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Manual Therapy in Chronic Shoulder Pain Treatment

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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

Tracking Information
First Submitted Date  ICMJE January 11, 2018
First Posted Date  ICMJE January 31, 2018
Last Update Posted Date March 27, 2018
Actual Study Start Date  ICMJE February 15, 2018
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • 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).
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Manual Therapy in Chronic Shoulder Pain Treatment
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Shoulder Pain
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Mobilization to the glenohumeral joint
  • 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.
    Interventions:
    • Procedure: The manual contact condition
    • Other: No-contact condition
  • No Intervention: No-contact condition
    There was no manual contact between the therapist and the participant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2018)
31
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 15, 2018
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03416556
Other Study ID Numbers  ICMJE H1496053548524
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Daniel Pecos Martín, University of Alcala
Study Sponsor  ICMJE University of Alcala
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Pecos-Martin, Dr Alcala University
PRS Account University of Alcala
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP