ASDASD-QoLNCT07749534
Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity.
A study testing first corrective surgery and Reoperation in people with ASD and Scoliosis Idiopathic Adolescent, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This study examines which factors influence quality of life in adults with a spinal deformity. It looks at imaging findings together with pain, daily functioning, psychosocial factors, and frailty to support more person-centred care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASD, Scoliosis Idiopathic Adolescent, Scoliosis Idiopathic Adolescent Treatment
- What is being tested?
- first corrective surgery and Reoperation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Aug 2026to Jul 2029
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Age at inclusion 18 years or older.
- Diagnosed with Adult spinal deformity
- Planned routine management through one of the following pathways:
- Conservative/non-operative management;
- Primary ASD surgery;
- Revision ASD surgery.
- Ability to complete the Dutch-language questionnaire package.
Who cannot join
- No valid informed consent.
- Missing baseline structural imaging required for endpoint determination. We allow images to be older than 2 years if no new radiographs are obtained, in accordance with the ALARA principle.
- Inability to complete the Dutch-language questionnaire package.
- Known cognitive impairment, severe psychiatric condition, or other condition that, in the Investigator's judgement, precludes valid informed consent or reliable completion of study assessments.
- Primary spinal condition other than adult spinal deformity that is expected to invalidate endpoint assessment, including acute traumatic, infectious, tumour-related, or inflammatory spinal pathology as the main reason for presentation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3200
Lieven prf. Moke, prf. dr, 016338827, lieven.moke@uzleuven.be
About this study
This study examines which factors influence quality of life in adults with a spinal deformity. It looks at imaging findings together with pain, daily functioning, psychosocial factors, and frailty to support more person-centred care.
A total of 320 adults will participate in three groups: conservative treatment, first corrective surgery, or reoperation. All care follows standard practice; no experimental treatments are added. Participants complete questionnaires, and routine FASD tests and existing EOS/X-ray images may be used.
Follow-up lasts up to 2 years, with scheduled assessments depending on whether treatment is surgical or conservative.
Read the detailed description
This study investigates which factors are associated with quality of life in adults with a spinal deformity. Among patients with a comparable spinal alignment, pain, daily functioning, and quality of life can vary greatly. Therefore, the study examines not only the structural abnormality on medical imaging, but also pain, limitations in daily functioning, anxiety and low mood, fear of movement, concern about falling, participation in daily life, and overall frailty. The results may contribute to a more person-centred assessment and treatment of adults with a spinal deformity.
A total of 320 adults with a spinal deformity will be included. The study compares three groups: patients treated conservatively, patients undergoing a first corrective surgery, and patients undergoing a reoperation. Treatment is entirely determined by the regular care team; the study does not add any experimental intervention. Participants complete questionnaires on quality of life, back symptoms, functioning, and psychosocial well-being. Where applicable, the Function Assessment Scale for Spinal Deformity (FASD) is administered, a functional movement test that is part of standard care. Available EOS or X-ray images from routine care are used; no additional images are taken solely for the study.
Follow-up lasts up to 2 years. For surgically treated participants, assessments may take place at surgery and around 6 weeks, 4 months, 1 year, and 2 years post-operatively. Conservatively treated participants are assessed at baseline and, where appropriate within routine care, around 1 and 2 years.
- Being tested
- first corrective surgery, Reoperation
- Keywords
- scoliosis, asd, QOL, quality of life
- Medical subject headings
- Scoliosis, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first corrective surgeryProcedure or surgery
patients undergoing a first corrective surgery or reoperation for ASD
ReoperationProcedure or surgery
patients undergoing a reoperation
| Study group | Role | What they receive |
|---|---|---|
| Fist corrective surgery | Experimental | patients undergoing a first corrective surgery Receives: Procedure: first corrective surgery |
| Reoperation | Experimental | patients undergoing a reoperation Receives: Procedure: Reoperation |
| treated conservatively | No intervention | patients who are treated conservatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
QoL is measured using the SRS-22r questionnaire during screening visit, at 6-weeks, 4 months, 1 year and 2 year.For Scoliosis Research Society 22 Revised (SRS-22r) questionaire a patient reported measure of health related quality of life in individuals with scoliosis. PROM assessing five domains: Function/Activity, Pain, Self image/Appearance, Mental Health, Satisfaction with Management. The mean score is located between 5 (Best) and 1 (Worst).
Measured: within a period of 2 year
Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
QoL is measured using EQ-5D-5L questionnaire questionnaire during screening visit, at 6-weeks, 4 months, 1 year and 2 year The EuroQol 5 Dimension 5 Level(EQ-5D-5L) include 5-digit health profile: Mobility, Self Care, Usual Activities, Pain/Discomfort, Anxiety/Depression converting it to an index value using the country-specific value set (range -0.59 to 1.0). EQ-5D-5L score expresses health status as a utility value ranging from <0 (worse than death) to 1 (full health). Higher values indicate better overall health.
