Low Back Pain Clinical Trial
Official title:
Classification Based "Cognitive Functional Therapy" vs. Manual Therapy for a Subgroup of Patients With Chronic NSLBP, Classified as Having a "Flexion Pattern"
This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients
receive a specific diagnosis, leaving the majority of patients diagnosed with non specific
low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. This
pilot study will compare manual therapy (manipulation and soft tissue treatment)and exercises
to a classification based biopsychosocial intervention (a cognitive/functional approach) as
described by Peter O`Sullivan, on a subgroup called "flexion pattern"
This pilot study has three specific aims:
(i) To determine the mean and standard deviation on the numerical rating scale of
participants in this setting who have a motor control flexion pattern, so that sample size
calculations for a fully powered randomized controlled trial could be performed.
(ii) To test the logistical and practical procedures that will be required to perform a fully
powered randomized controlled trial using these two treatments.
(iii) To gain a preliminary estimate of any difference in the effect of these two treatments,
so as to determine if the results of a fully powered randomized controlled trial might be
clinically important and therefore worthwhile undertaking
This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients
receive a specific diagnosis, leaving the majority of patients diagnosed with non specific
low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP.This
project will recruit patients , classified with a "flexion pattern" according to the
classification system proposed by Peter O´Sullivan. When classified with a flexion pattern
the patients will be randomized into either of two treatment arms. Manual therapy
(manipulation and soft tissue treatment)and exercises by a chiropractor or to a
classification based biopsychosocial intervention done by a physiotherapist, (a
cognitive/functional approach) as described by Peter O`Sullivan
This pilot study has three specific aims:
(i) To determine the mean and standard deviation on the numerical rating scale of
participants in this setting who have a motor control flexion pattern, so that sample size
calculations for a fully powered randomized controlled trial could be performed.
(ii) To test the logistical and practical procedures that will be required to perform a fully
powered randomized controlled trial using these two treatments.
(iii) To gain a preliminary estimate of any difference in the effect of these two treatments,
so as to determine if the results of a fully powered randomized controlled trial might be
clinically important and therefore worthwhile undertaking
;
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