ASD, Scoliosis Idiopathic Adolescent, Scoliosis Idiopathic Adolescent Treatment
Conditions
Keywords
scoliosis, asd, QOL, quality of life
Brief 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. 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.
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.
Interventions
PROCEDUREfirst corrective surgery
patients undergoing a first corrective surgery or reoperation for ASD
PROCEDUREReoperation
patients undergoing a reoperation
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Age at inclusion 18 years or older. 3. Diagnosed with Adult spinal deformity 4. Planned routine management through one of the following pathways: 1. Conservative/non-operative management; 2. Primary ASD surgery; 3. Revision ASD surgery. 5. Ability to complete the Dutch-language questionnaire package.
Exclusion criteria
1. No valid informed consent. 2. 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. 3. Inability to complete the Dutch-language questionnaire package. 4. 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. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cross-sectional associations in QoL between conservative, primary surgery, and revision surgery study groups. | within a period of 2 year | 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). |
| Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups. | Withing 2 years | 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. |
| Cross-sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups. | within a period of 2 year | 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. |
| Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups. | Withing 2 years | 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. |
| Cross-sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups. | within a period of 2 year | 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. |
| Cross sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups. | Withing 2 years | 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%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cross-sectional differences between conservative, primary surgery, and revision surgery groups. | within a period of 2 year | 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. |
Countries
Belgium
Contacts
CONTACTLieven Moke, prof. dr.
Outcome results
None listed