Frozen Shoulder Clinical Trial
Official title:
Minimally Invasive Technique to Increase the Range of Motion of the Shoulder Joint in Frozen Shoulder: Single Arm Prospective Study
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.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Allevio Pain Management | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Allevio Pain Management Clinic |
Canada,
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 M — View Citation
Hand GC, Athanasou NA, Matthews T, Carr AJ. The pathology of frozen shoulder. J Bone Joint Surg Br. 2007 Jul;89(7):928-32. — View Citation
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. Epub 2006 May 25. — View Citation
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 — View Citation
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. — View Citation
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. Review. — View Citation
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. 201 — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Riddle DL, Rothstein JM, Lamb RL. Goniometric reliability in a clinical setting. Shoulder measurements. Phys Ther. 1987 May;67(5):668-73. — View Citation
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. — View Citation
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. Revie — View Citation
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. — View Citation
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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. Review. — View Citation
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. Review. — View Citation
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in disability score | measured by Shoulder Disability Questionnaire (descriptive format No= no disability, Yes= disable) | 12 months | |
Primary | 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 | Changes in pain score (If there is any pain) | measured by short form of Brief Pain Inventory Questionnaire min 0, max 10, 0 means no pain and disability and 10 means the worst pain and disability | 12 months | |
Secondary | Changes in anxiety score | measured by General Anxiety Disorder Questionnaire min 0, max 21, 0 means no anxiety and 21 means the maximum anxiety | 12 months | |
Secondary | Changes in depression score | measured by Beck's Depression Inventory min 0, max 40, 0 means no depression and 40 means the sever depression | 12 months | |
Secondary | Changes in treatment satisfaction | using the Global Improvement and Satisfaction Score, between 1 to 5, 1 very dissatisfied, and 5 very satisfied | 12 months | |
Secondary | Frequency and duration of treatment related side | 12 months |
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