Addition of 3D Posture Corrective Orthosis To A Multimodal Program In The Treatment Of Nonspecific Neck Pain. A Randomized Pilot Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- questionnaire to assess Feasibility.
研究概览
简要总结
Nonspecific neck pain (NSNP) is one of the most common musculoskeletal problems treated by orthopaedic physicians and physiotherapists . NSNP has an annual incidence rate of 38 to 73% and a lifetime prevalence of approximately 48%, leading to both economic and social problems.
详细描述
Posture has emerged as a major risk factor associated with NSNP, but most previous studies have ignored correct posturing as an effective treatment. The few studies that used posture corrective strategies were based on a dated concept that did not incorporate the 3D nature of posture into the treatment strategy . Therefore, one of the major challenges faced by clinicians is how to incorporate 3D posture findings into the treatment plan.
Harrison and colleagues reported that posture problems occurred in the head, ribs and pelvis in three dimensions in the form of translations and rotational displacements. Therefore, we should consider three-dimensional postural assessment and correction during the treatment of NSNP to obtain long-lasting effects and prevent the recurrence of neck pain.
Several tools are available for objective postural measurements in clinical use, including simple plumb line measure, photographic techniques , moiré topography and various computer-assisted methods, such as electro goniometers. These methods are used in clinical assessments, but they have limitations, including the inability to measure neck posture as rotations and translations in six degrees of freedom, as mentioned by Harrison and colleagues.
The current study will use a 3D analysis system called the Global Postural System (GPS) , which is a novel device that investigates all postural variables at once and provides the managing physiotherapist with radiation-free and accurate measurements . This device also provides further information about foot pressure analysis and other 3D features that allow bracing designs to be tailored for each patient .
Numerous studies have shown that mirror images in motion exercises, which are prescribed specifically to help normalize the patient's neuromuscular dysfunction and postural deformation via reflecting the patient's posture across different planes, are more beneficial than a less personalized programme.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects age from 17 to 40 years
- •Neck pain with equal or greater than 3/10 on a visual analogue scale (VAS) and pain lasting more than 3 months (chronic neck pain) [26, 27]
- •Patients with neck disability; this is defined by a score of at least 5 (on a 50-point scale) on the neck disability index (NDI) [28]
- •Patients will be included if they have posture abnormalities by screening test using GPS at least 2 posture abnormalities.
- •Subjects must be able to continue treatment for 10 weeks and then attend 3-month follow-up
- •If patients can accept and sign informed consent form
排除标准
- •If patient report any of the following conditions:
- •Neck pain associated with whiplash injuries, medical red flag history (such as tumour, fracture, metabolic diseases, rheumatoid arthritis and osteoporosis) [27].
- •Neck pain with cervical radiculopathy or neck pain associated with externalized cervical disc herniation [27]
- •Fibromyalgia syndrome; to avoid the similarity of fibromyalgia with a NSNP diagnosis, a physician will use the criteria for the clinical diagnosis of fibromyalgia according to the American College of Rheumatology [29]
- •If the patient had previous surgery in the neck area (irrespective of the reason for the operation) [27]
- •Neck pain accompanied by vertigo caused by vertebra basilar insufficiency or accompanied by non-cervicogenic headaches [27]
- •People will also be excluded if they are undergoing any type of pain treatment or they have psychiatric disorders or other problems that contraindicate the use of the techniques in this study [27]
- •If patient has true leg length discrepancy and an associated pathology of upper and lower limbs that may interfere with the global posture (e.g., foot, knee or hip deformities)
- •The patients will be unable to attend a 10-week treatment programme and follow-up assessments after 3 months
研究组 & 干预措施
Control Group
1--Control group
. Conventional treatment:
- moist hot pack.
- manual therapy.
- Therapeutic Exercise.
- Home program routine.
干预措施: ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO) (Device)
Study or Experimental Group
2--Experimental or study group:
- moist hot pack.
- manual therapy.
- Therapeutic Exercise.
- Home program routine.
- ambulatory mirror image functional re-training through wearing 3D adjustable cervical thoracic Posture Corrective orthosis (CTPCO) For 10 weeks(3Times/week for 20 minutes).
干预措施: ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO) (Device)
结局指标
主要结局
questionnaire to assess Feasibility.
时间窗: Pre treatment at 1st day , post treatment after 10 weeks .
Feasibility to assess feasibility of conducting future RCT.
次要结局
- Neck Disability Index, Assess change of neck disability at baseline, after 10 weeks treatment and after 3 months follow up.(Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.)
- Active cervical ROM using CROM.(Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.)
- Zung Self-Rating Anxiety Scale (SAS)(Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.)
- Zung Self-Rating Depression Scale (SDS)(Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.)
- The Numeric Pain Rating Scale(Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.)
- Three-dimensional posture parameters measured by GPS device. Assess change of posture parameters before, after treatment 10 weeks and after follow up 3 months.(Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.)
研究者
Ahmed Samir Abdelkhalik Youssef
Principal Investigator, PHD Student at Department of Rehabilitation Medicine and Physical Therapy,Tongji Medical College,HUST,CHINA , Assistant Lecturer at Faculty of Physical Therapy - Beni-Suef University,Egypt.
Tongji Hospital