Hemiplegic Shoulder Pain and Rotator Cuff Injuries

NCT02465853 | Completed

• 1 other identifier: CMRPG8C0771
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Hemiplegic shoulder pain (HSP) is one of most complications after stroke. HSP would impede rehabilitation programs and the motor recovery of affected upper extremity. HSP was associated with impaired daily life activities and prolong hospital stay after stroke. Therefore, effective managements is important in stroke patients with HSP. Rotator cuffs injuries are related to HSP. Clinically, hyaluronic acid (HA) is used for rotator cuff injuries. Previous researchers reported that HA could provide pain relief, improved motion, and increased daily activities. In this study, fifty subacute stoke patients will be enrolled. These patients will be allocated into group A and B randomly. The patients in group A received HA injection while patients in group B received normal saline injection. Patients from both groups received injection for 3 times each on the 1st, 2nd, 3rd week. All the patients will still receive rehabilitation programs of physical therapy and occupational therapy. Each patient will receive physical, sonographic examinations, and stroke Specific Quality of Life Scale (SSQOL). The aims of this study are to investigate the benefits of HA injection on pain relief, motor function recovery, and life quality in subacute stroke patients with HSP before and after HA injection.

Conditions

Shoulder Pain; Stroke; Rotator Cuff Injuries

Keywords

hemiplegic shoulder pain; quality of Life; stroke

Outcome Measures

Primary Outcomes (1)

• the change from baseline on hemiplegic shoulder sonography

  use sonographic to investigate the soft tissues surrounding the hemiplegic shoulder

  1 week , 4th week, 3 month and 6 month

Secondary Outcomes (6)

• shoulder range of motion

  1 week , 4th week, 3 month and 6 month

• Quality of Life

  1 week , 4th week, 3 month and 6 month

• shoulder sensory

  1 week , 4th week, 3 month and 6 month

• shoulder pain

  1 week , 4th week, 3 month and 6 month

• shoulder spasticity

  1 week , 4th week, 3 month and 6 month

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Injection 0.9% Physiological saline solution\<2.5 ml and physical therapy and occupational therapy

Drug: Physiological saline solution; Other: physical therapy and occupational therapy

Hyaluronic Acid

EXPERIMENTAL

injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy

Drug: Hyaluronic Acid; Other: physical therapy and occupational therapy

Interventions

Hyaluronic Acid DRUG

Injection Hyaluronic Acid in the experimental group

Also known as: sodium hyaluronate

Hyaluronic Acid

Physiological saline solution DRUG

Injection 0.9% Physiological saline solution\<1.0 ml

Also known as: saline

Placebo group

physical therapy and occupational therapy OTHER

rehabilitation

Hyaluronic Acid; Placebo group

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subacute stroke patients with hemiplegic shoulder pain

You may not qualify if:

• previous shoulder pain or injury in recent 6 months
• local infection near the injection area
• shoulder arthropathy
• systemic neuromuscular disease;
• severe cardiovascular or pulmoanry disease
• impaired cognition function leading to poor communication

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

ChangGungMH

Kaohsiung City, 833, Taiwan

Location

Related Publications (32)

• Najenson T, Yacubovich E, Pikielni SS. Rotator cuff injury in shoulder joints of hemiplegic patients. Scand J Rehabil Med. 1971;3(3):131-7. No abstract available.

  PMID: 5156175 BACKGROUND

• Griffin J, Reddin G. Shoulder pain in patients with hemiplegia. A literature review. Phys Ther. 1981 Jul;61(7):1041-5. doi: 10.1093/ptj/61.7.1041. No abstract available.

  PMID: 6166017 BACKGROUND

• Bohannon RW, Larkin PA, Smith MB, Horton MG. Shoulder pain in hemiplegia: statistical relationship with five variables. Arch Phys Med Rehabil. 1986 Aug;67(8):514-6.

  PMID: 3741075 BACKGROUND

• Turner-Stokes L, Jackson D. Shoulder pain after stroke: a review of the evidence base to inform the development of an integrated care pathway. Clin Rehabil. 2002 May;16(3):276-98. doi: 10.1191/0269215502cr491oa.

  PMID: 12017515 BACKGROUND

• Snels IA, Dekker JH, van der Lee JH, Lankhorst GJ, Beckerman H, Bouter LM. Treating patients with hemiplegic shoulder pain. Am J Phys Med Rehabil. 2002 Feb;81(2):150-60. doi: 10.1097/00002060-200202000-00013.

  PMID: 11807352 BACKGROUND

• Van Ouwenaller C, Laplace PM, Chantraine A. Painful shoulder in hemiplegia. Arch Phys Med Rehabil. 1986 Jan;67(1):23-6.

  PMID: 3942479 BACKGROUND

• Gilmore PE, Spaulding SJ, Vandervoort AA. Hemiplegic shoulder pain: implications for occupational therapy treatment. Can J Occup Ther. 2004 Feb;71(1):36-46. doi: 10.1177/000841740407100108.

  PMID: 15015899 BACKGROUND

• Snels IA, Beckerman H, Twisk JW, Dekker JH, Peter De Koning, Koppe PA, Lankhorst GJ, Bouter LM. Effect of triamcinolone acetonide injections on hemiplegic shoulder pain : A randomized clinical trial. Stroke. 2000 Oct;31(10):2396-401. doi: 10.1161/01.str.31.10.2396.

  PMID: 11022070 BACKGROUND

• Parker VM, Wade DT, Langton Hewer R. Loss of arm function after stroke: measurement, frequency, and recovery. Int Rehabil Med. 1986;8(2):69-73. doi: 10.3109/03790798609166178.

  PMID: 3804600 BACKGROUND

• Wanklyn P, Forster A, Young J. Hemiplegic shoulder pain (HSP): natural history and investigation of associated features. Disabil Rehabil. 1996 Oct;18(10):497-501. doi: 10.3109/09638289609166035.

  PMID: 8902421 BACKGROUND

• Roy C SM, Hill L. Shoulder pain in acutely admitted hemiplegics. Clinical Rehabilitation. 1994;8:334-340

  BACKGROUND

• Lo SF, Chen SY, Lin HC, Jim YF, Meng NH, Kao MJ. Arthrographic and clinical findings in patients with hemiplegic shoulder pain. Arch Phys Med Rehabil. 2003 Dec;84(12):1786-91. doi: 10.1016/s0003-9993(03)00408-8.

  PMID: 14669184 BACKGROUND

• Ikai T, Tei K, Yoshida K, Miyano S, Yonemoto K. Evaluation and treatment of shoulder subluxation in hemiplegia: relationship between subluxation and pain. Am J Phys Med Rehabil. 1998 Sep-Oct;77(5):421-6. doi: 10.1097/00002060-199809000-00012.

  PMID: 9798835 BACKGROUND

• Poulin de Courval L, Barsauskas A, Berenbaum B, Dehaut F, Dussault R, Fontaine FS, Labrecque R, Leclerc C, Giroux F. Painful shoulder in the hemiplegic and unilateral neglect. Arch Phys Med Rehabil. 1990 Aug;71(9):673-6.

  PMID: 2375673 BACKGROUND

• Ada L, Goddard E, McCully J, Stavrinos T, Bampton J. Thirty minutes of positioning reduces the development of shoulder external rotation contracture after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2005 Feb;86(2):230-4. doi: 10.1016/j.apmr.2004.02.031.

  PMID: 15706548 BACKGROUND

• Griffin A, Bernhardt J. Strapping the hemiplegic shoulder prevents development of pain during rehabilitation: a randomized controlled trial. Clin Rehabil. 2006 Apr;20(4):287-95. doi: 10.1191/0269215505cr941oa.

  PMID: 16719027 BACKGROUND

• Ada L, Foongchomcheay A, Canning C. Supportive devices for preventing and treating subluxation of the shoulder after stroke. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003863. doi: 10.1002/14651858.CD003863.pub2.

  PMID: 15674917 BACKGROUND

• Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Fang ZP. Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. Am J Phys Med Rehabil. 2005 Nov;84(11):832-42. doi: 10.1097/01.phm.0000184154.01880.72.

  PMID: 16244520 BACKGROUND

• Chantraine A, Baribeault A, Uebelhart D, Gremion G. Shoulder pain and dysfunction in hemiplegia: effects of functional electrical stimulation. Arch Phys Med Rehabil. 1999 Mar;80(3):328-31. doi: 10.1016/s0003-9993(99)90146-6.

  PMID: 10084443 BACKGROUND

• Shibata Y, Midorikawa K, Emoto G, Naito M. Clinical evaluation of sodium hyaluronate for the treatment of patients with rotator cuff tear. J Shoulder Elbow Surg. 2001 May-Jun;10(3):209-16. doi: 10.1067/mse.2001.113501.

