## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** IRB15-00251
#### Organization
**Class:** OTHER
**Full Name:** Nationwide Children's Hospital
### Status Module
#### Completion Date
**Date:** 2019-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-07-16

**Type:** ACTUAL

**Last Update Submit Date:** 2019-07-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-07

**Type:** ACTUAL

#### Start Date
**Date:** 2015-05

**Status Verified Date:** 2019-07

#### Study First Post Date
**Date:** 2015-05-06
**Type:** ESTIMATED
**Study First Submit Date:** 2015-05-01
**Study First Submit QC Date:** 2015-05-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mitchell Selhorst

#### Responsible Party

**Investigator Affiliation:** Nationwide Children's Hospital

**Investigator Full Name:** Mitchell Selhorst

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Wrist Injuries

**Keywords:**

- wrist

- proximal strengthening

- hand therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 38

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Other: hand therapy

- Other: Proximal Strengthening

**Label:** Proximal strengthening + hand therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: hand therapy

**Label:** Traditional hand therapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Proximal strengthening + hand therapy

- Traditional hand therapy

**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.

**Name:** hand therapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Proximal strengthening + hand therapy

**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.

**Name:** Proximal Strengthening

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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).

**Measure:** Change in Patient Rated Wrist Evaluation (PRWE) score

**Time Frame:** 4 weeks (From initial evaluation to discharge)

#### Secondary Outcomes

**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.

**Measure:** Change in Grip Dynamometer strength

**Time Frame:** 4 weeks (From initial evaluation to discharge)

### Eligibility Module

**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

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Columbus

**Country:** United States

**Facility:** Nationwide Children's Hospital Sports and Ortho PT Ortho Center

**State:** Ohio

**Zip:** 43205

**Location 2:**

**City:** Columbus

**Country:** United States

**Facility:** Nationwide Children's Hospital Sports and Ortho PT East Broad

**State:** Ohio

**Zip:** 43213

**Location 3:**

**City:** Dublin

**Country:** United States

**Facility:** Nationwide Children's Hospital Sports and Ortho PT Dublin

**State:** Ohio

**Zip:** 43017

**Location 4:**

**City:** Westerville

**Country:** United States

**Facility:** Nationwide Children's Hospital Sports and Ortho PT Westerville

**State:** Ohio

**Zip:** 43082

#### Overall Officials

**Official 1:**

**Affiliation:** Nationwide Childrens Hospital

**Name:** Mitchell Selhorst, DPT

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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:** 18977836

**Citation:** 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:** 2219945

**Citation:** 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.

**PMID:** 19879677

**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.

**PMID:** 20710092

**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.

**PMID:** 25513795

**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.

**PMID:** 8784681

**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.

**PMID:** 23742175

**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.

**PMID:** 23481405

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001134

- Term: Arm Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M17692

- Name: Wrist Injuries

- Relevance: HIGH

- As Found: Wrist Injuries

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4444

- Name: Arm Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014954

- Term: Wrist Injuries

### Misc Info Module

- Version Holder: 2024-05-24
