Clinical trial NCT03331120: Addition of 3D Posture Corrective Orthosis to A Multimodal Program of Treatment Of NSNP.
Official title: Addition of 3D Posture Corrective Orthosis To A Multimodal Program In The Treatment Of Nonspecific Neck Pain. A Randomized Pilot Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain
Ambulatory
Orthotic
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 24
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot double-blind randomized controlled trial, 24 patients will be randomized into two groups (study and control) using random number generator. The both groups will receive conventional treatment consisting of moist hot pack, soft tissue mobilization, manual therapy, therapeutic exercise. Additionally, the study group will receive ambulatory mirror image functional re-training through wearing 3D adjustable CTPCO.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria

1. Male and female subjects age from 17 to 40 years
2. 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) \[26, 27\]
3. 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) \[28\]
4. Patients will be included if they have posture abnormalities by screening test using GPS at least 2 posture abnormalities.
5. Subjects must be able to continue treatment for 10 weeks and then attend 3-month follow-up
6. If patients can accept and sign informed consent form

Exclusion criteria

1. 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) \[27\].
2. Neck pain with cervical radiculopathy or neck pain associated with externalized cervical disc herniation \[27\]
3. 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 \[29\]
4. If the patient had previous surgery in the neck area (irrespective of the reason for the operation) \[27\]
5. Neck pain accompanied by vertigo caused by vertebra basilar insufficiency or accompanied by non-cervicogenic headaches \[27\]
6. 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 \[27\]
7. 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)
8. The patients will be unable to attend a 10-week treatment programme and follow-up assessments after 3 months

Primary outcomes:
measure: questionnaire to assess Feasibility.
timeFrame: Pre treatment at 1st day , post treatment after 10 weeks .
Secondary outcomes:
measure: The Numeric Pain Rating Scale
timeFrame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
measure: Neck Disability Index, Assess change of neck disability at baseline, after 10 weeks treatment and after 3 months follow up.
timeFrame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
measure: Three-dimensional posture parameters measured by GPS device. Assess change of posture parameters before, after treatment 10 weeks and after follow up 3 months.
timeFrame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
measure: Active cervical ROM using CROM.
timeFrame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
measure: Zung Self-Rating Anxiety Scale (SAS)
timeFrame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
measure: Zung Self-Rating Depression Scale (SDS)
timeFrame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Medical College
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiaolin Huang, Professor
role: STUDY_DIRECTOR
References:
citation: Youssef ASA, Xia N, Emara STE, Moustafa IM, Huang X. Addition of a new three-dimensional adjustable cervical thoracic orthosis to a multi-modal program in the treatment of nonspecific neck pain: study protocol for a randomised pilot trial. Trials. 2019 Apr 29;20(1):248. doi: 10.1186/s13063-019-3337-0.