Lumbar Spinal StenosisB-ATLASNCT06075862
Balance Amongst Patients With Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by Region Zealand at 2 sites in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Decompressive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesDenmark
- Study dates
- 21 Sep 2023to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 65 years of age referred to decompressive surgery for lumbar spinal stenosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge
Køge, 4600
Oliver B Zielinski, MD, +4593931049, oliver@bremerskov.dk
- Recruiting
Rygcenter Syddanmark, Middelfart Sygehus
Middelfart, 5500
Mikkel Ø Andersen, MD, mikkel.andersen.2@rsyd.dk
About this study
Official title: Postural Imbalance 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 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.
Read more
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.
Read the detailed description
Disease Background:
While lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, there is no universally accepted definition of LSS, and no accepted radiologic diagnostic criteria. LSS most often refers to a narrowing in the central canal of the vertebrae, the lateral recess, or the neural foramen. Changes to these can occur due to acquired degenerative spondylosis or spondylolisthesis, or more rarely due to conditions such as ankylosing spondylitis and space-occupying lesions, or congenital abnormalities. LSS can be classified according to anatomical location, etiology or severity of narrowing, though no validated classification has been published.
The lack of concrete definition has caused difficulties in estimating the prevalence of LSS. Studies using community-based sampling has shown a prevalence of acquired LSS, defined as a narrowing of the central canal to ≤ 10mm in the anterior-posterior direction, of 7.3%. The prevalence has been shown to rise with age, from 4.0% affected at < 40 years of age, to 14.3% amongst patients ≥ 60. No significant differences have been observed in overall prevalence according to gender, although there seems to be a slightly higher prevalence amongst elderly females than males.
Although LSS is often asymptomatic, common symptoms of LSS include low back pain, which worsens with prolonged ambulation, lumbar extension and standing, and which is relieved by rest and forward flexion, as well as lumbar radiculopathy. Patients may also complain of poor balance, and physical examination findings may include a wide-based gait and abnormal Romberg results. Symptoms are thought to occur due to compression of microvascular structures in the nerves, allowing for neural ischemia and defects in nerve conduction, and venous pooling resulting in inadequate oxygenation and metabolite accumulation.
Current treatment options for LSS range across both conservative and surgical management strategies. Conservative management has traditionally been regarded as first-line treatment, with a combination approach of physical therapy and pharmacological treatment with NSAIDs and analgesics. Epidural steroid injections have been used for symptom management, though with limited short and long-term benefits. Surgical management is often indicated in patients with ongoing pain despite attempts at conservative management for 3-6 months. Choice of surgical strategy to relieve the pressure on the neural structures depends on the anatomical location of stenosis and number of stenotic segments, as well as the intraoperative assessment of stability.
The effect of surgical decompression on disability, leg pain and back pain has been widely evaluated, but studies of the effect on postural control are sparse. The present study aims to investigate the effect of surgical decompression of symptomatic lumbar spinal stenosis on postural control by assessment of sway measures before and after surgery.
Postural Balance:
Mechanical balance is defined according to Newton's first law, stating that an object is at equilibrium (balanced) when the forces acting upon it are zero. When considering the balance of an object, the objects centre of gravity (COG) and its base of support (BOS) must be examined. For an object to remain balanced, a vertical line drawn from the COG to the objects BOS, the point of intersection defined as the centre of pressure (COP), must lie within the objects BOS. When the COP goes beyond the BOS, objects become unbalanced and may topple. If in a state of imbalance, humans and animals have physiological compensatory mechanisms to ensure that their COP returns to lie within their BOS. The act of keeping the COP within the BOS is what is intuitively know as human balance.
No central definition of postural balance exists, but a widely cited definition is 'the act of maintaining, achieving or restoring a state of balance during any posture or activity'. Postural balance has previously been considered a summation of postural reflexes alongside sensory feedback mechanisms, with a single neural circuit system integrating somatosensory, vestibular, and visual systems to maintain equilibrium. However, efforts have been made to move away from this viewpoint, and the act of postural balance is now seen as an independent motor skill, incorporating complex physiological mechanisms as well as high-level somatosensory information processing, influenced by individual body schema and personal cognitive elements. Maintaining postural balance is now seen as a summation of two simultaneous and overlapping systems; one to control posture through tonic muscle activity, and one to maintain equilibrium when exposed to internal and external perturbations. Balance is hereby maintained using skeletal muscle with both phasic and tonic activity, with signals originating from distinct neural circuits including from the brain stem, cerebellum, motor cortex etc.
