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Trial registered on ANZCTR


Registration number
ACTRN12618000997257
Ethics application status
Approved
Date submitted
16/05/2018
Date registered
14/06/2018
Date last updated
6/03/2020
Date data sharing statement initially provided
6/03/2020
Date results information initially provided
6/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a brief intervention of physical exercise on somatosensory processing, lumbar lengthening and endurance of chronic low back pain patients.
Scientific title
Effects of a brief intervention of physical exercise on somatosensory processing, lumbar lengthening and endurance of chronic low back pain patients.
Secondary ID [1] 294153 0
nil
Universal Trial Number (UTN)
U1111-1209-8768
Trial acronym
LOLA (LOw Level of Activity)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 306779 0
Condition category
Condition code
Musculoskeletal 305880 305880 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomly assigned to one of four study groups.
The study groups are composed of three intervention groups (1, 2 and 3) and one control group (4).
Intervention group (1):
A single sesion of 20 minutes of moderate intensity aerobic exercise, according to 3-4 at Borg Scale and 65-75% of maximum heart rate, will be performed on a treadmill.

Intervention group (2):
A single sesion of 20 minutes of individually (one-on-one) lumbar strengthening exercises, supervised by an expert, will be performed.
Participants will be prescribed exercises aimed at improving function of specific trunk muscles thought to control inter-segmental movement of the spine, including transversus abdominis, multifidus, the diaphragm or pelvic floor muscles.
Participants will be taught how to contract trunk muscles and progress until they will be able to maintain isolated contractions of the target muscles, each while maintaining normal respiration.
Each exercise will be carry out ten times during two series and series will progress according to the patient's tolerance.
Constant supervision and feedback such as palpation will be available to enhance learning of the task.

Intervention group (3):
A single sesion of 20 minutes of individually (one-on-one) lumbar flexibility exercises, supervised by an expert, will be performed according to the patient's tolerance.
Intervention code [1] 300443 0
Lifestyle
Intervention code [2] 300444 0
Behaviour
Comparator / control treatment
Control group (4):
A single sesion of 20 minutes of rest, filling out questionnaires, supervised by an expert, will be performed.
Control group
Active

Outcomes
Primary outcome [1] 304923 0
To evaluate sensitivity, it will be applied a sensitive stimulus with Von Frey filaments on different locations (erector spinae and gluteus medius trigger points, sacral base and index finger as control body locations). Subjects will be asked to indicate the moment they feel the contact of the filament.
Timepoint [1] 304923 0
The measurement will be performed immediately before the clinical interview and immediately after the exercises protocol.
3 measurements will be recorded and the average will be calculated.
Primary outcome [2] 304924 0
To evaluate hyperalgesia (a normally innocuous pressure of 2kg/cm2) and pain thresholds (with a maximum of 5kg/cm2) will be applied pressure on the same body locations than in primary outcome 1 (erector spinae and gluteus medius trigger points, sacral base and index finger as control body locations) with an algometer (area 1cm2).
Subjects will be asked to indicate their pain on a VAS scale.
Timepoint [2] 304924 0
The measurement will be performed immediately after the sensitivity assess.
3 measurements will be recorded and the average will be calculated.
Primary outcome [3] 304939 0
To analyze the differences in muscle lengthening, subjects will be asked to performance the back saver sit and reach test.
Timepoint [3] 304939 0
The measurement will be performed immediately after hyperalgesia and pain thresholds assess.
Two measurements will be recorded and the average will be calculated.
Secondary outcome [1] 343676 0
As a new primary outcome, to analyze the differences in muscle endurance, subjects will be asked to performance Ito test.
Timepoint [1] 343676 0
The measurement will be performed immediately after back saver sit and reach test.
Secondary outcome [2] 346860 0
6-Minute Walk Test (6MWT) will be used to asses aerobic capacity and endurance.
Timepoint [2] 346860 0
6MWT will be held 5 minutes before the exercises protocol.
Secondary outcome [3] 348053 0
We will also assess clinical and personal data (gender, age, height, weight, systolic and dyastolic blood preassure, pain, etc.) using a semi-structured interview, low back disability (using Oswestry Disability Index), mood state before exercise experiences (using SEES) and during the last week (POMS), physical activity enjoyment (PACES), and behavioral regultation in exercise (BREQ-3).
Timepoint [3] 348053 0
These data will be collected during the clinical interview, just before the 6-Minute Walk Test.

Eligibility
Key inclusion criteria
Patients with a history of mechanical and nonspecific low back pain for more than 6 weeks before the study or with intermittent low back pain who have experienced at least 3 episodes of back pain, each lasting more than a week during the year preceding the study.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suffering acute low back pain at the time of the study.
Suffering referred pain to the lower extremities.
Have a history of spinal surgery, vertebral fracture, pelvis fracture or lower limb fracture.
Have a history of hospitalization for severe trauma or accident
Suffering from arthritis or systemic diseases
Pregnancy

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)
Once accepted participation in the study, the volunteer will be registered with a code. Once registered, volunteers will be allocated to one of the four study groups.
An independent co-worker will allocate the subjects into the four study groups by means of sequentially numbered containers.
Neither evaluators nor intervention providers will be aware of intervention allocation sequence and group, or the aims of the study, in order to ensure blindness.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of secuence generation will be by simple randomization using Epidat program application.
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)
Efficacy
Statistical methods / analysis
We will conducted pre-post analyses of variance on sensory and pain thresholds and low back muscle lengthening and endurance.

