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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03416556
Other study ID # H1496053548524
Secondary ID
Status Completed
Phase N/A
First received January 11, 2018
Last updated March 25, 2018
Start date February 15, 2018
Est. completion date March 15, 2018

Study information

Verified date March 2018
Source University of Alcala
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Design: Double-blind, controlled, within-subjects repeated-measures design Method: Thirty-one overhead athletes with chronic shoulder pain participated. The effects of a 9-min, AP mobilization of the glenohumeral joint were compared with manual contact and no-contact interventions. Pressure pain threshold (PPT), range of movement (ROM), muscle strength, self-reported pain, and disability were measured immediately before and after each intervention.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date March 15, 2018
Est. primary completion date March 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- History of chronic shoulder pain lasting =3 months.

- Play overhead sport regularly.

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mobilization to the glenohumeral joint
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.
The manual contact condition
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.
Other:
No-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.

Locations

Country Name City State
Spain Clinical University Alcala de Henares Madrid

Sponsors (1)

Lead Sponsor Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Shoulder disability The DASH is comprised of 30 items (disability/symptom section) and two optional sections related to the impact of pathology on work and sports. Each item is scored from 1 to 5 with increasing values representing more severity of symptoms. The total score for the disability/symptoms section ranges from 30 to 150, but it is then transformed to a scale from 0 (better score possible) to 100 (worse score possible). Change from Baseline at 24 hours after treatment
Secondary Shoulder range of movement (ROM) Active elevation in the scapular plane and passive glenohumeral internal and external rotation were measured using a Standard BASELINE ® 12-inch plastic goniometer following previous guidelines. The 0 degrees of movement is worse and 180 degrees is the better Change from Baseline at and 5 minutes after treatment
Secondary Shoulder muscles strength Isometric strength of the shoulder internal and external rotator musculature was measured using a portable hand-held dynamometer (Nicholas Manual Muscle Tester, Lafayette Instruments, USA). Normal external rotation strength is 20 Newtons and 27 newton in internal rotation strength Change from Baseline at 5 minutes after treatment
Secondary Pressure pain threshold (PPT) The PPT was measured using an analogue Fisher algometer (Force Dial model FDK, Wagner Instruments) with a surface area at the round tip of 1cm2. The algometer probe tip was applied perpendicular to the skin at a rate of 1kg/cm2/s until the first onset of pain. The PPT value is specific in each subject.The minimal clinically important difference is 2Kg/cm Change from Baseline at 5 minutes after treatment
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