Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain

Back Pain Clinical Trial

Official title:

Efficacy of Educating Physical Therapists on Clinical Practice Guidelines and Pain Management in the Treatment of Patients With Nonspecific Chronic Low Back Pain: a Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02417402
• Other study ID #: UNICID032015
• Status: Withdrawn
• Phase: N/A
• First received: April 7, 2015
• Last updated: October 24, 2017
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2017
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this trial is to investigate if patients treated by physical therapists who received an update on clinical practice guidelines and pain management have better outcomes than patients treated by physical therapists who did not received such training.

Description:

The training "Update on the treatment of patients with nonspecific chronic low back pain" will be announced in the social network by members of the study. Interested physical therapists will send an email to one of the study authors with their information regarding the inclusion criteria. After two months of notice, interested and eligible physiotherapists will be randomized into two groups of 15 participants each.

The study arms are: 1) control group (physical therapist who will not receive training) and 2) experimental group (physical therapist who will receive training). Before and after training, attitudes, beliefs and knowledge about low back pain guidelines will be evaluated.

Each physical therapist will recruit for the study a total of fifteen consecutive patients with chronic nonspecific low back pain (total sample=150 patients). All the patients will be assessed before the first session by a blinded examiner who will be unaware about the group allocation.

Clinical outcomes (pain, disability, fear avoidance beliefs and pain catastrophizing) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years.

• physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the National Council of Physical Therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study.

Exclusion Criteria:

• patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy.

• physiotherapists who want to stop the activities for some reason that prevents participation in the study

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Control
The patients allocated to the Control group will be treated by physical therapists who did not carry out the training before treatment. The physical therapists will use their usual care for nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.
• Trained
The patients allocated to the Experimental group will be treated by physical therapists who carried out the training before treatment. The training will be designed to guide the physical therapists beliefs and attitudes to a biopsychosocial model; update knowledge contained in clinical practice guidelines; and enable physical therapists to identify, integrate and address psychosocial factors in patients with nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain attitudes and beliefs for physiotherapists (PABS.PT)	Pain Attitudes and Beliefs will be measured by the 19-item Pain Attitudes and Beliefs Scale for Physiotherapists (PABS.PT)	Baseline and 5 weeks after randomization
Other	Adherence to guidelines for physiotherapists (0-100% Low Back Pain Vignettes)	Adherence to guidelines for physiotherapist will be measured by the 0-100% Low Back Pain Vignettes	Baseline and 5 weeks after randomization
Primary	Pain intensity (Pain NRS)	Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)	5 weeks after randomization
Primary	Disability (24-item Roland Morris Disability Questionnaire)	Disability will be measured by the 24-item Roland Morris Disability Questionnaire	5 weeks after randomization
Secondary	Pain intensity (Pain NRS)	Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)	3 and 6 months after randomization
Secondary	Disability ( 24-item Roland Morris Disability Questionnaire)	Disability will be measured by the 24-item Roland Morris Disability Questionnaire	3 and 6 months after randomization
Secondary	Fear Avoidance Beliefs (FABQ)	Fear avoidance belief will be measured by the 16-item Fear Avoidance Belief Questionnaire (FABQ)	5 weeks, 3 months and 6 months after randomization
Secondary	Pain Catastrophizing (PCS)	Pain Catastrophizing will be measured by the 13-item Pain Catastrophizing Scale (PCS)	5 weeks, 3 months and 6 months after randomization