As of writing, no gold standard exists to measure balance, which has allowed a wide variety of techniques to be developed to measure postural balance skills amongst patients, and variables associated with postural control, either through instrumented or non-instrumented tests. Regarding the latter, expert consensus points to the use of the Berg Balance Scale or the Mini Balance Evaluation Systems Test when measuring postural balance in adult populations. However, while non-instrumented tests can give a gross indicator of postural balance, there exists a need for more granular analysis, which can be achieved using instrumented tests. The force platform remains the most widely used device for this purpose, allowing for the quantification of positional and dynamic variables associated with COP position, displacement, and trajectory.
The causes of imbalance are many. Any deficit or pathology relating to somatosensory, motor control or cognitive systems associated with postural control can lead to postural imbalance, including a wide range of pathological conditions such as visuo-vestibular and neurodegenerative diseases, as well as orthopaedic and rheumatological diseases of the musculoskeletal system. While aging itself does not seem to be an independent risk factor for postural imbalance, age-related changes in physiology have been linked to degeneration in postural imbalance, including decreased visual acuity, somatosensory loss, vestibular dysfunction, lower extremity muscle weakness and cognitive impairment.
As mentioned, objects which become unbalanced due to COP dislocation beyond the objects BOS may fall. Balance impairment, measured by dynamic variables using force plates as well as non-instrumental tests, have been shown to be predictors of falls amongst elderly. Falls represent a large healthcare burden, having serious risk of related injury, rising prevalence with age and being a significant cause of mortality amongst elderly. Furthermore, falls have been shown to be an independent risk factor of functional decline. As such, fall prevention is a topic of both national and international interest.
Spinal stenosis has shown to be a risk factor for both postural imbalance as well as a risk factor for falls. Previous studies have made efforts to quantify the effects of decompressive surgery on postural imbalance, though have remained limited by number of patients and short follow-up regimes, as well as lacking correlation between measurements of postural imbalance and risk of falls.
Wii Balance Board:
The Wii Balance Board (WBB), first released in 2007, has gained popularity as a low-cost, portable force-plate transducer, to use in postural balance assessment. It contains four transducers used to measure COP, as well as a scale to measure weight, and was originally used as a video game controller for the game WiiFit. Although capable of providing an intrinsic WiiFit Stillness score, this has shown limited usability in previous studies. However, using custom software, the WBB has been extensively validated against 'gold standard' laboratory-grade force plates, and shown to have good within-device and between-device reliability, as well as being a valid tool to measure balance amongst older adults. Work has been done to ensure that the WBB can be calibrated to minimize measurement error, and open-source algorithms exist for the calculation of positional and dynamic variables recorded by the WBB. While not recommended for clinical diagnostic measurements, the use of the WBB in longitudinal monitoring for research purposes remains viable.
Rationale of the study:
This study will be the first to correlate the effects of decompressive surgery in patients with symptomatic LSS with postural balance, and associated quality of life increases. Previous studies have been hampered by low power due to sampling size limitations, and short follow-up regimes, both of which is sought to be managed through multi-centre collaboration and inclusion, and a follow-up regime spanning two years from the time of surgery.
It is expected that the results of this study can facilitate an increased understanding of the role of postural balance when considering surgical management of symptomatic LSS patients, as well as enable targeted treatment of patients with postural imbalance and LSS.
Research question:
Do elderly patients with symptomatic LSS, who have undergone decompressive surgery, show an improvement in postural balance compared to pre-operative values?
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Decompressive surgery
- Keywords
- Spinal stenosis, Elderly, Balance, Surgery
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive surgeryProcedure or surgery
Decompressive lumbar spinal surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with lumbar spinal stenosis | Patients diagnosed with lumbar spinal stenosis and referred to operation. Balance will be measured once in this group before operation, and four times again after operation. Receives: Procedure: Decompressive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural balance
Postural balance, measured by sway area of center of pressure (mm^2)
Measured: Before surgery and 3, 6, 12 and 24 months after surgery
Secondary outcomes (4)
Postural balance
Postural balance measured by mean center of pressure velocity in the anterior-posterior and medio-lateral plane (mm^2/s)
Measured: Before surgery and 3, 6, 12 and 24 months after surgery
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.
