Neck PainNCT03331120
Addition of 3D Posture Corrective Orthosis to A Multimodal Program of Treatment Of NSNP.
A study testing ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO) in people with Neck Pain, run by Tongji Hospital at 1 site in China.
Trial 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. 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?
- ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 5 Nov 2019
- 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 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
Who cannot join
- 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]
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of 3D Posture Corrective Orthosis To A Multimodal Program In The Treatment Of Nonspecific Neck Pain. A Randomized Pilot Trial.
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)
- Keywords
- Neck pain, Ambulatory, Orthotic
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)Device
Also called moist hot pack, manual therapy, Therapeutic exercise, Home program routine
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 1--Control group
. Conventional treatment:
1. moist hot pack.
2. manual therapy.
3. Therapeutic Exercise.
4. Home program routine. Receives: 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). Receives: Device: ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire to assess Feasibility.
Feasibility to assess feasibility of conducting future RCT.
Measured: Pre treatment at 1st day , post treatment after 10 weeks .
Secondary outcomes (6)
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.
Measured: 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.
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 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.
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)
Measured: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 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, 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).
Measured: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 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 3 months.
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.
Measured: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Dec 2017
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samir Abdelkhalik Youssef, Tongji Hospital
- Investigators
- Xiaolin Huang, Professor, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331120
- Sponsor's protocol ID
- TJ-2017
- Status last verified
- Dec 2019
- First submitted
- 22 Oct 2017
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it is according to the opinion of my supervisor and also for the honesty of patients data as ethics it is not good to share its data in public. so we will see this issue at the end of study/
Publications
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.
PubMed 31036033
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of 3D Posture Corrective Orthosis To A Multimodal Program In The Treatment Of Nonspecific Neck Pain. A Randomized Pilot Trial.
- ClinicalTrials.gov ID
- NCT03331120
- Acronym / sponsor ID
- TJ-2017
- Conditions
- Neck Pain
- Keywords
- Neck pain, Ambulatory, Orthotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 6 Nov 2017 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)1--Control group . Conventional treatment: 1. moist hot pack. 2. manual therapy. 3. Therapeutic Exercise. 4. Home program routine. |
| Study or Experimental Group | Experimental | Device: ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)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). |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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]
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 |
|---|---|---|
| ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)Also: moist hot pack, manual therapy, Therapeutic exercise, Home program routineAmbulatory 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. | Device | Control Group, Study or Experimental Group |
Primary outcome
questionnaire to assess Feasibility.
Time frame: Pre treatment at 1st day , post treatment after 10 weeks .
Feasibility to assess feasibility of conducting future RCT.
6 secondary outcomes
The Numeric Pain Rating Scale
Time frame: 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.
Time frame: 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.
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
Active cervical ROM using CROM.
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
Zung Self-Rating Anxiety Scale (SAS)
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
Zung Self-Rating Depression Scale (SDS)
Time frame: Pre treatment at 1st day , post treatment after 10 weeks , follow up after 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Derived from this study: PubMed 31036033Youssef 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.
- Individual participant dataSharing planned: Undecided. it is according to the opinion of my supervisor and also for the honesty of patients data as ethics it is not good to share its data in public. so we will see this issue at the end of study/
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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 ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO) in people with Neck Pain, run by Tongji Hospital 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 17 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire to assess Feasibility. (time frame: Pre treatment at 1st day , post treatment after 10 weeks .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331120, which also lists 1 linked publication.
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 17 Dec 2019.