Trial Outcomes & Findings for Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis) (NCT NCT01943435)
NCT ID: NCT01943435
Last Updated: 2018-04-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
259 participants
Primary outcome timeframe
Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Results posted on
2018-04-02
Participant Flow
Participants were recruited from the general population in the City of Pittsburgh from November 2013 through November 2015.
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.
Participant milestones
| Measure |
Medical Care
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
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.
|
Manual Therapy and Exercise
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.
|
|---|---|---|---|
|
Baseline Eligibility and Randomization
STARTED
|
88
|
84
|
87
|
|
Baseline Eligibility and Randomization
COMPLETED
|
84
|
72
|
84
|
|
Baseline Eligibility and Randomization
NOT COMPLETED
|
4
|
12
|
3
|
|
Intervention Period
STARTED
|
84
|
72
|
84
|
|
Intervention Period
COMPLETED
|
81
|
69
|
80
|
|
Intervention Period
NOT COMPLETED
|
3
|
3
|
4
|
|
2 Month Follow up
STARTED
|
81
|
69
|
80
|
|
2 Month Follow up
COMPLETED
|
79
|
66
|
80
|
|
2 Month Follow up
NOT COMPLETED
|
2
|
3
|
0
|
|
6 Month Follow up
STARTED
|
79
|
66
|
80
|
|
6 Month Follow up
COMPLETED
|
67
|
59
|
65
|
|
6 Month Follow up
NOT COMPLETED
|
12
|
7
|
15
|
Reasons for withdrawal
| Measure |
Medical Care
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
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.
|
Manual Therapy and Exercise
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.
|
|---|---|---|---|
|
Baseline Eligibility and Randomization
Withdrawal by Subject
|
4
|
12
|
3
|
|
Intervention Period
Withdrawal by Subject
|
3
|
3
|
4
|
|
2 Month Follow up
Lost to Follow-up
|
2
|
3
|
0
|
|
6 Month Follow up
Lost to Follow-up
|
12
|
7
|
15
|
Baseline Characteristics
Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
Baseline characteristics by cohort
| Measure |
Usual Medical Care
n=88 Participants
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
n=84 Participants
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.
|
Manual Therapy and Exercise
n=87 Participants
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
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.0 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
72.9 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
72.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
72.4 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=5 Participants
|
84 participants
n=7 Participants
|
87 participants
n=5 Participants
|
259 participants
n=4 Participants
|
|
Swiss Spinal Stenosis Total Score
|
31.4 units on a scale
STANDARD_DEVIATION 5.8 • n=5 Participants
|
31.6 units on a scale
STANDARD_DEVIATION 6.0 • n=7 Participants
|
31.7 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
31.5 units on a scale
STANDARD_DEVIATION 6.0 • n=4 Participants
|
|
Self Paced Walk Test Total Distance
|
482.2 meters
STANDARD_DEVIATION 529.1 • n=5 Participants
|
433.4 meters
STANDARD_DEVIATION 421.2 • n=7 Participants
|
449.2 meters
STANDARD_DEVIATION 485.2 • n=5 Participants
|
455.3 meters
STANDARD_DEVIATION 480.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).Population: Analysis performed on all randomized participants and linear mixed models were used to account for missing data.
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.
Outcome measures
| Measure |
Medical Care
n=88 Participants
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
n=84 Participants
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.
|
Manual Therapy and Exercise
n=87 Participants
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.
|
|---|---|---|---|
|
Swiss Spinal Stenosis (SSS) Questionnaire Score
|
-2.0 units on a scale
Standard Deviation 5.5
|
-1.7 units on a scale
Standard Deviation 5.2
|
-4.1 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).Population: Analysis performed on all randomized participants and linear mixed models were used to account for missing data.
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.
Outcome measures
| Measure |
Medical Care
n=88 Participants
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
n=84 Participants
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.
|
Manual Therapy and Exercise
n=87 Participants
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.
|
|---|---|---|---|
|
Self Paced Walking Test (SPWT)
|
130.5 meters
Standard Deviation 478.7
|
219.2 meters
Standard Deviation 413.0
|
267.8 meters
Standard Deviation 507.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).Population: Analysis performed on all randomized participants and linear mixed models were used to account for missing data.
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.
Outcome measures
| Measure |
Medical Care
n=88 Participants
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
n=84 Participants
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.
|
Manual Therapy and Exercise
n=87 Participants
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.
|
|---|---|---|---|
|
Sense Wear Armband
|
-23.1 minutes per day
Standard Deviation 85.3
|
4.3 minutes per day
Standard Deviation 64.8
|
-6.0 minutes per day
Standard Deviation 76.0
|
Adverse Events
Medical Care
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Group Exercise
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Manual Therapy and Exercise
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medical Care
n=84 participants at risk
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
n=72 participants at risk
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.
|
Manual Therapy and Exercise
n=84 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Symptoms
|
7.1%
6/84 • Number of events 6 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
0.00%
0/72 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
0.00%
0/84 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
|
General disorders
Drowsiness
|
6.0%
5/84 • Number of events 5 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
0.00%
0/72 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
0.00%
0/84 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
|
General disorders
Dry Mouth
|
4.8%
4/84 • Number of events 4 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
0.00%
0/72 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
0.00%
0/84 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
|
Musculoskeletal and connective tissue disorders
Joint soreness
|
0.00%
0/84 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
13.9%
10/72 • Number of events 10 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
47.6%
40/84 • Number of events 93 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
6.0%
5/84 • Number of events 5 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
30.6%
22/72 • Number of events 26 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
52.4%
44/84 • Number of events 115 • Assessed from beginning of treatment up to 2 month follow up assessment.
|
Additional Information
Michael Schneider, PhD, DC - Associate Professor and Principal Investigator
University of Pittsburgh
Phone: 412-383-6640
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place