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Trial registered on ANZCTR


Registration number
ACTRN12617000097347
Ethics application status
Approved
Date submitted
26/02/2016
Date registered
17/01/2017
Date last updated
17/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Application of a neurophysiology pain education program in patients with chronic low back pain
Scientific title
Application of a neurophysiology pain education program in patients with chronic low back pain
Secondary ID [1] 288632 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 297799 0
Condition category
Condition code
Musculoskeletal 297976 297976 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 297977 297977 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It´s a longitudinal randomized clinical trial with blind assessment and 3 months follow-up to assess the effect of a Neurophysiology Pain Education program in patients with Chronic Low Back Pain.
Group 1: Experimental. This group received a Neurophysiology Pain Education (NPE) program and therapeutic exercises sessions, consisting in two sessions about pain concepts to understand his/her own pain situation, in small groups (4-6 patients) and of 30-50 minutes
duration; and a Therapeutic Exercise program based on stabilization exercises, stretching and basic aerobic exercise.

The frequency of the two NPE sessions was:

The one initial session
The second one a month after

The information provided at the NPE sessions was:

The main concepts of pain neurophysiology were explained to the participants using an appropriate language:
- Acute Vs. Chronic pain characteristics
- Purpose of acute pain
- How acute pain is originated in the nervous system: nociceptors, ion channels, neurons, action potential, peripheral sensitization, synapses, synaptic space, inhibitory and excitatory substances, spinal cord, ascending and descending pathways, role of the brain, memory and perception of pain.
- How pain becomes chronic: nervous system plasticity, modulation, modification, central sensitization, neuromatrix theory.
- Maintaining factors for central sensitization: emotions, stress, illness perception, thoughts of pain and pain behavior

The NPE sessions run for a physiotherapist with specific training in chronic pain and pain neurophysiology gave both PNE sessions to all subjects.

The therapeutic exercise program included::

a) a brief description of the exercises performed;
Motor control exercises included were:
- Isolated contraction of the transversus abdominis in supine crook lying. Subjects were told that the aim of the exercise was to achieve 10 contractions of 10 seconds of duration each. For the participants to be able to achieve this they were instructed to place the fingers in the antero-superior iliac spine (ASIS) and slowly contract to try to pull them together.
- Pelvic elevation with previous transversus abdominis contraction. The initial posture for this exercise was the same as before. Participants were instructed to do 10 repetitions keeping the pelvis up for 5 seconds (previous transversus abdominis contraction), and to descend in a controlled way. Progression of this exercise was to lift the foot 2 centimeters from the ground while keeping the pelvis up. As we said. These progressions where only done by those who performed the other exercises correctly.
- Combined contraction of the transversus abdominis and multifidi in prone. The subjects were told that the aim of the exercise was to be able to achieve 10 contractions of 10 seconds of duration each. In this case they where also given the instructions of “ think of moving the pelvis forward without actually moving it”. For those who found it difficult they where asked to place the fingers in the postero-superior iliac spine (PSIS) and slowly contract to pull them together to feel the contraction of the multifidi muscles and then try to combine both.
- Head and shoulder lift in prone on elbows, keeping the same contraction from the previous exercise they where instructed to lift and hold for 5 seconds, ten repetitions, and to control on the way down. These exercises where only performed by those who achieved the previous one correctly.
- Postural correction in sitting: they where asked to correct their posture keeping their feet on the floor in line with the hips, sitting on the isquiatic tuberosity (which they had felt with their hands), their spine in neural position. Once they had learned this posture they had to learn to maintain it using simultaneous contraction of the transversus and multifidi. They where asked to do this as much as possible during their daily activities.
- Piriformis stretch: in supine crook lying, placing the lateral side of the foot over the contralateral knee and pulling towards the chest with the hands.
- Erector spine stretch: on their knees, sitting on their heels, flexing the trunk and stretching the arms forwards
- 20-30 minute continuous walk at a plausible speed

The number, frequency and duration of sessions:
Two x 20 minutes sessions;
The one initial session after NPE session
The second one a month after NPE session

The format and location of sessions were supervised group sessions at the study site.
Both face-to-face sessions where done in the Clinic where the trial took place and were supervised by a physiotherapist.
The twice a day home exercises where done by the patients at their homes with no supervision.

Neither the Rating of Perceived Exertion Scale or any other were used because motor control exercises are low load exercises

Home exercise compliance was confirmed by asking in the last assessment how often they had performed the exercises. Patients had to choose from 5 possible answers from “never” to “always as demanded”.
Intervention code [1] 294040 0
Treatment: Other
Comparator / control treatment
Group 2: Control. This group received the same Therapeutic Exercise Program that experimental group:based on stabilization exercises, stretching and basic aerobic exercise.
Control group
Active