Measured: Before surgery and 3, 6, 12 and 24 months after surgery
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.
Measured: Before surgery and 3, 6, 12 and 24 months after surgery
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.
Measured: Before surgery and 3, 6, 12 and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start21 Sep 2023
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Region Syddanmark
- Responsible party
- Principal investigator, Oliver Bremerskov Zielinski, Region Zealand
- Investigators
- Oliver B Zielinski, MD, Principal investigator, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075862
- Sponsor's protocol ID
- B-ATLAS1
- Other IDs
- 010-0194/22-3000
- Acronym
- B-ATLAS
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified individual participant data collected during the trial will be made available to researchers who provide a methodologically sound proposal for use, subject to approval by the study authors.
Publications
Binder DK, Schmidt MH, Weinstein PR. Lumbar spinal stenosis. Semin Neurol. 2002 Jun;22(2):157-66. doi: 10.1055/s-2002-36539.
PubMed 12524561Schroeder GD, Kurd MF, Vaccaro AR. Lumbar Spinal Stenosis: How Is It Classified? J Am Acad Orthop Surg. 2016 Dec;24(12):843-852. doi: 10.5435/JAAOS-D-15-00034.
PubMed 27849674Kalichman L, Cole R, Kim DH, Li L, Suri P, Guermazi A, Hunter DJ. Spinal stenosis prevalence and association with symptoms: the Framingham Study. Spine J. 2009 Jul;9(7):545-50. doi: 10.1016/j.spinee.2009.03.005. Epub 2009 Apr 23.
PubMed 19398386Yabuki S, Fukumori N, Takegami M, Onishi Y, Otani K, Sekiguchi M, Wakita T, Kikuchi S, Fukuhara S, Konno S. Prevalence of lumbar spinal stenosis, using the diagnostic support tool, and correlated factors in Japan: a population-based study. J Orthop Sci. 2013 Nov;18(6):893-900. doi: 10.1007/s00776-013-0455-5. Epub 2013 Aug 21.
PubMed 23963588Katz JN, Dalgas M, Stucki G, Katz NP, Bayley J, Fossel AH, Chang LC, Lipson SJ. Degenerative lumbar spinal stenosis. Diagnostic value of the history and physical examination. Arthritis Rheum. 1995 Sep;38(9):1236-41. doi: 10.1002/art.1780380910.
PubMed 7575718Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.
PubMed 26727925Lee BH, Moon SH, Suk KS, Kim HS, Yang JH, Lee HM. Lumbar Spinal Stenosis: Pathophysiology and Treatment Principle: A Narrative Review. Asian Spine J. 2020 Oct;14(5):682-693. doi: 10.31616/asj.2020.0472. Epub 2020 Oct 14.
PubMed 33108834Mazanec DJ, Podichetty VK, Hsia A. Lumbar canal stenosis: start with nonsurgical therapy. Cleve Clin J Med. 2002 Nov;69(11):909-17. doi: 10.3949/ccjm.69.11.909.
PubMed 12430977Liu K, Liu P, Liu R, Wu X, Cai M. Steroid for epidural injection in spinal stenosis: a systematic review and meta-analysis. Drug Des Devel Ther. 2015 Jan 30;9:707-16. doi: 10.2147/DDDT.S78070. eCollection 2015.
PubMed 25678775Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1335-51. doi: 10.1097/BRS.0b013e31820c97b1.
PubMed 21311394Sengupta DK, Herkowitz HN. Lumbar spinal stenosis. Treatment strategies and indications for surgery. Orthop Clin North Am. 2003 Apr;34(2):281-95. doi: 10.1016/s0030-5898(02)00069-x.
PubMed 12914268Pollock AS, Durward BR, Rowe PJ, Paul JP. What is balance? Clin Rehabil. 2000 Aug;14(4):402-6. doi: 10.1191/0269215500cr342oa.
PubMed 10945424Ivanenko Y, Gurfinkel VS. Human Postural Control. Front Neurosci. 2018 Mar 20;12:171. doi: 10.3389/fnins.2018.00171. eCollection 2018.
