Clinical trial NCT02435979: 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
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Injuries
Keywords: wrist
proximal strengthening
hand therapy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 38
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Patient Rated Wrist Evaluation (PRWE) score
timeFrame: 4 weeks (From initial evaluation to discharge)
Secondary outcomes:
measure: Change in Grip Dynamometer strength
timeFrame: 4 weeks (From initial evaluation to discharge)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital Sports and Ortho PT Ortho Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital Sports and Ortho PT East Broad
state: Ohio
city: Dublin
country: United States
facility: Nationwide Children's Hospital Sports and Ortho PT Dublin
state: Ohio
city: Westerville
country: United States
facility: Nationwide Children's Hospital Sports and Ortho PT Westerville
state: Ohio
Study officials:
affiliation: Nationwide Childrens Hospital
name: Mitchell Selhorst, DPT
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.