Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000866101
Ethics application status
Approved
Date submitted
26/05/2019
Date registered
18/06/2019
Date last updated
9/02/2021
Date data sharing statement initially provided
18/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of neural glide versus manual placebo in patients with subacute non-specific low back pain and validation of a neurodynamic manual placebo technique.
Scientific title
Effectiveness of neural glide versus manual placebo in patients with subacute non-specific low back pain and validation of a neurodynamic manual placebo technique.
Secondary ID [1] 298328 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacute non-specific low back pain. 312963 0
Condition category
Condition code
Musculoskeletal 311471 311471 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 311473 311473 0 0
Physiotherapy
Neurological 311477 311477 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An analytical longitudinal-experimental randomized clinical trial is proposed.
Neurodynamics produce a sliding of the neural structures with respect to the mechanical interface and encompasses a combination of active and passive movements to reduce nerve mechanosensitivity, pain and disability.
The literature shows sufficient evidence of the effectiveness of neural mobilization techniques in the modulation of non-specific low back pain. This allows to affirm that these techniques -either when applied in isolation or in combination with others- produce a decrease in pain levels and disability in patients with non-specific low back pain.

The study interventions are:
1. Experimental group: a sciatic nerve neural glide in a decubitus lateral position.
2. Control group: A placebo technique that simulates a sciatic nerve neural glide in a decubitus lateral position.

The materials to be used will be:
1. Information sheet.
2. Informed consent form.
3. Personal data questionnaire.
4. Douleur Neuropathique -4 questions (DN4) questionnaire. The spine and lower limbs dermatomes will be evaluated with the Semmes-Weinstein Monofilaments.
5. Visual Analogue Scale (VAS). The patient will be asked to mark a point on the line with a pen to indicate the intensity of pain. This will be measured with a millimeter ruler.
6. Oswestry Low Back Pain Disability Questionnaire.
7. The modified Schober's test. This will be measured with a tape measure.
8. The Straight Leg Raise (SLR). The flexion hip range of motion will be assessed with a manual goniometer.
9. Pain Pressure threshold (PPT). This will be assessed with a mechanical pressure algometer (Force Gage, Wagner Instruments, Greenwich CT, USA model).
10. Data collection notebook.
11. Likert Scale.
12. Blinding scale.

Experimental group procedures:
A sciatic nerve neural slide intervention is performed in a lateral decubitus position with the most symptomatic side in contact with the stretcher.
The glide is performed in a neutral spine position in the sagittal plane by placing a cushion under the head and another one under the low back area and leaving the gaze in a horizontal plane.
The neural mobilization is performed over the lower leg in hip flexion with the knee extended up to 80º in a non-painful range of motion. The mobilization is performed starting with the lower leg in 20º of hip flexion and the physiotherapist will passively move the patient’s leg up to 70-80º of hip flexion while the participant is asked to do an active extension of the upper cervical spine.
The upper leg remains steady and stable at 0º of hip flexion with the knee extended resting on a cushion and in contact with the stretcher.
The neural mobilization is repeated during 10 minutes combining the hip flexion movements (passive) with suboccipital extension (active), and hip extension (passive), with the cervical spine in a neutral alignment (active), in a rhythmic and coordinated way with the patient.

This intervention will be delivered by a researcher who will know the participants assignment and will apply the specific treatment. This physiotherapist has 5 years of clinical experience.

Whilst the evaluation and data collection phases will be carried out by an external researcher who will not know the participants’ assignation. This physiotherapist has more than 5 years of clinical experience.

The intervention will be delivered applying the technique during ten minutes and revaluation will be immediately after treatment and one week after treatment.

All the participants will be reminded individually to complete the evaluation and reevaluation via e-mail and phone calls not to lose anybody and complete the study.

The intervention will be made in the Physiotherapy and Pain Research Center of the Universidad de Alcalá (UAH), located in the University Residential City, local 7 and 8; Ctra. Madrid-Barcelona, Km. 32, 28805; Alcalá de Henares (Madrid).
Intervention code [1] 314564 0
Rehabilitation
Intervention code [2] 314565 0
Treatment: Other
Comparator / control treatment
The control group will be treated instead with a sham technique where the same previously mentioned neural mobilization in the lateral decubitus position is simulated. The patient's expectations will be better than those of receiving a completely passive therapy such as "unplugged" electrotherapy.

Patients would lie down on the contralateral, not-painful side remaining the upper leg steady and stable at 0º of hip flexion with the knee extended and resting on a cushion.

The mobilization will be performed in a neutral spine position in the sagittal plane by placing a cushion under the head and another one under the low back area and leaving the gaze in a horizontal plane.

The passive mobilization in hip flexion-extension will be always less than 70º and combined with a hip abduction between 20-40º and with the foot in a neutral position not to tense sciatic nerve.

The mobilization will be performed over the lower leg starting in 15º hip flexion, 20-40º hip abduction with the knee extended. The physiotherapist will passively move the patient’s leg up to 30º of hip flexion while the patient is asked to perform an active extension of the upper cervical spine.

The simulating neural mobilization will be repeated for 10 minutes combining the hip flexion movements (passive) with suboccipital extension (active), and hip extension (passive) with the cervical spine in a neutral alignment (active), in a rhythmic and coordinated way with the patient.
Control group
Placebo

Outcomes
Primary outcome [1] 320180 0
Assess a blinding method measured on a scale of two possible options (NG technique and simulated technique).
Timepoint [1] 320180 0
Timepoint: one week after treatment.
Primary outcome [2] 326477 0
Assess the expectations on the received treatment with a 5-point Likert-type scale.
Timepoint [2] 326477 0
Timepoint: one week after treatment.
Secondary outcome [1] 370779 0
Change in range of movement in lumbar flexion measured by the modified Schober test.
Timepoint [1] 370779 0
Three measurements: baseline, immediately after treatment and one week after treatment.
Secondary outcome [2] 370780 0
Change in range of movement in hip flexion with the knee extended assessing hamstring muscle extensibility using the Straight Leg Raise test, using an universal goniometer.
Timepoint [2] 370780 0
Three measurements: baseline, immediately after treatment and one week after treatment.
Secondary outcome [3] 370781 0
Change in bilateral pain pressure threshold assessment of the tibial nerve using an manual algometer.
The average of three trial -waiting 30 seconds between each trial- is calculated.
Timepoint [3] 370781 0
Three measurements: baseline, immediately after treatment and one week after treatment.
Secondary outcome [4] 370784 0
Change in daily activities functionality using the Oswestry Low Back Pain Disability Questionnaire.
Timepoint [4] 370784 0
Two measurements: baseline and one week after treatment.
Secondary outcome [5] 371343 0
Change in bilateral pain pressure threshold assessment of the median nerve using an manual algometer.
The average of three trial -waiting 30 seconds between each trial- is calculated.
Timepoint [5] 371343 0
Three measurements: baseline, immediately after treatment and one week after treatment.
Secondary outcome [6] 391629 0
Change in intensity of pain measured with a 10 centimeters Visual Analogue Scale.
Timepoint [6] 391629 0
Timepoints: baseline, immediately after treatment and one week after treatment (primary endopoint).

Eligibility
Key inclusion criteria
1. People aged 18-65, of working age, of both sexes and any race.

2. People with subacute non-specific low back pain of less than 4 months of evolution and of more than 2 weeks, including people who also manifest referred pain above the knee in any of the two lower limbs.

3. They should not refer alterations in nerve conduction: hypoesthesia or anesthesia, osteotendinous reflexes abolished or loss of strength in lower limbs.

4. They should not have received physiotherapy treatment in the last 2 weeks before the study.

5. They should have voluntary signed the informed consent form.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Positive SLR test in a range of motion (ROM) less than 45º of hip flexion.

2. Alteration of the mechanosensitivity of the sciatic nerve (or its tibial branch) to the nerve algometry at the level of the popliteal fossa.

3. Patients categorized as neuropathic pain in the Questionnaire Douleur Neuropathique-4 questions (DN4). Validated in Spanish, it consists of descriptions and signs of pain that are evaluated with “1” (Yes) or “0” (No) to identify patients with a high probability of having neuropathic pain components. The exploration of tactile sensitivity of the spine and lower limbs is carried out with the Semmes-Weinstein monofilaments. The scores of the individual items are summed to obtain a maximum total score of 10, with a cut-off point of = 4.

4. Previous spine surgeries in any of its segments (causing a considerable deficit of strength, an altered sensitivity or the inhibition of osteotendinous reflexes).

5. Anatomopathological diagnosis observed by imaging (hernias, protrusion, spondylolisthesis, stenosis...), which cause a considerable deficit of strength, an altered sensitivity or the inhibition of osteotendinous reflexes.

