Low Back PainNCT04326621
Effectiveness of Pressure Release Technique in Patients With Chronic Low Back Pain
A study testing Pressure Release Technique (PRT) in people with Low Back Pain, run by Universidad Complutense de Madrid.
Trial summary
A Pressure Release Technique will be test in patient with low back pain compared to a sham Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pressure Release Technique (PRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic low back pain at least 6 months
Who cannot join
- hernia, neurologic pain
Trial locations and contacts
No sites are listed yet.
About this study
A Pressure Release Technique will be test in patient with low back pain compared to a sham
- Conditions
- Low Back Pain
- Being tested
- Pressure Release Technique (PRT), Control
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Release Technique (PRT)Other
A pressure applied on muscles trigger points with the finger of a physiotherapist and exercises
ControlOther
exercises
| Study group | Role | What they receive |
|---|---|---|
| PRT group | Experimental | pressure Release Technique and exercises Receives: Other: Pressure Release Technique (PRT); Other: Control |
| Exercises group | Active comparator | Only exercises Receives: Other: Pressure Release Technique (PRT); Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
self reported pain
Measured: immediately after treatment
VAS
self reported pain
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study startSep 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gema Serrano-Hernanz, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326621
- Sponsor's protocol ID
- Geserraher
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pressure Release Technique in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04326621
- Acronym / sponsor ID
- Geserraher
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 30 Mar 2020 (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.
A Pressure Release Technique will be test in patient with low back pain compared to a sham
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRT group | Experimental | Other: Pressure Release Technique (PRT), Other: Controlpressure Release Technique and exercises |
| Exercises group | Active comparator | Other: Pressure Release Technique (PRT), Other: ControlOnly exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic low back pain at least 6 months
Key exclusion criteria (1 listed)
- hernia, neurologic pain
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 |
|---|---|---|
| Pressure Release Technique (PRT)A pressure applied on muscles trigger points with the finger of a physiotherapist and exercises | Other | Exercises group, PRT group |
| Controlexercises | Other | Exercises group, PRT group |
Primary outcome
VAS
Time frame: immediately after treatment
self reported pain
VAS
Time frame: at 6 months
self reported pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Release Technique (PRT) in people with Low Back Pain, run by Universidad Complutense de Madrid.
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 1 inclusion and 1 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Gema Serrano-Hernanz, PhD (669332986, gema.serrano.hernanz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: immediately after treatment). 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 30 Mar 2020.