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

Sponsor

CEU San Pablo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04764890

Collaborator

(none)

Enrollment

Location

Arms

3.6

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sciatica Electroacupuncture Manual Therapy	Other: Electroacupuncture Other: Manual therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Electroacupuncture and manual therapyElectroacupuncture and manual therapy

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 11, 2021

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electroacupuncture and manual therapy Electroacupuncture in several points and manual therapy in the lumbar spine	Other: Electroacupuncture Electroacupuncture in several point Other: Manual therapy Manual therapy in the lower spine.
Active Comparator: Manual therapy Manual therapy in the lumbar spina	Other: Manual therapy Manual therapy in the lower spine.

Arm

Intervention/Treatment

Experimental: Electroacupuncture and manual therapy

Electroacupuncture in several points and manual therapy in the lumbar spine

Other: Electroacupuncture

Electroacupuncture in several point

Other: Manual therapy

Manual therapy in the lower spine.

Active Comparator: Manual therapy

Manual therapy in the lumbar spina

Other: Manual therapy

Manual therapy in the lower spine.

Outcome Measures

Primary Outcome Measures

Visual analog scale for pain [up to 5 weeks]
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 [up to 5 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged from 18 to 50 years old.
Diagnosis of sciatica

Exclusion Criteria:

Pregnancy.
Fear of needles.
Coagulation disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CEU-San Pablo Universtiy	Madrid		Spain	28922

Sponsors and Collaborators

CEU San Pablo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CEU San Pablo University

ClinicalTrials.gov Identifier:

NCT04764890

Other Study ID Numbers:

CEUSPU12

First Posted:

Feb 21, 2021

Last Update Posted:

Apr 19, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sciatica

Study Results

No Results Posted as of Apr 19, 2021