- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03416556
Manual Therapy in Chronic Shoulder Pain Treatment
The Initial Effects on Pain, Pain Sensitivity, Range of Motion and Muscle Strength of an Anteroposterior Mobilization of the Glenohumeral Joint in Overhead Athletes With Chronic Shoulder Pain
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid
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Alcala de Henares, Madrid, Spain, 2805
- Clinical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobilization to the glenohumeral joint
This condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder
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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.
Other Names:
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Sham Comparator: The manual contact condition
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.
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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.
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.
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No Intervention: No-contact condition
There was no manual contact between the therapist and the participant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported shoulder pain
Time Frame: Change from Baseline at 5 minutes after intervention
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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
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Change from Baseline at 5 minutes after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder disability
Time Frame: Change from Baseline at 24 hours after treatment
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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).
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Change from Baseline at 24 hours after treatment
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Shoulder range of movement (ROM)
Time Frame: Change from Baseline at and 5 minutes after treatment
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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
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Change from Baseline at and 5 minutes after treatment
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Shoulder muscles strength
Time Frame: Change from Baseline at 5 minutes after treatment
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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
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Change from Baseline at 5 minutes after treatment
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Pressure pain threshold (PPT)
Time Frame: Change from Baseline at 5 minutes after treatment
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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
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Change from Baseline at 5 minutes after treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Pecos-Martin, Dr, Alcala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H1496053548524
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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