Value of Manual Therapy Specificity Referred to Pain Intensity in Patients With Subacute and Unspecified Low Back Pain

NCT ID: NCT04955314

Last Updated: 2022-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-11

Study Completion Date

2021-09-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study proves the specificity of manual therapy in unspecified an subacute low back pain

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of the study is to determine the importance of manual therapy specificity in relation to subacute low back pain.

In order to do this, it will be selected a sample of at least 48 people who suffer low back pain whose duration has not exceeded 12 weeks. Patients will be divided into two groups and a different physiotherapist from the one who will subsequently perform the intervention, will assess and determine which is the most painful segment in each of them.

In the first group, the intervention to be carried out will be through posteroanterior (PA) vertebral mobilizations in the most painful lumbar segment. The members of the second group will undergo this same technique on a painful segment of the region adjacent to the one they have referred as the main source of pain.

Each of these sessions will continue until the patient's symptoms have decreased two points on the numerical scale of pain. There will be one session per week, for six weeks.

To determine the differences between the two groups, there will be carried out 4 measurements of pain, functional disability, quality of life and kinesiophobia, and 3 measurements of pressure pain threshold were performed. Each one of them will be carried out in the first session, in the third week of treatment, in the last session of the treatment and one month after the end of the treatment. The last measeurement will be executed online and that is why the pressure pain threshold will be measured three times while the rest will be do it.

The hypothesis is that it won´t be differences in the amount of pain between the tratment on the main painful segment and the treatment on his adyacent segment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be divided into two groups and a different physiotherapist from the one who will subsequently perform the intervention will assess and determine which is the most painful segment in each of them.

In the first of the groups, the intervention to be carried out will be through posteroanterior vertebral mobilizations in the most painful lumbar segment. The members of the second group will undergo this same technique on a painful segment of the region adjacent to the one they have referred as the main source of pain.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PA mobilizations on their main painfull vertebral segment

Patients who will be treated with PA mobilizations on their main painfull vertebral segment.

Group Type EXPERIMENTAL

PA vertebral mobilization

Intervention Type OTHER

A PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist

PA mobilizations on an adjacent vertebral segment from the most painful

Patients who will be treated with PA mobilizations on an adjacent vertebral segment from the most painful.

Group Type EXPERIMENTAL

PA vertebral mobilization

Intervention Type OTHER

A PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PA vertebral mobilization

A PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* People aged between 18 and 65 years old with unspecific and subacute low back pain.
* Participants must be capable of walking twice a week 20 minutes per day.

Exclusion Criteria

* People with history of spinal surgeries, osteoporosis and tumor.
* Pregnant and people with severe respiratory and cardiac illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Jaén

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alexander Achalandabaso

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander Achalandabaso

Role: STUDY_DIRECTOR

University of Jaen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad de Alcalá

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEIM/HU/2020/6/56

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.