- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02435979
Proximal Strengthening for the Management of Wrist Pain
Proximal Strengthening for the Management of Wrist Pain: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital Sports and Ortho PT Ortho Center
-
Columbus, Ohio, United States, 43213
- Nationwide Children's Hospital Sports and Ortho PT East Broad
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Dublin, Ohio, United States, 43017
- Nationwide Children's Hospital Sports and Ortho PT Dublin
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Westerville, Ohio, United States, 43082
- Nationwide Children's Hospital Sports and Ortho PT Westerville
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proximal strengthening + hand therapy
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
|
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.
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.
|
Active Comparator: Traditional hand therapy
This group will receive traditional hand therapy for 45-60 minutes each 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Rated Wrist Evaluation (PRWE) score
Time Frame: 4 weeks (From initial evaluation to discharge)
|
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).
|
4 weeks (From initial evaluation to discharge)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Grip Dynamometer strength
Time Frame: 4 weeks (From initial evaluation to discharge)
|
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.
|
4 weeks (From initial evaluation to discharge)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Alexander M, Franko OI, Makhni EC, Zurakowski D, Day CS. Validation of a modern activity hand survey with respect to reliability, construct and criterion validity. J Hand Surg Eur Vol. 2008 Oct;33(5):653-60. doi: 10.1177/1753193408093810.
- Metzler W, Kessler G, Benzer W, Mahr G. [Ophthalmological significance of stenosing carotid processes]. Wien Med Wochenschr. 1990 Jul 31;140(14):387-9. German.
- Emery K, De Serres SJ, McMillan A, Cote JN. The effects of a Pilates training program on arm-trunk posture and movement. Clin Biomech (Bristol, Avon). 2010 Feb;25(2):124-30. doi: 10.1016/j.clinbiomech.2009.10.003. Epub 2009 Oct 30.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB15-00251
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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