Back PainNCT02417402
Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain
A study testing Trained in people with Back Pain, run by Universidade Cidade de Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Trained
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
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.
Read the detailed 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.
- Conditions
- Back Pain
- Being tested
- Control, Trained
- Keywords
- back pain, low back pain, chronic low back pain
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called physical therapist education, guidelines implementation
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.
TrainedOther
Also called physical therapist education, guidelines implementation
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.
| Study group | Role | What they receive |
|---|---|---|
| Untrained Physical Therapists | Active comparator | The patients allocated to the Control group will be treated by physical therapists who did not receive any training about clinical practice guidelines and pain management. These patients will receive the usual care from their physical therapists. Receives: Other: Control |
| Trained Physical Therapists | Experimental | The patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management. Receives: Other: Trained |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Pain NRS)
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Measured: 5 weeks after randomization
Disability (24-item Roland Morris Disability Questionnaire)
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Measured: 5 weeks after randomization
Secondary outcomes (4)
Pain intensity (Pain NRS)
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Measured: 3 and 6 months after randomization
Disability ( 24-item Roland Morris Disability Questionnaire)
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Measured: 3 and 6 months after randomization
Fear Avoidance Beliefs (FABQ)
Fear avoidance belief will be measured by the 16-item Fear Avoidance Belief Questionnaire (FABQ)
Measured: 5 weeks, 3 months and 6 months after randomization
Pain Catastrophizing (PCS)
Pain Catastrophizing will be measured by the 13-item Pain Catastrophizing Scale (PCS)
Measured: 5 weeks, 3 months and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: We had many issues related to recruitment. After many attempts we want to suspend the study with 13 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Rossi Nogueira Rizzo, Universidade Cidade de Sao Paulo
- Investigators
- Leonardo OP Costa, PhD, Principal investigator, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417402
- Sponsor's protocol ID
- UNICID032015
- Status last verified
- Oct 2017
- First submitted
- 7 Apr 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02417402
- Acronym / sponsor ID
- UNICID032015
- Conditions
- Back Pain
- Keywords
- back pain, low back pain, chronic low back pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We had many issues related to recruitment. After many attempts we want to suspend the study with 13 patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Untrained Physical Therapists | Active comparator | Other: ControlThe patients allocated to the Control group will be treated by physical therapists who did not receive any training about clinical practice guidelines and pain management. These patients will receive the usual care from their physical therapists. |
| Trained Physical Therapists | Experimental | Other: TrainedThe patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: physical therapist education, guidelines implementationThe 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. | Other | Untrained Physical Therapists |
| TrainedAlso: physical therapist education, guidelines implementationThe 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. | Other | Trained Physical Therapists |
Primary outcome
Pain intensity (Pain NRS)
Time frame: 5 weeks after randomization
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability (24-item Roland Morris Disability Questionnaire)
Time frame: 5 weeks after randomization
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
4 secondary outcomes
Pain intensity (Pain NRS)
Time frame: 3 and 6 months after randomization
Disability ( 24-item Roland Morris Disability Questionnaire)
Time frame: 3 and 6 months after randomization
Fear Avoidance Beliefs (FABQ)
Time frame: 5 weeks, 3 months and 6 months after randomization
Pain Catastrophizing (PCS)
Time frame: 5 weeks, 3 months and 6 months after randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo OP Costa, PhD principal investigator
Universidade Cidade de São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Trained in people with Back Pain, run by Universidade Cidade de Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (Pain NRS) (time frame: 5 weeks after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.