Real Versus Sham Manual Therapy for RCRSP

NCT ID: NCT04440046

Last Updated: 2021-06-29

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2021-04-18

Brief Summary

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

A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks.

The hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with RCRSP.

Detailed Description

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

The objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain.

For this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied.

The investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.

Conditions

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

Shoulder 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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

Real manual therapy

Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program

Group Type EXPERIMENTAL

Manual therapy thoracic spine

Intervention Type OTHER

Manual therapy mobilization directed to the costovertebral joint.

Manual therapy glenohumeral joint

Intervention Type OTHER

Manual therapy mobilization directed to the glenohumeral joint.

Therapeutic exercise

Intervention Type OTHER

Therapeutic exercise program consisting on isometric exercise with progressive load.

Sham thoracic manual therapy

Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

Group Type SHAM_COMPARATOR

Manual therapy glenohumeral joint

Intervention Type OTHER

Manual therapy mobilization directed to the glenohumeral joint.

Sham thoracic manual therapy

Intervention Type OTHER

Sham manual therapy directed to the costovertebral joint.

Therapeutic exercise

Intervention Type OTHER

Therapeutic exercise program consisting on isometric exercise with progressive load.

Sham manual therapy

Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

Group Type SHAM_COMPARATOR

Sham thoracic manual therapy

Intervention Type OTHER

Sham manual therapy directed to the costovertebral joint.

Sham glenohumeral manual therapy

Intervention Type OTHER

Sham manual therapy directed to the glenohumeral joint.

Therapeutic exercise

Intervention Type OTHER

Therapeutic exercise program consisting on isometric exercise with progressive load.

Interventions

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

Manual therapy thoracic spine

Manual therapy mobilization directed to the costovertebral joint.

Intervention Type OTHER

Manual therapy glenohumeral joint

Manual therapy mobilization directed to the glenohumeral joint.

Intervention Type OTHER

Sham thoracic manual therapy

Sham manual therapy directed to the costovertebral joint.

Intervention Type OTHER

Sham glenohumeral manual therapy

Sham manual therapy directed to the glenohumeral joint.

Intervention Type OTHER

Therapeutic exercise

Therapeutic exercise program consisting on isometric exercise with progressive load.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* unilateral shoulder pain of non-traumatic origing lasting more than three months.
* Pain evoked with active shoulder movements.
* Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation.
* Minimal or no rest pain (less than 3 points in a numeric pain rating scale).

Exclusion Criteria

* Other shoulder pathologies than RCRSP.
* Systemic diseases.
* Neural symptoms.
* Neck pain.
* Radiculopathy.
* To have been treated for shoulder pain in the last three months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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 Alcala

OTHER

Sponsor Role lead

Responsible Party

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

Prof. Dr. Daniel Pecos Martín

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Daniel Pecos-Martin, PhD

Role: STUDY_DIRECTOR

University of Alcala

Locations

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

Ruben Fernandez-Matias

Alcalá de Henares, , 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.

2/111/729

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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