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the Evaluation of Four Non-operative Treatments for Degenerative Lumbar Spinal Stenosis

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ClinicalTrials.gov Identifier: NCT02592642
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
The Arthritis Society, Canada
Information provided by (Responsible Party):
Carlo Ammendolia, Mount Sinai Hospital, Canada

Brief Summary:
Arthritis of the spine causes narrowing of the spinal canals and compression of the spinal nerves traveling into the legs, limiting walking ability. The vast majority of individuals with arthritis of the spine are not suited for surgery and most receive non-surgical treatment. However, we do not know what non-surgical treatments are effective in improving walking in these people. The purpose of our research is to test four new treatments for arthritis of the spine to see if they can improve walking ability. Each treatment approach focuses on the changes that occur in the spine and the whole person as a result of the arthritis that directly or indirectly impacts the ability to walk and perform usual daily activities. Because arthritis of the spine is a chronic condition usually does not go away, it is important that people acquire the knowledge, skills, and tools to manage their condition on their own. The treatments that investigators plan to test as part of this research proposal are aimed at achieving this goal. However, before the investigators can promote the use of these treatments they need to formally test them using strict scientific methods to make sure they do more good than harm. The four treatments include 1) a six week training program referred to as "Boot Camp for Stenosis" which provides one-on-one training on exercise and self-management strategies 2) a patient educational workbook and video on how to self-manage, 3) an electrical device that is placed on the lower back to reduce nerve pain when walking and 4) a spinal stenosis belt that people can wear to reduce pressure on the nerves while walking. The plan is to assess the change in walking distance using the various treatments and assess what impact the treatments have on peoples' overall function and quality of life. Innovative treatment approaches with a long term perspective are urgently needed to deal with the growing number of people with arthritis of the spine who are disabled. It is likely that there is not one solution to this problem - many people will require more than one type of treatment, but an important first step is to determine which treatments are effective, then tailor the treatments to the needs of each person.

Condition or disease Intervention/treatment Phase
Degenerative Lumbar Spinal Stenosis Behavioral: Self-management Program, Workbook, Video, Pedometer Behavioral: Instructional Workbook, Video, and Pedometer Device: Para-spinal TENS Device: Para-spinal Placebo TENS Device: Prototype Spinal Stenosis Belt Device: Sham Spinal Stenosis Belt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-Management to Improve Walking Ability in Degenerative Lumbar Spinal Stenosis: the Evaluation of Four Novel Strategies.
Study Start Date : September 2014
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: Group 1
Self-management Program, Workbook, Video, Pedometer
Behavioral: Self-management Program, Workbook, Video, Pedometer
Participants will attend 12 sessions over a six week period. The following therapies will be provided by licensed chiropractors: instruction on self-management strategies, cognitive behavioural techniques; exercise instruction, manual therapy. An instructional workbook and video will provide education and instruction on how to perform exercises, and reinforce instructions received during the sessions. An exercise diary will outline the frequency and intensity of the exercises. All exercises will be performed twice per day at home with the number, intensity, and frequency increasing weekly. Participants will receive a pedometer and record the maximum number of continuous walking steps and time (minutes) to stop walking due to neurogenic symptoms weekly.

Active Comparator: Group 2
Instructional Workbook, Video, and Pedometer
Behavioral: Instructional Workbook, Video, and Pedometer
Participants will attend one session with a chiropractor at the beginning of the six week treatment period. The chiropractor will provide and explain the instructional workbook and video. The workbook and video will provide education and instruction on how to perform exercises all aimed at improving overall fitness in the back and lower extremity and facilitate lumbar flexion. An exercise diary will outline the frequency and intensity of the exercises. All exercises will be performed twice per day at home with the number, intensity, and frequency increasing weekly. Participants will receive a pedometer and record the maximum number of continuous walking steps and time (minutes) to stop walking due to neurogenic symptoms weekly.

