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Lumbar Spinal StenosisB-ATLASNCT06057428

Activity Levels Amongst Patients With Lumbar Spinal Stenosis

An observational study of Lumbar Spinal Stenosis, run by Region Zealand at 2 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • 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.

Oliver B Zielinski, MD contact

+4593931049

ozi@regionsjaelland.dk

Rune D Bech, MD, PhD contact

+4593931049

rudb@regionsjaelland.dk

Denmark2 sites, 2 recruiting
  • Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge

    Køge, 4600

    Oliver B Zielinski, MD, +4593931049, ozi@regionsjaelland.dk

    Not yet recruiting
  • Rygcenter Syddanmark, Middelfart Sygehus

    Middelfart, 5500

    Mikkel Ø Andersen, MD, mikkel.andersen.2@rsyd.dk

    Recruiting

Other trials in Denmark

About this study

Official 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.

Read more

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.

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 (AP) 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.

Activity levels:

Physical activity (PA) has been demonstrated to be correlated to physical and mental wellbeing, having been shown to offer significant benefits including preventing and managing cardiovascular disease, cancer, and diabetes, as well as reducing symptoms of depression and anxiety. A dose-response relationship has been observed, and while all PA can be beneficial, higher levels can have more positive effects. Likewise, the negative consequences of sedentary behaviour are well established, hereunder increasing risks of metabolic and musculoskeletal disorders as well as all-cause mortality. As such, PA as both an intervention tool and as a measurement of effect has been becoming increasingly prevalent in the literature.

It is currently recommended that adults should undertake regular PA, with a minimum of 150-300 min of moderate-vigorous physical activity (MVPA) every week. Adults who do not achieve this can be classified as physically inactive. It is worth keeping in mind though, that no definition of MVPA exists, as such a definition would need to be highly individualized.

Efforts have been made to quantify PA in the context of research; the doubly labelled water (DLW) technique has been shown to be highly accurate in measuring total daily energy expenditure and is considered the gold standard when measuring activity levels. However, as this technique is expensive, time-intensive and imposes a high degree of subject interference, it is not practical for large-scale studies.

Other measurements of activity have been developed and validated, including self-report questionnaires, self-report activity diaries, direct observation, and the use of devices such as accelerometers, pedometers, heart-rate monitors, and armbands. Among these, the use of accelerometers as an activity monitoring device has become increasingly prevalent due to the high frequency of measurements, large memory capacity, low subject interference and ability to differentiate between differing levels of activity. Accelerometer use has likewise been recommended as a clinical measurement of PA when undertaking intervention studies and has seen a rise in use in the field of orthopaedics.

Patients with LSS are often classified as physically inactive due to the ambulatory limitations that symptomatic LSS can present with, and rarely meet the abovementioned recommendations for PA, despite evidence suggesting the benefits of PA for LSS patients. Previous studies have not been able to prove a significant effect of decompressive surgery on activity levels for LSS patients six months post-operatively, measured by accelerometer. However, while comparable studies on patients undergoing total hip arthroplasty likewise found no significant improvement in activity levels after six months, studies with longer follow-up, up to a year post-operatively, have been able to show an activity level comparable to healthy control individuals. Likewise, studies measuring activity levels on LSS patients undergoing decompressive surgery using pedometer readings have been able to show a significant increase in activity after 12 months.

Activity monitoring device:

The ActiGraph wGT3X-BT is a triaxial accelerometer, recording inertia in three planes at a sampling rate up to 100 Hz. A proprietary filter can be applied to eliminate artifacts due to movement not caused by human activity, and data is summed as a total activity count per minute, which can then be used to estimate PAEE and MVPA. The wGT3X-BT has been widely validated against gold standard measurements such as DLW, and in appropriate patient groups such as the elderly, and has been shown to be valid and reliable in assessing physical activity intensity.

Rationale of the study:

This study will be the first to correlate the effects of decompressive surgery in patients with symptomatic LSS with activity levels, 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 this study seeks to manage 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 our study can facilitate an increased understanding of the role of activity when considering surgical management of symptomatic LSS patients, as well as enable targeted treatment of patients with LSS.

Research question:

Do elderly patients with symptomatic LSS, who have undergone decompressive surgery, show an improvement in activity level compared to pre-operative values?

Being tested
Decompressive surgery
Keywords
Spinal stenosis, Elderly, Activity, Surgery
Medical subject headings
Spinal Stenosis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decompressive surgeryProcedure or surgery

    Decompressive surgery for lumbar spinal stenosis

Study groups in NCT06057428
Study groupRoleWhat they receive
Patients with lumbar spinal stenosisPatients diagnosed with lumbar spinal stenosis and referred to operation. Measurements of activity levels will be undertaken before operation, and compared to after operation.
Receives: Procedure: Decompressive surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Activity level

    Activity level, measured by total activity counts per day (TAC/d)

    Measured: Before surgery and 3, 6, 12 and 24 months after surgery

Secondary outcomes (7)
  1. Physical activity

    Physical activity, measured by time spent in MVPA (minutes/day)

    Measured: Before surgery and 3, 6, 12 and 24 months after surgery

  2. Physical activity

    Physical activity, measured by physical activity energy expenditure (PAEE) (Kilojoules/d)

    Measured: Before surgery and 3, 6, 12 and 24 months after surgery

  3. Physical inactivity

    Physical inactivity, measured by sedentary time (hours/d)

    Measured: Before surgery and 3, 6, 12 and 24 months after surgery

  4. 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

  5. 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

  6. 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.

    Measured: Before surgery and 3, 6, 12 and 24 months after surgery

  7. 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.

  1. First posted28 Sep 2023
  2. Study start21 Sep 2023
  3. Primary completionAug 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06057428
Sponsor's protocol ID
B-ATLAS2
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 12524561
  • Schroeder 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 27849674
  • Yabuki 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 23963588
  • Katz 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 7575718
  • Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.

    PubMed 26727925
  • Lee 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 33108834
  • Mazanec 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 12430977
  • Liu 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 25678775
  • Kovacs 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 21311394
  • Sengupta 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 12914268
  • Aadahl M, Kjaer M, Jorgensen T. Associations between overall physical activity level and cardiovascular risk factors in an adult population. Eur J Epidemiol. 2007;22(6):369-78. doi: 10.1007/s10654-006-9100-3. Epub 2007 Feb 28.

    PubMed 17333472
  • Park JH, Moon JH, Kim HJ, Kong MH, Oh YH. Sedentary Lifestyle: Overview of Updated Evidence of Potential Health Risks. Korean J Fam Med. 2020 Nov;41(6):365-373. doi: 10.4082/kjfm.20.0165. Epub 2020 Nov 19.

    PubMed 33242381
  • Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

    PubMed 33239350
  • Tremblay MS, Aubert S, Barnes JD, Saunders TJ, Carson V, Latimer-Cheung AE, Chastin SFM, Altenburg TM, Chinapaw MJM; SBRN Terminology Consensus Project Participants. Sedentary Behavior Research Network (SBRN) - Terminology Consensus Project process and outcome. Int J Behav Nutr Phys Act. 2017 Jun 10;14(1):75. doi: 10.1186/s12966-017-0525-8.

    PubMed 28599680
  • MacIntosh BR, Murias JM, Keir DA, Weir JM. What Is Moderate to Vigorous Exercise Intensity? Front Physiol. 2021 Sep 22;12:682233. doi: 10.3389/fphys.2021.682233. eCollection 2021.

    PubMed 34630133

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?

Activity level (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 NCT06057428, which also lists 28 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.

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