Lumbar Spinal StenosisNCT03388983
Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis Surgery
A study testing 6-week prehabilitation in people with Lumbar Spinal Stenosis and Prehabilitation, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Prehabilitation
- What is being tested?
- 6-week prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Aug 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signs of neurogenic claudication
- radiological signs of degenerative LSS on magnetic resonance images or computed tomography images
- radiculopathy with or without low back pain for more than 3 months that is unresponsive to conservative intervention
- Oswestry Disability Index (ODI) > 30 out of 100
- patients undergoing open or minimally invasive laminotomy/laminectomy
- willing to complete pre- and post-operative questionnaires and physical assessments at prescheduled time points
Who cannot join
- inability to read, speak and understand English/Chinese
- inability to give informed consent
- surgical management for lumbar fractures, tumors, synovial cysts, and scoliosis correction
- any revision lumbar spine surgery, (5) diagnosis of chronic pain conditions (e.g. fibromyalgia)
- presence of a neurological or systematic neuromuscular diseases (e.g. multiple sclerosis, stroke, or rheumatoid arthritis)
- planning for spinal fusion
- discogenic nerve compression or instability (flexion-extension X-ray film shows > 5mm of sagittal-plane translation)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Jason Cheung, MBBS, 852-2255-4581, cheungjp@hku.hk
About this study
Official title: The Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis: A Randomized Clinical Trial
Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space available for the neural and vascular tissues in the lumbar spine. Patients with LSS,who do not respond to conservative treatments after 3 months or more, will be eligible for spinal decompression surgery in order to improve functional outcomes.
While various studies have shown that preoperative exercises (prehabilitation) may benefit patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament reconstruction), little is known regarding the effect of prehabilitation for patients undergoing LSS surgery.
The aim of the current randomized controlled trial is to compare the effectiveness of a 6-week prehabilitation program with usual preoperative care in improving multiple outcomes of patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and 6 months postoperatively. It is hypothesized that prehabilitation will yield significantly better pre- and post-operative clinical outcomes as compared to usual preoperative care.
Read the detailed description
Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space available for the neural and vascular tissues in the lumbar spine. Clinical symptoms of LSS include pain, numbness, weakness and warmth in bilateral/unilateral buttock or legs that is precipitated by walking or prolonged standing but is alleviated by sitting or forward bending.
Acquired (degenerative) LSS is the most common degenerative conditions that leads to spinal surgery in adults aged 65 years or older.[2] It is known that the occurrence of degenerative LSS increases with age. Given the aging of the global population (including Hong Kong), the prevalence of degenerative LSS is expected to increase. Major causes of degenerative LSS in older adults are the compression and/or ischemia of nerve roots in diminished lateral or central spinal canals secondary to lumbar spondylosis, progressive hypertrophy of ligamentous/osteocartilaginous structures, or degenerative spondylolisthesis. When patients fail to improve after conservative treatments, surgical intervention is recommended for symptomatic LSS. While decompressive laminectomy/laminotomy with or without spinal fusion for LSS has shown significantly less leg symptoms than conservative treatments, up to 40% of patients undergoing LSS surgery were unsatisfied with the postoperative neurogenic claudication and/or radicular leg symptoms. Accordingly, evidence-based management is needed for patients undergoing LSS surgery to optimize patients' recovery.
Various studies have shown that preoperative exercises (prehabilitation) may benefit patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament reconstruction). Although there is a paucity of prehabilitation for patients undergoing LSS surgery. the potential benefits of prehabilitation substantiate the investigation of prehabilitation for patients undergoing LSS surgery.
Given the above, the aim of the current randomized controlled trial is to compare the effectiveness of a 6-week prehabilitation program with usual preoperative care in improving multiple outcomes of patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and 6 months postoperatively. It is hypothesized that prehabilitation will yield significantly better pre- and post-operative clinical outcomes as compared to usual preoperative care.
- Conditions
- Lumbar Spinal Stenosis, Prehabilitation
- Being tested
- 6-week prehabilitation
- Keywords
- Prehabilitation, Physical activity, Lumbar decompression surgery, Randomized controlled trial
- 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.
