TalkBack: Effectiveness of Therapeutic Alliance and Minimal Intervention for Chronic Low Back Pain
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: 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.
|
| Active Comparator: 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. |
Behavioral: 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.
|
| Other: 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. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- Pain intensity [One month after randomization]
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
- Specific disability [One month after randomization]
Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.
Secondary Outcome Measures
- Pain intensity [Six and twelve months after randomization]
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
- Specific disability [Six and twelve months after randomization]
Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.
- Disability [One, six and twelve months after randomization]
Disability associated with low back pain will be measured by the 0-100 scale of the Oswestry Disability Index
- Global impression of recovery [One, six and twelve months after randomization]
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Other Outcome Measures
- Empathy [One week after the first session of treatment]
Empathy will be measured by a 50-point scale of the Consultation and Relational Empathy (CARE) questionnaire
- Credibility [After the first session of treatment]
The credibility regarding the treatment will be evaluated using 0-24 point scale.
- Expectation of improvement [One week after the first session of treatment]
The expectation of improvement will be assessed with a numerical scale of 11 points
Eligibility Criteria
Criteria
Inclusion Criteria
-
Patients waiting for treatment in the waiting list of physical therapy clinics
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Diagnosis of chronic non-specific low back pain (over 12 weeks)
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More than 18 years
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Able to read and write the Portuguese language
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Low risk of psychosocial factors (less than 3 points in the STarT Back Screening Tool).
Exclusion criteria
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Spine surgery history
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Nerve root compromise
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Cognitive impairment related disorders
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Pregnants
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Physical Therapy Outpatient Department | Sao Paulo | SP | Brazil | 03071000 |
Sponsors and Collaborators
- Universidade Cidade de Sao Paulo
Investigators
- Principal Investigator: Felipe RC Fagundes, MsC, Universidade Cidade de São Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
- 44720315.5.0000.5372