Effectiveness of Adding Behavioral Therapy to Physical Therapy to Treat Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is a very common problem and the most common cause of job-related disability.
      While some occurrences of low back pain disappear within a couple of days, other occurrences
      take much longer to resolve or lead to more serious conditions. The purpose of this study is
      to determine the effectiveness of two behavioral types of therapy in reducing future
      disability in people who are receiving physical therapy for low back pain and tend to fear
      and avoid pain.
    

Detailed description: 
      Psychosocial factors, such as fear and avoidance, appear to play a role in the development of
      long-term disability from low back pain. The Fear-Avoidance Model of Exaggerated Pain
      Perception (FAMEPP) is a biopsychosocial model that attempts to explain how and why some
      individuals develop a more substantial psychological component to their low back pain problem
      than do others. FAMEPP suggests that an individual's pain-related fear and avoidance are the
      most important factors in determining whether long-term disability will result from an
      episode of low back pain. For example, FAMEPP suggests that individuals with high
      pain-related fear and avoidance are likely to use an avoidance response to low back pain,
      leading to both physical and psychological consequences. In contrast, individuals with low
      pain-related fear and avoidance are likely to use a confrontation type of response to low
      back pain and gradually return to their normal social and physical functioning.

      Treatment based on FAMEPP involves two specific behavioral interventions that encourage
      people to confront their low back pain. The first intervention, graded exposure, places the
      individual in fearful situations and gradually increases their exposure to such situations.
      The second intervention, graded exercise, increases an individual's tolerance to activity
      over time. The purpose of this pilot study is to determine the effectiveness of graded
      exposure and graded exercise, when combined with traditional physical therapy, in reducing
      future disability in adults with low back pain who tend to fear and avoid pain.

      Participants in this study will be randomly assigned to one of three groups:

        -  Group 1 will undergo graded exposure in addition to normal physical therapy during
           treatment sessions.

        -  Group 2 will undergo graded exercise in addition to normal physical therapy during
           treatment sessions.

        -  Group 3 will participate in only normal physical therapy during treatment sessions.

      The number of treatment sessions will vary, depending on how a participant is improving. At
      Week 4 and Month 6, all participants will be evaluated with a pain symptom assessment and
      questionnaires on pain intensity, pain-related disability, fear-avoidance beliefs,
      overreaction to pain, and physical impairment. There will be no other follow-up visits for
      this study.
    

Intervention name(s): Standard physical therapy; Graded exercise; Graded exposure
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Treatment-based classification physical therapy; Graded exercise increases an individual's tolerance to activity over time; Graded exposure places the individual in fearful situations and gradually increases their exposure to such situations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Secondary prevention; Physical therapy; Fear-avoidance beliefs; Disability