Low Back Pain
Conditions
Keywords
Back pain, spinal manipulation
Brief summary
We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.
Detailed description
To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization. 148 patients with chronic non-specific low back pain will be enrolled for this clinical trial. Patients will undergo to a specific physical examination in order to determine the ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain pressure threshold, global perceived effect and disability associated with back pain. After the first assessment patients will be randomly assigned to two groups that will receive 10 sessions of spinal manipulation over a period of four weeks, and may receive manipulation according to the findings on physical examination (specific manipulation) or may receive manipulation in the upper thoracic region, disregarding the physical examination findings (nonspecific manipulation).
Interventions
OTHERSpecific manipulation
Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.
OTHERNon-specific manipulation
Patients allocated to the specific manipulation group will receive spinal manipulation on the upper thoracic spine that will be not related to the physical examination performed prior to the treatment allocation.
Sponsors
Universidade Cidade de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- Patients with low back pain duration from 3 to 24 months.
Exclusion criteria
* Patients with a pain duration lower than 3 months and higher than 24 months. * Patients with nerve root compromise or with serious spinal pathology, * Pregnant patients, * Previous back surgery * Patients with any contra-indication to spinal manipulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 4 weeks | Pain intensity will be measured using a 0-10 numerical rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 3 and 6 months after randomization | Pain intensity will be measured using a 0-10 numerical rating scale |
| Disability | 4 weeks, 3 and 6 months after randomization | Disability will be measured by the 0-24 Roland Morris Disability Questionnaire |
| Global Impression of Recovery | 4 weeks, 3 and 6 months after randomization | Global impression of recovery will be measured by an 11-item Global Perceived Effect Scale |
| Pressure Pain Threshold | 4 weeks after randomization | Pressure Pain Threshold will be measure by a digital pressure algomoter |
Countries
Brazil
Outcome results
None listed