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This study aims to evaluate the effectiveness of minimal intervention and therapeutic alliance in pain, specific and general disability, global perceived effect, empathy, credibility and expectation of improvement in patients with chronic non-specific low back pain
Low back pain remains a global public health problem. The classification of patients in low back pain subgroups aims to optimize the health system and provide the quantity and the type of proper technique for each patient. Several factors may influence physical therapy. The therapeutic alliance may be defined as harmony or social connection between the therapist and the patient and may influence the treatment effect. The aim of this study is to evaluate the effectiveness of the addition of the therapeutic alliance to a minimum intervention for the treatment of chronic non-specific low back pain with low risk of psychosocial factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Therapeutic Alliance | Experimental | Intervention involving reassurance and information related to the return to daily activities, advice on dealing with the pain and clear explanation of signs and symptoms. The session will take 60 minutes and will be structured to increase the therapeutic alliance and empathy. Patients will be instructed to return in a week for further consultation to clarify doubts. |
|
| Usual Care | Active Comparator | Information about low back pain based on Back Book. The therapy will be performed with limited interaction between patient and therapist and the information will be transmitted in a clear and direct way. The limited interaction between patient and therapist in this group will be established at the first session lasting 45-60 minutes. Patients will be instructed to return for a visit after a week to clarify questions. |
|
| Control group | Other | Patients will not receive intervention in the first mo nth of enrollment. After a year, the treatment offered to the Positive Therapeutic Alliance or Usual Care group will be available for patients who are interested. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Therapeutic Alliance | Behavioral | Intervention involving reassurance and information related to the return to daily activities, advice on dealing with the pain and clear explanation of signs and symptoms. The session will take 60 minutes and will be structured to increase the therapeutic alliance and empathy. Patients will be instructed to return in a week for further consultation to clarify doubts. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity will be measured by an 11-point Pain Numerical Rating Scale | One month after randomization |
| Specific disability | Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale. | One month after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity will be measured by an 11-point Pain Numerical Rating Scale | Six and twelve months after randomization |
| Specific disability | Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Empathy | Empathy will be measured by a 50-point scale of the Consultation and Relational Empathy (CARE) questionnaire | One week after the first session of treatment |
| Credibility | The credibility regarding the treatment will be evaluated using 0-24 point scale. |
Inclusion Criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Felipe RC Fagundes, MsC | Universidade Cidade de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Therapy Outpatient Department | São Paulo | São Paulo | 03071000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28143504 | Background | Fagundes FR, de Melo do Espirito Santo C, de Luna Teixeira FM, Tonini TV, Cabral CM. Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial). Trials. 2017 Jan 31;18(1):49. doi: 10.1186/s13063-017-1784-z. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Usual care | Behavioral | Information about low back pain based on Back Book. The therapy will be performed with limited interaction between patient and therapist and the information will be transmitted in a clear and direct way. The limited interaction between patient and therapist in this group will be established at the first session lasting 45-60 minutes. Patients will be instructed to return for a visit after a week to clarify questions. |
|
| Control group | Other | Patients will not receive intervention in the first month in which they are enrolled. After a year, the treatment offered to the Positive Therapeutic Alliance or Usual Care group will be available for patients who are interested. |
|
| Six and twelve months after randomization |
| Disability | Disability associated with low back pain will be measured by the 0-100 scale of the Oswestry Disability Index | One, six and twelve months after randomization |
| Global impression of recovery | Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale | One, six and twelve months after randomization |
| After the first session of treatment |
| Expectation of improvement | The expectation of improvement will be assessed with a numerical scale of 11 points | One week after the first session of treatment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |