Scoliosis IdiopathicNCT06512038
The Use of DXA in Scoliosis
A study testing DEXA Scan in people with Scoliosis Idiopathic, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a pilot study to look at image quality of iDXA AP supine spinal images to see if the investigators can accurately measure the size of the curve from iDXA images and to see how patients with scoliosis feel about iDXA imaging compared to normal x-rays. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- DEXA Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with Adolescent Idiopathic Scoliosis (AIS, aged 10-16 years) or Juvenile Idiopathic Scoliosis (JIS, aged 4-9 years) having an x-ray to look for curve progression OR to guide design of a new brace.
- Patients with quadriplegic Cerebral Palsy (CP) having an x-ray to look for curve progression. Within the age range for inclusion for patients with CP, the recruiting clinician will make a clinical judgement on whether the patient is able to lie still long enough to undertake the iDXA, before inviting the patient to take part.
Who cannot join
- Parents unable to understand the study procedures.
- Patients unable to lie still for 1-2 minutes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, S10 2TH
About this study
Official title: A Pilot Study of the Use of Dual-Energy X-ray Absorptiometry (DXA) in Scoliosis
This is a pilot study to look at image quality of iDXA AP supine spinal images to see if the investigators can accurately measure the size of the curve from iDXA images and to see how patients with scoliosis feel about iDXA imaging compared to normal x-rays. With normal x-rays being taken standing (or sitting if patients are in a wheelchair), it is important that the investigators understand how the lying down images compare to the standing images. Where there may be some clinical benefit, images will be taken standing (normal x-rays) and lying down (iDXA images). The investigators will see if the addition of iDXA images can help in brace design and brace monitoring.
Read the detailed description
This pilot study is an interventional study where patients having routine standing or sitting spinal x-rays for scoliosis monitoring or as part of a treatment protocol will be approached to see if they would have an additional supine AP DXA image. Participants will only have one additional DXA image during the pilot study. The consent will be obtained by one of the spinal surgeons or a specialist spinal nurse. The DXA scan will be performed by one of the radiographers. This study may be performed by a medical student or junior doctor (either would be part of the care team) and supervised by the PI.
The pilot study is expected to last 9 months and consist of 25 patients. The DXA images will be reviewed by 2 consultant spinal surgeons and a consultant radiologist who will make a collective decision every month as to whether the study, or that part of the study, should continue.
Two scoliosis patients have read the study protocol and given their input. The Sheffield Children's Hospital Scoliosis PPI group will feedback on key aspects during the study and help define future studies suggested by this study.
- Conditions
- Scoliosis Idiopathic
- Being tested
- DEXA Scan
- Keywords
- scoliosis, Juvenile Scoliosis, Adolescent Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA ScanRadiation
If the participant consents to take part in the trial, they will have an additional DEXA scan.
| Study group | Role | What they receive |
|---|---|---|
| ADDITIONAL DEXA SCAN | Other | There is only 1 arm on this trial, if a participant agrees to take part they will have additional DEXA radiograph. Receives: Radiation: DEXA Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Dosage
DXA in comparison to X-Ray
Measured: Through study completion, an average of 6 months
Patient Satisfaction Questionnaire about the use of DXA in Scoliosis
This will be self reported questionnaire completed by patients. They will use a simple pictorial scale to report about their experiences having both a DXA and X-ray. The Scale ranges from 'Very Uncomfortable/ very unacceptable', 'Uncomfortable / unacceptable' to 'Okay'.
Measured: through study completion, an average of 6 months
DXA Image Quality
Image quality as judged by 2 spinal surgeons and a consultant radiologist on a 4 point scale as:
- Excellent - almost as good as an x-ray
- Good - Good quality and easily able to see required anatomical landmarks for measurement
- Adequate - Poor quality but just able to see required anatomical landmarks for measurement
- Poor - Unable to see required anatomical landmarks for measurement
Measured: Through study completion, an average of 6 months
Imaging Angles
Cobb angle, apical vertebral translation and apical vertebral rotation will be measured from the x-rays and DXA scans for all the curves
Measured: Through study completion, an average of 6 months
Beighton Score for joint flexibility
Beighton score (flexibility) will be recorded by a clinician for all the patients with idiopathic scoliosis. The score will evaluate each patient's:
- Passive dorsiflexion and hyperextension of the fifth MCP joint beyond 90°
- Passive apposition of the thumb to the flexor aspect of the forearm
- Passive hyperextension of the elbow beyond 10°
- Passive hyperextension of the knee beyond 10°
- Active forward flexion of the trunk with the knees fully extended so that the palms of the hands rest flat on the floor
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start8 May 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512038
- Sponsor's protocol ID
- 335664
- Status last verified
- Apr 2026
- First submitted
- 8 May 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Use of Dual-Energy X-ray Absorptiometry (DXA) in Scoliosis
- ClinicalTrials.gov ID
- NCT06512038
- Acronym / sponsor ID
- 335664
- Conditions
- Scoliosis Idiopathic
- Keywords
- scoliosis, Juvenile Scoliosis, Adolescent Scoliosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 22 Jul 2024 (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.
