Addition of 3D Posture Corrective Orthosis to A Multimodal Program of Treatment Of NSNP.

NCT03331120 | Completed

• 1 other identifier: TJ-2017
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

Neck pain; Ambulatory; Orthotic

Outcome Measures

Primary Outcomes (1)

• questionnaire to assess Feasibility.

  Feasibility to assess feasibility of conducting future RCT.

  Pre treatment at 1st day , post treatment after 10 weeks .

Secondary Outcomes (6)

• The Numeric Pain Rating Scale

  Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.

• 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.

• 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.

• 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.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

1--Control group . Conventional treatment: 1. moist hot pack. 2. manual therapy. 3. Therapeutic Exercise. 4. Home program routine.

Device: ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)

Study or Experimental Group

EXPERIMENTAL

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).

Device: ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)

Interventions

ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO) DEVICE

Ambulatory a mirror image functional re-training This way of functional training will deliver via the use of adjustable cervicothoracic orthosis with 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 exercise.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 and Hawes et al., approach, this program will be repeated 3 Times /week for 10 weeks.

Also known as: moist hot pack, manual therapy, Therapeutic exercise, Home program routine

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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Medical College

Wuhan, Hubei, 432000, China

Location

Related Publications (1)

• 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.

  PMID: 31036033 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal Manipulations; Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Xiaolin Huang, Professor

  Tongji Hospital

  STUDY DIRECTOR

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: PRINCIPAL INVESTIGATOR
• PI Title: 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.

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: November 6, 2017
• Study Start: December 1, 2017
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

CN (1)