Low back pain
Conditions
Interventions
Experimental group: 38 individuals with nonspecific chronic low back pain and functional constipation according to Rome III will receive the visceral osteopathic manipulation, which will be composed o
Procedure/surgery
H02.403.640
Sponsors
Associação Educacional Nover de Julho
Universidade Nove de Julho
Associação Educacional Nover de Julho
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 18 to 65 years; nonspecific low back pain for at least 3 months; pain intensity of at least 2 points as measured with 0 - to 10 - point Pain Numerical Rating Scale; functional constipation according criterias to Rome III.
Exclusion criteria
Exclusion criteria: Patients with any contraindication to osteopathic visceral manipulation or that submitted to treatment at least 6 months ago. previous spine surgery within the preceding 6 months; serious spinal pathology (e.g., metastasis, spinal fracture, inflammatory, and infective diseases, caudal equine syndrome, canal stenosis); Serious cardiovascular or metabolic diseases; pregnancy; red flags signals; nor currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecysticis, renal calculi, peritonitis, appendicitis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Difference in pain intensity measured through numerical verbal pain scale comparing pre-treatment with immediate post, post 6 weeks and 3-month follow-up. Expected outcome 2: Difference in lumbar disability measured through Oswestry Disability Index pre-treatment with immediate post, post 6 weeks and 3-month follow-up.;For the primary outcomes of the study, statistically significant differences favoring the Osteopathic Visceral Manipulation OVM group were found regarding reductions in pain and disability. The OVM group reported a reduction in pain intensity after six weeks of treatment (treatment effect = -1.34, 95% CI: -2.58 to -0.09, p-value = 0.03) and at the three-month evaluation (treatment effect = -2.00, 95% CI: -3.27 to -0.73, p = 0.002). An improvement in the ODI was also found in the OVM group after six weeks of treatment (treatment effect = -6.59, 95% CI: -12.01 to -1.17, p = 0.01) and at the three-month evaluation (treatment effect = -6.02, 95% CI: -11.55 to -0.49, p = 0.03). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Difference in paravertebral muscle activity measured through electromyography during the flexion relaxation phenomenon, comparing the pre-treatment with the immediate post, post 6 weeks and 3-month follow-up. Expected outcome 2: Difference in general flexibility measured through fingertip-to-floor test, comparing the pre-treatment with the immediate post, post 6 weeks and 3-month follow-up. Expected outcome 3: Difference in individuals' beliefs and fears regarding their low back pain measured through the Fear Avoidance Beliefs Questionnaire (FABQ), comparing pre-treatment with post 6 weeks and 3-month follow-up.;For the secondary outcomes, statistically significant differences were found after the six weeks of treatment only with regard to electromyographic muscle activity during the flexion (treatment effect = 4.44, 95% CI: 1.03 to 7.85, p = 0.01) and extension (treatment effect = 4.78, 95% CI: 0.5 to 9.02, p = 0.02) phases of the flexion-extension cycle, whereas no significant differences were found during the resting phase. No significant differences were found in any phase of the movement at the three-month follow-up evaluation. No significant differences were found regarding the finger-to-floor distance after six weeks of treatment (treatment effect = -0.03, 95% CI: -2.29 to 2.22, p = 0.97) or at the three-month follow-up evaluation (treatment effect = -1.44, 95% CI: -3.77 to 0.87, p = 0.20). Likewise, no significant differences were found regarding the Fear Avoidance Beliefs Questionnaire (FABQ) after six weeks of treatment (treatment effect = -1.23, 95% CI: -4.75 to 2.29, p = 0.13) or at the three-month follow-up evaluation (treatment effect = -2.72, 95% CI: -6.32 to 0.88, p = 0.13). | — |
Countries
Brazil
Contacts
Public ContactWalkyria Fernandes
Universidade Federal de Mato Grosso
Outcome results
None listed