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

NCT02592642 | Completed

• 1 other identifier: SOG-13-003
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Lumbar Spinal Stenosis

Keywords

lumbar spinal stenosis; neurogenic claudication; non-operative; treatment; outcomes; clinical trial

Outcome Measures

Primary Outcomes (1)

• Change in The Self-Paced Walk Test

  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.

  Change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention

Secondary Outcomes (5)

• Zurich Claudication Questionnaire

  change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention

• Oswestry Disability Index

  change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention

• Numeric Rating Scale

  change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention

• Medical Outcomes Study Short-Form Health Survey version two (SF-36)

  change form baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention

• Centre for Epidemiological Studies Depression Scale

  Change from baseline to 6 weeks (immediately post-intervention), 3 months, 6 months, and 12 months post-intervention

Study Arms (6)

Group 1

EXPERIMENTAL

Self-management Program, Workbook, Video, Pedometer

Behavioral: Self-management Program, Workbook, Video, Pedometer

Group 2

ACTIVE COMPARATOR

Instructional Workbook, Video, and Pedometer

Behavioral: Instructional Workbook, Video, and Pedometer

Group a

EXPERIMENTAL

Para-spinal TENS

Device: Para-spinal TENS

Group b

PLACEBO COMPARATOR

Para-spinal Placebo TENS

Device: Para-spinal Placebo TENS

Group c

EXPERIMENTAL

Prototype Spinal Stenosis Belt

Device: Prototype Spinal Stenosis Belt

Group d

SHAM COMPARATOR

Sham spinal stenosis belt

Device: Sham Spinal Stenosis Belt

Interventions

Self-management Program, Workbook, Video, Pedometer BEHAVIORAL

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.

Group 1

Instructional Workbook, Video, and Pedometer BEHAVIORAL

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.

Group 2

Para-spinal TENS DEVICE

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.

Group a

Para-spinal Placebo TENS DEVICE

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).

Group b

Prototype Spinal Stenosis Belt DEVICE

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.

Group c

Sham Spinal Stenosis Belt DEVICE

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.

Group d

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• The Arthritis Society, Canada: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

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• Huang TT, Wang WS. Comparison of three established measures of fear of falling in community-dwelling older adults: psychometric testing. Int J Nurs Stud. 2009 Oct;46(10):1313-9. doi: 10.1016/j.ijnurstu.2009.03.010. Epub 2009 Apr 24.

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• Greenland SR. Introduction to stratified analysis. In Modern Epidemiology. Philadelphia, PA: Lippincott-Raven; 1998.

  BACKGROUND

• Ammendolia C, Cote P, Rampersaud YR, Southerst D, Schneider M, Ahmed A, Bombardier C, Hawker G, Budgell B. Effect of active TENS versus de-tuned TENS on walking capacity in patients with lumbar spinal stenosis: a randomized controlled trial. Chiropr Man Therap. 2019 Jun 19;27:24. doi: 10.1186/s12998-019-0245-z. eCollection 2019.

  PMID: 31244992 DERIVED

• Ammendolia C, Cote P, Southerst D, Schneider M, Budgell B, Bombardier C, Hawker G, Rampersaud YR. Comprehensive Nonsurgical Treatment Versus Self-directed Care to Improve Walking Ability in Lumbar Spinal Stenosis: A Randomized Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2408-2419.e2. doi: 10.1016/j.apmr.2018.05.014. Epub 2018 Jun 20.

  PMID: 29935152 DERIVED

• Ammendolia C, Cote P, Rampersaud YR, Southerst D, Budgell B, Bombardier C, Hawker G. Effect of TENS Versus Placebo on Walking Capacity in Patients With Lumbar Spinal Stenosis: A Protocol for a Randomized Controlled Trial. J Chiropr Med. 2016 Sep;15(3):197-203. doi: 10.1016/j.jcm.2016.04.001. Epub 2016 Jun 20.

  PMID: 27660596 DERIVED

• Ammendolia C, Cote P, Rampersaud YR, Southerst D, Budgell B, Bombardier C, Hawker G. The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial. Chiropr Man Therap. 2016 Jul 18;24:25. doi: 10.1186/s12998-016-0106-y. eCollection 2016.

  PMID: 27433335 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Self-Management; Videotape Recording

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Carlo Ammendolia, PhD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 30, 2015
• Study Start: September 1, 2014
• Primary Completion: February 15, 2017
• Study Completion: March 1, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

CA (1)