Suprascapular Nerve Block Versus Intraarticular Steroid Injection in Hemiplegic Shoulder Pain

NCT04128605 | Unknown

• 1 other identifier: 201945-7301
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Suprascapular nerve block versus(vs) intra-articular steroid injection in the management of hemiplegic shoulder pain (HSP): a randomised, double blinded, controlled trial BACKGROUND Hemiplegic shoulder pain (HSP) is a common complication of stroke. It can happen as early as one week post stroke with a frequency as high as 72%. HSP can result in significant disability as pain and limited shoulder range of motion (ROM) decrease hand function, reduce participation in rehabilitation activity and delay functional recovery of the patients. Management of HSP focused on reducing pain and improving shoulder ROM. Minimally invasive treatment of HSP with intra-articular shoulder steroid (IAS) injection and supra-scapular nerve block (SSNB) have gained interest. OBJECTIVES Primary objective:

1. 1.To assess the analgesic effect of SSNB vs IAS in HSP among Malaysian stroke population.
2. 2.To assess the improvement of passive ROM post SSNB versus IAS in HSP.
3. 3.To assess for improvement of functional outcome post SSNB versus IAS in HSP.

Conditions

Hemiplegic Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Changes in Numerical rating score (NRS) pain score at maximum passive range of motion (ROM) of shoulder flexion, abduction, internal and external rotation

  The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  To be collected at baseline, 1 hour, 1 month and 3 months post injection

Secondary Outcomes (3)

• Changes in maximum passive ROM of affected shoulder flexion, abduction, internal and external rotation

  Measured at baseline, 1 hour, 1 month and 3 months post injection.

• Shoulder Pain and Disability Index (SPADI)

  Measured at baseline, 1 month and 3 months post intervention. *SPADI not measured at 1 hour post injection as functional outcome measure are not expected to change within 1 hour.

• Shoulder Disability Questionnaire (SDQ)

  Measured at baseline, 1 month and 3 months post intervention. *SDQ not measured at 1 hour post injection as it requires the patient to answer questions regarding the painful shoulder in the preceding 24 hours

Study Arms (2)

Intervention: Suprascapular nerve block (SSNB)

EXPERIMENTAL

SSNB performed by skilled interventionist who is not blinded for safety reason. 5 mls of Bupivacaine, 5 mls Lidocaine and 10 mls of saline.

Procedure: Suprascapular nerve block (SSNB)

Control: Intraarticular shoulder steroid injection (IAS)

ACTIVE COMPARATOR

IAS performed by skilled interventionist who is blinded on patient's initial measurement. 40 mg of Triamcenolone Acetate + 2 ml of Lidocaine 1%

Procedure: Intraarticular shoulder steroid injection (IAS)

Interventions

Suprascapular nerve block (SSNB) PROCEDURE

SSNB is performed using ultrasound guidance by skilled interventionist under ultrasound guidance. Skin area at posterior shoulder is first infiltrated with Lidocaine 1%. Then, a mixture of 5 mls of Bupivacaine, 5 mls Lidocaine 1% and 10 mls of saline are injected at posterior shoulder towards suprascapular notch surrounding suprascapular nerve.

Intervention: Suprascapular nerve block (SSNB)

Intraarticular shoulder steroid injection (IAS) PROCEDURE

IAS is performed using ultrasound guidance by skilled interventionist under ultrasound guidance. Skin area at posterior shoulder is first infiltrated with Lidocaine 1%. IAS is performed by injecting 40 mg of Triamcenolone Acetonide along with 2 ml of Lidocaine 1% into glenohumeral articular space

Control: Intraarticular shoulder steroid injection (IAS)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Brain lesion recognized by CT Brain scan or MRI brain
• Hemiplegic shoulder pain of at least 2 weeks in duration
• Failed standard treatment with oral medications and physical modalities
• Age 20-70 years old
• Pain score of at least numerical rating scale (NRS) 3/10 at movement
• Mini Mental State Examination(MMSE) at least 24/30

You may not qualify if:

• Neuropathic pain
• Severe aphasia affecting communication
• Previous trauma history to affected shoulder and preexisting shoulder pain/pathology
• Previous shoulder injection within the past 3 months

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Rehabilitation Medicine Clinic, Pusat Perubatan Universiti Malaya,

Kuala Lumpur, 59100, Malaysia

RECRUITING

Related Publications (14)

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  PMID: 10835436 BACKGROUND

• Poduri KR. Shoulder pain in stroke patients and its effects on rehabilitation. J Stroke Cerebrovasc Dis. 1993;3(4):261-6. doi: 10.1016/S1052-3057(10)80071-0. Epub 2010 Jun 8.

  PMID: 26487463 BACKGROUND

• Viana R, Pereira S, Mehta S, Miller T, Teasell R. Evidence for therapeutic interventions for hemiplegic shoulder pain during the chronic stage of stroke: a review. Top Stroke Rehabil. 2012 Nov-Dec;19(6):514-22. doi: 10.1310/tsr1906-514.

  PMID: 23192716 BACKGROUND

• Caglar NS, Akin T, Aytekin E, Komut EA, Ustabasioglu F, Okur S, Dogan Y, Erdem HI, Ataoglu E, Yalcinkaya E. Pain syndromes in hemiplegic patients and their effects on rehabilitation results. J Phys Ther Sci. 2016 Mar;28(3):731-7. doi: 10.1589/jpts.28.731. Epub 2016 Mar 31.