  PMID: 11408900 BACKGROUND

• Blair B, Rokito AS, Cuomo F, Jarolem K, Zuckerman JD. Efficacy of injections of corticosteroids for subacromial impingement syndrome. J Bone Joint Surg Am. 1996 Nov;78(11):1685-9. doi: 10.2106/00004623-199611000-00007.

  PMID: 8934482 BACKGROUND

• Vecchio PC, Hazleman BL, King RH. A double-blind trial comparing subacromial methylprednisolone and lignocaine in acute rotator cuff tendinitis. Br J Rheumatol. 1993 Aug;32(8):743-5. doi: 10.1093/rheumatology/32.8.743.

  PMID: 8348279 BACKGROUND

• Plafki C, Steffen R, Willburger RE, Wittenberg RH. Local anaesthetic injection with and without corticosteroids for subacromial impingement syndrome. Int Orthop. 2000;24(1):40-2. doi: 10.1007/s002640050010.

  PMID: 10774861 BACKGROUND

• Akgun K, Birtane M, Akarirmak U. Is local subacromial corticosteroid injection beneficial in subacromial impingement syndrome? Clin Rheumatol. 2004 Dec;23(6):496-500. doi: 10.1007/s10067-004-0930-7.

  PMID: 15278758 BACKGROUND

• Penning LI, de Bie RA, Walenkamp GH. The effectiveness of injections of hyaluronic acid or corticosteroid in patients with subacromial impingement: a three-arm randomised controlled trial. J Bone Joint Surg Br. 2012 Sep;94(9):1246-52. doi: 10.1302/0301-620X.94B9.28750.

  PMID: 22933498 BACKGROUND

• Iwata H. Pharmacologic and clinical aspects of intraarticular injection of hyaluronate. Clin Orthop Relat Res. 1993 Apr;(289):285-91.

  PMID: 8472428 BACKGROUND

• Meloni F, Milia F, Cavazzuti M, Doria C, Lisai P, Profili S, Meloni GB. Clinical evaluation of sodium hyaluronate in the treatment of patients with sopraspinatus tendinosis under echographic guide: experimental study of periarticular injections. Eur J Radiol. 2008 Oct;68(1):170-3. doi: 10.1016/j.ejrad.2007.11.001. Epub 2007 Dec 21.

  PMID: 18096343 BACKGROUND

• Chou WY, Ko JY, Wang FS, Huang CC, Wong T, Wang CJ, Chang HE. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg. 2010 Jun;19(4):557-63. doi: 10.1016/j.jse.2009.08.006. Epub 2009 Dec 5.

  PMID: 19963403 BACKGROUND

• Byun SD, Park DH, Choi WD, Lee ZI. Subacromial Bursa Injection of Hyaluronate with Steroid in Patients with Peri-articular Shoulder Disorders. Ann Rehabil Med. 2011 Oct;35(5):664-72. doi: 10.5535/arm.2011.35.5.664. Epub 2011 Oct 31.

  PMID: 22506189 BACKGROUND

• Blaine T, Moskowitz R, Udell J, Skyhar M, Levin R, Friedlander J, Daley M, Altman R. Treatment of persistent shoulder pain with sodium hyaluronate: a randomized, controlled trial. A multicenter study. J Bone Joint Surg Am. 2008 May;90(5):970-9. doi: 10.2106/JBJS.F.01116.

  PMID: 18451387 BACKGROUND

• Itokazu M, Matsunaga T. Clinical evaluation of high-molecular-weight sodium hyaluronate for the treatment of patients with periarthritis of the shoulder. Clin Ther. 1995 Sep-Oct;17(5):946-55. doi: 10.1016/0149-2918(95)80072-7.

  PMID: 8595646 BACKGROUND

• Ko JY, Wang FS, Huang HY, Wang CJ, Tseng SL, Hsu C. Increased IL-1beta expression and myofibroblast recruitment in subacromial bursa is associated with rotator cuff lesions with shoulder stiffness. J Orthop Res. 2008 Aug;26(8):1090-7. doi: 10.1002/jor.20631.

  PMID: 18327798 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Stroke; Rotator Cuff Injuries

Interventions

Hyaluronic Acid; Sodium Chloride; Physical Therapy Modalities; Occupational Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Huang Yu Chi, Bachelor

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: June 9, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 26, 2018

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)