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Manual Therapy in Chronic Shoulder Pain Treatment

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mobilization to the glenohumeral joint
The manual contact condition
No-contact condition
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Mobilization to the glenohumeral joint

The manual contact condition

No-contact condition

Arm Description

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

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.

There was no manual contact between the therapist and the participant

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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
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
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

Full Information

First Posted
January 11, 2018
Last Updated
March 25, 2018
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT03416556
Brief Title
Manual Therapy in Chronic Shoulder Pain Treatment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The participant were assigned to the treatment group with a computer program. Outcomes assessor did´t know the treatment applied to the participants
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobilization to the glenohumeral joint
Arm Type
Experimental
Arm Description
This condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder
Arm Title
The manual contact condition
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
No-contact condition
Arm Type
No Intervention
Arm Description
There was no manual contact between the therapist and the participant
Intervention Type
Procedure
Intervention Name(s)
Mobilization to the glenohumeral joint
Other Intervention Name(s)
Joint Manipulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
The manual contact condition
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No-contact condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported shoulder pain
Description
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
Time Frame
Change from Baseline at 5 minutes after intervention
Secondary Outcome Measure Information:
Title
Shoulder disability
Description
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).
Time Frame
Change from Baseline at 24 hours after treatment
Title
Shoulder range of movement (ROM)
Description
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
Time Frame
Change from Baseline at and 5 minutes after treatment
Title
Shoulder muscles strength
Description
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
Time Frame
Change from Baseline at 5 minutes after treatment
Title
Pressure pain threshold (PPT)
Description
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
Time Frame
Change from Baseline at 5 minutes after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martin, Dr
Organizational Affiliation
Alcala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical University
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
2805
Country
Spain

12. IPD Sharing Statement

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Manual Therapy in Chronic Shoulder Pain Treatment

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