Addition of 3D Posture Corrective Orthosis To A Multimodal Program In The Treatment Of Nonspecific Neck Pain. A Randomized Pilot Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neck Pain
- Sponsor
- Tongji Hospital
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- questionnaire to assess Feasibility.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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. With these considerations in mind and to integrate the findings of 3D postural assessment into the treatment programme, we designed an adjustable cervico thoracic posture corrective orthotic (CTPCO) to be worn by the patient for a short time. The device has the ability to reflect all transitional displacements and rotational movements of the head. Ambulatory exercises will be performed using a treadmill while the CTPCO holds the patient's reverse posture. We designed a randomized two-arm pilot trial to investigate the hypothesis that the addition of a 3D adjustable CTPCO to a multimodal programme will produce short- and long-term improvement effects on NSNP management outcomes (i.e., neck pain, neck disability and 3D posture parameters of the head). The primary aim of this study is to evaluate the feasibility of conducting a larger randomized trial that considers recruitment, compliance to study protocols and adverse events. The secondary aim is to investigate the effect size of the addition of ambulatory mirror image functional re-training via the wearing of a 3D adjustable CTPCO compared to control group interventions for neck pain, disability and 3D posture parameters.
Investigators
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
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
questionnaire to assess Feasibility.
Time Frame: Pre treatment at 1st day , post treatment after 10 weeks .
Feasibility to assess feasibility of conducting future RCT.
Secondary Outcomes
- 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.)