SciaticaNCT04764890
Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica
A study testing Electroacupuncture and Manual therapy in people with Sciatica and Electroacupuncture, run by CEU San Pablo University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Sciatica, Electroacupuncture, Manual Therapy
- What is being tested?
- Electroacupuncture and Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2021to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged from 18 to 50 years old.
- Diagnosis of sciatica
Who cannot join
- Pregnancy.
- Fear of needles.
- Coagulation disorders.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
CEU-San Pablo Universtiy
Madrid, 28922
Juan Carlos Zuil-Escobar, PhD, 913724700, jczuil@ceu.es
About this study
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.
- Conditions
- Sciatica, Electroacupuncture, Manual Therapy
- Being tested
- Electroacupuncture, Manual therapy
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
Electroacupuncture in several point
Manual therapyOther
Manual therapy in the lower spine.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture and manual therapy | Experimental | Electroacupuncture in several points and manual therapy in the lumbar spine Receives: Other: Electroacupuncture; Other: Manual therapy |
| Manual therapy | Active comparator | Manual therapy in the lumbar spina Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 5 weeks
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.
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start11 Feb 2021
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Electroacupuncture and manual therapy
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764890
- Sponsor's protocol ID
- CEUSPU12
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica
- ClinicalTrials.gov ID
- NCT04764890
- Acronym / sponsor ID
- CEUSPU12
- Conditions
- Sciatica, Electroacupuncture, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Electroacupuncture and manual therapy
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture and manual therapy | Experimental | Other: Electroacupuncture, Other: Manual therapyElectroacupuncture in several points and manual therapy in the lumbar spine |
| Manual therapy | Active comparator | Other: Manual therapyManual therapy in the lumbar spina |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged from 18 to 50 years old.
- Diagnosis of sciatica
Key exclusion criteria (3 listed)
- Pregnancy.
- Fear of needles.
- Coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureElectroacupuncture in several point | Other | Electroacupuncture and manual therapy |
| Manual therapyManual therapy in the lower spine. | Other | Electroacupuncture and manual therapy, Manual therapy |
Primary outcome
Visual analog scale for pain
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Manual therapy in people with Sciatica and Electroacupuncture, run by CEU San Pablo University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos Zuil Escobar, PhD (+3491372400, jczuil@ceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale for pain (time frame: up to 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.