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Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01943435
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : May 17, 2017
Last Update Posted : April 2, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Michael Schneider, DC, PhD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lumbar Spinal Stenosis
Interventions Drug: NSAIDs; adjunctive analgesics; adjunctive anti-depressants
Procedure: Lumbar epidural injection
Other: Joint Mobilizations (spine, sacroiliac, hip)
Other: Individualized exercises: clinical setting
Other: Group Exercise: community setting
Enrollment 259
Recruitment Details Participants were recruited from the general population in the City of Pittsburgh from November 2013 through November 2015.
Pre-assignment Details We consented and randomized a total of 259 subjects. However, 19 of those randomized subjects who never received any treatment...i.e. they dropped out after randomization but before their first scheduled treatment. Therefore, we a total of 240 subjects who were actually enrolled and received at least one treatment.
Arm/Group Title Medical Care Group Exercise Manual Therapy and Exercise
Hide Arm/Group Description

Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:

NSAIDs, Adjunctive analgesics, antidepressants,

Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.

Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.

Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers.

This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:

Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations

Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor.

Period Title: Baseline Eligibility and Randomization
Started 88 84 87
Completed 84 72 84
Not Completed 4 12 3
Reason Not Completed
Withdrawal by Subject             4             12             3
Period Title: Intervention Period
Started 84 72 84
Completed 81 69 80
Not Completed 3 3 4
Reason Not Completed
Withdrawal by Subject             3             3             4
Period Title: 2 Month Follow up
Started 81 69 80
Completed 79 66 80
Not Completed 2 3 0
Reason Not Completed
Lost to Follow-up             2             3             0
Period Title: 6 Month Follow up
Started 79 66 80
Completed 67 59 65
Not Completed 12 7 15
Reason Not Completed
Lost to Follow-up             12             7             15
Arm/Group Title Usual Medical Care Group Exercise Manual Therapy and Exercise Total
Hide Arm/Group Description

Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.

Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.

Lumbar epidural injection: these will be prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications.

NSAIDs; adjunctive analgesics; adjunctive anti-depressants: Physician will administer these medications based upon the individual needs of each patient.

Lumbar epidural injection: The attending physician may refer s

Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.

Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers.

This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:

Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations

Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor.

Total of all reporting groups
Overall Number of Baseline Participants 88 84 87 259
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 84 participants 87 participants 259 participants
72.0  (7.4) 72.9  (8.1) 72.1  (8.1) 72.4  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 84 participants 87 participants 259 participants
Female
46
  52.3%
39
  46.4%
52
  59.8%
137
  52.9%
Male
42
  47.7%
45
  53.6%
35
  40.2%
122
  47.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 84 participants 87 participants 259 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
88
 100.0%
84
 100.0%
87
 100.0%
259
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 84 participants 87 participants 259 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.1%
1
   0.4%
Asian
1
   1.1%
0
   0.0%
0
   0.0%
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
19
  21.6%
18
  21.4%
19
  21.8%
56
  21.6%
White
68
  77.3%
66
  78.6%
67
  77.0%
201
  77.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 88 participants 84 participants 87 participants 259 participants
88 84 87 259
Swiss Spinal Stenosis Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 88 participants 84 participants 87 participants 259 participants
31.4  (5.8) 31.6  (6.0) 31.7  (6.1) 31.5  (6.0)
[1]
Measure Description: The SSS is a patient self-reported measure of pain and function related to spinal stenosis. The total score range is 12-55 with increasing values representing worsening disability.
Self Paced Walk Test Total Distance  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 88 participants 84 participants 87 participants 259 participants
482.2  (529.1) 433.4  (421.2) 449.2  (485.2) 455.3  (480.0)
1.Primary Outcome
Title Swiss Spinal Stenosis (SSS) Questionnaire Score
Hide Description Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS total score between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS total score range is 12-55. For our analysis, we compared the change in the 12-item Total score from baseline to 8 weeks.
Time Frame Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on all randomized participants and linear mixed models were used to account for missing data.
Arm/Group Title Medical Care Group Exercise Manual Therapy and Exercise
Hide Arm/Group Description:

Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:

NSAIDs, Adjunctive analgesics, antidepressants,

Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.

Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.

Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers.

This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:

Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.

Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor.

Overall Number of Participants Analyzed 88 84 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.0  (5.5) -1.7  (5.2) -4.1  (5.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medical Care, Group Exercise
Comments The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.
Type of Statistical Test Superiority
Comments For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Regression, Linear
Comments Linear mixed models were adjusted for randomization stratification factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.5 to 2.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Medical Care, Manual Therapy and Exercise
Comments The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.
Type of Statistical Test Superiority
Comments For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Linear
Comments Linear mixed models were adjusted for randomization stratification factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-3.9 to -0.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group Exercise, Manual Therapy and Exercise
Comments The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.
Type of Statistical Test Superiority
Comments For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Linear
Comments Linear mixed models were adjusted for randomization stratification factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
0.6 to 4.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Self Paced Walking Test (SPWT)
Hide Description Our primary aim also included a performance-based outcome measure, which was the distance walked during the SPWT. The analysis was a comparison of between-group changes in SPWT between baseline and 8 weeks. The Self-Paced Walking Test (SPWT) is a validated objective measure of a patient's walking capacity, which is performed on a level walking surface. The patient is instructed to walk at their own pace and to stop when the symptoms are troublesome enough that s/he needs to sit down to rest. The total time and total distance walked are measured by the research assistant. Our unit of measure was the total distance walked, expressed in meters.
Time Frame Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on all randomized participants and linear mixed models were used to account for missing data.
Arm/Group Title Medical Care Group Exercise Manual Therapy and Exercise
Hide Arm/Group Description:

Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:

NSAIDs, Adjunctive analgesics, antidepressants,

Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.

Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.

Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers.

This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:

Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.

Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor.

Overall Number of Participants Analyzed 88 84 87
Mean (Standard Deviation)
Unit of Measure: meters
130.5  (478.7) 219.2  (413.0) 267.8  (507.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medical Care, Group Exercise
Comments This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Regression, Linear
Comments Linear mixed models were adjusted for randomization stratification factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 87.0
Confidence Interval (2-Sided) 95%
-75.2 to 249.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Medical Care, Manual Therapy and Exercise
Comments This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Regression, Linear
Comments Linear mixed models were adjusted for randomization stratification factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 129.7
Confidence Interval (2-Sided) 95%
-27.2 to 286.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group Exercise, Manual Therapy and Exercise
Comments This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Regression, Linear
Comments Linear mixed models were adjusted for randomization stratification factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -42.7
Confidence Interval (2-Sided) 95%
-205.4 to 120.0
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Sense Wear Armband
Hide Description Our secondary aim was to measure the change in physical activity between baseline and 8 weeks using the Sense Wear armband (SWA). The outcome measure was the average number of minutes spent daily performing physical activities >1.5 metabolic equivalents (METs).The SWA is a small device that collects information from multiple sensors: a triaxial accelerometer, heat flux, skin temperature, and galvanic signal. The information is integrated and processed by software using proprietary algorithms utilizing subjects' demographic characteristics (gender, age, height, and weight) to provide minute-by-minute estimates of physical activity. The SWA has shown good reliability and validity. The research participants in our study will wear the SWA for a week before and after they complete the treatment interventions.
Time Frame Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on all randomized participants and linear mixed models were used to account for missing data.
Arm/Group Title Medical Care Group Exercise Manual Therapy and Exercise
Hide Arm/Group Description:

Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:

NSAIDs, Adjunctive analgesics, antidepressants,

Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.

Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.

Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers.

This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:

Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.

Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor.

Overall Number of Participants Analyzed 88 84 87
Mean (Standard Deviation)
Unit of Measure: minutes per day
-23.1  (85.3) 4.3  (64.8) -6.0  (76.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medical Care, Group Exercise
Comments This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities >1.5 METs), while adjusting for randomization stratification factors.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Linear
Comments Linear mixed models were adjusted for randomization stratification factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 30.5
Confidence Interval (2-Sided) 95%
3.1 to 57.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Medical Care, Manual Therapy and Exercise
Comments This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities >1.5 METs), while adjusting for randomization stratification factors.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Regression, Linear
Comments Linear mixed models were adjusted for randomization stratification factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.7
Confidence Interval (2-Sided) 95%
-7.6 to 45.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group Exercise, Manual Therapy and Exercise
Comments This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities >1.5 METs), while adjusting for randomization stratification factors.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Regression, Linear
Comments Linear mixed models were adjusted for randomization stratification factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.8
Confidence Interval (2-Sided) 95%
-15.6 to 39.1
Estimation Comments [Not Specified]
Time Frame Assessed from beginning of treatment up to 2 month follow up assessment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Medical Care Group Exercise Manual Therapy and Exercise
Hide Arm/Group Description

Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.

Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.

Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.

Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers.

This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:

Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations

Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor.

All-Cause Mortality
Medical Care Group Exercise Manual Therapy and Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Medical Care Group Exercise Manual Therapy and Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/84 (0.00%)      0/72 (0.00%)      0/84 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Medical Care Group Exercise Manual Therapy and Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/84 (21.43%)      25/72 (34.72%)      54/84 (64.29%)    
Gastrointestinal disorders       
Gastrointestinal Symptoms   6/84 (7.14%)  6 0/72 (0.00%)  0 0/84 (0.00%)  0
General disorders       
Drowsiness   5/84 (5.95%)  5 0/72 (0.00%)  0 0/84 (0.00%)  0
Dry Mouth   4/84 (4.76%)  4 0/72 (0.00%)  0 0/84 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Joint soreness   0/84 (0.00%)  0 10/72 (13.89%)  10 40/84 (47.62%)  93
Muscle soreness   5/84 (5.95%)  5 22/72 (30.56%)  26 44/84 (52.38%)  115
Indicates events were collected by systematic assessment
We realize in retrospect that our original choice of the term "usual medical care" may have been confusing, because there is great variation in the medical management of patients with stenosis. We suggest that "medical care" is a better term.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Schneider, PhD, DC - Associate Professor and Principal Investigator
Organization: University of Pittsburgh
Phone: 412-383-6640
EMail: mjs5@pitt.edu
Layout table for additonal information
Responsible Party: Michael Schneider, DC, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01943435    
Other Study ID Numbers: PRO12120422
587 ( Other Grant/Funding Number: PCORI )
First Submitted: September 8, 2013
First Posted: September 17, 2013
Results First Submitted: February 9, 2017
Results First Posted: May 17, 2017
Last Update Posted: April 2, 2018