The Effectiveness of Isometric Exercise on the Management of Chronic Shoulder Pain

NCT ID: NCT04475965

Last Updated: 2020-07-17

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

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-10-05

Brief Summary

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

The aim of this study was to evaluate the influence of the intensity of Isometric Contraction of shoulder external rotators, comparing the effect of a high-level IC (80% maximal voluntary isometric contraction) versus a low-level Isometric Contraction (20% maximal voluntary isometric contraction) on pain intensity, pain thresholds, and function in chronic pain shoulder patients.

Detailed Description

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

This was a single-blinded, randomized parallel study. Eighty-two patients presenting chronic musculoskeletal shoulder pain were allocated to two groups. Patients in group 1 (n= 41) received a five-series Isometric Contraction of shoulder external rotators at 20% maximal voluntary isometric contraction, while patients in group 2 (n= 41) received similar protocol but the intensity of contraction was set at 80% maximal voluntary isometric contraction. In both cases, each series of IC was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period. Outcome measures included muscle pain sensitivity (pressure pain thresholds) and pain intensity (pain intensity numerical rating score), and shoulder function (Constant Score).

Conditions

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

Chronic 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

Participants were randomly assigned to groups by using a random number table. This procedure was conducted by an external assessor. The allocation concealment strategy included the use of sealed-opaque and consecutively numbered envelopes.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The assessor responsible for the outcome measures was blinded to the subjetc´s treatment assignment. The assessor was not present in the room while the treatment was delivered. He returned once the treatment was completed to perform the measurements.

Study Groups

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

Group 1 20% maximal voluntary isometric contraction

Patients in group 1 received a five-series Isometric Contraction of shoulder external rotators at 20% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.

Group Type EXPERIMENTAL

Isometric exercise for shoulder external rotators

Intervention Type OTHER

The intervention included the application of a series of isometric contraction for the external rotators shoulder muscles. The exercise protocol included two intensities; high-level isometric contraction (80% maximal voluntary isometric contraction) versus a low-level isometric contraction (20% maximal voluntary isometric contraction).

Group 2 80% maximal voluntary isometric contraction

Patients in group 2 received a five-series Isometric Contraction of shoulder external rotators at 80% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.

Group Type ACTIVE_COMPARATOR

Isometric exercise for shoulder external rotators

Intervention Type OTHER

The intervention included the application of a series of isometric contraction for the external rotators shoulder muscles. The exercise protocol included two intensities; high-level isometric contraction (80% maximal voluntary isometric contraction) versus a low-level isometric contraction (20% maximal voluntary isometric contraction).

Interventions

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

Isometric exercise for shoulder external rotators

The intervention included the application of a series of isometric contraction for the external rotators shoulder muscles. The exercise protocol included two intensities; high-level isometric contraction (80% maximal voluntary isometric contraction) versus a low-level isometric contraction (20% maximal voluntary isometric contraction).

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Male or female having a chronic shoulder soft-tissue injury of at least 3 month duration resulting in a mild to moderate level of disability (Constant score scale), pain intensity score between 3 and 8 points (pain intensity numerical rating scale), and age between 18 and 65 years.

Exclusion Criteria

* Participants were excluded if they had any contraindications related to the application of isometric exercise, neurological problems (central or peripheral), concomitant physiotherapy or chiropractic treatment, fibromyalgia or general systemic disease conditions, had participated in any moderate or vigorous physical activity in the las 72 hours previous the outcome assessment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Jorge Fuentes

OTHER

Sponsor Role lead

Responsible Party

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

Jorge Fuentes

Clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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

Hans Neira, BSc

Role: PRINCIPAL_INVESTIGATOR

Concepcion University

Locations

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

Hospital Traumatológico

Concepción, Bio Bio, Chile

Site Status

Countries

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

Chile

Other Identifiers

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

EIH UCM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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