Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Cross-sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Fist corrective surgery
patients undergoing a first corrective surgery
干预措施: first corrective surgery (Procedure)
Reoperation
patients undergoing a reoperation
干预措施: Reoperation (Procedure)
treated conservatively
patients who are treated conservatively
结局指标
主要结局
Cross-sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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%)
次要结局
- Cross-sectional differences between conservative, primary surgery, and revision surgery groups.(within a period of 2 year)