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

Early Phase 1

Completed

• Conditions: Shoulder Pain; Manual Theapy; Exercises Therapy
• Interventions: Other: Home Exercises; Other: Manipulative Therapy Techniques

• Registration Number: NCT02214199
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-09
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-12
• Primary Completion: 2015-05
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Therapy	Home Exercises	Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle.
Manipulative Therapy Techniques	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.

Primary Outcome Measures

Name	Time	Method
Disability Questionnaire Arm, Shoulder and Hand (DASHe)	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

Name	Time	Method
Shoulder Disability Questionnaire	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.
Hawkins-Kennedy Test	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.
Neer Test.	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.
Range of Motion	At baseline and 5 weeks	The range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction.
Visual Analogue Scale	At baseline and 5 weeks	A 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain.

Trial Locations

Locations (1)

Universidad de Almeria; 🇪🇸 Almería, Spain