Electrical Stimulation With Interferential Current in the Non-especific Chronic Low Back Pain: Effects on the Autonomic Nervous System.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Autonomic Imbalance
- Chronic Low Back Pain
- Chronic Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants diagnosed with chronic low back pain will be divided into two different groups with 28 patients each: Experimental group: Participants in this group will receive electrical stimulation with interferential current. They will get also instructions to perform core strengthening exercises at home, after variable collection. Control group: Participants in this group will recieve the same electrical stimulation than in the experimental group but with no intensity. This group will get too instructions to perform core strengthening exercises at home (after variable collection) and follow General Practitioner indications about pharmacology. Masking: Single (Participant)Masking Description: Randomization process will be masked by opaques envelopes with numbers. Participants choose one random envelope, unaware the number and group relation. Later, a researcher will associate participants, groups and numbers.Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Only males
Description
In the first place, a meeting will be organized with the patients to resolve any doubt about the study and its process. The investigators will make sure every instruction is understandable, giving enough time to read and ask pertinent questions. Secondly, patients will be provided of an informed con...
In the first place, a meeting will be organized with the patients to resolve any doubt about the study and its process. The investigators will make sure every instruction is understandable, giving enough time to read and ask pertinent questions. Secondly, patients will be provided of an informed consent specific for the present study, according to the legal forms. Participants must agree with all the information and sign the document. At this point, patients will be interviewed individually by a researcher to collect all the data regarding to the Clinical History in Physiotherapy. In the next step, patients will be randomized into two different groups by choosing one opaque envelope, containing a number for the allocation. A researcher will make the final allocation depending on the number. Patients were unaware of the group allocation for masking. This study has to possible groups with a common indication for both: Experimental group: Patients allocated in this group will receive one single session of interferential current (IFC). Current used a carrier frequency of 4.000 Hz, 65Hz of amplitude modulated frequency (AMF) with sweep frecuency of 95Hz in a 1:1 swing pattern (quadripolar technique). Intensity was adjusted according to patient's tolerance without visible muscle twitches. The session will last 25 min. Control group: This group will receive the same intervention than experimental one but with no intensity, for 25 minutes. Patients will keep his general practitioner's indications about pharmacology. Common indication: Both groups will get instructions to perform a set of home-based exercises for core strengthening after variable collecting. Before and after the session, all the variable measurements will be collected in the same environmental conditions by the same researcher. Basal measurement (before intervention) will be recorded 15 minutes before session for 10 minutes. The second measurement will be taken while the patient recieves the intervention for 20 minutes.
Tracking Information
- NCT #
- NCT04483128
- Collaborators
- Not Provided
- Investigators
- Not Provided
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