NCT03300375

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 extremity amputees who suffer from Low Back Pain. The study will follow the principles of the Consolidated Standards of Reporting Trials for randomized, two group, parallel studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

September 14, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

September 28, 2017

Last Update Submit

March 5, 2020

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

  • Pain assessment

    Pain and Catastrophizing Scale (PCS) is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is broken into three subscales being magnification, rumination, and helplessness. The scale was developed as a self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations.

    Up to 6 months

  • Functional impairment due to back pain

    Roland Disability Questionnaire consist of 24 items (see below). Those 24 questions are related specifically to physical functions that were likely to be affected by low back pain. Greater levels of disability are reflected by higher numbers. Scores under 4 and over 20 may not show significant change over time in patients with scores of less than 4 and deterioration in patients who have scores greater than 20.

    Up to 6 months

  • Quality of Life Assessment

    Medical Outcomes Short-Form 36 (SF-36) This instrument has 36 items and yields eight domain scores and two component scores (Mental, Physical). The eight domains are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and emotional well-being. The SF-36 has shown good internal consistency (Cronbach's range of 0.95-0.93). This instrument has been used to track QOL after traumatic injury, such as amputation.50

    Up to 6 months

Secondary Outcomes (1)

  • Functional disability in patients with low back pain

    up to 6 months

Study Arms (2)

Home-Based Resistance Exercise Intervention Group

ACTIVE COMPARATOR

Participants in the HBRX group will be coached through six phases of the intervention with two weeks per phase. Exercise will use body weight and resistance exercise bands. A set of commercial elastic resistive bands and a stability pad (TheraBand, Inc.) will be provided to each participant to keep for personal use after their participation in the study. The use of elastic bands for resistance training can induce similar results in neuromuscular adaptations as well as strength to those achieved by weight machines and free-weights.

Other: Home exercise program

Wait-List Control Condition Group

EXPERIMENTAL

Participants who are assigned to the CON group will wait to participate in the resistance training after a three month wait period. Participants will follow all instructions provided to them by their physician and care team, but will be asked to refrain from starting any new strengthening exercise protocols or begin any new physical therapies during this time. The participants will be contacted by phone on a monthly basis during the study period to determine if any changes in LBP symptoms have occurred. At month three, these participants will also receive the elastic resistive bands and a stability pad.

Other: Home exercise programOther: Post Op instructions

Interventions

Home exercise programOTHER

Home-based, progressive exercise program using resistance bands

Home-Based Resistance Exercise Intervention GroupWait-List Control Condition Group
Post Op instructionsOTHER

Participants will follow all instructions provided to them by their physician and care team, but will be asked to refrain from starting any new strengthening exercise protocols or begin any new physical therapies during this time.

Wait-List Control Condition Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Wasser JG, Herman DC, Horodyski M, Zaremski JL, Tripp B, Page P, Vincent KR, Vincent HK. Exercise intervention for unilateral amputees with low back pain: study protocol for a randomised, controlled trial. Trials. 2017 Dec 29;18(1):630. doi: 10.1186/s13063-017-2362-0.

    PMID: 29284521DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heather Vincent, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Permuted block randomization with block sizes of four will made by means of a computer algorithm to ensure balanced group sizes and allocation concealment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two group, parallel study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 3, 2017

Study Start

September 14, 2017

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

US(1)