RCT of Addition of 3D Posture Corrective Orthosis to A Multimodal Program of Treatment Of Chronic Postural Neck Pain.

NCT04263883 | Unknown

• 1 other identifier: TJ-2019..
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Nonspecific neck pain (NSNP) is one of the most common musculoskeletal problems treated by orthopedic 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.Due to increased disability-adjusted life-years from 17 million (95% confidence interval (CI): 11.4-23.7) in 1990 to 29 million (95% CI: 19.5-40.5) in 2016, Chronic neck pain is a common musculoskeletal disorder worldwide. No specific cause for neck symptoms assigned for most patients so it described as non-specific chronic neck pain (NSNP)

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (2)

• Neck Disability Index, assessing change of disability of neck patients

  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 6 months.

• Three-dimensional posture parameters of the head in relation to thoracic measured by global posture system (GPS) device.assessing the change of posture of neck patients

  Postural translation of the head 1. Tx(mediolateral translation ) 2. Tz(anteroposterior translation ) Postural rotations of the 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)

  Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.

Secondary Outcomes (4)

• The Numeric Pain Rating Scale (NPRS)

  Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.

• Active cervical ROM using CROM

  Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.

• Zung Self-Rating Anxiety Scale (SAS)

  Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.

• Tampa Scale of Kinesiophobia (TSK)

  Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.

Other Outcomes (1)

• Global Perceived Effect Questionnaire (GPE)

  post treatment after 10 weeks , follow up after 6 months.

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Usual Care Group: Conventional treatment: moist hot pack. manual therapy, Therapeutic Exercise.Home program routine.

Device: Study or Experimental Group

Study or Experimental Group

EXPERIMENTAL

1. moist hot pack. 2. manual therapy. 3. Therapeutic Exercise. 4. Home program routine. 5.3D PCO to make mirror image therapy (reverse posture training) during the patient walking on motorized treadmill. For 10 weeks(3Times/week for 20 minutes).

Device: Study or Experimental Group

Interventions

Study or Experimental Group DEVICE

3D PCO to make mirror image therapy (reverse posture training) during the patient walking on motorized treadmill, This way of functional training will deliver via the use of the adjustable cervicothoracic orthosis during the patient walking at approximately 2-3 miles per hour on a standard, motorized treadmill. The brace will reverse the abnormal posture according to the 3D posture analysis data. To facilitate tissue remodeling by reverse posture training, this called mirror image traction.then the ambulatory exercises by using treadmill will be performed while the patient's mirror image posture will be held by the adjustable orthosis, ambulatory exercises for 20 minutes by using treadmill based on Harrison et al., approach, this program will be repeated 2-3 times /week for 10weeks.

Conventional treatment; Study or Experimental Group

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female subjects with age from 17-40 years old.
• Neck pain with equal or greater than 3/10 on a The Numeric Pain Rating Scale (NPRS) and the pain lasted more than 3 months (chronic neck pain).
• Participants with neck disability at least score on neck disability index (NDI) was 5 from the total score 50.
• Participants were included if they had posture deviations by screening test using GPS
• Posture displacements:
• An anterior head translation more than 2.5 cm.
• Side shifting of the head in related to thoracic more than .5 cm.
• Posture rotations:
• Rotation of head more than or equal three degrees.
• Side bending of the head more than or equal three degrees.
• Flexion or extension position of the head, normal angle 18 degrees, if more than that degree, it is meaning extension in upper cervical and if less means flexion in upper cervical. Participants included if they had at least two posture deviations whatever displacements or rotations. We included more obvious degrees or displacement of head posture related to thoracic to avoid variability of measurement between people and the posture deviations could be appeared and examined by visual examination.
• If subjects could be able to continue treatment for 10 weeks then for 3 months of follow up.
• If Participants accepted and signed an informed consent form.

You may not qualify if:

• If Participant reported any of the following conditions: Neck pain associated with whiplash injuries, medical red flag history(such as a tumor, fracture, metabolic diseases, rheumatoid arthritis, and osteoporosis).
• Neck pain with cervical radiculopathy, neck pain associated with externalized cervical disc herniation.
• Fibromyalgia syndrome, to avoid the similarity of fibromyalgia with an NP diagnosis, a physician used the criteria for the clinical diagnosis of fibromyalgia according to the American College of Rheumatology.
• If the patient made surgery in the neck area before whatever the cause of operation.
• Neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches.
• People were excluded if they were undergoing any type of pain treatment they have psychiatric disorders or other problems that contraindicate the use of the techniques in this study.
• If Participants reported any of the following conditions: (1) a history of cervical or facial trauma or surgery. (2) Congenital anomalies involving the spine (cervical, thoracic, lumbar). (3) Bony abnormalities such as scoliosis.(4) Any systemic arthritis. (5) Recurrent middle ear infections over the last5 years or any hearing impairment requiring the use of a hearing aid. (6)Persistent respiratory difficulties over the last 5 years that had necessitated absence from work, required long-term medication or interfered with daily activities. (7) Any visual impairment not corrected by glasses. (8) Any disorder of the central nervous system. (9) pregnancy or breastfeeding because these conditions affect head posture.
• Participants could be unable to attend a 10-week treatment program and follow-up as¬sessments after 3 months.

Sponsors & Collaborators

• Huang Xiaolin: lead

Study Sites (1)

TongjiHospital

Wuhan, Hubei, 432000, China

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaolin Huang, Professor

  Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Ahmed Youssef, PHD Student

CONTACT

0086 -13129937059; dr.ahmedsameer@pt.bsu.edu.eg

Xiaolin Huang, professor

CONTACT

8613871261957; xiaolinh2006@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor of Rehabilitation

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: February 11, 2020
• Study Start: January 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

CN (1)