cm proximal to cubital fossa. Now, pressure pain threshold 2cm lateral to L5 spinous process was measured. Afterwards, the cuff was inflated to 260mmHg and maintained until the patient perceived a pain intensity of 6 on a 0-10 numeric rating pain scale. Then, the pressure pain threshold was measured again at the same spot during the conditioning stimulus and then the cuff pressure was released. The conditioned pain modulation value is the result of the subtraction of the value of the PPT during the conditioning stimulus minus the PPT without it.
次要结局
- Pain Catastrophizing(Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).)
- Central sensitization(Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).)
- Kinesiophobia(Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).)
- Depression(Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).)
- Disability(Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).)
研究者
Josue Fernandez Carnero
PhD
Universidad Rey Juan Carlos