Lumbar Spinal Stenosis Clinical Trial
— B-ATLASOfficial title:
Activity Levels Amongst Elderly Patients With Symptomatic Lumbar Spinal Stenosis Before and After Decompressive Surgery
Lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, with symptoms including low back pain which worsens with ambulation, poor balance, decreased activity due to pain, and a marked decrease in quality of life (QoL). Prevalence rises with age, and current treatment options range from varied conservative management strategies, to surgical intervention with decompression of neural structures. While the effects of surgical decompression on back pain and QoL has been widely researched, the effects of surgery on activity levels is less well understood. Though patients generally have subjective improvements in this parameter after surgery, objective measurements in this patient group have been lacking. This study aims to investigate the effects of decompressive surgery on activity levels in elderly patients with LSS. Measurements of activity will be taken before and after decompressive surgery, as well as with regular intervals during a two-year follow-up period. A better understanding of the effect that LSS has on activity may lead to more patients being able to receive surgical treatment, which is hypothesized to lead to an increase in QoL and less perceived disability amongst this patient group.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | April 2028 |
Est. primary completion date | August 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Age = 65 years - Referred to decompressive spinal surgery due to symptomatic lumbar spinal stenosis at = 1 level - Central canal LSS grade B or C (Schizas classification) at = 1 level by Magnetic Resonance Imaging - Minimum of 3 months of unsuccessful non-operative treatment Exclusion Criteria: - Signs of malignancy or infection in the spinal column - Severe comorbidities incl. neurodegenerative conditions which may contribute to balance problems - Revision surgery (previous decompression surgery at the same vertebral level) - Spinal surgery up to 1 year prior to the date of inclusion - Mini Mental State Exam (MMSE) score of = 27 points - Degenerative spondylolisthesis more than 3mm on pre-operative imaging diagnostics |
Country | Name | City | State |
---|---|---|---|
Denmark | Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge | Køge | |
Denmark | Rygcenter Syddanmark, Middelfart Sygehus | Middelfart |
Lead Sponsor | Collaborator |
---|---|
Region Zealand | Region Syddanmark |
Denmark,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Activity level | Activity level, measured by total activity counts per day (TAC/d) | Before surgery and 3, 6, 12 and 24 months after surgery | |
Secondary | Physical activity | Physical activity, measured by time spent in MVPA (minutes/day) | Before surgery and 3, 6, 12 and 24 months after surgery | |
Secondary | Physical activity | Physical activity, measured by physical activity energy expenditure (PAEE) (Kilojoules/d) | Before surgery and 3, 6, 12 and 24 months after surgery | |
Secondary | Physical inactivity | Physical inactivity, measured by sedentary time (hours/d) | Before surgery and 3, 6, 12 and 24 months after surgery | |
Secondary | Quality of life | Subjective QoL, measured by European Quality of Life - 5 Dimensions score (EQ-5D) The EQ-5D consists of six questions regarding current perceived health status and quality of life.
Questions 1 - 5 have a range of 1 to 3, lower is better. The answer to questions 6 is given on a scale of 0 to 100, where lower is better. |
Before surgery and 3, 6, 12 and 24 months after surgery | |
Secondary | Functional disability | Subjective functional disability, measured by Zurich Claudication Questionnaire score (ZCQ) The ZCQ consists of 12 questions for all patients, and a further six questions for patients who have received treatment.
The questionnaire is divided into three subscales: Symptom severity scale (questions 1 - 7): range of the score is 1 to 5, lower is better. Physical function scale (questions 8 - 12): range of the score is 1 to 4, lower is better. Satisfaction with treatment scale (questions 13 - 18): range of the score is 1 to 4, lower is better. |
Before surgery and 3, 6, 12 and 24 months after surgery | |
Secondary | Self-reported activity | Self-reported activity, measured by International Physical Activity Questionnaire - Short Form score (IPAQ-SF) The IPAQ-SF is a short form health survey consisting of 4 questions relating to self-reported physical activity during the last week.
Each question asks the participant to note how many days during the past week that they carried out vigorous, moderate, light, or sedentary activity. If the number of days is greater or equal to 1, the participant is asked to estimate the amount of hours and minutes they have spent doing that activity. |
Before surgery and 3, 6, 12 and 24 months after surgery | |
Secondary | Quality of life | Subjective Quality-of-life, measured by the Short Form Health Survey (SF-36). The SF-36 is a short form questionnaire concerning patients perceived health and quality-of-life (QoL). It consists of 36 questions regarding various aspects of the patients health status, including current and past perceived physical and mental health, and subjective physical function.
Questions 1,2 and 20 - 22 each have a range of 1 to 5, lower is better. Question 32 likewise has a range of 1 - 5, though where higher is better. Questions 3 - 12 have a range of 1 - 3, higher is better. Questions 13 - 19 have a range of 1 - 2, higher is better. Questions 23 - 31 and 33 - 36 have a range of 1 - 5. The better score depends on the specific question. |
Before surgery and 3, 6, 12 and 24 months after surgery |
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