Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change in Patient Specific Functional Scale (PSFS)
研究概览
简要总结
Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in at that point as well. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.
详细描述
Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups: 1) control group, 2) fascial manipulation (FM) and movement control exercises (MCE), 3) sham-FM and MCE, 4) FM and sham-MCE and 5) sham-FM and sham-MCE. Physical therapists who perform treatments (FM), prescribing MCE and performing the measurements are blinded to each other. Physical therapist who is performing measurements is also blinded for the baseline measurements. There and 4 treatments of sham-FM, 4-5 treatments of FM, 4 treatments of sham-MCE and 4-6 treatments of MCE. Control group will receive only university hospital rehabilitation and will participate into the baseline and follow-up measurements. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in as at baseline. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.
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
Participant are not aware which treatment and exercises they will have, physical therapist who perform treatments and exercise prescription were blinded for measurements and each others work. Outcome assessor was blinded for baseline study results and treatment groups. Investigator was blinded for all the work done by others.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic non-operatively treated low back pain or pain after the low back operation. Participation in multidisciplinary rehabilitation at University Hospital of Oulu.
排除标准
- •Specific low back pain cause and earlier fascial manipulation treatment given.
结局指标
主要结局
Change in Patient Specific Functional Scale (PSFS)
时间窗: Baseline, 3, 6 and 12 months
Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.
次要结局
- Change in PROMIS(Baseline, 3, 6 and 12 months)
- Change in Mobility of the hips(Change from baseline at 3 month)
- Change in Lef-right discrimination(Change from baseline at 3 month)
- Change in Ultrasound of the fascia(Change from baseline at 3 month)
- Change in Tampa Scale of Kinesiophobia(Baseline, 3, 6 and 12 months)
- Change in Visual analogue Scale(Baseline, 3, 6 and 12 months)
- Change in Linton Örebro(Baseline, 3, 6 and 12 months)
- Change in Start back(Baseline, 3, 6 and 12 months)
- Change in Spinal mouse(Change from baseline at 3 month)
- Change in Oswestry(Baseline, 3, 6 and 12 months)
- Change in Movement control tests(Change from baseline at 3 month)
- Change in Balance measured with computer(Change from baseline at 3 month)
- Change in Two-point discrimination(Change from baseline at 3 month)
研究者
Jani Takatalo
Resident of PRM, PhD, MD
Oulu University Hospital