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Osteoarthritis ShoulderNCT04641546

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

A study testing Therapeutic Exercise and Occupation-Based Intervention in people with Osteoarthritis Shoulder, run by Bay Path University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Osteoarthritis Shoulder
What is being tested?
Therapeutic Exercise and Occupation-Based Intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
28 Oct 2019to 10 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bay Path University

    Jacksonville, Florida, 32223

Other trials in United States

About this study

Official title: Effectiveness of an Occupation-Based Intervention Compared With Therapeutic Exercise for Older Adults With Shoulder Osteoarthritis: A Pilot Randomized Controlled Trial

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.

Read the detailed 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.

Being tested
Therapeutic Exercise, Occupation-Based Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic ExerciseProcedure or surgery

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

  • Occupation-Based InterventionProcedure or surgery

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

Study groups in NCT04641546
Study groupRoleWhat they receive
Occupation-Based Intervention + Therapeutic Exercise Intervention GroupExperimentalSixty-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.
Receives: Procedure: Therapeutic Exercise; Procedure: Occupation-Based Intervention
Therapeutic Exercise Control GroupExperimentalSixty-minute occupational therapy sessions were completed two times a week for six weeks consisting of therapeutic exercise only.
Receives: Procedure: Therapeutic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Pre-Intervention

  2. 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)

    Measured: 1-week Post-Intervention

  3. 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)

    Measured: 4-weeks Post-Intervention

  4. 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)

    Measured: 4-weeks Post-Intervention

Secondary outcomes (16)

  1. 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)

    Measured: Pre-Intervention

  2. 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)

    Measured: 1-week Post-Intervention

  3. 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)

    Measured: 4-weeks Post-Intervention

  4. 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)

    Measured: 4-weeks Post-Intervention

  5. 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)

    Measured: Pre-Intervention

  6. 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)

    Measured: 1-week Post-Intervention

  7. 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)

    Measured: 4-weeks Post-Intervention

  8. 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)

    Measured: 4-weeks Post-Intervention

  9. Jamar Hand Dynamometer Baseline Scores

    To measure grip strength.

    • Minimum Value: 0 pounds
    • Maximum Value: 200 pounds
    • Higher scores = Better outcome (increased grip strength)

    Measured: Pre-Intervention

  10. 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)

    Measured: 1-week Post-Intervention

  11. 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)

    Measured: 4-weeks Post-Intervention

  12. 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)

    Measured: 4-weeks Post-Intervention

  13. 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)

    Measured: Pre-Intervention

  14. 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)

    Measured: 1-week Post-Intervention

  15. 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)

    Measured: 4-weeks Post-Intervention

  16. 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)

    Measured: 4-weeks Post-Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start28 Oct 2019
  3. Primary completion6 Dec 2019
  4. Study completion10 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04641546
Sponsor's protocol ID
BayPathU
Status last verified
Nov 2020
First submitted
11 Nov 2020
Last updated
24 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan to publish research findings to the American Journal of Occupational Therapy (AJOT).

Publications

  • 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.

    PubMed 15866967

  • 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.

    PubMed 27583004

  • 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.

    PubMed 24534849

  • 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.

    PubMed 26847318

  • 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.

    PubMed 22588748

  • 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.

    PubMed 10104738

  • 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.

    PubMed 18163497

  • 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.

    PubMed 21889366

  • 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.

    PubMed 20699161

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

    PubMed 18788237

  • 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.

    PubMed 21701816

  • 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.

    PubMed 30017413

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Exercise and Occupation-Based Intervention in people with Osteoarthritis Shoulder, run by Bay Path University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Baseline scores (time frame: Pre-Intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04641546, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.

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