Proximal Strengthening for the Management of Wrist Pain
Primary Purpose
Wrist Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hand therapy
Proximal Strengthening
Sponsored by
About this trial
This is an interventional treatment trial for Wrist Injuries focused on measuring wrist, proximal strengthening, hand therapy
Eligibility Criteria
Inclusion Criteria:
- Wrist pain
Exclusion Criteria:
- <8 years of age
- any neurological disorder
- Juvenile rheumatoid arthritis
- juvenile idiopathic arthritis
- Wrist fractures < 16 weeks from date of injury or surgery
- Tendon repair
- Nerve injury or repair
- Inability to follow directions
- Inability to attend follow-up appointments
Sites / Locations
- Nationwide Children's Hospital Sports and Ortho PT Ortho Center
- Nationwide Children's Hospital Sports and Ortho PT East Broad
- Nationwide Children's Hospital Sports and Ortho PT Dublin
- Nationwide Children's Hospital Sports and Ortho PT Westerville
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Proximal strengthening + hand therapy
Traditional hand therapy
Arm Description
Patients in this group will perform traditional hand therapy for 30 minutes and proximal strengthening of the core, cervical spine, and shoulder complex for up to 30 minutes
This group will receive traditional hand therapy for 45-60 minutes each session.
Outcomes
Primary Outcome Measures
Change in Patient Rated Wrist Evaluation (PRWE) score
The PRWE is a 15 item self-report questionnaire which measure pain and function. It has been found valid and reliable for measure changes in pain and function for patients with wrist pain. The minimal clinical important difference of this scale is 14 (Sorensen, 2013).
Secondary Outcome Measures
Change in Grip Dynamometer strength
Grip strength will be measured using a Jamar dynamometer on 2nd setting with elbow at 90 deg and shoulder in adduction at the patient's side, with the patient seated. Grip strength will be expressed as a percentage of body weight to account for differences in patients size and strength.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02435979
Brief Title
Proximal Strengthening for the Management of Wrist Pain
Official Title
Proximal Strengthening for the Management of Wrist Pain: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mitchell Selhorst
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be a randomized controlled trial comparing proximal strengthening vs. traditional hand therapy for patients with wrist pain. Patients will attend 2 hand therapy sessions per week for 4 weeks. Change in patient function and pain as measured by the patient rated wrist evaluation will be the primary outcome of interest
Detailed Description
This will be a non-blinded randomized controlled trial using a sample of consecutive patients with wrist pain. Patients who are referred to Nationwide Children's Hospital Hand therapy clinics with a primary complaint of wrist pain will be considered for this study.
Patients will be randomly assigned to one of two treatment groups; The proximal strengthening group or Traditional Hand Therapy Group. Both treatment groups will be evaluated and treated by the certified hand therapists for 2 sessions per week for 4 weeks. Both groups will receive similar treatment durations of 45-60 minutes per session based on each patient's individual needs.
Proximal strengthening group-The experimental proximal strengthening group consists of treatment where the hand therapist address specific impairments at the wrist and hand for 20-30 minutes at each treatment session. Patients allocated to this treatment group will also perform a standardized proximal strengthening protocol consisting of cervical, periscapular, and shoulder strengthening exercises. Depending on the pace and guidance needed for these exercises 25-30 minutes will be spent on proximal strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase.
Traditional Hand Therapy Group This active comparator group consists of treatment where the hand therapist address specific impairments at the wrist and hand for 45-60 minutes at each treatment session. Treatment can include stretching, motion, and strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase. Modalities for pain control and tissue mobility, and bracing or splinting if necessary. All treatments for the traditional hand therapy treatment group will occur seated at the hand therapy treatment table.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Injuries
Keywords
wrist, proximal strengthening, hand therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proximal strengthening + hand therapy
Arm Type
Experimental
Arm Description
Patients in this group will perform traditional hand therapy for 30 minutes and proximal strengthening of the core, cervical spine, and shoulder complex for up to 30 minutes
Arm Title
Traditional hand therapy
Arm Type
Active Comparator
Arm Description
This group will receive traditional hand therapy for 45-60 minutes each session.
