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

April 20, 2016 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Universidad de Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and 5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Collaborators

Andaluz Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 9, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/2013

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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