Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Suprascapular Nerve Block Versus Intraarticular Steroid Injection in Hemiplegic Shoulder Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128605
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Anwar Suhaimi, University of Malaya

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. To assess the analgesic effect of SSNB vs IAS in HSP among Malaysian stroke population.

    Secondary objectives:

  2. To assess the improvement of passive ROM post SSNB versus IAS in HSP.
  3. To assess for improvement of functional outcome post SSNB versus IAS in HSP.

METHOD

A prospective, double blinded interventional study will be conducted in the Rehabilitation Medicine Clinic, University of Malaya Medical Centre for a duration of 1 year. Eligible subjects will be enrolled from all referrals of hemiplegic shoulder pain (HSP), following computer-generated randomization they will be allocated to either supra-scapular nerve block (SSNB) (intervention) or intra-articular shoulder steroid injection (IAS) (control) groups. The subjects and assessors are blinded to the intervention received, which will be performed by an experienced interventionist, not participating in randomization or data collection and analysis. Demographics of participants time since stroke, etiology, presence of spasticity, Numerical Rating Score (NRS) pain score at maximal passive ROM, maximum passive ROM of shoulder flexion, abduction, internal and external rotation as well as SDQ and SPADI will recorded prior to injection, 1 hour, 1 month and 3 months post injection. Mann-Whitney U tests and Chi-Square test of association will be used as appropriate to compare groups at baseline. Shoulder ROM and NRS pre and post intervention will be analysed using paired t-test and ANOVA. Functional outcome of SDQ and SPADI pre and post intervention will be analysed using paired t-test as well.


Condition or disease Intervention/treatment Phase
Hemiplegic Shoulder Pain Procedure: Suprascapular nerve block (SSNB) Procedure: Intraarticular shoulder steroid injection (IAS) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  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)
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Suprascapular Nerve Block Versus Intraarticular Steroid Injection in Hemiplegic Shoulder Pain: A Randomized Double Blinded Control Trial
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Intervention: Suprascapular nerve block (SSNB)
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)

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.


Active Comparator: Control: Intraarticular shoulder steroid injection (IAS)

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)

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





Primary Outcome Measures :
  1. Changes in Numerical rating score (NRS) pain score at maximum passive range of motion (ROM) of shoulder flexion, abduction, internal and external rotation [ Time Frame: To be collected at baseline, 1 hour, 1 month and 3 months post injection ]
    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).


Secondary Outcome Measures :
  1. Changes in maximum passive ROM of affected shoulder flexion, abduction, internal and external rotation [ Time Frame: Measured at baseline, 1 hour, 1 month and 3 months post injection. ]
    Measured by assessor who is blinded to the intervention in supine position.

  2. Shoulder Pain and Disability Index (SPADI) [ Time Frame: 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 Pain and Disability Index (SPADI) was developed to assess pain and disability related to shoulder problems.

    Pain dimension has 5 questions regarding the pain severity. Disability components are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.

    Every question is given a scale from 0 to 10.

    For Pain component, 0 = no pain and 10 = the worst pain imaginable For disability component, 0 = no difficulty and 10 = so difficult that it requires help.

    The total score from both components will be divided by 130 X 100 and will be in percentage.

    The higher the score indicates the worse outcome.


  3. Shoulder Disability Questionnaire (SDQ) [ Time Frame: 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 ]

    It contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. All items refer to the preceding 24 hours.

    It is a useful instrument to assess functional disability in longitudinal studies

    The 16 questions requires Yes or No answer. The total Yes will then be divided by 16 X 100 and will be in percentage.

    The higher the marks, the greater the disability is and indicates the worse outcome.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128605


Contacts
Layout table for location contacts
Contact: TUAN FARHAN BIN TUAN IBRAHIM, MB BCh BAO +60379494422 ext 6560 tuanfarhan@ummc.edu.my
Contact: ANWAR BIN SUHAIMI, MBBS +60379494422 ext 6560 anwar@ummc.edu.my

Locations
Layout table for location information
Malaysia
Rehabilitation Medicine Clinic, Pusat Perubatan Universiti Malaya, Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Tuan Farhan bin T Ibrahim, MB BCh BAO    +60379496560 ext 6560    tuanfarhan@ummc.edu.my   
Contact: Anwar Bin Suhaimi, MBBS    +60379494422 ext 6560    anwar@ummc.edu.my   
Principal Investigator: ANWAR BIN SUHAIMI, MBBS         
Sub-Investigator: TUAN FARHAN BIN TUAN IBRAHIM, MB BCh BAO         
Sub-Investigator: SOO CHIN CHAN, MBBS         
Sponsors and Collaborators
University of Malaya
Investigators
Layout table for investigator information
Principal Investigator: ANWAR BIN SUHAIMI, MBBS SENIOR LECTURER AND REHABILITATION PHYSICIAN
Principal Investigator: SOO CHIN CHAN, MBBS LECTURER AND REHABILITATION PHYSICIAN
Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: Dr Anwar Suhaimi, Senior Lecturer and Rehabilitation Physician, University of Malaya
ClinicalTrials.gov Identifier: NCT04128605    
Other Study ID Numbers: 201945-7301
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations