NCT03416556

Brief Summary

Background: Passive oscillatory mobilizations are often employed by physiotherapists to reduce shoulder pain and increase function. However, there is little data about the neurophysiological effects of these mobilizations. Objectives: To investigate the initial effects of an anteroposterior (AP) shoulder joint mobilization on measures of pain and function in overhead athletes with chronic shoulder pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

28 days

First QC Date

January 11, 2018

Last Update Submit

March 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-reported shoulder pain

    Participants were asked to indicate the intensity of their current shoulder pain using a numeric rating pain scale (NRPS). In this scale, 0 is not pain and 10 is the worse pain possible

    Change from Baseline at 5 minutes after intervention

Secondary Outcomes (4)

  • Shoulder disability

    Change from Baseline at 24 hours after treatment

  • Shoulder range of movement (ROM)

    Change from Baseline at and 5 minutes after treatment

  • Shoulder muscles strength

    Change from Baseline at 5 minutes after treatment

  • Pressure pain threshold (PPT)

    Change from Baseline at 5 minutes after treatment

Study Arms (3)

Mobilization to the glenohumeral joint

EXPERIMENTAL

This condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder

Procedure: Mobilization to the glenohumeral joint

The manual contact condition

SHAM COMPARATOR

In this condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition.

Procedure: The manual contact conditionOther: No-contact condition

No-contact condition

NO INTERVENTION

There was no manual contact between the therapist and the participant

Interventions

The treatment condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder. In particular, a Grade III AP glide to the humeral head with the arm positioned in 90º of glenohumeral abduction and full internal rotation was used. The posterior gliding force to the humeral head was applied maintaining the glide at right angles to the plane of movement and at a frequency of 2 Hz which was controlled by means of a metronome. The arm was returned to its original position between each set.

Also known as: Joint Manipulation
Mobilization to the glenohumeral joint

During the manual contact condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition. However, a simulated posterior glide was performed but with minimal pressure actually applied. The number of repetitions and sets were as per the treatment condition.

The manual contact condition

During the no-contact condition, the subject remained in the initial starting position thorough the entire session but there was no manual contact between the therapist and the participant. The total treatment time was the same as per the other conditions.

The manual contact condition

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of chronic shoulder pain lasting ≥3 months.
  • Play overhead sport regularly.

You may not qualify if:

  • Had a non-musculoskeletal origin of shoulder pain.
  • Previous surgery to the shoulder complex.
  • Frozen shoulder.
  • Any co-existing inflammatory, infectious or neurological condition.
  • The patient from physiotherapy treatment.
  • Any evidence of pain referred from the cervical spine to the shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical University

Alcalá de Henares, Madrid, 2805, Spain

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Pecos-Martin, Dr

    Alcala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
* The participant were assigned to the treatment group with a computer program. * Outcomes assessor did´t know the treatment applied to the participants
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 31, 2018

Study Start

February 15, 2018

Primary Completion

March 15, 2018

Study Completion

March 15, 2018

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations