Effectiveness of Occupation-Based Intervention Compared With Therapeutic Exercise for Older Adults With Shoulder OA.

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641546
• Other study ID #: BayPathU
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: November 2020
• Source: Bay Path University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Importance: There is a need for evidence to support occupation-based intervention (OBI) for older adults with shoulder osteoarthritis (OA). Objective: To evaluate the effectiveness of OBI on function in older adults with shoulder OA compared to therapeutic exercise (TE). Design: Randomized controlled trial. Six-week intervention. 1-week and 4-week follow-up. Setting: Outpatient clinic. Participants: Ten older adults with diagnosis of shoulder OA via convenience sampling. Intervention: Participants were seen two times/week for six weeks. The OBI group completed 30 minutes of TE followed by 30 minutes of OBI. The TE group completed 60 minutes of TE. Outcome and Measures: Functional outcomes were assessed at pre-, 1-week post, and 4-weeks posttreatment using the QuickDASH as the primary outcome measure.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Shoulder

Intervention

Procedure:
• Therapeutic Exercise
Passive range of motion (PROM), active-assistive range of motion (AAROM), active range of motion (AROM), and strengthening activities.
• Occupation-Based Intervention
Collecting and placing items in cabinets, washing windows and tables, and hanging clothes on a clothesline.

Locations

Country	Name	City	State
United States	Bay Path University	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bay Path University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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

Outcome

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