Outcomes
Primary outcome [1] 297497 0
Pain intensity: it’s the main outcome by Numeric Rating Scale (NRS)
Timepoint [1] 297497 0
Baseline, post- first session, post-1 month, post-3 months.
Primary outcome [2] 297498 0
- Disability: Roland Morris Disability Questionnaire (RMDQ).
Timepoint [2] 297498 0
Baseline, post-1 month, post-3 months.
Secondary outcome [1] 321229 0
Psychosocial correlates: Pain Catastrophysing Scale (PCS),
Timepoint [1] 321229 0
Baseline, post-1 month, post-3 months.
Secondary outcome [2] 321230 0
Physical correlates: pressure pain threshold (PPT) with a pressure algometer,
Timepoint [2] 321230 0
Baseline, post- first session, post-1 month and 3 month
Secondary outcome [3] 329678 0
Psychosocial correlates: Tampa Scale for Kinesophobia (TSK)
Timepoint [3] 329678 0
Baseline, post- first session, post-1 month and 3 month
Secondary outcome [4] 329903 0
finger-to-floor distance (FFD) with a rigid ruler.
Timepoint [4] 329903 0
Baseline, post- first session, post-1 month and 3 month

Eligibility
Key inclusion criteria
- Patients ages ranged between 18 and 70 years, with low back pain more than 6 months.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unstable neurological symptoms.
- Osteoporotic and rheumatologic diseases, infectious process, metastasis.
- Cognitive impairment
- Economic compensation or concomitant therapies
- Diagnosed psychological illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject was allocated. Allocation was concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7623 0
Spain
State/province [1] 7623 0
Madrid

Funding & Sponsors
Funding source category [1] 292990 0
University
Name [1] 292990 0
Alcala University.
Address [1] 292990 0
Faculty of Health Sciences. Physiotherapy
Crta. Madrid - Barcelona, 33. 600
Alcala de Henares
Madrid
Country [1] 292990 0
Spain
Primary sponsor type
University
Name
Alcala University
Address
Faculty of Health Sciences. Physiotherapy
Crta. Madrid- Valencia, 33.600
Alcala de Henares
Madrid
Country
Spain
Secondary sponsor category [1] 291764 0
None
Name [1] 291764 0
Address [1] 291764 0
Country [1] 291764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294498 0
Ethic Committee of Alcala University
Ethics committee address [1] 294498 0
Office of research
Plaza San Diego, s/n
28801 Alcala de Henares
Madrid
Ethics committee country [1] 294498 0
Spain
Date submitted for ethics approval [1] 294498 0
06/05/2014
Approval date [1] 294498 0
17/09/2014
Ethics approval number [1] 294498 0
2013/048/20140531

Summary
Brief summary
The Last scientific researches about changes in brain mechanisms in patients with pain, specifically in Chronic Low Back Pain (CLBP), have promoted new treatment approaches like Neurophysiology Pain Education (NPE). Aim: To assess the effect of a NPE program in patients with CLBP. Design/ Methods: a longitudinal randomized clinical trial with blind assessment and 3 months follow-up. 60 CLBP patients with ages ranged between 18 and 70 years and pain for more than 3 months were randomly allocated into two groups. The control group received a therapeutic exercise program based on stabilization exercises, stretching and basic aerobic exercise. The experimental group received the same therapeutic exercise program and a NPE program consisting in two sessions, in small groups (4-6 patients) and about 30-50 minutes of duration. The main outcome was pain intensity (Numeric Rating Scale). Others outcome measures were: pressure pain threshold (PPT), finger-to-floor distance (FFD), the Roland Morris Disability Questionnaire (RMDQ), the Pain Catastrophising Scale (PCS), the Tampa Scale for Kinesiophobia (TSK), and the Patient Global Impression of Change (PGIC). Measures were taken at baseline, after the first session and at 1 and 3 months follow-up. Discussion: if NPE programs improve pain in patients with CLBP, then usual care physiotherapy programs should include it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63934 0
Dr Daniel Pecos-Martin
Address 63934 0
Alcala University (www.uah.es)
Faculty of Health Sciences. Physiotherapy.
Physiotherapy Department.
Crta. Madrid - Barcelona, 33.600
Alcala de Henares
Madrid
Country 63934 0
Spain
Phone 63934 0
+34 91 8855142
Fax 63934 0
Email 63934 0
daniel.pecos@uah.es
Contact person for public queries
Name 63935 0
Prof Patricia Martinez - Merinero
Address 63935 0
Alcala University (www.uah.es)
Faculty of Health Sciences. Physiotherapy.
Physiotherapy Department.
Crta. Madrid - Barcelona, 33.600
Alcala de Henares
Madrid
Country 63935 0
Spain
Phone 63935 0
+34 661637862
Fax 63935 0
Email 63935 0
patricia.m.merinero@gmail.com
Contact person for scientific queries
Name 63936 0
Dr Daniel Pecos-Martín
Address 63936 0
Alcala University (www.uah.es)
Faculty of Health Sciences. Physiotherapy.
Physiotherapy Department.
Crta. Madrid - Barcelona, 33.600
Alcala de Henares
Madrid
Country 63936 0
Spain
Phone 63936 0
+34 91 8855142
Fax 63936 0
Email 63936 0
daniel.pecos@uah.es

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary