NCT04687735

Brief Summary

The purpose of this study is to evaluate the effect of combination of brachial plexus block plus physical therapy on quality of life improvement in patients with frozen shoulder condition via standard questionnaires.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 23, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

December 3, 2020

Last Update Submit

June 22, 2022

Conditions

Frozen Shoulder

Keywords

Brachial Plexus BlockPhysical TherapyQuality of Life

Outcome Measures

Primary Outcomes (2)

  • changes in disability score

    measured by Shoulder Disability Questionnaire (descriptive format No= no disability, Yes= disable)

    12 months

  • changes in disability score

    measured by Shoulder Pain and Disability Index, min 0, max 10, 0 means no pain and disability and 10 means the worst pain and disability

    12 months

Secondary Outcomes (5)

  • Changes in pain score (If there is any pain)

    12 months

  • Changes in anxiety score

    12 months

  • Changes in depression score

    12 months

  • Changes in treatment satisfaction

    12 months

  • Frequency and duration of treatment related side

    12 months

Study Arms (1)

Intervention arm

EXPERIMENTAL

Patients with frozen shoulders at any stage

Other: Intervention after nerve block

Interventions

Intervention after nerve blockOTHER

Brachial plexus block + Physical therapy

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Diagnosis of unilateral or bilateral frozen shoulder, defined as greater than 50% limitation of passive ROM relative to the non affected side in one or more of three movement directions (i.e., abduction in the frontal plane, forward flexion in the sagittal plane, or external rotation in 0° of abduction) with a hard end feel
  • Symptoms of frozen shoulder that had lasted for at least 3 months.
  • Willing and able to provide informed consent and perform home-based exercises as instructed.
  • Willing and able to complete study questionnaires

You may not qualify if:

  • Previous manipulation of the affected shoulder under anesthesia in the last year;
  • Other rheumatic conditions involving the shoulder (e.g., rheumatoid arthritis, ankylosing Spondylitis,
  • Fracture or dislocation of the affected shoulder;
  • Previous shoulder surgery;
  • Hill-Sachs lesion, severe osteoporosis, or malignancies in the shoulder region);
  • Neurologic deficits affecting shoulder function;
  • History of allergy to lidocaine;
  • Corticosteroid injection in the affected shoulder during the receding 4 weeks.
  • Non-English speakers;
  • Active non- controlled mental disorders
  • Multiple complete tear in ligaments of rotator cuff
  • Any infection including COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allevio Pain Management

Toronto, Ontario, M3B 3S6, Canada

RECRUITING

Related Publications (19)

  • Pal B, Anderson J, Dick WC, Griffiths ID. Limitation of joint mobility and shoulder capsulitis in insulin- and non-insulin-dependent diabetes mellitus. Br J Rheumatol. 1986 May;25(2):147-51. doi: 10.1093/rheumatology/25.2.147.

    PMID: 3708230RESULT

  • Uppal HS, Evans JP, Smith C. Frozen shoulder: A systematic review of therapeutic options. World J Orthop. 2015 Mar 18;6(2):263-8. doi: 10.5312/wjo.v6.i2.263. eCollection 2015 Mar 18.

    PMID: 25793166RESULT

  • Hand GC, Athanasou NA, Matthews T, Carr AJ. The pathology of frozen shoulder. J Bone Joint Surg Br. 2007 Jul;89(7):928-32. doi: 10.1302/0301-620X.89B7.19097.

    PMID: 17673588RESULT

  • Rodeo SA, Hannafin JA, Tom J, Warren RF, Wickiewicz TL. Immunolocalization of cytokines and their receptors in adhesive capsulitis of the shoulder. J Orthop Res. 1997 May;15(3):427-36. doi: 10.1002/jor.1100150316.

    PMID: 9246090RESULT

  • Tamai K, Akutsu M, Yano Y. Primary frozen shoulder: brief review of pathology and imaging abnormalities. J Orthop Sci. 2014 Jan;19(1):1-5. doi: 10.1007/s00776-013-0495-x. Epub 2013 Dec 4.

