NCT04641546

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 28, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 11, 2020

Last Update Submit

November 17, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (16)

  • Canadian Occupational Performance Measure (COPM) Baseline Scores

    Pre-Intervention

  • Change between Pre-Intervention and 1-week Post-Intervention Canadian Occupational Performance Measure (COPM) scores

    1-week Post-Intervention

  • Change between Pre-Intervention and 4-weeks Post-Intervention Canadian Occupational Performance Measure (COPM) scores

    4-weeks Post-Intervention

  • Change between 1-week and 4-weeks Post-Intervention Canadian Occupational Performance Measure (COPM) scores

    4-weeks Post-Intervention

  • Shoulder Range of Motion (ROM) Baseline Scores

    Pre-Intervention

  • +11 more secondary outcomes

Study Arms (2)

Occupation-Based Intervention + Therapeutic Exercise Intervention Group

EXPERIMENTAL

Sixty-minute occupational therapy sessions were completed two times a week for six weeks consisting of 30 minutes therapeutic exercise followed by 30 minutes of occupation-based intervention.

Procedure: Therapeutic ExerciseProcedure: Occupation-Based Intervention

Therapeutic Exercise Control Group

EXPERIMENTAL

Sixty-minute occupational therapy sessions were completed two times a week for six weeks consisting of therapeutic exercise only.

Procedure: Therapeutic Exercise

Interventions

Passive range of motion (PROM), active-assistive range of motion (AAROM), active range of motion (AROM), and strengthening activities.

Occupation-Based Intervention + Therapeutic Exercise Intervention GroupTherapeutic Exercise Control Group

Collecting and placing items in cabinets, washing windows and tables, and hanging clothes on a clothesline.

Occupation-Based Intervention + Therapeutic Exercise Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosis of shoulder osteoarthritis (confirmed by physician examination or radiographic imaging)
  • Aged 65 years or older

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bay Path University

Jacksonville, Florida, 32223, United States

Location

Related 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. doi: 10.2106/JBJS.D.02060.

    PMID: 15866967BACKGROUND
  • 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.

    PMID: 27583004BACKGROUND
  • 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.

    PMID: 24534849BACKGROUND
  • 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.

    PMID: 26847318BACKGROUND
  • 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. No abstract available.

    PMID: 22588748BACKGROUND
  • 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. doi: 10.1177/000841749005700207.

    PMID: 10104738BACKGROUND
  • 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.

    PMID: 18163497BACKGROUND
  • 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.

    PMID: 21889366BACKGROUND
  • 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.

    PMID: 20699161BACKGROUND
  • Millett PJ, Gobezie R, Boykin RE. Shoulder osteoarthritis: diagnosis and management. Am Fam Physician. 2008 Sep 1;78(5):605-11.

    PMID: 18788237BACKGROUND
  • 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.

    PMID: 21701816BACKGROUND
  • 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.

    PMID: 30017413BACKGROUND

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Kelli A Cabrera

    Bay Path University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 24, 2020

Study Start

October 28, 2019

Primary Completion

December 6, 2019

Study Completion

January 10, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Plan to publish research findings to the American Journal of Occupational Therapy (AJOT).

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Within the next year

Locations