Measured: Withing 2 years
Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
QoL is measured using VAS questionnaire during screening visit, at 6-weeks, 4 months, 1 year and 2 year The Visual Anlog Score (VAS) - ranges from 0 to 100, where 0 means "worst imaginable health" and 100 means "best imaginable health." A higher VAS score reflects better self perceived health.
Measured: Withing 2 years
Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
QoL in non-revision ASD patients, adjusted for structural deformity severity, demographic characteristics, treatment pathway, and frailty-related health status. Structural covariates include Sagittal Vertical Axis(SVA), Pelvic tilt(PT), Pelvic incidence-lumbar lordosis mismatch (PI-LL) mismatch, and coronal Cobb angle. Frailty-related health status will be measured using the mFI-5. The modified 5-item frailty index (mFI-5) which assesses five clinical deficits: diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disease, and functional dependence. Each deficit is scored as 0 (absent) or 1 (present). The unit of measure is the total frailty score ranging from 0 to 5, where higher scores indicate greater frailty.
Measured: Withing 2 years
Cross-sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.
Measures include HADS during screening visit, at 6-weeks, 4 months, 1 year and 2 year. Hospital Anxiety and Depression Scale (HADS) a validated 14 item self report questionnaire assessing symptoms of anxiety and depression. Each item is scored on a 0-3 Likert scale, and the unit of measure is the subscale total score for Anxiety (HADS A, range 0-21) and Depression (HADS D, range 0-21). Higher scores indicate more severe symptoms.
Measured: within a period of 2 year
Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.
Measures include FABQ-DV during screening visit, at 6-weeks, 4 months, 1 year and 2 year. Fear Avoidance Beliefs Questionnaire - Dutch Version( FABQ-DV) validated self report instrument assessing fear avoidance beliefs related to physical activity and work. The questionnaire contains items scored on a Likert scale from 0 to 6, where higher scores indicate stronger fear avoidance beliefs. The unit of measure is the total score per subscale (Physical Activity and Work), each expressed as the sum of item scores, with higher totals reflecting greater fear avoidance.
Measured: Withing 2 years
Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.
Measures include FES-I during screening visit, at 6-weeks, 4 months, 1 year and 2 year. Falls Efficacy Scale - International (FES-I) a validated self report questionnaire assessing fear of falling during everyday activities. The instrument contains 16 items, each scored on a 4 point Likert scale (1-4). The unit of measure is the total score ranging from 16 to 64, where higher scores indicate greater fear of falling.
Measured: Withing 2 years
Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.
Measures include IPA during screening visit, at 6-weeks, 4 months, 1 year and 2 year. Impact on Participation and Autonomy Questionnaire (IPA) a validated self report instrument assessing perceived participation restrictions and autonomy in daily life. The questionnaire contains multiple domains (e.g., Autonomy Indoors, Autonomy Outdoors, Social Life, Family Role, Work/Education), with items scored on a Likert scale from 0 to 4. The unit of measure is the domain score, expressed as the mean or sum of item scores, where higher scores indicate greater perceived limitations in participation and autonomy.
Measured: Withing 2 years
Cross-sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups.
Measures include FASD. Function Assessment scale for Spinal Deformity (FASD) contains 14 items across three subscales: spinal balance/mobility, stability limits/sensory integration, and ADL/gait. Each is graded on an ordinal 3- or 4-point scale. The maximum total score is 56; higher numbers represent better functional performance.
Measured: within a period of 2 year
Cross sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups.
Measures include ODI. Oswestry Disability Index (ODI) summerise the points from all 10 completed sections like pain intensity, lifting, and walking (each scored from 0 (least disability) to 5 (severe disability). Score is reported as a percentage from 0% to 100% that measures functional impairment from low back pain, divided into five standard ranges: minimal disability (0-20%), moderate disability (21-40%), severe disability (41-60%), crippled (61-80%), and bed-bound or exaggerating symptoms (81-100%)
Measured: Withing 2 years
Secondary outcomes (1)
Cross-sectional differences between conservative, primary surgery, and revision surgery groups.
Cross-sectional differences between conservative, primary surgery, and revision surgery groups in QoL, psychosocial burden, functional impairment, structural deformity severity, spine-specific symptom burden, and frailty-related health status. Longitudinal within-patient changes across repeated routine-care follow-up timepoints in SRS-22r, EQ-5D-5L, HADS, FABQ-DV, FES-I, IPA, FASD, ODI, COMI, SVA, PT, PI-LL mismatch, coronal Cobb angle, and mFI-5. The use of these scales is already described in the primary outcomes.
Measured: within a period of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start28 Aug 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749534
- Sponsor's protocol ID
- S72384
- Other IDs
- Research chair IORT
- Acronym
- ASD-QoL
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided