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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| specific manipulation | Experimental | Participants allocated to group "specific manipulation", will have their lumbar spine manipulated according to the previous clinical examination. |
|
| non-specific manipulation | Experimental | Participants allocated to group "non-specific manipulation" will have their upper thoracic spine manipulated (also known as "global manipulation") regardless of the previous clinical examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific manipulation | Other | Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain intensity will be measured using a 0-10 numerical rating scale | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain intensity will be measured using a 0-10 numerical rating scale | 3 and 6 months after randomization |
| Disability | Disability will be measured by the 0-24 Roland Morris Disability Questionnaire |
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Inclusion Criteria:
- Patients with low back pain duration from 3 to 24 months.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo Costa, PT, PhD | Universidade Cidade de São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Cidade de São Paulo | São Paulo | 03071-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32660919 | Derived | de Oliveira RF, Costa LOP, Nascimento LP, Rissato LL. Directed vertebral manipulation is not better than generic vertebral manipulation in patients with chronic low back pain: a randomised trial. J Physiother. 2020 Jul;66(3):174-179. doi: 10.1016/j.jphys.2020.06.007. Epub 2020 Jul 10. |
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We are happy to share our data with researchers that would like to use it on an IPD.
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Non-specific manipulation | Other | 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. |
|
| 4 weeks, 3 and 6 months after randomization |
| Global Impression of Recovery | Global impression of recovery will be measured by an 11-item Global Perceived Effect Scale | 4 weeks, 3 and 6 months after randomization |
| Pressure Pain Threshold | Pressure Pain Threshold will be measure by a digital pressure algomoter | 4 weeks after randomization |