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Orthotic Use for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT00976664
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : November 17, 2014
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Foot Levelers, Inc.
Information provided by (Responsible Party):
Jerrilyn Cambron, DC, PhD, National University of Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Low Back Pain
Interventions Device: Shoe orthotic
Device: Shoe Orthotic Wait Group
Enrollment 50
Recruitment Details We recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area.
Pre-assignment Details 143 people were screened by phone, eligible patients (58) attended a baseline visit. Subjects were eligible if they were 18+ years of age and symptomatic with pain between T12-S1 joints with or without radiating pain for at least 3 months. Patients were randomized to a treatment group receiving custom-made orthotics or a wait-list control group.
Arm/Group Title Orthotic Group Wait Group
Hide Arm/Group Description This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks. This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
Period Title: Overall Study
Started 25 25
Completed 22 24
Not Completed 3 1
Arm/Group Title Orthotic Group Wait Group Total
Hide Arm/Group Description This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks. This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age, Customized Number Analyzed 25 participants 25 participants 50 participants
51  (16) 53  (16) 52  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
15
  60.0%
13
  52.0%
28
  56.0%
Male
10
  40.0%
12
  48.0%
22
  44.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Visual Analog Scale (VAS)
Hide Description This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.
Time Frame Randomization, Week 6, and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.
Arm/Group Title Orthotic Group Wait Group
Hide Arm/Group Description:
This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
Overall Number of Participants Analyzed 22 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Randomization 5.0  (2.2) 4.3  (1.9)
Week 6 2.8  (2.6) 4.1  (2.3)
Week 12 2.7  (2.5) 2.9  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orthotic Group, Wait Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0007
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Group differences in VAS for low back pain from randomization visit to 6-week visit were assessed via the Wilcoxon rank sums test.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Orthotic Group, Wait Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .3913
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Group differences in VAS for low back pain from randomization visit to 12-week visit were assessed via the Wilcoxon rank sums test.
2.Primary Outcome
Title Oswestry Disability Index (ODI)
Hide Description This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.
Time Frame Randomization, Week 6, and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.
Arm/Group Title Orthotic Group Wait Group
Hide Arm/Group Description:
This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
Overall Number of Participants Analyzed 22 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Randomization 10.0  (4.9) 10.4  (5.8)
Week 6 6.2  (5.2) 10.2  (5.4)
Week 12 6.1  (5.3) 8.9  (5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orthotic Group, Wait Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Group differences in ODI for low back pain from randomization visit to 6-week visit were assessed using the Wilcoxon rank sums test.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Orthotic Group, Wait Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0336
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Group differences in ODI for low back pain from randomization visit to 12-week visit were assessed using the Wilcoxon rank sums test.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Orthotic Group Wait Group
Hide Arm/Group Description This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks. This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
All-Cause Mortality
Orthotic Group Wait Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Orthotic Group Wait Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Orthotic Group Wait Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Subjects and clinicians were not blind to group. Subjects came from 1 region of the US, majority were white and ~50 years old. One type of orthotic was used as the only form of care. Several subjects felt discomfort/stiffness rather than pain.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jerrilyn Cambron
Organization: National University of Health Sciences
Phone: 630-889-6536
Responsible Party: Jerrilyn Cambron, DC, PhD, National University of Health Sciences
ClinicalTrials.gov Identifier: NCT00976664     History of Changes
Other Study ID Numbers: NUHS IRB H-0904
First Submitted: September 11, 2009
First Posted: September 14, 2009
Results First Submitted: April 30, 2012
Results First Posted: November 17, 2014
Last Update Posted: May 3, 2017