Low Back Pain
Conditions
Keywords
Low back pain, Empathy, Subgroups, Minimal intervention
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
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.
Interventions
BEHAVIORALPositive 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.
BEHAVIORALUsual 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.
OTHERControl 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.
Sponsors
Universidade Cidade de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients waiting for treatment in the waiting list of physical therapy clinics * 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
* Spine surgery history * Nerve root compromise * Cognitive impairment related disorders * Pregnants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Six and twelve months after randomization | Pain intensity will be measured by an 11-point Pain Numerical Rating 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 |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Credibility | After the first session of treatment | The credibility regarding the treatment will be evaluated using 0-24 point scale. |
| 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 |
| 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 |
Countries
Brazil
Outcome results
None listed