Balance Amongst Patients With Lumbar Spinal Stenosis
ConditionLumbar Spinal Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorRegion Zealand
About this trial
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 patient balance 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 postural balance in elderly patients with LSS. Measurements of postural balance 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 balance 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients over 65 years of age referred to decompressive surgery for lumbar spinal stenosis
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Decompressive surgery
Procedure/SurgeryDecompressive lumbar spinal surgery
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Patients with lumbar spinal stenosis1 intervention
Trial outcomes
Primary outcomes
1
Postural balance
Postural balance, measured by sway area of center of pressure (mm\^2)
Time frame
Before surgery and 3, 6, 12 and 24 months after surgerySecondary outcomes
1
Postural balance
Postural balance measured by mean center of pressure velocity in the anterior-posterior and medio-lateral plane (mm\^2/s)
Time frame
Before surgery and 3, 6, 12 and 24 months after surgery2
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.
Time frame
Before surgery and 3, 6, 12 and 24 months after surgery3
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.
Time frame
Before surgery and 3, 6, 12 and 24 months after surgery4
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.
Time frame
Before surgery and 3, 6, 12 and 24 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Zealand
Lead sponsor
Region Syddanmark
Collaborator
Source ClinicalTrials.gov