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Effectiveness of Cervicothoracic Manipulative Treatment in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial.

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: NCT02214199
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : April 21, 2016
Sponsor:
Collaborator:
Andaluz Health Service
Information provided by (Responsible Party):
Adelaida María Castro-Sánchez, Universidad de Almeria

Brief Summary:
The objective of this protocol is to compare degree of improvement can be achieved in patients with shoulder pain by treatment with Manipulative Techniques for the cervicothoracic spine versus home exercises.

Condition or disease Intervention/treatment Phase
Shoulder Pain Manual Theapy Exercises Therapy Other: Manipulative Therapy Techniques Other: Home Exercises Early Phase 1

Detailed Description:

Design: Randomized Clinical Trial. Objective: to determine the effects of manipulative techniques for the ervicothoracic spine versus home exercises on pain, disability, and range of movement in patients with unilateral shoulder inmingement syndrome.

Methods and Measures: ninety-two subjects will be randomly assigned to one of two groups.

Intervention: For 5-weeks, the groups 1 will undergo tratment comprising manipulative protocol techniques for the cervicothoracic spine (2/week) and the group 2 will develop a home exercise (2/week).

Main Outcome Measures: Intensity of pain, disability, and range of motion data will be collected at baseline, and 24hr after the last therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exercise Therapy
Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle.
Other: Home Exercises
Experimental: Manipulative Therapy Techniques
Lift Technique for mid-thoracic spine. Mobilization by low cervical spine on the upper lateral thoracic translation. Technical Dog flexion for high thoracic spine (T1-T4). Technical Dog flexion for mid-thoracic spine (T5-T8). Technical Dog flexed to low thoracic spine (T9-T12). Direct drive technology prone to mid-thoracic spine.
Other: Manipulative Therapy Techniques



Primary Outcome Measures :
  1. Disability Questionnaire Arm, Shoulder and Hand (DASHe) [ Time Frame: At baseline and 5 weeks ]
    This questionnaire asks about the symptoms as well as your ability to perform certain activities. This questionnaire has 30 items, and the results are clasified in: no difficulty, mild difficulty, moderate dificulty, severe dificulty and unable


Secondary Outcome Measures :
  1. Shoulder Disability Questionnaire [ Time Frame: At baseline and 5 weeks ]
    Shoulder Disability Questionnaire is a mesure covering 16 items designed to evaluate functional status limitation in patients with shoulder disorders.

  2. Hawkins-Kennedy Test [ Time Frame: At baseline and 5 weeks ]
    The Hawkins and Kennedy test was interpreted as indicative of impingement between the greater tuberosity of the humerus against the coraco- humeral ligament, trapping all those structures which intervene. It has been reported as less reliable than the Neer impingement test.

  3. Neer Test. [ Time Frame: At baseline and 5 weeks ]
    Neer's Test assesses for possible rotator cuff impingement. Stabilize the scapula and with the thumb pointing down and passively flex the arm. Pain is a positive test.

  4. Range of Motion [ Time Frame: At baseline and 5 weeks ]
    The range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction.

  5. Visual Analogue Scale [ Time Frame: At baseline and 5 weeks ]
    A 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Report of pain or dysfunction with overhead activities
  2. Demonstration of pain during active shoulder movements
  3. Demonstration of a positive Neer/Hawkins-Kennedy test
  4. Recent onset within the last 12 months
  5. Report of non-traumatic onset
  6. Demonstration of a painful arc of the arm from 60° to 120° of flexion
  7. Report of a baseline pain level of ≥2/10 on an 11 point numeric scale

Exclusion Criteria:

  • The presence of any red flags
  • A history of frozen shoulder
  • Disorders of the acromioclavicular joint
  • Degenerative arthritis of the glenohumeral joint
  • Known calcifying tendonitis (if identified by radiograph)
  • Shoulder instability
  • Posttraumatic disorders
  • Shoulder surgery and/or elbow, hand, wrist and blatantly misdiagnosed cervical spine disorders

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): NCT02214199


Locations
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Spain
Universidad de Almeria
Almería, Spain, 04120
Sponsors and Collaborators
Universidad de Almeria
Andaluz Health Service

Publications:

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Responsible Party: Adelaida María Castro-Sánchez, PhD (Lecturer), Universidad de Almeria
ClinicalTrials.gov Identifier: NCT02214199    
Other Study ID Numbers: 21/2013
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Keywords provided by Adelaida María Castro-Sánchez, Universidad de Almeria:
Shoulder Pain
Shoulder Impingement Syndrome
Exercise therapy
Randomized Controlled Trial
Additional relevant MeSH terms:
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Shoulder Pain
Shoulder Impingement Syndrome
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Shoulder Injuries
Wounds and Injuries