104
Participants
Start Date
September 30, 2014
Primary Completion Date
February 15, 2017
Study Completion Date
March 1, 2017
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.
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.
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.
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).
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 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.
Mount Sinai Hospital, Toronto
The Arthritis Society, Canada
OTHER
Mount Sinai Hospital, Canada
OTHER