Neck Pain Clinical Trial
Official title:
Addition of 3D Posture Corrective Orthosis To A Multimodal Program In The Treatment Of Nonspecific Neck Pain. A Randomized Pilot Trial.
Verified date | December 2019 |
Source | Tongji Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | November 5, 2019 |
Est. primary completion date | November 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Tongji Medical College | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | questionnaire to assess Feasibility. | Feasibility to assess feasibility of conducting future RCT. | Pre treatment at 1st day , post treatment after 10 weeks . | |
Secondary | The Numeric Pain Rating Scale | 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. | Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. | |
Secondary | Neck Disability Index, Assess change of neck disability at baseline, after 10 weeks treatment and after 3 months follow up. | 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. |
Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. | |
Secondary | Three-dimensional posture parameters measured by GPS device. Assess change of posture parameters before, after treatment 10 weeks and after follow up 3 months. | Postural translation of head Tx(medio lateral translation ) Tz(antero posterior translation ) Postural rotations of head Rx(flexion or extension position) Ry (r.t rot. Or l.t rot.) RZ (r.t side bending or l.t side bending) |
Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. | |
Secondary | Active cervical ROM using CROM. | 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). |
Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. | |
Secondary | Zung Self-Rating Anxiety Scale (SAS) | 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. | Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. | |
Secondary | Zung Self-Rating Depression Scale (SDS) | 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. | Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months. |
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