Exercise Intervention for Unilateral Amputees With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Home exercise program; Post Op instructions
Intervention type(s): Other; Other
Intervention description(s): Home-based, progressive exercise program using resistance bands; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group, parallel study
Masking: Single (Participant)
Primary purpose: Treatment