NCT02435979

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

May 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

4.2 years

First QC Date

May 1, 2015

Last Update Submit

July 15, 2019

Conditions

Wrist Injuries

Keywords

wristproximal strengtheninghand therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    4 weeks (From initial evaluation to discharge)

Secondary Outcomes (1)

  • Change in Grip Dynamometer strength

    4 weeks (From initial evaluation to discharge)

Study Arms (2)

Proximal strengthening + hand therapy

EXPERIMENTAL

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

Other: hand therapyOther: Proximal Strengthening

Traditional hand therapy

ACTIVE COMPARATOR

This group will receive traditional hand therapy for 45-60 minutes each session.

Other: hand therapy

Interventions

hand therapyOTHER

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.

Proximal strengthening + hand therapyTraditional hand therapy
Proximal StrengtheningOTHER

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.

Proximal strengthening + hand therapy

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Wrist pain

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nationwide Children's Hospital Sports and Ortho PT Ortho Center

Columbus, Ohio, 43205, United States

Location

Nationwide Children's Hospital Sports and Ortho PT East Broad

Columbus, Ohio, 43213, United States

Location

Nationwide Children's Hospital Sports and Ortho PT Dublin

Dublin, Ohio, 43017, United States

Location

Nationwide Children's Hospital Sports and Ortho PT Westerville

Westerville, Ohio, 43082, United States

Location

Related Publications (8)

  • 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.

    PMID: 18977836BACKGROUND

  • 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.

    PMID: 2219945BACKGROUND

  • 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). 2010 Feb;25(2):124-30. doi: 10.1016/j.clinbiomech.2009.10.003. Epub 2009 Oct 30.

    PMID: 19879677BACKGROUND

  • 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.

    PMID: 20710092BACKGROUND

  • 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.

    PMID: 25513795BACKGROUND

  • 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.

    PMID: 8784681BACKGROUND

  • 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.

    PMID: 23742175BACKGROUND

  • 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.

    PMID: 23481405RESULT

MeSH Terms

Conditions

Wrist Injuries

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Study Officials

  • Mitchell Selhorst, DPT

    Nationwide Childrens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2015

First Posted

May 6, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

US(4)