NCT01865539

Brief Summary

A randomized sham controlled trial evaluating the efficacy of the use of custom foot orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes that those veterans with chronic lower back pain who receive the custom foot orthotics will show greater improvements in pain and disability associated with the chronic lower back pain than those who receive the sham orthotic.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
6 years until next milestone

Results Posted

Study results publicly available

May 16, 2022

Completed
Last Updated

May 16, 2022

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

May 20, 2013

Results QC Date

February 7, 2017

Last Update Submit

April 21, 2022

Conditions

Back Pain Lower Back Chronic

Keywords

Chronic lower back painCustom foot orthoticsVeterans

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    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.

    24 weeks.

Secondary Outcomes (2)

  • Modified Oswestry Disability Index (mODI)

    24 weeks.

  • Patient Reported Outcome Measurement Information System (PROMIS) Physical Function

    24 weeks.

Study Arms (2)

Custom Foot Orthotic

ACTIVE COMPARATOR

Custom foot orthotic

Device: Custom Foot Orthotic

Sham Orthotic

SHAM COMPARATOR

Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads.

Device: Sham Orthotic

Interventions

Custom Foot OrthoticDEVICE

Custom foot orthotic with custom design pads

Also known as: Foot Levelers Custom Foot Orthotic
Custom Foot Orthotic
Sham OrthoticDEVICE

Leather insert without the custom design pads

Sham Orthotic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-65 Lower back pain ≥ 3 months in duration Pain elicited upon deep palpation of the lumbar erector spinae musculature Primary complaint of CLBP from L1 to Sacroiliac joint inclusive. Ability/willingness to use orthotics in their shoes Numeric Pain Rating Scale (NRPS) of ≥ 3
  • mm on the Visual Analogue Scale (VAS)
  • % for the Modified Oswestry Disability Index (mODI)

You may not qualify if:

  • spinal surgery, spinal injections or injections in their feet within the past 6 months Inability to use orthotics in shoes Custom foot orthotics within the past 12 months Currently undergoing Chiropractic, Physical Therapy or Acupuncture treatment for their chronic lower back pain.
  • evidence of cauda equina syndrome, spinal neoplasia or metastatic disease, destructive joint pathology such as rheumatoid arthritis bowel/bladder dysfunction (associated with the back pain) peripheral neuropathy or progressive lumbosacral radiculopathy, progressive myelopathy or neurogenic claudication.
  • open workers compensation or no fault case.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center

Rochester, New York, 14620, United States

Location

Related Publications (1)

  • Sahar T, Cohen MJ, Uval-Ne'eman V, Kandel L, Odebiyi DO, Lev I, Brezis M, Lahad A. Insoles for prevention and treatment of back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine (Phila Pa 1976). 2009 Apr 20;34(9):924-33. doi: 10.1097/BRS.0b013e31819f29be.

    PMID: 19359999BACKGROUND

Related Links

Limitations and Caveats

Due to low power secondary to issues with subject recruitment, the findings of this study were inconclusive.

Results Point of Contact

Title
Dr. Paul Dougherty, PI
Organization
Canandaigua VA Medical Center
paul.dougherty@va.gov
585-463-2673

Study Officials

  • Paul E Dougherty, DC

    Canandaigua VA Medical Center/ New York Chiropractic College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chiropractor

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 31, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

May 16, 2022

Results First Posted

May 16, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)