Feasibility of Using Functional Progression to Guide the Treatment of Adolescent Low Back Pain
Condition: Low Back Pain; Spondylolysis; Spondylolisthesis
MeSH terms: Spondylolisthesis; Spondylolysis; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The goal of the proposed research is to test the feasibility of a functional progression
      program to reduce cost and possible radiation exposure for adolescent athletes with low back
      pain. Specifically the investigators plan to test the feasibility of using progression in
      rehabilitation to pragmatically differentially diagnose and treat adolescent athletes with
      low back pain, instead of using advanced imaging which is the current practice. The
      investigators propose to recruit 20 participants, with 10 of usual care (advanced imaging)
      and 10 of proposed intervention (functional progression) to assess the feasibility of using
      functional progress to guide treatment. The outcomes measured will be number of days for
      rest, time to start regular rehabilitation, pain experienced, functional outcomes, ability to
      return to sport, time needed to return to sport. If this pilot demonstrates the feasibility
      and a decreased rate of advanced imaging and similar clinical outcomes the investigators plan
      to progress this work into larger trials.
    

Detailed description: 
      Low back pain (LBP) is a common complaint in adolescent athletes, with rates reported as high
      as 50% by the mid-teen years. Although low back pain in adolescent athletes may result from
      several different pathologies, spondylolysis--a fracture at the pars interarticularis--is the
      most common cause in this demographic, with a prevalence as high as 47%. The recommended
      treatment of spondylolysis and non-specific mechanical LBP is quite different. Patients with
      mechanical LBP are recommended to stay active, and perform rehabilitation if necessary, while
      the primary treatment for spondylolysis is rest for 3 months, physical therapy and bracing as
      needed. With the diagnosis of spondylolysis being fairly common in young athletes with low
      back pain, physicians need to have a high index of suspicion in making the diagnosis.
      Advanced imaging is often necessary to confidently rule in or out the diagnosis of
      spondylolysis. Advanced imaging increases diagnostic accuracy, but adds to the cost and
      potentially considerable radiation exposure. However, advanced imaging may not be necessary
      to effectively treat adolescents with low back pain.

      Function, not imaging, is used to determine when a patient has healed from a spondylolytic
      injury. In fact, results of healing on imaging have no association with clinical outcome.
      Most defects do not heal with non-operative treatment suggesting that a successful clinical
      outcome does not depend on healing of the lesion. The functional progress that patients make
      is markedly different between patients with mechanical LBP and patients with a spondylolysis.
      The majority of adolescents with mechanical LBP can make a full functional recovery on their
      own or with a short period of rehabilitation. A patient with a spondylolytic injury may
      demonstrate an inability to make a full return to activity with rehabilitation and requires a
      period of rest from sport and high level activity to make a full functional recovery. Due to
      the differences in progression between mechanical LBP and spondylolysis, functional progress
      could be used to differentially diagnose these conditions. If effective, using functional
      progress instead of advanced imaging would be more cost-effective and expose the patient to
      significantly less radiation. In a retrospective review of adolescent patients presenting to
      the investigators sports medicine clinic with LBP, 80% had advanced imaging performed due to
      a concern of spondylolysis. Thirty-two percent of patients were positive for spondylolysis on
      advanced imaging, and 11% of patients had multiple advanced imaging performed due to lack of
      progress. No other significant findings were noted on advanced imaging. By using functional
      progress to determine the course of care, and only using advanced imaging when a patient does
      not respond to conservative care, there is the potential to significantly reduce the need for
      advanced imaging.

      The primary risk of using functional progress in physical therapy (PT) instead of advanced
      imaging to determine to the course of care in adolescents with LBP is a delayed diagnosis for
      those who fail to respond to conservative care. The risk of missing a sinister pathology
      mimicking LBP can be minimized with a thorough clinical evaluation and radiographs if
      warranted. The results of the investigators' previous work demonstrate that early PT care in
      patients with a spondylolytic injury is safe and reduces time to return to sport. In a
      retrospective review with a cross-sectional follow-up, patients with an acute spondylolysis
      who began physical therapy as soon a 4 weeks (mean of 2 months) made a quicker functional
      recovery back to all activity and had similar clinical outcomes at 1-5 year follow-ups. A
      delayed diagnosis does not negatively impact long-term functional outcomes for patients with
      a spondylolysis as duration of symptoms is not found to be associated with outcome. Using
      logistic regression on the same dataset as above to determine factors associated with good
      short and long-term clinical outcomes, duration of symtpoms or time to diagnosis was not
      found to impact outcomes. On the other hand, delaying PT care to obtain advanced imaging is
      found to negatively impact outcomes in patients with mechanical LBP.

