Osteoarthritis Shoulder Clinical Trial
Official title:
Effectiveness of an Occupation-Based Intervention Compared With Therapeutic Exercise for Older Adults With Shoulder Osteoarthritis: A Pilot Randomized Controlled Trial
Verified date | November 2020 |
Source | Bay Path University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
As a registered and licensed occupational therapist, I completed a six-week evidence based research study to determine the effects of occupation-based intervention and therapeutic exercises versus therapeutic exercises alone.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 10, 2020 |
Est. primary completion date | December 6, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of shoulder osteoarthritis (confirmed by physician examination or radiographic imaging) - Aged 65 years or older Exclusion Criteria: - Previous shoulder injuries - Acute pathology - Previous shoulder surgery - Current use of pain medication - Inflammatory arthritis - Upper extremity neuropathy or myopathy - Current participation in a home exercise program - Score of <18 on the Mini-Mental State Examination (MMSE) |
Country | Name | City | State |
---|---|---|---|
United States | Bay Path University | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Bay Path University |
United States,
Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. — View Citation
Bull D, Tai Kie A, Hanusch B, Kulkarni R, Rees J, Rangan A. Is there sufficient evidence to support intervention to manage shoulder arthritis? Shoulder Elbow. 2016 Apr;8(2):77-89. doi: 10.1177/1758573215622385. Epub 2016 Jan 8. Review. — View Citation
Burner T, Abbott D, Huber K, Stout M, Fleming R, Wessel B, Massey E, Rosenthal A, Burns E. Shoulder symptoms and function in geriatric patients. J Geriatr Phys Ther. 2014 Oct-Dec;37(4):154-8. doi: 10.1519/JPT.0b013e3182abe7d6. — View Citation
Che Daud AZ, Yau MK, Barnett F, Judd J, Jones RE, Muhammad Nawawi RF. Integration of occupation based intervention in hand injury rehabilitation: A Randomized Controlled Trial. J Hand Ther. 2016 Jan-Mar;29(1):30-40. doi: 10.1016/j.jht.2015.09.004. Epub 2015 Nov 6. — View Citation
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. Review. — View Citation
Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990 Apr;57(2):82-7. — View Citation
Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176. — View Citation
Marinko LN, Chacko JM, Dalton D, Chacko CC. The effectiveness of therapeutic exercise for painful shoulder conditions: a meta-analysis. J Shoulder Elbow Surg. 2011 Dec;20(8):1351-9. doi: 10.1016/j.jse.2011.05.013. Epub 2011 Sep 1. Review. — View Citation
McDonough CM, Jette AM. The contribution of osteoarthritis to functional limitations and disability. Clin Geriatr Med. 2010 Aug;26(3):387-99. doi: 10.1016/j.cger.2010.04.001. Review. — View Citation
Millett PJ, Gobezie R, Boykin RE. Shoulder osteoarthritis: diagnosis and management. Am Fam Physician. 2008 Sep 1;78(5):605-11. — View Citation
Mushtaq S, Choudhary R, Scanzello CR. Non-surgical treatment of osteoarthritis-related pain in the elderly. Curr Rev Musculoskelet Med. 2011 Sep;4(3):113-22. doi: 10.1007/s12178-011-9084-9. — View Citation
Weinstock-Zlotnick G, Mehta SP. A systematic review of the benefits of occupation-based intervention for patients with upper extremity musculoskeletal disorders. J Hand Ther. 2019 Apr - Jun;32(2):141-152. doi: 10.1016/j.jht.2018.04.001. Epub 2018 Jul 14. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Baseline scores | To assess the impact of the intervention on physical function and symptoms of shoulder osteoarthritis.
Minimum Value: 0 (no disability) Maximum Value: 100 (most severe disability) Higher scores = Worse outcome (greater upper extremity dysfunction) |
Pre-Intervention | |
Primary | Change between Pre-Intervention and 1-week Post-Intervention Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores | To assess the impact of the intervention on physical function and symptoms of shoulder osteoarthritis.
Minimum Value: 0 (no disability) Maximum Value: 100 (most severe disability) Higher scores = Worse outcome (greater upper extremity dysfunction) |
1-week Post-Intervention | |
Primary | Change between Pre-Intervention and 4-weeks Post-Intervention Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores | To assess the impact of the intervention on physical function and symptoms of shoulder osteoarthritis.
Minimum Value: 0 (no disability) Maximum Value: 100 (most severe disability) Higher scores = Worse outcome (greater upper extremity dysfunction) |
4-weeks Post-Intervention | |
Primary | Change between 1-week and 4-weeks Post-Intervention Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores | To assess the impact of the intervention on physical function and symptoms of shoulder osteoarthritis.
Minimum Value: 0 (no disability) Maximum Value: 100 (most severe disability) Higher scores = Worse outcome (greater upper extremity dysfunction) |
4-weeks Post-Intervention | |
Secondary | Canadian Occupational Performance Measure (COPM) Baseline Scores | To determine the effect of the intervention on participants' self-perception of occupational performance and satisfaction over time.
Minimum Value: 0 Maximum Value: 10 Higher scores = Better outcome (greater client-perceived changes in satisfaction and performance of daily occupations) |
Pre-Intervention | |
Secondary | Change between Pre-Intervention and 1-week Post-Intervention Canadian Occupational Performance Measure (COPM) scores | To determine the effect of the intervention on participants' self-perception of occupational performance and satisfaction over time.
Minimum Value: 0 Maximum Value: 10 Higher scores = Better outcome (greater client-perceived changes in satisfaction and performance of daily occupations) |
1-week Post-Intervention | |
Secondary | Change between Pre-Intervention and 4-weeks Post-Intervention Canadian Occupational Performance Measure (COPM) scores | To determine the effect of the intervention on participants' self-perception of occupational performance and satisfaction over time.