PubMed 29615859Paillard T, Noe F. Techniques and Methods for Testing the Postural Function in Healthy and Pathological Subjects. Biomed Res Int. 2015;2015:891390. doi: 10.1155/2015/891390. Epub 2015 Nov 12.
PubMed 26640800Sibley KM, Howe T, Lamb SE, Lord SR, Maki BE, Rose DJ, Scott V, Stathokostas L, Straus SE, Jaglal SB. Recommendations for a core outcome set for measuring standing balance in adult populations: a consensus-based approach. PLoS One. 2015 Mar 13;10(3):e0120568. doi: 10.1371/journal.pone.0120568. eCollection 2015.
PubMed 25768435
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Imbalance Amongst Elderly Patients With Symptomatic Lumbar Spinal Stenosis Before and After Decompressive Surgery
- ClinicalTrials.gov ID
- NCT06075862
- Acronym / sponsor ID
- B-ATLAS / B-ATLAS1
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Spinal stenosis, Elderly, Balance, Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Region ZealandUniversity, hospital or other
- Collaborators
- Region Syddanmark
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Disease Background:
While lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, there is no universally accepted definition of LSS, and no accepted radiologic diagnostic criteria. LSS most often refers to a narrowing in the central canal of the vertebrae, the lateral recess, or the neural foramen. Changes to these can occur due to acquired degenerative spondylosis or spondylolisthesis, or more rarely due to conditions such as ankylosing spondylitis and space-occupying lesions, or congenital abnormalities. LSS can be classified according to anatomical location, etiology or severity of narrowing, though no validated classification has been published.
The lack of concrete definition has caused difficulties in estimating the prevalence of LSS. Studies using community-based sampling has shown a prevalence of acquired LSS, defined as a narrowing of the central canal to ≤ 10mm in the anterior-posterior direction, of 7.3%. The prevalence has been shown to rise with age, from 4.0% affected at < 40 years of age, to 14.3% amongst patients ≥ 60. No significant differences have been observed in overall prevalence according to gender, although there seems to be a slightly higher prevalence amongst elderly females than males.
Although LSS is often asymptomatic, common symptoms of LSS include low back pain, which worsens with prolonged ambulation, lumbar extension and standing, and which is relieved by rest and forward flexion, as well as lumbar radiculopathy. Patients may also complain of poor balance, and physical examination findings may include a wide-based gait and abnormal Romberg results. Symptoms are thought to occur due to compression of microvascular structures in the nerves, allowing for neural ischemia and defects in nerve conduction, and venous pooling resulting in inadequate oxygenation and metabolite accumulation.
Current treatment options for LSS range across both conservative and surgical management strategies. Conservative management has traditionally been regarded as first-line treatment, with a combination approach of physical therapy and pharmacological treatment with NSAIDs and analgesics. Epidural steroid injections have been used for symptom management, though with limited short and long-term benefits. Surgical management is often indicated in patients with ongoing pain despite attempts at conservative management for 3-6 months. Choice of surgical strategy to relieve the pressure on the neural structures depends on the anatomical location of stenosis and number of stenotic segments, as well as the intraoperative assessment of stability.
The effect of surgical decompression on disability, leg pain and back pain has been widely evaluated, but studies of the effect on postural control are sparse. The present study aims to investigate the effect of surgical decompression of symptomatic lumbar spinal stenosis on postural control by assessment of sway measures before and after surgery.
Postural Balance:
Mechanical balance is defined according to Newton's first law, stating that an object is at equilibrium (balanced) when the forces acting upon it are zero. When considering the balance of an object, the objects centre of gravity (COG) and its base of support (BOS) must be examined. For an object to remain balanced, a vertical line drawn from the COG to the objects BOS, the point of intersection defined as the centre of pressure (COP), must lie within the objects BOS. When the COP goes beyond the BOS, objects become unbalanced and may topple. If in a state of imbalance, humans and animals have physiological compensatory mechanisms to ensure that their COP returns to lie within their BOS. The act of keeping the COP within the BOS is what is intuitively know as human balance.
