Wrist InjuriesNCT02435979
Proximal Strengthening for the Management of Wrist Pain
A study testing hand therapy and Proximal Strengthening in people with Wrist Injuries, run by Mitchell Selhorst at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Wrist Injuries
- What is being tested?
- hand therapy and Proximal Strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Wrist pain
Who cannot join
- <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
Show all 9Show fewer
- Nerve injury or repair
- Inability to follow directions
- Inability to attend follow-up appointments
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Nationwide Children's Hospital Sports and Ortho PT Ortho Center
Columbus, Ohio, 43205
Nationwide Children's Hospital Sports and Ortho PT East Broad
Columbus, Ohio, 43213
Nationwide Children's Hospital Sports and Ortho PT Dublin
Dublin, Ohio, 43017
Nationwide Children's Hospital Sports and Ortho PT Westerville
Westerville, Ohio, 43082
About this study
Official title: Proximal Strengthening for the Management of Wrist Pain: A Randomized Controlled Trial
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
Read the 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
- Wrist Injuries
- Being tested
- hand therapy, Proximal Strengthening
- Keywords
- wrist, proximal strengthening, hand therapy
- Medical subject headings
- Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: hand therapy; Other: Proximal Strengthening |
| Traditional hand therapy | Active comparator | This group will receive traditional hand therapy for 45-60 minutes each session. Receives: Other: hand therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks (From initial evaluation to discharge)
Secondary outcomes (1)
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.
Measured: 4 weeks (From initial evaluation to discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Wrist InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitchell Selhorst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mitchell Selhorst, Nationwide Children's Hospital
- Investigators
- Mitchell Selhorst, DPT, Principal investigator, Nationwide Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435979
- Sponsor's protocol ID
- IRB15-00251
- Status last verified
- Jul 2019
- First submitted
- 1 May 2015
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18977836Metzler W, Kessler G, Benzer W, Mahr G. [Ophthalmological significance of stenosing carotid processes]. Wien Med Wochenschr. 1990 Jul 31;140(14):387-9. German.
PubMed 2219945Emery 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.
PubMed 19879677Kalra 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.
PubMed 20710092Kong 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.
PubMed 25513795MacDermid 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.
PubMed 8784681Park 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.
PubMed 23742175Sorensen 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.
PubMed 23481405
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Strengthening for the Management of Wrist Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02435979
- Acronym / sponsor ID
- IRB15-00251
- Conditions
- Wrist Injuries
- Keywords
- wrist, proximal strengthening, hand therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mitchell SelhorstUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal strengthening + hand therapy | Experimental | Other: hand therapy, Other: Proximal StrengtheningPatients 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 |
| Traditional hand therapy | Active comparator | Other: hand therapyThis group will receive traditional hand therapy for 45-60 minutes each session. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Wrist pain
Key exclusion criteria (9 listed)
- <8 years of age
- any neurological disorder
- Juvenile rheumatoid arthritis
- juvenile idiopathic arthritis
- Wrist fractures < 16 weeks from date of injury or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hand therapyTreatment 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. | Other | Proximal strengthening + hand therapy, Traditional hand therapy |
| Proximal StrengtheningPatients 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. | Other | Proximal strengthening + hand therapy |
Primary outcome
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).
1 secondary outcome
Change in Grip Dynamometer strength
Time frame: 4 weeks (From initial evaluation to discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 18977836Alexander 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.
- Background: PubMed 2219945Metzler W, Kessler G, Benzer W, Mahr G. [Ophthalmological significance of stenosing carotid processes]. Wien Med Wochenschr. 1990 Jul 31;140(14):387-9. German.
- Background: PubMed 19879677Emery 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.
- Background: PubMed 20710092Kalra 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.
- Background: PubMed 25513795Kong 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.
- Background: PubMed 8784681MacDermid 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.
- Background: PubMed 23742175Park 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 publication: PubMed 23481405Sorensen 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.
Related trials for Wrist Injuries
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Selhorst, DPT principal investigator
Nationwide Childrens Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand therapy and Proximal Strengthening in people with Wrist Injuries, run by Mitchell Selhorst at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Rated Wrist Evaluation (PRWE) score (time frame: 4 weeks (From initial evaluation to discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435979, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.