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

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

Interventions

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.

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.

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.

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).

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.

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.

Sponsors & Collaborators

• The Arthritis Society, Canada

  collaborator OTHER

• Mount Sinai Hospital, Canada

  lead OTHER

Principal Investigators

• Carlo Ammendolia, PhD · MOUNT SINAI HOSPITAL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2017-02-15

Completion

2017-03-01

Countries

• Canada

Study Locations