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Completed

NCT Number: NCT02214199

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Universidad de Almeria

Almería, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Report of pain or dysfunction with overhead activities
  • Demonstration of pain during active shoulder movements
  • Demonstration of a positive Neer/Hawkins-Kennedy test
  • Recent onset within the last 12 months
  • Report of non-traumatic onset
  • Demonstration of a painful arc of the arm from 60° to 120° of flexion
  • 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

Treatment and study plan

Manipulative Therapy Techniques

Other

Home Exercises

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Collaborators

  • Andaluz Health Service

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2014
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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