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Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica

Primary Purpose

Sciatica, Electroacupuncture, Manual Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Electroacupuncture
Manual therapy
Sponsored by
CEU San Pablo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged from 18 to 50 years old.
  • Diagnosis of sciatica

Exclusion Criteria:

  • Pregnancy.
  • Fear of needles.
  • Coagulation disorders.

Sites / Locations

  • CEU-San Pablo UniverstiyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electroacupuncture and manual therapy

Manual therapy

Arm Description

Electroacupuncture in several points and manual therapy in the lumbar spine

Manual therapy in the lumbar spina

Outcomes

Primary Outcome Measures

Visual analog scale for pain
Pain measurement: 100-mm visual analog scale (VAS), horizontal line ranging from 0 mm (nopain) to 100 (worts imaginable pain)
Oswestry Low Back Pain Disability Questionnaire
This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2021
Last Updated
April 16, 2021
Sponsor
CEU San Pablo University
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1. Study Identification

Unique Protocol Identification Number
NCT04764890
Brief Title
Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica
Official Title
Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEU San Pablo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aims of the study are: To study the pain efficacy of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica. To study the efficacy on function of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica, Electroacupuncture, Manual Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Electroacupuncture and manual therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture and manual therapy
Arm Type
Experimental
Arm Description
Electroacupuncture in several points and manual therapy in the lumbar spine
Arm Title
Manual therapy
Arm Type
Active Comparator
Arm Description
Manual therapy in the lumbar spina
Intervention Type
Other
Intervention Name(s)
Electroacupuncture
Intervention Description
Electroacupuncture in several point
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
Manual therapy in the lower spine.
Primary Outcome Measure Information:
Title
Visual analog scale for pain
Description
Pain measurement: 100-mm visual analog scale (VAS), horizontal line ranging from 0 mm (nopain) to 100 (worts imaginable pain)
Time Frame
up to 5 weeks
Title
Oswestry Low Back Pain Disability Questionnaire
Description
This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life.
Time Frame
up to 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged from 18 to 50 years old. Diagnosis of sciatica Exclusion Criteria: Pregnancy. Fear of needles. Coagulation disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos Zuil Escobar, PhD
Phone
+3491372400
Email
jczuil@ceu.es
Facility Information:
Facility Name
CEU-San Pablo Universtiy
City
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Zuil-Escobar, PhD
Phone
913724700
Email
jczuil@ceu.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica

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