Structural Integration for Chronic Low Back Pain

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.

Inclusion Criteria:

- Chronic low back pain patient-rated >=3 on a VAS (0-10) with retrospective duration
of at least 6 months

- Low back pain attributed to mechanical as opposed to infectious, neoplastic or
inflammatory causes

- Age 18-65

- English speaking

- Male or female

- Mental capacity sufficient to provide informed consent

- Able to commit to up to 27 study meetings over a period of 5 months.

Exclusion Criteria:

- Impairment of hearing, speech, vision, mobility or English fluency sufficient to
interfere with participation in the study

- Current or anticipated receipt of payments from Workmen's Compensation or other
insurance for disability attributed to low back pain.

- Reports any prior treatment with Structural Integration (Rolf or other varieties,
including "structural massage")

- Plans to initiate additional treatment for back pain during the period of the study
other than usual rehabilitation care provided at Spaulding Medford clinic,
particularly massage or other manual therapy (e.g. chiropractic, osteopathic)

- Unresolved musculoskeletal pathology of the lower limbs

- Pregnancy

- Clinical judgment by Spaulding Medford medical director that the candidate will
require either surgery or epidural analgesia within the next five months.

- Alcohol of substance abuse

- Any implanted medical device (e.g. cardio-pacemaker, shunts)

- Prior discectomy or implantation of rods, screws or plates (bulging disc without
radicular pain is not exclusionary; hip or shoulder replacement is not exclusionary)

- Current medication with coumadin or prednisone, chronic use of steroid medications,
daily use of narcotic analgesics.

- Current diagnosis with any of the following

1. Balance problems due to vestibular or other neurological impairments

2. Osteoporosis (osteopenia is not exclusionary)

3. Fibromyalgia

4. Severe or progressive neurological deficits, including neuromotor impairment

5. Any hypercoagulation condition

6. Eczema, skin infections, deep vein thrombosis

7. Burns or other acute trauma including unhealed bone fractures or open wounds.

8. Psychiatric illness not well controlled, or current episode of exacerbated major
depressive disorder.

- Any other major medical condition that has not been stabilized, or that would impair
the patient's ability to complete the activities required by the study

- Body Mass Index >= 40