Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Manual Therapy in Chronic Shoulder Pain Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416556
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Daniel Pecos Martín, University of Alcala

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.


Condition or disease Intervention/treatment Phase
Shoulder Pain Procedure: Mobilization to the glenohumeral joint Procedure: The manual contact condition Other: No-contact condition Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes 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
Primary Purpose: 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
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : March 15, 2018

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
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.
Other Name: Joint Manipulation

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.
Procedure: 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.

No Intervention: No-contact condition
There was no manual contact between the therapist and the participant



Primary Outcome Measures :
  1. Self-reported shoulder pain [ Time Frame: Change from Baseline at 5 minutes after intervention ]
    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 :
  1. Shoulder disability [ Time Frame: Change from Baseline at 24 hours after treatment ]
    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).

  2. Shoulder range of movement (ROM) [ Time Frame: Change from Baseline at and 5 minutes after treatment ]
    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

  3. Shoulder muscles strength [ Time Frame: Change from Baseline at 5 minutes after treatment ]
    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

  4. Pressure pain threshold (PPT) [ Time Frame: Change from Baseline at 5 minutes after treatment ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416556


Locations
Layout table for location information
Spain
Clinical University
Alcala de Henares, Madrid, Spain, 2805
Sponsors and Collaborators
University of Alcala
Investigators
Layout table for investigator information
Principal Investigator: Daniel Pecos-Martin, Dr Alcala University
  Study Documents (Full-Text)

Documents provided by Prof. Dr. Daniel Pecos Martín, University of Alcala:
Study Protocol  [PDF] January 11, 2018

Layout table for additonal information
Responsible Party: Prof. Dr. Daniel Pecos Martín, Professor, University of Alcala
ClinicalTrials.gov Identifier: NCT03416556    
Other Study ID Numbers: H1496053548524
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms