Clinical trial NCT02214199: Effectiveness of Cervicothoracic Manipulative Treatment in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Shoulder Pain
Manual Theapy
Exercises Therapy
Keywords: Shoulder Pain
Shoulder Impingement Syndrome
Exercise therapy
Randomized Controlled Trial
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Andaluz Health Service
First posted: 2014-08-12
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Disability Questionnaire Arm, Shoulder and Hand (DASHe)
timeFrame: At baseline and 5 weeks
Secondary outcomes:
measure: Shoulder Disability Questionnaire
timeFrame: At baseline and 5 weeks
measure: Hawkins-Kennedy Test
timeFrame: At baseline and 5 weeks
measure: Neer Test.
timeFrame: At baseline and 5 weeks
measure: Range of Motion
timeFrame: At baseline and 5 weeks
measure: Visual Analogue Scale
timeFrame: At baseline and 5 weeks
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almeria
Study officials:
References:
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citation: Koike Y, Sano H, Kinjyo T, Imamura I, Masahiro O, Goto M, Ooyama M, Kita A, Itoi E. Shoulder surface temperature and bone scintigraphy findings in patients with rotator cuff tears. Ups J Med Sci. 2011 May;116(2):142-7. doi: 10.3109/03009734.2010.545150. Epub 2011 Feb 16.
citation: Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.
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