Effectiveness of Therapeutic Alliance and Minimal Intervention for Chronic Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Other: Control groupBehavioral: Positive Therapeutic AllianceBehavioral: Usual care
- Registration Number
- NCT02497625
- Lead Sponsor
- Universidade Cidade de Sao Paulo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group 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. Positive Therapeutic Alliance 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 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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.
Trial Locations
- Locations (1)
Physical Therapy Outpatient Department
🇧🇷Sao Paulo, SP, Brazil