6. Tumors.

7. Pregnant.

8. Previous traumas or traffic accidents.

9. Systemic processes, immunosuppressed, rheumatic diseases.

10. Diabetes, thyroid diseases.

11. Pharmacological treatment with opiates, antidepressants or antiepileptic drugs and drug use. The secondary pharmacological treatment to subacute non-specific low back pain and the consumption of narcotics, could alter the obtaining of results.

12. Do not tolerate the position during the evaluation.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Following what has been done in previous studies where neurodynamics were compared with placebo, the study sample size will be at least 40 participants to get a relevant clinically difference. Nevertheless, a possible 20% participants loss was assumed, which is why the simple size will be of 50 participants dividing the patients into two groups of 25 participants. The G® Power version 3.1.9.2 software was used.

The randomization method was carried out through the Epidat software 4.2 version which -following a process of simple randomization and consecutive sampling- divides the patients into two groups (intervention and control) with a minimum of 25 patients per group.

The statistical analysis will be carried out by an intention-to-treat (ITT) method which will include every participant according to the randomized treatment assignment and will ignore anything that could happen after randomization.

The data will be organized and then analyzed using the statistical package SPSS version 25.0 for Windows. All statistical tests will be runned considering a 95% confidence interval (CI) and a level of significance a = 0.05. So, a p-value <0.05 will allow to reject the null hypothesis (HO).

1. Data descriptive statistics analysis. The dependent variables normality will be measured using the Shapiro-Wilk statistical test. Both the average and standard deviation will be calculated in the case of variable normality; while the median and interquartile range will be calculated in the case of variable abnormality. Regarding the qualitative dependent variables the frequencies and percentages for each category will be calculated.

2. The Initial groups homogeneity analysis for the qualitative variables will be checked using Pearson's Chi-square statistical test, or alternatively, with Fisher exact test. Regarding the quantitative variables according to the normality it will be used the T Student’s test or the U Mann–Whitney test.

3. Intra-groups analysis. The “Oswestry” variable which only have two measurements (pre-intervention and post-intervention) will be analysed by the Wilcoxon signed rank test while the variables with three measurements (pre-intervention, post-intervention1 and post-intervention2) will be analysed by the Repeated measures ANOVA test or the Friedman test according to the normality.

5. Inter-groups analysis. If all the measures fit the normal we will use a Factorial ANOVA -according to the normality-, but if the variables do not fit the normal we will use the Mann-Whitney U test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2020
Actual
21/02/2020
Date of last participant enrolment
Anticipated
4/05/2020
Actual
27/03/2020
Date of last data collection
Anticipated
Actual
3/04/2020
Sample size
Target
50
Accrual to date
Final
51
Recruitment outside Australia
Country [1] 21525 0
Spain
State/province [1] 21525 0
Madrid

Funding & Sponsors
Funding source category [1] 302866 0
University
Name [1] 302866 0
Universidad de Alcalá.
Country [1] 302866 0
Spain
Primary sponsor type
University
Name
Departamento de Enfermería y Fisioterapia de la Universidad de Alcalá.
Address
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country
Spain
Secondary sponsor category [1] 302819 0
None
Name [1] 302819 0
Address [1] 302819 0
Country [1] 302819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303443 0
Comité de Ética de la Investigación y Experimentación Animal de la Universidad Alcalá.
Ethics committee address [1] 303443 0
Ethics committee country [1] 303443 0
Spain
Date submitted for ethics approval [1] 303443 0
29/06/2018
Approval date [1] 303443 0
11/10/2018
Ethics approval number [1] 303443 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93682 0
Mr Alvaro Cuñado Gonzalez.
Address 93682 0
Universidad de Alcalá (UAH). Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country 93682 0
Spain
Phone 93682 0
+34618473519
Fax 93682 0
Email 93682 0
[email protected]
Contact person for public queries
Name 93683 0
Sergio Belda Berenguer
Address 93683 0
Universidad de Alcalá (UAH). Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country 93683 0
Spain
Phone 93683 0
+34657239405
Fax 93683 0
Email 93683 0
[email protected]
Contact person for scientific queries
Name 93684 0
Alvaro Cuñado Gonzalez.
Address 93684 0
Universidad de Alcalá (UAH). Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country 93684 0
Spain
Phone 93684 0
+34618473519
Fax 93684 0
Email 93684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
European Data Protection Law.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2174Ethical approval    377656-(Uploaded-26-05-2019-02-54-33)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseValidation of a sham novel neural mobilization technique in patients with non-specific low back pain: A randomized, placebo-controlled trial.2021https://dx.doi.org/10.1016/j.msksp.2021.102378
N.B. These documents automatically identified may not have been verified by the study sponsor.