Intervention Type
Other
Intervention Name(s)
hand therapy
Intervention Description
Treatment can include stretching, motion, and strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase. Modalities for pain control and tissue mobility, and bracing or splinting if necessary. All treatments for the traditional hand therapy treatment group will occur seated at the hand therapy treatment table.
Intervention Type
Other
Intervention Name(s)
Proximal Strengthening
Intervention Description
Patients will perform a standardized proximal strengthening protocol consisting of cervical, periscapular, and shoulder strengthening exercises. Depending on the pace and guidance needed for these exercises 25-30 minutes will be spent on proximal strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase.
Primary Outcome Measure Information:
Title
Change in Patient Rated Wrist Evaluation (PRWE) score
Description
The PRWE is a 15 item self-report questionnaire which measure pain and function. It has been found valid and reliable for measure changes in pain and function for patients with wrist pain. The minimal clinical important difference of this scale is 14 (Sorensen, 2013).
Time Frame
4 weeks (From initial evaluation to discharge)
Secondary Outcome Measure Information:
Title
Change in Grip Dynamometer strength
Description
Grip strength will be measured using a Jamar dynamometer on 2nd setting with elbow at 90 deg and shoulder in adduction at the patient's side, with the patient seated. Grip strength will be expressed as a percentage of body weight to account for differences in patients size and strength.
Time Frame
4 weeks (From initial evaluation to discharge)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Wrist pain
Exclusion Criteria:
<8 years of age
any neurological disorder
Juvenile rheumatoid arthritis
juvenile idiopathic arthritis
Wrist fractures < 16 weeks from date of injury or surgery
Tendon repair
Nerve injury or repair
Inability to follow directions
Inability to attend follow-up appointments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Selhorst, DPT
Organizational Affiliation
Nationwide Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital Sports and Ortho PT Ortho Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Nationwide Children's Hospital Sports and Ortho PT East Broad
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Nationwide Children's Hospital Sports and Ortho PT Dublin
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Nationwide Children's Hospital Sports and Ortho PT Westerville
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18977836
Citation
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Results Reference
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PubMed Identifier
2219945
Citation
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Results Reference
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PubMed Identifier
19879677
Citation
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Results Reference
background
PubMed Identifier
20710092
Citation
Kalra N, Seitz AL, Boardman ND 3rd, Michener LA. Effect of posture on acromiohumeral distance with arm elevation in subjects with and without rotator cuff disease using ultrasonography. J Orthop Sports Phys Ther. 2010 Oct;40(10):633-40. doi: 10.2519/jospt.2010.3155.
Results Reference
background
PubMed Identifier
25513795
Citation
Kong YK. The effects of co-ordinating postures with shoulder and elbow flexion angles on maximum grip strength and upper-limb muscle activity in standing and sitting postures. Int J Occup Saf Ergon. 2014;20(4):595-606. doi: 10.1080/10803548.2014.11077077.
Results Reference
background
PubMed Identifier
8784681
Citation
MacDermid JC. Development of a scale for patient rating of wrist pain and disability. J Hand Ther. 1996 Apr-Jun;9(2):178-83. doi: 10.1016/s0894-1130(96)80076-7. No abstract available.
Results Reference
background
PubMed Identifier
23742175
Citation
Park JK, Buchholz B. Effects of work surface height on muscle activity and posture of the upper extremity during simulated pipetting. Ergonomics. 2013;56(7):1147-58. doi: 10.1080/00140139.2013.799234. Epub 2013 Jun 6.
Results Reference
background
PubMed Identifier
23481405
Citation
Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am. 2013 Apr;38(4):641-9. doi: 10.1016/j.jhsa.2012.12.032. Epub 2013 Mar 6.
Results Reference
result
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Proximal Strengthening for the Management of Wrist Pain
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