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

Primary Purpose

Shoulder Pain, Manual Theapy, Exercises Therapy

Status

Completed

Phase

Early Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Manipulative Therapy Techniques

Home Exercises

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder Pain, Shoulder Impingement Syndrome, Exercise therapy, Randomized Controlled Trial

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universidad de Almeria

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Exercise Therapy

Manipulative Therapy Techniques

Arm Description

Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle.

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.

Outcomes

Primary Outcome Measures

Disability Questionnaire Arm, Shoulder and Hand (DASHe)

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

Shoulder Disability Questionnaire

Shoulder Disability Questionnaire is a mesure covering 16 items designed to evaluate functional status limitation in patients with shoulder disorders.

Hawkins-Kennedy Test

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.

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

The range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction.

Visual Analogue Scale

A 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain.

Full Information

NCT ID

NCT02214199

First Posted

August 9, 2014

Last Updated

April 20, 2016

Sponsor

Universidad de Almeria

Collaborators

Andaluz Health Service

1. Study Identification

Unique Protocol Identification Number

NCT02214199

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Almeria

Collaborators

Andaluz Health Service

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain, Manual Theapy, Exercises Therapy

Keywords

Shoulder Pain, Shoulder Impingement Syndrome, Exercise therapy, Randomized Controlled Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise Therapy

Arm Type

Active Comparator

Arm Description

Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle.

Arm Title

Manipulative Therapy Techniques

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Manipulative Therapy Techniques

Intervention Type

Other

Intervention Name(s)

Home Exercises

Primary Outcome Measure Information:

Title

Disability Questionnaire Arm, Shoulder and Hand (DASHe)

Description

Time Frame

At baseline and 5 weeks

Secondary Outcome Measure Information:

Title

Shoulder Disability Questionnaire

Description

Shoulder Disability Questionnaire is a mesure covering 16 items designed to evaluate functional status limitation in patients with shoulder disorders.

Time Frame

At baseline and 5 weeks

Title

Hawkins-Kennedy Test

Description

Time Frame

At baseline and 5 weeks

Title

Neer Test.

Description

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.

Time Frame

At baseline and 5 weeks

Title

Range of Motion

Description

The range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction.

Time Frame

At baseline and 5 weeks

Title

Visual Analogue Scale

Description

A 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain.

Time Frame

At baseline and 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Universidad de Almeria

City

Almería

ZIP/Postal Code

04120

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

25089860

Citation

Rhon DI, Boyles RB, Cleland JA. One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management of the unilateral shoulder impingement syndrome: a pragmatic randomized trial. Ann Intern Med. 2014 Aug 5;161(3):161-9. doi: 10.7326/M13-2199.

Results Reference

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PubMed Identifier

23791561

Citation

Cook C, Learman K, Houghton S, Showalter C, O'Halloran B. The addition of cervical unilateral posterior-anterior mobilisation in the treatment of patients with shoulder impingement syndrome: a randomised clinical trial. Man Ther. 2014 Feb;19(1):18-24. doi: 10.1016/j.math.2013.05.007. Epub 2013 Jun 20.

Results Reference

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PubMed Identifier

23328323

Citation

Alburquerque-Sendin F, Camargo PR, Vieira A, Salvini TF. Bilateral myofascial trigger points and pressure pain thresholds in the shoulder muscles in patients with unilateral shoulder impingement syndrome: a blinded, controlled study. Clin J Pain. 2013 Jun;29(6):478-86. doi: 10.1097/AJP.0b013e3182652d65.

Results Reference

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PubMed Identifier

22581193

Citation

Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.

Results Reference

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PubMed Identifier

22441232

Citation

Camargo PR, Avila MA, Alburquerque-Sendin F, Asso NA, Hashimoto LH, Salvini TF. Eccentric training for shoulder abductors improves pain, function and isokinetic performance in subjects with shoulder impingement syndrome: a case series. Rev Bras Fisioter. 2012 Jan-Feb;16(1):74-83. doi: 10.1590/s1413-35552012000100013.

Results Reference

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PubMed Identifier

21943613

Citation

Hidalgo-Lozano A, Fernandez-de-las-Penas C, Diaz-Rodriguez L, Gonzalez-Iglesias J, Palacios-Cena D, Arroyo-Morales M. Changes in pain and pressure pain sensitivity after manual treatment of active trigger points in patients with unilateral shoulder impingement: a case series. J Bodyw Mov Ther. 2011 Oct;15(4):399-404. doi: 10.1016/j.jbmt.2010.12.003. Epub 2011 Jan 17.

Results Reference

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PubMed Identifier

21464489

Citation

Gwilym SE, Oag HC, Tracey I, Carr AJ. Evidence that central sensitisation is present in patients with shoulder impingement syndrome and influences the outcome after surgery. J Bone Joint Surg Br. 2011 Apr;93(4):498-502. doi: 10.1302/0301-620X.93B4.25054.

Results Reference

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PubMed Identifier

21323485

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.

Results Reference

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PubMed Identifier

20186400

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.

Results Reference

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PubMed Identifier

20148093

Citation

Osteras H, Torstensen TA. The dose-response effect of medical exercise therapy on impairment in patients with unilateral longstanding subacromial pain. Open Orthop J. 2010 Jan 5;4:1-6. doi: 10.2174/1874325001004010001.

Results Reference

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

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