6-week prehabilitationOther
Participants will be trained at 3 sessions/week for 6 weeks before the surgery to enhance the overall muscle strength, endurance and spinal stability. A physiotherapist/physical trainer in the participating hospital will supervise the preoperative training. The 45-minute exercise regime will include warm-up and cool-down exercises, and a cardiovascular training on a stationary bicycle, stabilization exercises with emphasis on co-contraction of abdominal and back muscles, and hip raise and hip abduction exercises. The number of repetitions and sets of each exercise will be determined based on individual's ability. Each exercise will be slightly modified based on individual progress. The exercise intensity and complexity will be increased over time.
| Study group | Role | What they receive |
|---|---|---|
| 6-week prehabilitation group | Experimental | 6-week prehabilitation Receives: Other: 6-week prehabilitation |
| Control group | No intervention | Patients will receive standard preoperative care (including information about the surgery from an orthopedic surgeon, and a pamphlet summarizing tips of maintaining proper posture and staying active). The usual postoperative care does not include routine rehabilitation program though a short course of rehabilitation may be given based on orthopedic surgeons' discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese/English Version Oswestry Disability Index (ODI)
The ODI comprises 10 questions covering areas related to: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, sexual life and traveling.
Measured: 6 months
Secondary outcomes (8)
Pain medication
Dosage of pain medication taken by the participant each day will be recorded.
Measured: 6 months
Duration of hospital stay
The length of hospital stay will be documented
Measured: 6 months
11-point numeric pain rating scale (NPRS) for measuring back/leg pain
The current back/leg pain intensity of each participant will be quantified by an 11-point NPRS, where 0 means no pain and 10 means the worst imaginable pain.
Measured: 6 months
Physical activity monitoring
An ActiGraph sensor will be used to quantify physical activity level of patients before and after surgery at different time points.
Measured: 6 months
The Chinese version of EuroQol-5D-3L for measuring quality of life
The Chinese version of EuroQol-5D-3L questionnaire comprises the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The descriptive system involves 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has three levels of responses: no problems, some problems, extreme problems. The participant chooses the most appropriate statement in each domain. The EQ VAS quantifies the respondent's perceived health-related quality of life on a vertical VAS where 0 means 'worst imaginable health state', and 100 means 'best imaginable health state'.
Measured: 6 months
Swiss Spinal Stenosis Questionnaire
This self-administered questionnaire comprises 18 questions in three subscales: 6 questions in the symptom severity scale (ranging from 1 to 5), 6 questions in the physical function scale (ranging from 1 to 4), and 6 questions in the patient's satisfaction with treatment scale (ranging from 1 to 4). The result is expressed as a percentage of the maximum possible score. A higher score indicates more disability.
Measured: 6 months
International Physical Activity Questionnaire
International Physical Activity Questionnaire (Chinese short-form version) is a 9-item questionnaire aiming to monitor an individual's leisure-time physical activity, work/transport-related physical activity, and domestic/gardening physical activity over the last 7-day period. Based on the duration, frequency and intensity of the reported physical activity, a person will be classified as physically inactive, minimally active, and health-enhancing physically active.
Measured: 6 months
Clinical Global Impression of Change
The patient's perceived changes immediately after the prehabilitation will be measured by the Clinical Global Impression of Change scale, which is a 7-point numerical rating scale. The value of 1 indicates very much improved, while 7 means very much worse. It will help evaluate the effect of prehabilitation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start10 Aug 2018
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Université du Québec à Trois-Rivières, The University of Hong Kong
- Responsible party
- Principal investigator, Dr Arnold Wong Yu Lok, The Hong Kong Polytechnic University
- Investigators
- Arnold Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388983
- Sponsor's protocol ID
- HSEARS20171204001
- Status last verified
- Feb 2021
- First submitted
- 23 Dec 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03388983
- Acronym / sponsor ID
- HSEARS20171204001
- Conditions
- Lumbar Spinal Stenosis, Prehabilitation
- Keywords
- Prehabilitation, Physical activity, Lumbar decompression surgery, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Université du Québec à Trois-Rivières, The University of Hong Kong
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 3 Jan 2018 (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 a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space available for the neural and vascular tissues in the lumbar spine. Patients with LSS,who do not respond to conservative treatments after 3 months or more, will be eligible for spinal decompression surgery in order to improve functional outcomes.
While various studies have shown that preoperative exercises (prehabilitation) may benefit patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament reconstruction), little is known regarding the effect of prehabilitation for patients undergoing LSS surgery.
The aim of the current randomized controlled trial is to compare the effectiveness of a 6-week prehabilitation program with usual preoperative care in improving multiple outcomes of patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and 6 months postoperatively. It is hypothesized that prehabilitation will yield significantly better pre- and post-operative clinical outcomes as compared to usual preoperative care.
