MedDataX Logo

INSTRUMENTED-MANUAL PHYSIOTHERAPY VERSUS NONINSTRUMENTED

NCT ID: NCT02953236

Last Updated: 2017-03-31

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-03-31

Brief Summary

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

This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.

Detailed Description

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

Background: There are several therapies currently used to treat myofascial trigger points, including conservative and invasive techniques. It has been shown that conservative techniques including therapeutic massage, stretching, transcutaneal electrical nerve stimulation, spray and stretch, cold laser treatment, and ultrasound are the most applied treatments for myofascial pain syndrome, but no single strategy has proved to be universally successful. Instrumented massage has shown clinical effectiveness on shoulder pain, low back pain, and only one study (case report) on myofascial trigger points. This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.

Methods/Design: The study includes 31 volunteers with myofascial trigger points on right trapezius muscle. Clinical and patient data were obtained from questionnaires, VAS, algometry, sono-myoelastography and myotonometry. Also, physiotherapist grip strength was measured. Subjects were randomly allocated into one of two groups: Instrumented massage or Manual massage. The intervention consisted in a single 20 minutes session of massage on the back and neck by the same therapist, depending of the group, massage was applied manually or instrumented.

Conditions

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

Neck 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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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

Instrumented massage

Group Type EXPERIMENTAL

Instrumented massage

Intervention Type PROCEDURE

The first group will receive a 20 min session of instrumented massage on back and neck areas. Subjects will be in prone position and physical therapist will applied instrumental massage in a protocolised way from low back until neck muscles, both in left and right side of the body.

Manual massage

Group Type ACTIVE_COMPARATOR

Manual massage

Intervention Type PROCEDURE

The second group will receive a 20 min session of manual massage on back and neck areas. Subjects will be in prone position and physical therapist will applied manual massage in a protocolised way from low back until neck muscles, both in left and right side of the body.

Interventions

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

Instrumented massage

The first group will receive a 20 min session of instrumented massage on back and neck areas. Subjects will be in prone position and physical therapist will applied instrumental massage in a protocolised way from low back until neck muscles, both in left and right side of the body.

Intervention Type PROCEDURE

Manual massage

The second group will receive a 20 min session of manual massage on back and neck areas. Subjects will be in prone position and physical therapist will applied manual massage in a protocolised way from low back until neck muscles, both in left and right side of the body.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* • To be of legal age.

* To understand correctly Spanish.
* To show their approval by signing the informed consent.
* Suffering from mechanical neck pain

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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

Dr. Antonio I Cuesta-Vargas

Principal Research PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Antonio Cuesta-Vargas

Málaga, Malaga, 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.

103-2015-H

Identifier Type: -

Identifier Source: org_study_id