Experimental: Group a
Para-spinal TENS
Device: Para-spinal TENS
Participants randomized to this subgroup will have disposable self-adhesive electrical pads (Blue Sensor P, Ambu A/S, Denmark) applied over the para-spinal musculature from L3 to S1 by a licensed chiropractor. The electrical pad electrodes will be connected to a TENS machine (NeuroTrac TENS from Verity Medical Ltd U.K.) which will be worn by the subject concealed within a waist pouch. The TENS will be programmed for a frequency of 65-100 Hz modulated over 3-second intervals with a pulse width of 100-200 usec, and turned on 2 minutes before the start and during the SPWT. Current intensity will be set to the level of comfort of the patient, approximately 3 milliamps in pilot experiments, and below the level causing muscle twitch.

Placebo Comparator: Group b
Para-spinal Placebo TENS
Device: Para-spinal Placebo TENS
Group b: Participants randomized to this subgroup will have disposable self-adhesive electrical pads (Blue Sensor P, Ambu A/S, Denmark) applied over the para-spinal muscular from L3 to S1 by a licensed chiropractor. The electrical pad electrodes will be connected to a TENS machine [NeuroTrac TENS from Verity Medical Ltd (U.K.)] which will be worn by the subject concealed within a waist pouch. The TENS will be programmed using a transient placebo frequency and intensity (45) i.e. the unit will be active for the first 30 seconds then ramping down to zero stimulus over 15 seconds and worn from 2 minutes before the start and during the Self-Paced Walk Test (SPWT).

Experimental: Group c
Prototype Spinal Stenosis Belt
Device: Prototype Spinal Stenosis Belt
Participants randomized to this subgroup will be fitted with the prototype spinal stenosis belt by a licensed chiropractor. The belt is designed as garment that will snugly fit over the sacrum and pelvic girdle with a pump that place pressure over the sacrum aimed at reducing lordosis.

Sham Comparator: Group d
Sham spinal stenosis belt
Device: Sham Spinal Stenosis Belt
Participants randomized to this subgroup will have a standard lumbar support belt (Tensor Adjustable Back Brace from 3M, 207744) fitted around the lumbar spine above the iliac crest comfortably according the manufacturer's instructions for wear. We speculate that the placement of the stenosis belt around the lumbar spine should not have any impact on the lumbar lordosis.




Primary Outcome Measures :
  1. Change in The Self-Paced Walk Test [ Time Frame: Change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention ]
    The Self-Paced Walk Test requires subjects to walk on a level surface without support at their own pace until forced to stop due to symptoms of DLSS or after a time limit of 30 minutes (54). Test termination will be defined as a complete stop of 3 seconds. A blinded assessor will follow one meter behind the subject, without conversing, with a distance instrument (Lufkin Pro-Series Model PSMW38), and stop watch. Distance walked and time to test termination will be recorded.


Secondary Outcome Measures :
  1. Zurich Claudication Questionnaire [ Time Frame: change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention ]
    The Zurich Claudication Questionnaire (ZCQ), also known as the Swiss Spinal Stenosis Scale, will be used as a measure of physical function and symptom severity. The questionnaire consists of three scales; a physical performance scale, a symptom severity scale, and a patient satisfaction scale (56, 57). The physical performance scale consists of five questions related to walking ability. The mean un-weighted score will be calculated. The symptom scale consists of seven questions pertaining to overall severity of pain, pain frequency, back pain and, pain in the leg, numbness, weakness, and balance disturbance.

  2. Oswestry Disability Index [ Time Frame: change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention ]
    The Oswestry Disability Index will be used to assess back related disability. The total score will be calculated where 0 represents no disability and 100 represent the worse possible disability. We will also record separately the score of the walking section (ODI walk) of the ODI.

  3. Numeric Rating Scale [ Time Frame: change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention ]
    The Numeric Rating Scale will be used to assess leg and back pain intensity while walking. It is an 11-point scale anchored by two extremes of pain intensity ranging from 0 (referring to "No pain") to 10 (referring to "Pain as bad as it could be").

