Addition of 3D Posture Corrective Orthosis to A Multimodal Program of Treatment Of NSNP.
- Conditions
- Neck Pain
- Interventions
- Device: ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)
- Registration Number
- NCT03331120
- Lead Sponsor
- Tongji Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study or Experimental Group ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO) 2--Experimental or study group: 1. moist hot pack. 2. manual therapy. 3. Therapeutic Exercise. 4. Home program routine. 5. ambulatory mirror image functional re-training through wearing 3D adjustable cervical thoracic Posture Corrective orthosis (CTPCO) For 10 weeks(3Times/week for 20 minutes). Control Group ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO) 1--Control group . Conventional treatment: 1. moist hot pack. 2. manual therapy. 3. Therapeutic Exercise. 4. Home program routine.
- Primary Outcome Measures
Name Time Method questionnaire to assess Feasibility. Pre treatment at 1st day , post treatment after 10 weeks . Feasibility to assess feasibility of conducting future RCT.
- Secondary Outcome Measures
Name Time Method 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. The NDI is a modification of the Oswestry Low Back Pain Disability Index. It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain The NDI can be scored as a raw score \[2\]or doubled and expressed as a percent \[3\]. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.
0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation.Active cervical ROM using CROM. Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. with an inclinometer (CROM Deluxe model, Performance Attainment Associates, Lindstrom, Minnesota).
The CROM consists of 2 gravity-dependent goniometers, one compass dial, and a head-mounted frame allowing measurement of ROM in 3 planes (flexion/ extension, lateral flexion, rotation). A magnetic yoke consisting of 2 bar magnets held anteriorly and posteriorly was provided to reduce the influence of thoracic rotation. The CROM has demonstrated good concurrent validity for active ROM. According to the systematic review by Chen et al, the mean normative values of cervical ROM were determined to be: 52 degrees for flexion, 71 degrees for the extension, 72 degrees for rotation, and 43 degrees for lateral flexion. Documentation of cervical ROM was rendered in the form of the full range (ie, a total value for the sagittal, frontal, or transverse plane, yielding 3 measurements).Zung Self-Rating Anxiety Scale (SAS) Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. The SAS test is self-administered, with each response using a 4-point scale, from 'none of the time" to "most of the time." There are 20 questions with 15 increasing anxiety level questions and 5 decreasing anxiety questions. There are two formats, self-evaluations and clinical evaluations.
Zung Self-Rating Depression Scale (SDS) Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. scoring the SDS, a value of 1, 2, 3 and 4 is assigned to a response depending upon whether the item is worded positively or negatively. For items 1, 3, 4, 7, 8, 9, 10, 13, 15, 19 the scoring is:• A little of the time = 1• Some of the time = 2• Good part of the time = 3• Most of the time = 4 Items 2, 5, 6, 11, 12, 14, 16, 17, 18, 20 are reverse scored as follows:• Most of the time = 1• Good part of the time = 2• Some of the time = 3• A little of the time = 4 The SDS index is derived by dividing the sum of the values (raw scores) obtained on the 20 items by the maximum possible score of 80, and expressed as a decimal point.
The Numeric Pain Rating Scale Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. is an 11-point numeric pain intensity ranging from 0 ('no pain') to 10 ('as much pain as possible'). A change of two points or more was identified as the minimal clinically an important difference in patients with chronic neck pain.
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. Postural translation of head
1. Tx(medio lateral translation )
2. Tz(antero posterior translation )
Postural rotations of head
1. Rx(flexion or extension position)
2. Ry (r.t rot. Or l.t rot.)
3. RZ (r.t side bending or l.t side bending)
Trial Locations
- Locations (1)
Tongji Medical College
🇨🇳Wuhan, Hubei, China