    PMID: 24306579RESULT

  • Riddle DL, Rothstein JM, Lamb RL. Goniometric reliability in a clinical setting. Shoulder measurements. Phys Ther. 1987 May;67(5):668-73. doi: 10.1093/ptj/67.5.668.

    PMID: 3575423RESULT

  • Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.

    PMID: 20110457RESULT

  • Homsi C, Bordalo-Rodrigues M, da Silva JJ, Stump XM. Ultrasound in adhesive capsulitis of the shoulder: is assessment of the coracohumeral ligament a valuable diagnostic tool? Skeletal Radiol. 2006 Sep;35(9):673-8. doi: 10.1007/s00256-006-0136-y. Epub 2006 May 25.

    PMID: 16724200RESULT

  • Ando A, Hamada J, Hagiwara Y, Sekiguchi T, Koide M, Itoi E. Short-term Clinical Results of Manipulation Under Ultrasound-Guided Brachial Plexus Block in Patients with Idiopathic Frozen Shoulder and Diabetic Secondary Frozen Shoulder. Open Orthop J. 2018 Mar 16;12:99-104. doi: 10.2174/1874325001812010099. eCollection 2018.

    PMID: 29619123RESULT

  • YAMSHON LJ. Frozen shoulder: methods for bringing about early mobilization. Calif Med. 1958 Nov;89(5):333-4.

    PMID: 13585158RESULT

  • Hsu WC, Wang TL, Lin YJ, Hsieh LF, Tsai CM, Huang KH. Addition of lidocaine injection immediately before physiotherapy for frozen shoulder: a randomized controlled trial. PLoS One. 2015 Feb 25;10(2):e0118217. doi: 10.1371/journal.pone.0118217. eCollection 2015.

    PMID: 25714415RESULT

  • Kanbe K. Clinical outcome of arthroscopic capsular release for frozen shoulder: essential technical points in 255 patients. J Orthop Surg Res. 2018 Mar 16;13(1):56. doi: 10.1186/s13018-018-0758-5.

    PMID: 29548325RESULT

  • Paul A, Rajkumar JS, Peter S, Lambert L. Effectiveness of sustained stretching of the inferior capsule in the management of a frozen shoulder. Clin Orthop Relat Res. 2014 Jul;472(7):2262-8. doi: 10.1007/s11999-014-3581-2. Epub 2014 Mar 25.

    PMID: 24664198RESULT

  • Rymaruk S, Peach C. Indications for hydrodilatation for frozen shoulder. EFORT Open Rev. 2017 Nov 22;2(11):462-468. doi: 10.1302/2058-5241.2.160061. eCollection 2017 Nov.

    PMID: 29218231RESULT

  • Maund E, Craig D, Suekarran S, Neilson A, Wright K, Brealey S, Dennis L, Goodchild L, Hanchard N, Rangan A, Richardson G, Robertson J, McDaid C. Management of frozen shoulder: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2012;16(11):1-264. doi: 10.3310/hta16110.

    PMID: 22405512RESULT

  • Lewis J. Frozen shoulder contracture syndrome - Aetiology, diagnosis and management. Man Ther. 2015 Feb;20(1):2-9. doi: 10.1016/j.math.2014.07.006. Epub 2014 Jul 18.

    PMID: 25107826RESULT

  • Rookmoneea M, Dennis L, Brealey S, Rangan A, White B, McDaid C, Harden M. The effectiveness of interventions in the management of patients with primary frozen shoulder. J Bone Joint Surg Br. 2010 Sep;92(9):1267-72. doi: 10.1302/0301-620X.92B9.24282.

    PMID: 20798446RESULT

  • Vastamaki H, Varjonen L, Vastamaki M. Optimal time for manipulation of frozen shoulder may be between 6 and 9 months. Scand J Surg. 2015 Dec;104(4):260-6. doi: 10.1177/1457496914566637. Epub 2015 Jan 26.

    PMID: 25623916RESULT

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171RESULT

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Ramin Safakish, MD, FRCPC

CONTACT

6474788462Ramin.Safakish@AllevioClinic.com

Michael Lehr, D.C

CONTACT

6474788462Michael.Lehr@AllevioClinic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single-center, prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 29, 2020

Study Start

January 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 23, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)