Trial Outcomes & Findings for Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain (NCT NCT01865539)

Results Overview

Visual Analog Scales (VAS): VAS is rated from 0 to 100mm with 0 being no pain at all and 100mm being the worst pain imaginable. The test has shown test-retest reliability, intra-examiner reliability and inter-examiner reliability.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

24 weeks.

Results posted on

2022-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Custom Foot Orthotic Custom foot orthotic Custom Foot Orthotic: Custom foot orthotic with custom design pads	Sham Orthotic Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads. Sham Orthotic: Leather insert without the custom design pads
Overall Study STARTED	21	30
Overall Study COMPLETED	21	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Custom Foot Orthotic n=21 Participants Custom foot orthotic Custom Foot Orthotic: Custom foot orthotic with custom design pads	Sham Orthotic n=30 Participants Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads. Sham Orthotic: Leather insert without the custom design pads	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	30 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	58.2 years STANDARD_DEVIATION 8.1 • n=5 Participants	55.1 years STANDARD_DEVIATION 10.5 • n=7 Participants	56.4 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	30 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks.

Visual Analog Scales (VAS): VAS is rated from 0 to 100mm with 0 being no pain at all and 100mm being the worst pain imaginable. The test has shown test-retest reliability, intra-examiner reliability and inter-examiner reliability.

Outcome measures

Outcome measures
Measure	Custom Foot Orthotic n=21 Participants Custom foot orthotic Custom Foot Orthotic: Custom foot orthotic with custom design pads	Sham Orthotic n=30 Participants Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads. Sham Orthotic: Leather insert without the custom design pads
Visual Analog Scale (VAS)	57.7 units on a scale Standard Deviation 15.6	59.2 units on a scale Standard Deviation 14.9

SECONDARY outcome

Timeframe: 24 weeks.

The back pain specific, self-rating scale evaluates the degree of functional impairment that a patient is experiencing in a number of activities of daily living. Oswestry is scored on a scale of 0-50 with 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled

Outcome measures

Outcome measures
Measure	Custom Foot Orthotic n=21 Participants Custom foot orthotic Custom Foot Orthotic: Custom foot orthotic with custom design pads	Sham Orthotic n=30 Participants Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads. Sham Orthotic: Leather insert without the custom design pads
Modified Oswestry Disability Index (mODI)	40.3 units on a scale Standard Deviation 13.2	37.1 units on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: 24 weeks.

For PROMIS measures, higher scores equals more of the concept being measured (more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. Specifically for PROMIS Physical function 50 indicates the reference population, therefore a score of 40 would be lower physical function.

Outcome measures

Outcome measures
Measure	Custom Foot Orthotic n=21 Participants Custom foot orthotic Custom Foot Orthotic: Custom foot orthotic with custom design pads	Sham Orthotic n=30 Participants Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads. Sham Orthotic: Leather insert without the custom design pads
Patient Reported Outcome Measurement Information System (PROMIS) Physical Function	38.3 units on a scale Standard Deviation 3.9	40.9 units on a scale Standard Deviation 4.1

Adverse Events

Custom Foot Orthotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Orthotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Dougherty, PI

Canandaigua VA Medical Center

Phone: 585-463-2673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place