  4. Medical Outcomes Study Short-Form Health Survey version two (SF-36) [ Time Frame: change form baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention ]
    We will use the Medical Outcomes Study Short-Form Health Survey version two (SF-36) to measure health-related quality of life (H-RQoL). The SF-36 has 36 items which measure the H-RQoL of a subject. Two summary scores can be computed: the physical component score and the mental component score.

  5. Centre for Epidemiological Studies Depression Scale [ Time Frame: Change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention ]
    The Center for Epidemiological Studies-Depression Scale (CES-D) will be used to measure depressive symptomatology in the previous week. The CES-D is a widely used 20-item self-report scale designed to measure current level of depressive symptomatology in population-based epidemiologic research (65).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater or equal to 50 years
  • Clinical symptoms of back and/or radiating lower limb or buttock pain; fatigue or loss of sensation in the lower limbs aggravated by walking and/or standing and relieved by sitting
  • Intermittent or persistent pain without progressive neurological dysfunction
  • Duration of symptoms and signs for more than 3 months
  • Imaging confirmed spinal canal narrowing using MRI, CT scan, myelography or ultrasound
  • Clinical signs and symptoms corresponding to segmental level of narrowing identified by imaging
  • Patients with degenerative spondylolisthesis are included
  • Not considered to be a surgical candidate (in the next 12 months) or patient unwilling to have surgery
  • Able to perform mild-moderate exercise
  • Able to walk without assistive devices for at least 20 metres and less than 30 minutes continuously
  • Able to give written informed consent and complete interviews and questionnaires in English.

Exclusion Criteria:

  • Severe degenerative stenosis with intractable pain and progressive neurological dysfunction
  • Lumbar spinal stenosis not caused by degeneration
  • Lumbar herniated disc diagnosed during the last 12 months
  • Previous back surgery for lumbar spinal stenosis or instability
  • Underlying spinal disorder such as ankylosing spondylitis, neoplasm, infection or metabolic disease
  • Intermittent claudication due to vascular disease
  • Severe osteoarthrosis or arthritis of lower extremities causing limited walking ability
  • Neurologic disease causing impaired function of the lower limbs, including diabetes
  • Psychiatric disorders and /or cognitively impaired

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592642


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5T 3L9
Sponsors and Collaborators
Mount Sinai Hospital, Canada
The Arthritis Society, Canada
Investigators
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Principal Investigator: Carlo Ammendolia, PhD MOUNT SINAI HOSPITAL
Publications:
Diggle P. Analysis of longitudinal data. Press OU, editor. New York2009.
Roche PAT, H; Stanton WR. Modification of induced ischaemic pain by placebo electrotherapy. . Physiotherapy Theory Practice. 2002;18:131-9.
Elashoff J. nQuery Advisor. Version 70 User's Guide. 7.0 User's Guide ed. Los Angeles, CA USA2007.
Maitland G. Peripheral Manipulation. Butterworth-Heinemann O, editor1991.
McGill S. Low back disorders: evidence-based prevention and rehabilitation: Human Kinetics 1; 2007.
64. Radloff LS. The CES-D scale A self-report depression scale for research in the general population. Applied psychological measurement. 1977;1(3):385-401
National Institute for Health and Care Excellence (2013) Falls: assessment and prevention of falls in older people. CG161. London: National Institute for Health and Care Excellence.
Greenland SR. Introduction to stratified analysis. In Modern Epidemiology. Philadelphia, PA: Lippincott-Raven; 1998.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carlo Ammendolia, Associate Scientist, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02592642    
Other Study ID Numbers: SOG-13-003
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Keywords provided by Carlo Ammendolia, Mount Sinai Hospital, Canada:
lumbar spinal stenosis
neurogenic claudication
non-operative
treatment
outcomes
clinical trial
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases