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Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity. (ASD-QoL)

4. august 2026 opdateret af: Universitaire Ziekenhuizen KU Leuven

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

320

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fist corrective surgery
patients undergoing a first corrective surgery
Procedure: first corrective surgery
patients undergoing a first corrective surgery or reoperation for ASD
Eksperimentel: Reoperation
patients undergoing a reoperation
Procedure: Reoperation
patients undergoing a reoperation
Ingen indgriben: treated conservatively
patients who are treated conservatively

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cross-sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
Tidsramme: 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).
within a period of 2 year
Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
Tidsramme: 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.
Withing 2 years
Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
Tidsramme: Withing 2 years
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.
Withing 2 years
Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
Tidsramme: Withing 2 years
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.
Withing 2 years
Cross-sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.
Tidsramme: 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.
within a period of 2 year
Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.
Tidsramme: 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.
Withing 2 years
Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.
Tidsramme: Withing 2 years
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.
Withing 2 years
Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.
Tidsramme: Withing 2 years
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.
Withing 2 years
Cross-sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups.
Tidsramme: 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.
within a period of 2 year
Cross sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups.
Tidsramme: 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%)
Withing 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cross-sectional differences between conservative, primary surgery, and revision surgery groups.
Tidsramme: 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.
within a period of 2 year

Samarbejdspartnere og efterforskere

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Sponsor

Universitaire Ziekenhuizen KU Leuven

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. juli 2029

Studieafslutning (Anslået)

1. juli 2029

Datoer for studieregistrering

Først indsendt

14. juli 2026

Først indsendt, der opfyldte QC-kriterier

4. august 2026

Først opslået (Faktiske)

6. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S72384
  • Research chair IORT (Andet bevillings-/finansieringsnummer: Medtronic)

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