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

NCT02214199 | Completed Early Phase 1

• 1 other identifier: 21/2013
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Manual Theapy; Exercises Therapy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Shoulder Disability Questionnaire

  At baseline and 5 weeks

• Hawkins-Kennedy Test

  At baseline and 5 weeks

• Neer Test.

  At baseline and 5 weeks

• Range of Motion

  At baseline and 5 weeks

• Visual Analogue Scale

  At baseline and 5 weeks

Study Arms (2)

Exercise Therapy

ACTIVE COMPARATOR

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

Other: Home Exercises

Manipulative Therapy Techniques

EXPERIMENTAL

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.

Other: Manipulative Therapy Techniques

Interventions

Manipulative Therapy Techniques OTHER

Manipulative Therapy Techniques

Home Exercises OTHER

Exercise Therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Almeria: lead
• Andaluz Health Service: collaborator

Study Sites (1)

Universidad de Almeria

Almería, Almería, 04120, Spain

Location

Related Publications (10)

• 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.

  PMID: 25089860 BACKGROUND

• 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.

  PMID: 23791561 BACKGROUND

• 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.

  PMID: 23328323 BACKGROUND

• 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.

  PMID: 22581193 BACKGROUND

• 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.

  PMID: 22441232 BACKGROUND

• 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.

  PMID: 21943613 BACKGROUND

• 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.

  PMID: 21464489 BACKGROUND

• 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.

  PMID: 21323485 BACKGROUND

• 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.

  PMID: 20186400 BACKGROUND

• 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.

  PMID: 20148093 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD (Lecturer)

Study Record Dates

• First Submitted: August 9, 2014
• First Posted: August 12, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

ES (1)