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

Shoulder Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214199
• Other study ID #: 21/2013
• Status: Completed
• Phase: Phase 0
• First received: August 9, 2014
• Last updated: April 20, 2016
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercises Therapy
• Manual Theapy
• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

Other:
• Manipulative Therapy Techniques

• Home Exercises

Locations

Country	Name	City	State
Spain	Universidad de Almeria	Almería

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Almeria	Andaluz Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Alburquerque-Sendín 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. — View Citation

Camargo PR, Avila MA, Alburquerque-Sendín 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. — View 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. — View 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. — View Citation

Hidalgo-Lozano A, Fernández-de-las-Peñas 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. — View Citation

Hidalgo-Lozano A, Fernández-de-las-Peñas C, Díaz-Rodríguez L, González-Iglesias J, Palacios-Ceña 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. — View 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. — View 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. — View Citation

Osterås 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline and 5 weeks	No
Secondary	Shoulder Disability Questionnaire	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	No
Secondary	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.	At baseline and 5 weeks	No
Secondary	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.	At baseline and 5 weeks	No
Secondary	Range of Motion	The range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction.	At baseline and 5 weeks	No
Secondary	Visual Analogue Scale	A 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain.	At baseline and 5 weeks	No