Structural Integration for Chronic Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The primary purpose of study is the collection of feasibility data for a larger trial of
      Structural Integration (SI)(an alternative manual therapy) for chronic low back pain. The
      secondary purpose is the collection of preliminary data on 1) the therapeutic effect of SI
      plus usual care versus usual care alone - the hypothesis being the the effect size will be
      significantly greater in the SI plus usual care arm; and on 2) specific hypothesized
      mechanisms of that hypothesized therapeutic effect: a) improvements in cognitive behavioral
      factors; b) improvements in standing balance and gait, and c) improvements in selected blood
      biomarkers.
    

Detailed description: 
      Chronic, non-specific low back pain is among the most burdensome health problems in both
      prevalence and cost of care. Up to one third of acute low back pain cases may become chronic
      and lead to disability. A large fraction of chronic cases are absent of findings of
      well-understood causes, i.e. neoplastic, infectious or inflammatory conditions, or nerve
      compression, and are generally designated as "uncomplicated," "non-specific," or
      "mechanical." Usual care typically includes oral and injected medication, physical therapy
      and exercise. Therapeutic response is difficult to predict and many outcomes are
      unsatisfactory, with high rates of relapse.

      Structural Integration (SI) is an alternative method of manual therapy and somato-sensory
      training that purports to improve the biomechanical functioning of the body as a whole rather
      than to focus on the treatment of specific symptoms. SI is delivered in a series of ten
      treatments, referred to as "the Ten Series," each of approximately one hour in duration. The
      Ten Series protocol includes manipulation of all major joints and anatomical segments. Each
      of the ten sessions aims to achieve a different, specified set of biomechanical changes which
      are regarded as contributing to the progressive approximation of specific ideals of posture
      and movement.

      Forty (40) subjects will be recruited from among individuals entering treatment for chronic
      low back pain at outpatient rehabilitation clinics in the Boston area. Following baseline
      measures, subjects will be randomized with equal probability (50/50) to usual care alone
      versus usual care plus ten sessions of SI. SI treatment will be provided by qualified SI
      therapists at their private practice offices. They will be supervised on a monthly basis by a
      co-investigator with extensive prior experience in the clinical practice of SI.

      Data will be collected at baseline, end-of-treatment, and endpoint. Baseline data will be
      collected prior to the subject's first treatment appointment, and endpoint data will be
      collected from all subjects at 20 weeks post-baseline. End-of-treatment measures will be
      conducted during the week following each subject's completion of their assigned treatment
      arm. Consequently, the average time elapsed between baseline and end-of-treatment will differ
      across the two treatment arms, because of different amounts of time allowed for the
      completion of usual care alone (3-7 weeks) versus usual care plus SI (10-15) weeks.

      Analysis relevant to the primary aim of the study will be conducted as follows: The
      demographic characteristics of candidates referred, subjects enrolled, and dropouts will
      described. Descriptive statistics, both aggregate and per treatment arm, will be computed for
      data on retention and compliance with treatment, and on the use of concurrent medications.
      Each adverse events will be characterized by subject demographics and by treatment arm, and
      will also be rated for severity, likelihood of relation to the study, and expected versus
      unexpected.

      Analysis relevant to the secondary aim of the study will be conducted as follows: Baseline to
      endpoint changes in therapeutic outcomes, cognitive-behavioral measures and blood assay
      values will be compared across treatment arms using appropriate statistical tests. Baseline
      to endpoint changes in standing balance and gait parameters will be analyzed using methods
      that are standard in the current literature. In addition to appropriate statistical tests,
      these include the visual inspection of graphic displays of the phase relationships between
      rotational movements of body segments during gait. The association between each mechanistic
      parameter - cognitive-behavioral, biomechanical, and blood biomarkers - and the primary and
      secondary therapeutic outcomes will be explored per treatment arm and in aggregate.

      Data on changes between baseline and end-of-treatment will be subject to exploratory analysis
      within treatment arms only. Comparison across arms is inappropriate because of systematic
      variation in the average duration of treatment in usual care alone (estimated at 5 weeks)
      versus usual care plus SI (estimated at 12.5 weeks). Analysis will include the exploration of
      associations between changes in therapeutic outcomes on one hand, and mechanistic parameters
      on the other, but only within each treatment arm.
    

Intervention name(s): Structural Integration; Usual care
Intervention type(s): Procedure; Procedure
Intervention description(s): Structural Integration (SI) is an alternative method of manual therapy and somato-sensory training that purports to improve biomechanical functioning of the body as a whole rather than to focus on the treatment of specific symptoms. SI therapists employ both manipulation and somatosensory education. SI is delivered in a series of ten treatments, referred to as "the Ten Series," each of approximately one hour in duration. The Ten Series protocol includes manipulation of all major joints and anatomical segments. Each of the ten sessions aims to achieve a different set of biomechanical changes, which are regarded as contributing to the progressive approximation of specific ideals of posture and movement.; Usual care in this study consists of the treatment regimen provided for chronic low back pain at Spaulding Medford Rehabilitation clinic, which may include pain medication, exercise and physical therapy. Frequency of treatment averages twice weekly, duration ranges from 3 to 7 weeks
Other intervention name(s): Rolfing, a registered service mark of the Rolf Institute; Standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low back pain; chronic pain; manual therapy; Structural Integration