Minimum Value: 0 Maximum Value: 10 Higher scores = Better outcome (greater client-perceived changes in satisfaction and performance of daily occupations) |
4-weeks Post-Intervention | |
Secondary | Change between 1-week and 4-weeks Post-Intervention Canadian Occupational Performance Measure (COPM) scores | To determine the effect of the intervention on participants' self-perception of occupational performance and satisfaction over time.
Minimum Value: 0 Maximum Value: 10 Higher scores = Better outcome (greater client-perceived changes in satisfaction and performance of daily occupations) |
4-weeks Post-Intervention | |
Secondary | Shoulder Range of Motion (ROM) Baseline Scores | Observing and grading ROM on a 3-point Likert scale to determine shoulder mobility and pain with movement.
Minimum Value: 0 (unable/no pain) Maximum Value: 3 (full able/lots of pain) Higher scores = Better outcome (fully ROM/no pain with ROM) |
Pre-Intervention | |
Secondary | Change between Pre-Intervention and 1-week Shoulder Range of Motion (ROM) scores | Observing and grading ROM on a 3-point Likert scale to determine shoulder mobility and pain with movement.
Minimum Value: 0 (unable/no pain) Maximum Value: 3 (fully able/lots of pain) Higher scores = Better outcome (full ROM/no pain with ROM) |
1-week Post-Intervention | |
Secondary | Change between Pre-Intervention and 4-weeks Post-Intervention Shoulder Range of Motion (ROM) scores | Observing and grading ROM on a 3-point Likert scale to determine shoulder mobility and pain with movement.
Minimum Value: 0 (unable/no pain) Maximum Value: 3 (fully able/lots of pain) Higher scores = Better outcome (full ROM/no pain with ROM) |
4-weeks Post-Intervention | |
Secondary | Change between 1-week and 4-weeks Post-Intervention Shoulder Range of Motion (ROM) scores | Observing and grading ROM on a 3-point Likert scale to determine shoulder mobility and pain with movement.
Minimum Value: 0 (unable/no pain) Maximum Value: 3 (fully able/lots of pain) Higher scores = Better outcome (full ROM/no pain with ROM) |
4-weeks Post-Intervention | |
Secondary | Jamar Hand Dynamometer Baseline Scores | To measure grip strength.
Minimum Value: 0 pounds Maximum Value: 200 pounds Higher scores = Better outcome (increased grip strength) |
Pre-Intervention | |
Secondary | Change between Pre-Intervention and 1-week Jamar Hand Dynamometer scores | To measure grip strength.
Minimum Value: 0 pounds Maximum Value: 200 pounds Higher scores = Better outcome (increased grip strength) |
1-week Post-Intervention | |
Secondary | Change between Pre-Intervention and 4-weeks Post-Intervention Jamar Hand Dynamometer scores | To measure grip strength.
Minimum Value: 0 pounds Maximum Value: 200 pounds Higher scores = Better outcome (increased grip strength) |
4-weeks Post-Intervention | |
Secondary | Change between 1-week and 4-weeks Post-Intervention Jamar Hand Dynamometer Scores | To measure grip strength.
Minimum Value: 0 pounds Maximum Value: 200 pounds Higher scores = Better outcome (increased grip strength) |
4-weeks Post-Intervention | |
Secondary | Numeric Pain Rating Scale (NPRS) Baseline Scores | To measure pain.
Minimum Value: 0 (no pain) Maximum Value: 10 (worst possible pain) Higher scores = Worse outcome (increased pain) |
Pre-Intervention | |
Secondary | Change between Pre-Intervention and 1-week Numeric Pain Rating Scale (NPRS) Scores | To measure pain.
Minimum Value: 0 (no pain) Maximum Value: 10 (worst possible pain) Higher scores = Worse outcome (increased pain) |
1-week Post-Intervention | |
Secondary | Change between Pre-Intervention and 4-weeks Post-Intervention Numeric Pain Rating Scale (NPRS) Scores | To measure pain.
Minimum Value: 0 (no pain) Maximum Value: 10 (worst possible pain) Higher scores = Worse outcome (increased pain) |
4-weeks Post-Intervention | |
Secondary | Change between 1-week and 4-weeks Post-Intervention Numeric Pain Rating Scale (NPRS) scores | To measure pain.
Minimum Value: 0 (no pain) Maximum Value: 10 (worst possible pain) Higher scores = Worse outcome (increased pain) |
4-weeks Post-Intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
Not yet recruiting |
NCT06032416 -
DenCT Shoulder Bone Quality Evaluation
|
N/A | |
Enrolling by invitation |
NCT05067543 -
Perform Humeral System Study
|
||
Recruiting |
NCT05868148 -
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
|
||
Completed |
NCT03431857 -
Multi Centre Study on TESS V2 Shoulder System
|
||
Recruiting |
NCT05861960 -
Endogenous Pain Modulation Study
|
||
Recruiting |
NCT06078865 -
FX Shoulder Prospective Clinical Study
|
||
Recruiting |
NCT04929951 -
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
|
Phase 1 | |
Recruiting |
NCT04968405 -
Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty
|
N/A | |
Enrolling by invitation |
NCT05500066 -
AEQUALIS™ FLEX REVIVE™ Study (REVIVE)
|
||
Active, not recruiting |
NCT05002959 -
TESS V3 Modular Total Shoulder System PMCF
|
||
Recruiting |
NCT06077942 -
FX Shoulder Solutions Retrospective / Prospective Clinical Study
|
||
Active, not recruiting |
NCT06171542 -
Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis
|
Phase 1 | |
Recruiting |
NCT05487274 -
TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion
|
N/A |