This is a pilot study to look at image quality of iDXA AP supine spinal images to see if the investigators can accurately measure the size of the curve from iDXA images and to see how patients with scoliosis feel about iDXA imaging compared to normal x-rays. With normal x-rays being taken standing (or sitting if patients are in a wheelchair), it is important that the investigators understand how the lying down images compare to the standing images. Where there may be some clinical benefit, images will be taken standing (normal x-rays) and lying down (iDXA images). The investigators will see if the addition of iDXA images can help in brace design and brace monitoring.
Detailed description
This pilot study is an interventional study where patients having routine standing or sitting spinal x-rays for scoliosis monitoring or as part of a treatment protocol will be approached to see if they would have an additional supine AP DXA image. Participants will only have one additional DXA image during the pilot study. The consent will be obtained by one of the spinal surgeons or a specialist spinal nurse. The DXA scan will be performed by one of the radiographers. This study may be performed by a medical student or junior doctor (either would be part of the care team) and supervised by the PI.
The pilot study is expected to last 9 months and consist of 25 patients. The DXA images will be reviewed by 2 consultant spinal surgeons and a consultant radiologist who will make a collective decision every month as to whether the study, or that part of the study, should continue.
Two scoliosis patients have read the study protocol and given their input. The Sheffield Children's Hospital Scoliosis PPI group will feedback on key aspects during the study and help define future studies suggested by this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADDITIONAL DEXA SCAN | Other | Radiation: DEXA ScanThere is only 1 arm on this trial, if a participant agrees to take part they will have additional DEXA radiograph. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with Adolescent Idiopathic Scoliosis (AIS, aged 10-16 years) or Juvenile Idiopathic Scoliosis (JIS, aged 4-9 years) having an x-ray to look for curve progression OR to guide design of a new brace.
- Patients with quadriplegic Cerebral Palsy (CP) having an x-ray to look for curve progression. Within the age range for inclusion for patients with CP, the recruiting clinician will make a clinical judgement on whether the patient is able to lie still long enough to undertake the iDXA, before inviting the patient to take part.
Key exclusion criteria (2 listed)
- Parents unable to understand the study procedures.
- Patients unable to lie still for 1-2 minutes
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 |
|---|---|---|
| DEXA ScanIf the participant consents to take part in the trial, they will have an additional DEXA scan. | Radiation | ADDITIONAL DEXA SCAN |
Primary outcome
Radiation Dosage
Time frame: Through study completion, an average of 6 months
DXA in comparison to X-Ray
Patient Satisfaction Questionnaire about the use of DXA in Scoliosis
Time frame: through study completion, an average of 6 months
This will be self reported questionnaire completed by patients. They will use a simple pictorial scale to report about their experiences having both a DXA and X-ray. The Scale ranges from 'Very Uncomfortable/ very unacceptable', 'Uncomfortable / unacceptable' to 'Okay'.
DXA Image Quality
Time frame: Through study completion, an average of 6 months
Image quality as judged by 2 spinal surgeons and a consultant radiologist on a 4 point scale as: 1. Excellent - almost as good as an x-ray 2. Good - Good quality and easily able to see required anatomical landmarks for measurement 3. Adequate - Poor quality but just able to see required anatomical landmarks for measurement 4. Poor - Unable to see required anatomical landmarks for measurement
Imaging Angles
Time frame: Through study completion, an average of 6 months
Cobb angle, apical vertebral translation and apical vertebral rotation will be measured from the x-rays and DXA scans for all the curves
Beighton Score for joint flexibility
Time frame: Through study completion, an average of 6 months
Beighton score (flexibility) will be recorded by a clinician for all the patients with idiopathic scoliosis. The score will evaluate each patient's: * Passive dorsiflexion and hyperextension of the fifth MCP joint beyond 90° * Passive apposition of the thumb to the flexor aspect of the forearm * Passive hyperextension of the elbow beyond 10° * Passive hyperextension of the knee beyond 10° * Active forward flexion of the trunk with the knees fully extended so that the palms of the hands rest flat on the floor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEXA Scan in people with Scoliosis Idiopathic, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Radiation Dosage (time frame: Through study completion, an average of 6 months). The study lists 5 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 20 Apr 2026.