Status:

COMPLETED

Exercise Intervention for Unilateral Amputees With Low Back Pain

Lead Sponsor:

University of Florida

Conditions:

Low Back Pain

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

A three-month, randomized, controlled study will be used to examine the effects of a home-based resistance exercise program on improving pain severity and functional ability in unilateral lower extrem...

Detailed Description

Amputation to the lower extremity is a life-changing event. Approximately 2 million Americans live with limb loss, with \~45% of losses occurring from traumatic mechanisms. After the injury has healed...

Eligibility Criteria

Inclusion

  • Between 18-60 years of age
  • English speaking
  • Suffering from chronic LBP (\>3 months with ≥3 pain episodes per week)
  • Baseline pain of ≥3 points out of 10 on the NRSPain scale
  • Amputation ≥1 year prior and their current prosthesis must have been worn for at least 6 months (prosthesis K-Level of K2 or greater, indicating the subject is able to ambulate and traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces).
  • Must have regular access to a computer for skype, or a mobile phone or iPAD to perform facetime

Exclusion

  • Acute back injury
  • Any other chronic back pathology (i.e. herniated disc, ankylosing spondylosis, other related neurologic disease)
  • Pain symptoms or functional limitations (including those that may require assistive devices) that preclude participation in resistance exercise or physical activity
  • Back surgery within the past two years that restrict daily physical activities
  • Currently enrolled in any other resistance or strengthening exercise interventions
  • Pregnant

Key Trial Info

Start Date :

September 14 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 4 2020

Estimated Enrollment :

6 Patients enrolled

Trial Details

Trial ID

NCT03300375

Start Date

September 14 2017

End Date

March 4 2020

Last Update

March 6 2020

Active Locations (1)

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1

University of Florida

Gainesville, Florida, United States, 32611