  PMID: 27134349 BACKGROUND

• Taskaynatan MA, Yilmaz B, Ozgul A, Yazicioglu K, Kalyon TA. Suprascapular nerve block versus steroid injection for non-specific shoulder pain. Tohoku J Exp Med. 2005 Jan;205(1):19-25. doi: 10.1620/tjem.205.19.

  PMID: 15635270 BACKGROUND

• Shanahan EM, Ahern M, Smith M, Wetherall M, Bresnihan B, FitzGerald O. Suprascapular nerve block (using bupivacaine and methylprednisolone acetate) in chronic shoulder pain. Ann Rheum Dis. 2003 May;62(5):400-6. doi: 10.1136/ard.62.5.400.

  PMID: 12695149 BACKGROUND

• Di Lorenzo L, Pappagallo M, Gimigliano R, Palmieri E, Saviano E, Bello A, Forte A, DeBlasio E, Trombetti C. Pain relief in early rehabilitation of rotator cuff tendinitis: any role for indirect suprascapular nerve block? Eura Medicophys. 2006 Sep;42(3):195-204.

  PMID: 17039215 BACKGROUND

• Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.

  PMID: 12535501 BACKGROUND

• Johansson K, Oberg B, Adolfsson L, Foldevi M. A combination of systematic review and clinicians' beliefs in interventions for subacromial pain. Br J Gen Pract. 2002 Feb;52(475):145-52.

  PMID: 11885825 BACKGROUND

• Adey-Wakeling Z, Liu E, Crotty M, Leyden J, Kleinig T, Anderson CS, Newbury J. Hemiplegic Shoulder Pain Reduces Quality of Life After Acute Stroke: A Prospective Population-Based Study. Am J Phys Med Rehabil. 2016 Oct;95(10):758-63. doi: 10.1097/PHM.0000000000000496.

  PMID: 27003204 BACKGROUND

• Rah UW, Yoon SH, Moon DJ, Kwack KS, Hong JY, Lim YC, Joen B. Subacromial corticosteroid injection on poststroke hemiplegic shoulder pain: a randomized, triple-blind, placebo-controlled trial. Arch Phys Med Rehabil. 2012 Jun;93(6):949-56. doi: 10.1016/j.apmr.2012.02.002. Epub 2012 Apr 5.

  PMID: 22483593 BACKGROUND

• Chae J, Mascarenhas D, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Fang ZP. Poststroke shoulder pain: its relationship to motor impairment, activity limitation, and quality of life. Arch Phys Med Rehabil. 2007 Mar;88(3):298-301. doi: 10.1016/j.apmr.2006.12.007.

  PMID: 17321820 BACKGROUND

• Yasar E, Vural D, Safaz I, Balaban B, Yilmaz B, Goktepe AS, Alaca R. Which treatment approach is better for hemiplegic shoulder pain in stroke patients: intra-articular steroid or suprascapular nerve block? A randomized controlled trial. Clin Rehabil. 2011 Jan;25(1):60-8. doi: 10.1177/0269215510380827. Epub 2010 Oct 13.

  PMID: 20943716 RESULT

• Jeon WH, Park GW, Jeong HJ, Sim YJ. The Comparison of Effects of Suprascapular Nerve Block, Intra-articular Steroid Injection, and a Combination Therapy on Hemiplegic Shoulder Pain: Pilot Study. Ann Rehabil Med. 2014 Apr;38(2):167-73. doi: 10.5535/arm.2014.38.2.167. Epub 2014 Apr 29.

  PMID: 24855610 RESULT

Study Officials

• ANWAR BIN SUHAIMI, MBBS

  SENIOR LECTURER AND REHABILITATION PHYSICIAN

  PRINCIPAL INVESTIGATOR

• SOO CHIN CHAN, MBBS

  LECTURER AND REHABILITATION PHYSICIAN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TUAN FARHAN BIN TUAN IBRAHIM, MB BCh BAO

CONTACT

+60379494422; tuanfarhan@ummc.edu.my

ANWAR BIN SUHAIMI, MBBS

CONTACT

+60379494422; anwar@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded from knowing the intervention they're receiving. Both suprascapular nerve block and intraarticular shoulder steroid injection will be performed at posterior aspect of shoulder while participant is in seated position and facing forward. The assessor will also be blinded from knowing which group the participants belong to. All the medical record related to this study will be inaccessible by the assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer and Rehabilitation Physician

Model Details: 1. Patients referred to Rehabilitation Clinic for hemiplegic shoulder pain (HSP) will be recruited. 2. Patients will be randomly allocated using a computer program into suprascapular nerve block (SSNB) (Intervention) vs intra-articular shoulder steroid injection (IAS) (Control) group 3. Intervention Group SSNB performed by skilled interventionist who is not blinded for safety reason 5 mls of Bupivacaine, 5 mls Lidocaine and 10 mls of saline 4. Control group IAS performed by skilled interventionist who is blinded on patient's initial measurement 40 mg of Triamcinolone Acetate + 2 ml of Lidocaine 1% 5. Evaluations will be repeated at: * 1 hour, 1 month and 3 months for maximum (max) passive range of motion (PROM), numerical rating scale (NRS) at max PROM * 1 month and 3 months for shoulder disability questionnaire (SDQ) and shoulder pain and disability index (SPADI)

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: October 16, 2019
• Study Start: July 11, 2019
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)