Back-related leg pain (BRLP) is a costly
and often disabling variation of low back pain that
affects much of society. As health care costs soar,
the search for effective treatments with few side effects
is critical. While there is preliminary evidence suggesting
chiropractic spinal manipulative therapy (SMT) is beneficial
for patients with BRLP, high quality, randomized clinical
trials (RCTs) are needed. The proposed team of chiropractic
and allopathic investigators has designed the first
full-scale RCT assessing the clinical efficacy of chiropractic
SMT for patients with sub-acute and chronic BRLP. The
long-term goal is to identify effective conservative
care options for these patients.
The primary aims of the project are to determine the
clinical efficacy of chiropractic SMT plus self-care
education versus self-care education alone in 192 patients
with sub-acute and chronic BRLP in both the short-term
(after 12 weeks) and long-term (after 52 weeks). The
primary outcome variable is leg pain and secondary outcome
variables include low back pain, disability, bothersomeness
and frequency of symptoms, general health status, and
fear avoidance behavior.
Secondary aims are to describe and estimate between
group differences in patient satisfaction, improvement,
medication use, straight leg raise, torso endurance,
and three biomechanical measures: continuous spinal
motion, postural sway, and neuromuscular response to
sudden load. Patient perceptions of treatment will also
be assessed.
Experienced teams of chiropractic and allopathic professionals,
with established track records in low back pain and
chiropractic research, join together to conduct this
multi-site RCT. Patients will be recruited from the
Twin Cities and Quad Cities metropolitan areas. The
Office of Data Management and Biostatistics at PCCR
will serve as the Data Coordinating Center.
|