Detailed description
Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space available for the neural and vascular tissues in the lumbar spine. Clinical symptoms of LSS include pain, numbness, weakness and warmth in bilateral/unilateral buttock or legs that is precipitated by walking or prolonged standing but is alleviated by sitting or forward bending.
Acquired (degenerative) LSS is the most common degenerative conditions that leads to spinal surgery in adults aged 65 years or older.[2] It is known that the occurrence of degenerative LSS increases with age. Given the aging of the global population (including Hong Kong), the prevalence of degenerative LSS is expected to increase. Major causes of degenerative LSS in older adults are the compression and/or ischemia of nerve roots in diminished lateral or central spinal canals secondary to lumbar spondylosis, progressive hypertrophy of ligamentous/osteocartilaginous structures, or degenerative spondylolisthesis. When patients fail to improve after conservative treatments, surgical intervention is recommended for symptomatic LSS. While decompressive laminectomy/laminotomy with or without spinal fusion for LSS has shown significantly less leg symptoms than conservative treatments, up to 40% of patients undergoing LSS surgery were unsatisfied with the postoperative neurogenic claudication and/or radicular leg symptoms. Accordingly, evidence-based management is needed for patients undergoing LSS surgery to optimize patients' recovery.
Various studies have shown that preoperative exercises (prehabilitation) may benefit patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament reconstruction). Although there is a paucity of prehabilitation for patients undergoing LSS surgery. the potential benefits of prehabilitation substantiate the investigation of prehabilitation for patients undergoing LSS surgery.
Given the above, the aim of the current randomized controlled trial is to compare the effectiveness of a 6-week prehabilitation program with usual preoperative care in improving multiple outcomes of patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and 6 months postoperatively. It is hypothesized that prehabilitation will yield significantly better pre- and post-operative clinical outcomes as compared to usual preoperative care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 6-week prehabilitation group | Experimental | Other: 6-week prehabilitation6-week prehabilitation |
| Control group | No intervention | –Patients will receive standard preoperative care (including information about the surgery from an orthopedic surgeon, and a pamphlet summarizing tips of maintaining proper posture and staying active). The usual postoperative care does not include routine rehabilitation program though a short course of rehabilitation may be given based on orthopedic surgeons' discretion. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signs of neurogenic claudication
- radiological signs of degenerative LSS on magnetic resonance images or computed tomography images
- radiculopathy with or without low back pain for more than 3 months that is unresponsive to conservative intervention
- Oswestry Disability Index (ODI) > 30 out of 100
- patients undergoing open or minimally invasive laminotomy/laminectomy
Key exclusion criteria (7 listed)
- inability to read, speak and understand English/Chinese
- inability to give informed consent
- surgical management for lumbar fractures, tumors, synovial cysts, and scoliosis correction
- any revision lumbar spine surgery, (5) diagnosis of chronic pain conditions (e.g. fibromyalgia)
- presence of a neurological or systematic neuromuscular diseases (e.g. multiple sclerosis, stroke, or rheumatoid arthritis)
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 |
|---|---|---|
| 6-week prehabilitationParticipants will be trained at 3 sessions/week for 6 weeks before the surgery to enhance the overall muscle strength, endurance and spinal stability. A physiotherapist/physical trainer in the participating hospital will supervise the preoperative training. The 45-minute exercise regime will include warm-up and cool-down exercises, and a cardiovascular training on a stationary bicycle, stabilization exercises with emphasis on co-contraction of abdominal and back muscles, and hip raise and hip abduction exercises. The number of repetitions and sets of each exercise will be determined based on individual's ability. Each exercise will be slightly modified based on individual progress. The exercise intensity and complexity will be increased over time. | Other | 6-week prehabilitation group |
Primary outcome
Chinese/English Version Oswestry Disability Index (ODI)
Time frame: 6 months
The ODI comprises 10 questions covering areas related to: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, sexual life and traveling.
8 secondary outcomes
Pain medication
Time frame: 6 months
Duration of hospital stay
Time frame: 6 months
11-point numeric pain rating scale (NPRS) for measuring back/leg pain
Time frame: 6 months
Physical activity monitoring
Time frame: 6 months
The Chinese version of EuroQol-5D-3L for measuring quality of life
Time frame: 6 months
Swiss Spinal Stenosis Questionnaire
Time frame: 6 months
International Physical Activity Questionnaire
Time frame: 6 months
Clinical Global Impression of Change
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Arnold Wong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-week prehabilitation in people with Lumbar Spinal Stenosis and Prehabilitation, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnold Wong, PhD (+852 2766 6741, arnold.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese/English Version Oswestry Disability Index (ODI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2021.