Effectiveness of Therapeutic Alliance and Minimal Intervention for Chronic Low Back Pain
NCT ID: NCT02497625
Last Updated: 2021-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
222 participants
INTERVENTIONAL
2015-09-30
2021-02-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Positive Therapeutic Alliance
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.
Positive Therapeutic Alliance
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
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.
Usual care
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
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.
Control group
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.
Interventions
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Positive Therapeutic Alliance
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic non-specific low back pain (over 12 weeks)
* More than 18 years
* Able to read and write the Portuguese language
* Low risk of psychosocial factors (less than 3 points in the STarT Back Screening Tool).
Exclusion Criteria
* Nerve root compromise
* Cognitive impairment related disorders
* Pregnants
18 Years
80 Years
ALL
No
Sponsors
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Universidade Cidade de Sao Paulo
OTHER
Responsible Party
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Cristina Maria Nunes Cabral
Professor PhD
Principal Investigators
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Felipe RC Fagundes, MsC
Role: PRINCIPAL_INVESTIGATOR
Universidade Cidade de São Paulo
Locations
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Physical Therapy Outpatient Department
São Paulo, São Paulo, Brazil
Countries
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References
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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.
Other Identifiers
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44720315.5.0000.5372
Identifier Type: -
Identifier Source: org_study_id
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