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Effectiveness of neural glide versus manual placebo in patients with subacute non-specific low back pain and validation of a neurodynamic manual placebo technique.

Effectiveness of neural glide versus manual placebo in patients with subacute non-specific low back pain and validation of a neurodynamic manual placebo technique.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000866101
Enrollment
51
Registered
2019-06-18
Start date
2020-02-21
Completion date
2020-03-27
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The hypothesis proposed in this study is that a manual placebo technique has a good blinding method and meets the treatment's expectations of the participants, Thus, it can be used in patients with subacute non-specific low back pain. The main objective of this study is to examine if the participants blinding is valid and if the participants treatment expectations are met. Secondary objectives: 1. To examine if sciatic nerve slides are more effective in the short term than placebo in reducing pain in patients with subacute non-specific low back pain. 2. To examine if sciatic nerve slides are more effective in the short term than placebo in improving hamstring extensibility in patients with subacute non-specific low back pain. 3. To examine if sciatic nerve slides are more effective in the short term than placebo in improving the range of motion in lumbar flexion in patients with subacute non-specific low back pain. 4. To examine if sciatic nerve slides are more effective in the short term than placebo in improving the pain threshold to sciatic nerve pressure in patients with subacute non-specific low back pain. 5. To examine if sciatic nerve slides are more effective in the short term than placebo in improving the pain threshold to the median nerve pressure in patients with subacute non-specific low back pain. 6. To examine if the sciatic nerve slides are more effective in the short term than placebo in improving the daily activities functionality in patients with subacute non-specific low back pain.

Interventions

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 ap

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).

Sponsors

Departamento de Enfermería y Fisioterapia de la Universidad de Alcalá.
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026