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] 9628 0
Spain
State/province [1] 9628 0
Islas Baleares

Funding & Sponsors
Funding source category [1] 298791 0
Government body
Name [1] 298791 0
Spanish Ministry of Economy, Industry and Competitiviness (MINECO)
Address [1] 298791 0
Paseo de la Castellana, 162
28046 Madrid
Country [1] 298791 0
Spain
Primary sponsor type
Individual
Name
Carolina Sitges
Address
Universidad de las Islas Baleares.
Edificio científico-técnico (IUNICS)
Carretera de valldemossa Km 7,5. 07122 Palma de Mallorca
Islas Baleares.
Country
Spain
Secondary sponsor category [1] 298783 0
Individual
Name [1] 298783 0
Olga Velasco
Address [1] 298783 0
Universidad de las Islas Baleares.
Edificio Beatriu de Pinós
Carretera de valldemossa Km 7,5. 07122 Palma de Mallorca
Islas Baleares.
Country [1] 298783 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299735 0
Comite de Etica de la Investigación de las Islas Baleares (CEIC-IB)
Ethics committee address [1] 299735 0
Conselleria de Salut i Consum
Camino de Jesus, 38 A
07011 Palma de Mallorca. Islas Baleares.
Ethics committee country [1] 299735 0
Spain
Date submitted for ethics approval [1] 299735 0
05/09/2016
Approval date [1] 299735 0
26/10/2016
Ethics approval number [1] 299735 0
IB898/07 PI

Summary
Brief summary
This research project aims to recording short-term changes on the pain thresholds, flexibility and strength, in chronic pain patients, after a brief session of physical exercise (aerobic exercise vs. strength exercises vs. flexibility exercises vs. control)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81406 0
Dr Carolina Sitges Quirós
Address 81406 0
Universidad de las Islas Baleares. Edificio científico-técnico (IUNICS).
Carretera de valldemossa Km 7,5. 07122 Palma de Mallorca
Islas Baleares.
Country 81406 0
Spain
Phone 81406 0
+34971259809
Fax 81406 0
Email 81406 0
carol.sitges@uib.es
Contact person for public queries
Name 81407 0
Dr Olga Velasco Roldán
Address 81407 0
Universidad de las Islas Baleares. Edificio Beatriu de Pinos.
Carretera de valldemossa Km 7,5. 07122 Palma de Mallorca
Islas Baleares.
Country 81407 0
Spain
Phone 81407 0
+34 971172713
Fax 81407 0
Email 81407 0
olga.velasco@uib.es
Contact person for scientific queries
Name 81408 0
Dr Carolina Sitges Quirós
Address 81408 0
Universidad de las Islas Baleares. Edificio científico-técnico (IUNICS).
Carretera de valldemossa Km 7,5. 07122 Palma de Mallorca
Islas Baleares.
Country 81408 0
Spain
Phone 81408 0
+34971259809
Fax 81408 0
Email 81408 0
carol.sitges@uib.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing individual participant data will be only used to validate published results and answer research questions.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 7270 0
Informed consent form
Citation [1] 7270 0
Link [1] 7270 0
Email [1] 7270 0
Other [1] 7270 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
1. Research question
Acute effects of a 20-minute exercise intervention on tactile and Pressure Pain Thresholds, Lumbar Muscle Endurance and Flexibility in patients with chronic non-specific low back pain.

2. Background information
According to a recent epidemiological review of chronic noncancer pain, 17.25% of the Spanish adult population suffers pain and this percentage increased as so does age. Most are women (51.53%) of 51-57 years, which tend to overweight. Also, although the majority of patients are treated, it is often not appropriate and is not very effective. Recent research on chronic pain states have revealed that these patients present substantial changes in the central nervous system (CNS), which represent a key to maintaining the pain factor in time.
Thus, our research and findings of other groups have shown that patients with chronic pain have ab-normal processing of somatosensory, affective and cognitive information, which increases pain per-ception and promotes the maintenance of other associated symptoms.
Moreover, animal and human studies show that exercise leads to obvious changes in the structure and function of the brain, in addition to the known at metabolic, cardiorespiratory and musculoskeletal level, that could bring benefits to patients with pain chronic. In this regard, recent studies have shown that, mild to moderate, aerobic exercise programs reduce pain, fatigue, depressed mood and limitations of health-related quality of life, as well as improve fitness in these patients.
Although some research shows that not only aerobic exercises can have benefits for the health of these patients, but also the strength and flexibility exercises.
Therefore, this first part of this research project aims to recording improvements in physical fitness (cardiovascular endurance, flexibility and strengthening) and physical symptoms (pain perception) in patients with chronic pain in the short term, after one session of physical exercise

1. Participant characteristics
Patients with a history of mechanical and nonspecific low back pain for more than 6 weeks before the study or with intermittent low back pain who have experienced at least 3 episodes of back pain, each lasting more than a week during the year preceding the study

2. Key results
In baseline comparison between groups, no differences were found for the physical and clinical char-acteristics of participants
Groups were comparable in terms of sex, age, blood pressure, body mass index (BMI), pain (at the present time, usually and in the worst moments) and the rest of the control variables examined.
Flexibility group presented greater lumbar flexibility; Strength group, a lower sensitivity to pain in the index finger, but a greater lumbar hyperalgesia; Aerobic group, a greater tactile sensitivity in the lum-bar region, but a lower sensitivity to pain in the sacrum; control group, lower sensitivity to gluteal pain, but lower lumbar strength.

5. Limitations
A larger sample size could have generated more accurate results. Further investigations of other affec-tive variables as kinesiophobia, pain catastrophizing or fear avoidance beliefs, that can interfere in pain perception, are needed.