No central definition of postural balance exists, but a widely cited definition is 'the act of maintaining, achieving or restoring a state of balance during any posture or activity'. Postural balance has previously been considered a summation of postural reflexes alongside sensory feedback mechanisms, with a single neural circuit system integrating somatosensory, vestibular, and visual systems to maintain equilibrium. However, efforts have been made to move away from this viewpoint, and the act of postural balance is now seen as an independent motor skill, incorporating complex physiological mechanisms as well as high-level somatosensory information processing, influenced by individual body schema and personal cognitive elements. Maintaining postural balance is now seen as a summation of two simultaneous and overlapping systems; one to control posture through tonic muscle activity, and one to maintain equilibrium when exposed to internal and external perturbations. Balance is hereby maintained using skeletal muscle with both phasic and tonic activity, with signals originating from distinct neural circuits including from the brain stem, cerebellum, motor cortex etc.
As of writing, no gold standard exists to measure balance, which has allowed a wide variety of techniques to be developed to measure postural balance skills amongst patients, and variables associated with postural control, either through instrumented or non-instrumented tests. Regarding the latter, expert consensus points to the use of the Berg Balance Scale or the Mini Balance Evaluation Systems Test when measuring postural balance in adult populations. However, while non-instrumented tests can give a gross indicator of postural balance, there exists a need for more granular analysis, which can be achieved using instrumented tests. The force platform remains the most widely used device for this purpose, allowing for the quantification of positional and dynamic variables associated with COP position, displacement, and trajectory.
The causes of imbalance are many. Any deficit or pathology relating to somatosensory, motor control or cognitive systems associated with postural control can lead to postural imbalance, including a wide range of pathological conditions such as visuo-vestibular and neurodegenerative diseases, as well as orthopaedic and rheumatological diseases of the musculoskeletal system. While aging itself does not seem to be an independent risk factor for postural imbalance, age-related changes in physiology have been linked to degeneration in postural imbalance, including decreased visual acuity, somatosensory loss, vestibular dysfunction, lower extremity muscle weakness and cognitive impairment.
As mentioned, objects which become unbalanced due to COP dislocation beyond the objects BOS may fall. Balance impairment, measured by dynamic variables using force plates as well as non-instrumental tests, have been shown to be predictors of falls amongst elderly. Falls represent a large healthcare burden, having serious risk of related injury, rising prevalence with age and being a significant cause of mortality amongst elderly. Furthermore, falls have been shown to be an independent risk factor of functional decline. As such, fall prevention is a topic of both national and international interest.
Spinal stenosis has shown to be a risk factor for both postural imbalance as well as a risk factor for falls. Previous studies have made efforts to quantify the effects of decompressive surgery on postural imbalance, though have remained limited by number of patients and short follow-up regimes, as well as lacking correlation between measurements of postural imbalance and risk of falls.
Wii Balance Board:
The Wii Balance Board (WBB), first released in 2007, has gained popularity as a low-cost, portable force-plate transducer, to use in postural balance assessment. It contains four transducers used to measure COP, as well as a scale to measure weight, and was originally used as a video game controller for the game WiiFit. Although capable of providing an intrinsic WiiFit Stillness score, this has shown limited usability in previous studies. However, using custom software, the WBB has been extensively validated against 'gold standard' laboratory-grade force plates, and shown to have good within-device and between-device reliability, as well as being a valid tool to measure balance amongst older adults. Work has been done to ensure that the WBB can be calibrated to minimize measurement error, and open-source algorithms exist for the calculation of positional and dynamic variables recorded by the WBB. While not recommended for clinical diagnostic measurements, the use of the WBB in longitudinal monitoring for research purposes remains viable.
Rationale of the study:
This study will be the first to correlate the effects of decompressive surgery in patients with symptomatic LSS with postural balance, and associated quality of life increases. Previous studies have been hampered by low power due to sampling size limitations, and short follow-up regimes, both of which is sought to be managed through multi-centre collaboration and inclusion, and a follow-up regime spanning two years from the time of surgery.
It is expected that the results of this study can facilitate an increased understanding of the role of postural balance when considering surgical management of symptomatic LSS patients, as well as enable targeted treatment of patients with postural imbalance and LSS.
Research question:
Do elderly patients with symptomatic LSS, who have undergone decompressive surgery, show an improvement in postural balance compared to pre-operative values?
