NCT04326621

Brief Summary

A Pressure Release Technique will be test in patient with low back pain compared to a sham

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 19, 2020

Last Update Submit

March 26, 2020

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • VAS

    self reported pain

    immediately after treatment

  • VAS

    self reported pain

    at 6 months

Study Arms (2)

PRT group

EXPERIMENTAL

pressure Release Technique and exercises

Other: Pressure Release Technique (PRT)Other: Control

Exercises group

ACTIVE COMPARATOR

Only exercises

Other: Pressure Release Technique (PRT)Other: Control

Interventions

Pressure Release Technique (PRT)OTHER

A pressure applied on muscles trigger points with the finger of a physiotherapist and exercises

Exercises groupPRT group
ControlOTHER

exercises

Exercises groupPRT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic low back pain at least 6 months

You may not qualify if:

  • hernia, neurologic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Gema Serrano-Hernanz, PhD

CONTACT

669332986gema.serrano.hernanz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 30, 2020

Study Start

September 1, 2020

Primary Completion

January 1, 2021

Study Completion

April 1, 2021

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share