Lower Back Pain Clinical Trial
Official title:
Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain: a Pilot Study
Verified date | October 2021 |
Source | University of Seville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation. In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Thirty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds
Status | Completed |
Enrollment | 30 |
Est. completion date | July 1, 2020 |
Est. primary completion date | May 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Diagnosis of Lower Back Pain - Having no other therapy Exclusion Criteria: - Other pathology (discal hernia, injured limbs, neurological pathology) - Belenophobia |
Country | Name | City | State |
---|---|---|---|
Spain | Blanca de la Cruz Torres | Seville |
Lead Sponsor | Collaborator |
---|---|
University of Seville |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of pain | Measured by Visual Analogue Scale (0, no pain; 100, max pain) | From baseline measurement up to 1 week | |
Primary | Range of motion | Measured by goniometer. Hip flexion, external and internal rotation range of motion | From baseline measurement up to 1 week | |
Primary | Y Balance Test | Stability body | From baseline measurement up to 1 week | |
Primary | Owestry questionnaire | Lower back pain questionnaire | From baseline measurement up to 1 week |
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