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lumbar spinal stenosis | – | Procedure: Decompressive surgeryPatients diagnosed with lumbar spinal stenosis and referred to operation. Balance will be measured once in this group before operation, and four times again after operation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 65 years of age referred to decompressive surgery for lumbar spinal stenosis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompressive surgeryDecompressive lumbar spinal surgery | Procedure or surgery | Patients with lumbar spinal stenosis |
Primary outcome
Postural balance
Time frame: Before surgery and 3, 6, 12 and 24 months after surgery
Postural balance, measured by sway area of center of pressure (mm^2)
4 secondary outcomes
Postural balance
Time frame: Before surgery and 3, 6, 12 and 24 months after surgery
Quality of life
Time frame: Before surgery and 3, 6, 12 and 24 months after surgery
Functional disability
Time frame: Before surgery and 3, 6, 12 and 24 months after surgery
Quality of life
Time frame: Before surgery and 3, 6, 12 and 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 12524561Binder DK, Schmidt MH, Weinstein PR. Lumbar spinal stenosis. Semin Neurol. 2002 Jun;22(2):157-66. doi: 10.1055/s-2002-36539.
- Background: PubMed 27849674Schroeder GD, Kurd MF, Vaccaro AR. Lumbar Spinal Stenosis: How Is It Classified? J Am Acad Orthop Surg. 2016 Dec;24(12):843-852. doi: 10.5435/JAAOS-D-15-00034.
- Background: PubMed 19398386Kalichman L, Cole R, Kim DH, Li L, Suri P, Guermazi A, Hunter DJ. Spinal stenosis prevalence and association with symptoms: the Framingham Study. Spine J. 2009 Jul;9(7):545-50. doi: 10.1016/j.spinee.2009.03.005. Epub 2009 Apr 23.
- Background: PubMed 23963588Yabuki S, Fukumori N, Takegami M, Onishi Y, Otani K, Sekiguchi M, Wakita T, Kikuchi S, Fukuhara S, Konno S. Prevalence of lumbar spinal stenosis, using the diagnostic support tool, and correlated factors in Japan: a population-based study. J Orthop Sci. 2013 Nov;18(6):893-900. doi: 10.1007/s00776-013-0455-5. Epub 2013 Aug 21.
- Background: PubMed 7575718Katz JN, Dalgas M, Stucki G, Katz NP, Bayley J, Fossel AH, Chang LC, Lipson SJ. Degenerative lumbar spinal stenosis. Diagnostic value of the history and physical examination. Arthritis Rheum. 1995 Sep;38(9):1236-41. doi: 10.1002/art.1780380910.
- Background: PubMed 26727925Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.
- Background: PubMed 33108834Lee BH, Moon SH, Suk KS, Kim HS, Yang JH, Lee HM. Lumbar Spinal Stenosis: Pathophysiology and Treatment Principle: A Narrative Review. Asian Spine J. 2020 Oct;14(5):682-693. doi: 10.31616/asj.2020.0472. Epub 2020 Oct 14.
- Background: PubMed 12430977Mazanec DJ, Podichetty VK, Hsia A. Lumbar canal stenosis: start with nonsurgical therapy. Cleve Clin J Med. 2002 Nov;69(11):909-17. doi: 10.3949/ccjm.69.11.909.
- Background: PubMed 25678775Liu K, Liu P, Liu R, Wu X, Cai M. Steroid for epidural injection in spinal stenosis: a systematic review and meta-analysis. Drug Des Devel Ther. 2015 Jan 30;9:707-16. doi: 10.2147/DDDT.S78070. eCollection 2015.
- Background: PubMed 21311394Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1335-51. doi: 10.1097/BRS.0b013e31820c97b1.
- Background: PubMed 12914268Sengupta DK, Herkowitz HN. Lumbar spinal stenosis. Treatment strategies and indications for surgery. Orthop Clin North Am. 2003 Apr;34(2):281-95. doi: 10.1016/s0030-5898(02)00069-x.
- Background: PubMed 10945424Pollock AS, Durward BR, Rowe PJ, Paul JP. What is balance? Clin Rehabil. 2000 Aug;14(4):402-6. doi: 10.1191/0269215500cr342oa.
- Individual participant dataSharing planned: Yes. All deidentified individual participant data collected during the trial will be made available to researchers who provide a methodologically sound proposal for use, subject to approval by the study authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver B Zielinski, MD principal investigator
Region Zealand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Region Zealand at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliver B Zielinski, MD (+4593931049, ozi@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural balance (time frame: Before surgery and 3, 6, 12 and 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06075862, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.