Clinical trial NCT03300375: Exercise Intervention for Unilateral Amputees With Low Back Pain
Official title: Exercise Intervention for Unilateral Amputees With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group, parallel study
Primary purpose: TREATMENT

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.

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 and a prosthetic limb is fitted, the long-term care for amputees typically focuses on maintenance of the prosthesis fit and optimizing physical function. Even with high-quality prostheses, amputation permanently impacts biomechanical symmetry of gait. After unilateral transtibial or transfemoral amputation, skeletal muscle atrophy occurs in the lower extremity and back. Asymmetric gait causes mechanical stresses at lumbar spine, and loss of muscle mass and strength, all of which exaggerate gait aberrations. As a result, chronic low back pain (LBP) can develop. LBP is a common, but often unaddressed, secondary complication in over half of the unilateral amputee population.

Lower extremity amputees face numerous physical and emotional challenges after their injuries. Performing ambulatory activities are more physically demanding with an amputation than without. The psychological stress levels are often high after an amputation, contributing to activity avoidance and limiting participation in load-bearing activities. LBP independently contributes to costly health burdens such as addiction to pain medicine, depression and lifestyle diseases and LBP erodes physical and mental quality of life (QOL). Pain is also related to skeletal muscle atrophy in the low back. The combination of an amputation injury and LBP may amplify ambulation-related limitations and further deteriorate QOL. Unilateral lower extremity amputees who suffer from chronic LBP therefore may therefore experience greater walking limitations, physical activity avoidance and physiological changes to skeletal muscle, strength and perceived QOL than people with back pain or amputation alone.

Long-term care for amputees requires a team of physicians, prostheticians, therapists and other specialists. Patients often travel long distances to receive their care. Patients with limited resources may not be able to maintain a long-term relationship with therapists due to cost restrictions. Home-based interventions that target LBP could substantially impact the secondary disease burden and help restore QOL in the amputee population. In the general population, evidence indicates that consistently-performed muscle strengthening activity is associated with significantly lower odds of developing back pain in men and women. Resistance exercise is effective for lumbar muscle strength gains, functional gains in ambulation and movement and for improving both physical and mental aspects of QOL. Resistance training benefits in strength, motor skills, and many aspects of quality of life (both functional and psychosocial) are seen throughout several different demographics; from young adults to the elderly.

Current clinical paradigms to treat general LBP include referral to physical therapy for strengthening exercise programs. For amputees, challenges to receiving therapeutic care include travel distance, and financial limitations for exercise facility memberships or therapy copayments. Patients may not be able to sustain and therapy gains over the long-term when therapy benefits run out. Thus, exercise to treat LBP in amputees must be accessible, low or no cost and sustainable. A significant deficit in the clinical literature is that the study team does not know the effectiveness of home-based resistance training on different chronic musculoskeletal pains in amputees. Moreover, the mechanisms that may contribute to effectiveness of strength training on pain relief in amputees are not clear. The problem is therefore multifaceted: 1) amputees experience permanent anatomic changes that impact load-bearing activity, back pain and QOL; 2) chronic LBP treatment is not often a focus for the long-term management of the unilateral lower extremity amputee; 3) chronic LBP can develop in amputees as a consequence of asymmetric movement patterns, lumbar muscle atrophy and low muscle strength, but the relative contribution of each to pain severity is not known. These evidence gaps are significant barriers to the optimization of care for this special population by clinical teams who care for these individuals, and for determination of pain responders with strengthening exercise.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Pain assessment
timeFrame: Up to 6 months
measure: Functional impairment due to back pain
timeFrame: Up to 6 months
measure: Quality of Life Assessment
timeFrame: Up to 6 months
Secondary outcomes:
measure: Functional disability in patients with low back pain
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Heather Vincent, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.