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We had many issues related to recruitment. After many attempts we want to suspend the study with 13 patients.
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The aim of this trial is to investigate if patients treated by physical therapists who received an update on clinical practice guidelines and pain management have better outcomes than patients treated by physical therapists who did not received such training.
The training "Update on the treatment of patients with nonspecific chronic low back pain" will be announced in the social network by members of the study. Interested physical therapists will send an email to one of the study authors with their information regarding the inclusion criteria. After two months of notice, interested and eligible physiotherapists will be randomized into two groups of 15 participants each.
The study arms are: 1) control group (physical therapist who will not receive training) and 2) experimental group (physical therapist who will receive training). Before and after training, attitudes, beliefs and knowledge about low back pain guidelines will be evaluated.
Each physical therapist will recruit for the study a total of fifteen consecutive patients with chronic nonspecific low back pain (total sample=150 patients). All the patients will be assessed before the first session by a blinded examiner who will be unaware about the group allocation.
Clinical outcomes (pain, disability, fear avoidance beliefs and pain catastrophizing) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Untrained Physical Therapists | Active Comparator | The patients allocated to the Control group will be treated by physical therapists who did not receive any training about clinical practice guidelines and pain management. These patients will receive the usual care from their physical therapists. |
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| Trained Physical Therapists | Experimental | The patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | The patients allocated to the Control group will be treated by physical therapists who did not carry out the training before treatment. The physical therapists will use their usual care for nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (Pain NRS) | Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) | 5 weeks after randomization |
| Disability (24-item Roland Morris Disability Questionnaire) | Disability will be measured by the 24-item Roland Morris Disability Questionnaire | 5 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (Pain NRS) | Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) | 3 and 6 months after randomization |
| Disability ( 24-item Roland Morris Disability Questionnaire) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain attitudes and beliefs for physiotherapists (PABS.PT) | Pain Attitudes and Beliefs will be measured by the 19-item Pain Attitudes and Beliefs Scale for Physiotherapists (PABS.PT) | Baseline and 5 weeks after randomization |
| Adherence to guidelines for physiotherapists (0-100% Low Back Pain Vignettes) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo OP Costa, PhD | Universidade Cidade de São Paulo | Principal Investigator |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000094384 | Trained Immunity |
| ID | Term |
|---|---|
| D007113 | Immunity, Innate |
| D007109 | Immunity |
| D055633 | Immune System Phenomena |
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| Trained | Other | The patients allocated to the Experimental group will be treated by physical therapists who carried out the training before treatment. The training will be designed to guide the physical therapists beliefs and attitudes to a biopsychosocial model; update knowledge contained in clinical practice guidelines; and enable physical therapists to identify, integrate and address psychosocial factors in patients with nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes. |
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Disability will be measured by the 24-item Roland Morris Disability Questionnaire
| 3 and 6 months after randomization |
| Fear Avoidance Beliefs (FABQ) | Fear avoidance belief will be measured by the 16-item Fear Avoidance Belief Questionnaire (FABQ) | 5 weeks, 3 months and 6 months after randomization |
| Pain Catastrophizing (PCS) | Pain Catastrophizing will be measured by the 13-item Pain Catastrophizing Scale (PCS) | 5 weeks, 3 months and 6 months after randomization |
Adherence to guidelines for physiotherapist will be measured by the 0-100% Low Back Pain Vignettes |
| Baseline and 5 weeks after randomization |