Neck PainNCT04263883
RCT of Addition of 3D Posture Corrective Orthosis to A Multimodal Program of Treatment Of Chronic Postural Neck Pain.
A study testing Study or Experimental Group in people with Neck Pain, run by Huang Xiaolin at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 40 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Study or Experimental Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TongjiHospital
Wuhan, Hubei, 432000
Xiaolin Huang, Professor, 8613871261957, xiaolinh2006@126.com
Ahmed Youssef, PHD Student, 0086 -13129937059, dr.ahmedsameer@pt.bsu.edu.eg
About this study
Official title: Randomized Control Trial of Addition of 3D Posture Corrective Orthosis to A Multimodal Program of Treatment Of NSNP.
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)
Read the detailed description
Although the exact relationship between posture and NSNP is unsettled, the posture of the cervical spine appears to influence dorsal neck muscle activity at rest and during movement. Additionally, the forward head posture associated with thoracic kyphosis indirectly affects cervical flexion and rotational range of motion (ROM) also sustained computer work and prolonged using smart phones often in positions that encourage a functional kyphosis, appears to modify neck posture, as well as scapular positioning and upper trapezius muscle activity. Besides that Ergonomic intervention, including adjustments of the workplace station and postural correction, have been demonstrated to be effective in reducing NP with some work conditions. In addition, modalities that used to correct sagittal alignment of the cervical spine proved statistical and clinically significant results related to pain, disability, and improved nerve function. That is accomplish cause and effect relationship between bad posture and neck symptoms. According to the systematic review of Anabela et al., about head posture assessment useful for neck patients or not? The answer, of course, was yes, but it must be considered in relation to the patient's symptoms and related functional problems. Harrison and his colleagues reported that posture abnormalities occurred in the head, ribs, and pelvis in three dimensions in the form of translations and rotational displacements. Therefore, we should consider three dimensional (3D)postural assessment and correction during the treatment of NSNP associated with significant posture problems of the head in relation to thoracic. Growing research about using mirror image traction during ambulatory exercise, which is prescribed specifically to help normalize the patient's neuromuscular dysfunction and postural deformation via reflecting the patient's posture across different planes, is more beneficial than a less personalized program. With these considerations in mind and to combine the findings of 3D postural assessment into the treatment program, we designed adjustable 3D posture corrective orthotic (PCO) 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 then ask the patient to make ambulatory exercise using a treadmill while the PCO holds the patient's reverse posture. To our knowledge, no randomized clinical trial (RCT) had evaluated the addition of a 3D adjustable PCO to usual care program and investigate its short- and moderate-term improvement effects on NSNP management outcomes (i.e., neck pain, neck disability and 3-dimensional posture parameters of the head). The primary aim of our study was to evaluate of conducting an RCT using neck disability index (NDI )and 3D posture parameters. The secondary aim was NPRS and Active CervicalROM. investigate the effect size of the addition of ambulatory mirror-image traction via the wearing of 3D adjustable PCO compared to control group interventions for neck pain, disability, and 3D posture parameters.
- Conditions
- Neck Pain
- Being tested
- Study or Experimental Group
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study or Experimental GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | Usual Care Group: Conventional treatment: moist hot pack. manual therapy, Therapeutic Exercise.Home program routine. Receives: 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). Receives: Device: Study or Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- Tx(mediolateral translation )
- 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)
Measured: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
Secondary outcomes (4)
The Numeric Pain Rating Scale (NPRS)
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 important difference in patients with chronic neck pain.
Measured: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
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, 72degrees 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).
Measured: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
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.
Measured: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
Tampa Scale of Kinesiophobia (TSK)
Kinesiophobia was assessed with the 13-item Chinese version of the Tampa Scale of Kinesiophobia (TSK)
Measured: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2020
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huang Xiaolin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huang Xiaolin, Tongji Hospital
- Investigators
- Xiaolin Huang, Professor, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263883
- Sponsor's protocol ID
- TJ-2019..
- Status last verified
- Sep 2020
- First submitted
- 8 Jan 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Addition of 3D Posture Corrective Orthosis to A Multimodal Program of Treatment Of NSNP.
- ClinicalTrials.gov ID
- NCT04263883
- Acronym / sponsor ID
- TJ-2019..
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Huang XiaolinUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Although the exact relationship between posture and NSNP is unsettled, the posture of the cervical spine appears to influence dorsal neck muscle activity at rest and during movement. Additionally, the forward head posture associated with thoracic kyphosis indirectly affects cervical flexion and rotational range of motion (ROM) also sustained computer work and prolonged using smart phones often in positions that encourage a functional kyphosis, appears to modify neck posture, as well as scapular positioning and upper trapezius muscle activity. Besides that Ergonomic intervention, including adjustments of the workplace station and postural correction, have been demonstrated to be effective in reducing NP with some work conditions. In addition, modalities that used to correct sagittal alignment of the cervical spine proved statistical and clinically significant results related to pain, disability, and improved nerve function. That is accomplish cause and effect relationship between bad posture and neck symptoms. According to the systematic review of Anabela et al., about head posture assessment useful for neck patients or not? The answer, of course, was yes, but it must be considered in relation to the patient's symptoms and related functional problems. Harrison and his colleagues reported that posture abnormalities occurred in the head, ribs, and pelvis in three dimensions in the form of translations and rotational displacements. Therefore, we should consider three dimensional (3D)postural assessment and correction during the treatment of NSNP associated with significant posture problems of the head in relation to thoracic. Growing research about using mirror image traction during ambulatory exercise, which is prescribed specifically to help normalize the patient's neuromuscular dysfunction and postural deformation via reflecting the patient's posture across different planes, is more beneficial than a less personalized program. With these considerations in mind and to combine the findings of 3D postural assessment into the treatment program, we designed adjustable 3D posture corrective orthotic (PCO) 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 then ask the patient to make ambulatory exercise using a treadmill while the PCO holds the patient's reverse posture. To our knowledge, no randomized clinical trial (RCT) had evaluated the addition of a 3D adjustable PCO to usual care program and investigate its short- and moderate-term improvement effects on NSNP management outcomes (i.e., neck pain, neck disability and 3-dimensional posture parameters of the head). The primary aim of our study was to evaluate of conducting an RCT using neck disability index (NDI )and 3D posture parameters. The secondary aim was NPRS and Active CervicalROM. investigate the effect size of the addition of ambulatory mirror-image traction via the wearing of 3D adjustable PCO compared to control group interventions for neck pain, disability, and 3D posture parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Device: Study or Experimental GroupUsual Care Group: Conventional treatment: moist hot pack. manual therapy, Therapeutic Exercise.Home program routine. |
| Study or Experimental Group | Experimental | Device: Study or Experimental Group1. 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). |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study or Experimental Group3D 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. | Device | Conventional treatment, Study or Experimental Group |
Primary outcome
Neck Disability Index, assessing change of disability of neck patients
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 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.
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
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
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)
4 secondary outcomes
The Numeric Pain Rating Scale (NPRS)
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
Active cervical ROM using CROM
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
Zung Self-Rating Anxiety Scale (SAS)
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
Tampa Scale of Kinesiophobia (TSK)
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaolin Huang, Professor study director
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study or Experimental Group in people with Neck Pain, run by Huang Xiaolin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Youssef, PHD Student (0086 -13129937059, dr.ahmedsameer@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index, assessing change of disability of neck patients (time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.