      This project will lay the groundwork to demonstrate the feasibility of a functional
      progression to treat adolescent athletes with LBP. If successful, additional study will be
      proposed to test the effectiveness of intervention (functional progression) as compared to
      usual care (imaging) in improving the recovery outcome of LBP. Ultimately, this research
      would lead to change in the way adolescent athletes with LBP are treated, resulting in
      decreased cost, decreased exposure to radiation, and decreased time to begin rehabilitation.
      The results of this work would positively impact patients, clinicians, and decreased the
      costs to the health care system.

      Control Cohort A series of 10 individuals who meet the inclusion criteria and are patients of
      the sports medicine physicians (Dr.s James MacDonald, Ravindran), physicians who are not
      recruiting patients for the experimental cohort but are still co-investigators, will serve as
      a non-randomized control cohort of typical clinical care and outcomes.

      Description of the functional progression to guide treatment protocol. (Figure 1) Patients
      will be evaluated by their physician to determine appropriateness for participation in this
      study. Patients who meet the inclusion criteria and consent to participate in the pilot study
      as a part of the experimental cohort will not have advanced imaging done and will be referred
      directly to PT care for 2 times per week for 3 weeks. The functional progression protocol
      will be performed by physical therapists trained in the treatment and progression protocol.
      Patients will perform phase I of the PT protocol and progress to phase II as able without an
      increase in pain and with sufficiently proper mechanics. (Table 1) Patients will be assessed
      at each session to determine if they meet the criteria to begin the next step of functional
      PT progression back to sport. (Table 2) Those patients who meet these criteria within the
      designated 3 week period will progress into the next phase of functional PT for return to
      sport activity with an additional 2 weeks of PT. If these patients progress well in this
      third phase, and are able to meet the return to sport criteria, they will be discharged from
      PT and monitored by phone for recurrence of symptoms until 2 months. (Table 3) Those patients
      who do not progress through phase I or II functionally or without pain will be braced, as
      determined by their physician, and placed on rest from all activities excepting ADL's and
      their PT home exercise program and will be treated as patients with a presumed spondylolysis.
      Additionally, patients who are unable to meet the return to sport criteria within 5 weeks of
      PT will be braced, as deemed necessary by their physician, and placed on rest from all
      activities except ADL's and their PT home exercise program and will be treated as having a
      presumed spondylolysis. These patients will follow care appropriate for the condition. They
      will rest from sport until >2 months after initial evaluation , be braced as necessary, and
      ultimately complete 4 weeks of PT care to progress them as able back to sport activity.
      Patients who are treated as having a presumed spondylolysis will not be returned to sport
      before 3 months of rest as this period of rest has been found to produce optimal results.(El
      Rassi et al., 2013) Patients will have monthly re-evaluations with their physician until
      discharge. If at any point the patient is not responding as expected or the physician has
      concerns over the patient's safety, the physician can take the appropriate steps they feel
      are necessary for the safety of the patient. Patients who are classified as non-responders
      will be those who do not progress as expected for the typical course of mechanical LBP or
      spondylolysis.

      Specific Outcome Variables

        1. Advanced imaging use during the episode of care: Computed tomography (CT), single-photon
           emission computed tomography (SPECT), and magnetic resonance imaging (MRI).

        2. Total cost will be calculated as the billed costs of physician visits, physical therapy
           visits, radiographs, advanced imaging, prescribed brace, and prescribed medication.

        3. Total number of PT visits will be calculated as the number of physical therapy visits
           completed for the LBP episode of care.

        4. The number of days from when the physician initially evaluates the patient and places
           them on hold from sport activity to when the patient was cleared to return to sport.

        5. , Clinical outcomes: Modified Odom's Criteria, and Micheli Functional Scale. Ability to
           return to sport This pilot study will not be randomized. All patients consenting to
           participate will be treated according to the treatment approach the co-investigating
           physicians have agreed to perform.

      Blinding No blinding will be performed in this pilot trial as it is not feasible to blind
      either the clinicians or the patient to the treatment cohort.

      Data Analysis Descriptive statistics of the patient demographics and outcome variables will
      be reported. The two treatment groups will be compared based on cost, imaging usage, and
      outcomes but will not perform statistical analysis due to the small sample size.

      Treatment received Patient Characteristics (eg gender, age) Injury characteristics (eg
      duration of symptoms, type of symptoms Number of patients utilizing advanced imaging. Total
      cost of episode of care for LBP Total number of PT visits. Number of days to return to all
      sporting activity Clinical outcomes (eg pain, function, patient perceived improvement)
    

Intervention name(s): Standard Model of Care; Alternative Model of Care
Intervention type(s): Other; Other
Other intervention name(s): Functional progression program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Adolescent; Low Back Pain; Athlete