Even-Up to Minimize Secondary Site Pain For Ankle Fracture

Arthralgia Clinical Trial

Official title:

A Randomized Controlled Trial of Non-Operative Ankle Fractures: Even-Up Orthotic Shoe Lift and CAM Walking Boot Wear

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04164563
• Other study ID #: 2019P002694
• Status: Terminated
• Phase: N/A
• Start date: November 14, 2019
• Est. completion date: September 10, 2020

Study information

• Verified date: September 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluating impact of use of Even-Up shoe wear device for patients treated in CAM boot walker for an ankle fracture. Randomized controlled trial, randomizing patients into control group with boot treatment only versus boot treatment with Even-Up device on contralateral extremity.

Description:

A variety of foot and ankle injuries can be treated effectively through the use of a controlled ankle movement (CAM) walker boot. CAM walker boots protect the injured area by restricting foot and ankle motion, providing a stable platform to distribute forces while bearing weight, and allowing the user to rollover the foot during ambulation because of a rocker bottom-shaped sole. Such qualities lend the CAM walker boot to provide ankle support that can be advantageous compared with other commonly used methods. Despite their utility, CAM walker boots create a simulated leg-length discrepancy (LLD), which can result in altered biomechanics during ambulation. Additionally, a LLD can be associated with lower back and joint pain.

We have previously conducted a study that suggests a relationship exists between CAM walker boot treatment and pain at sites other than the extremity being treated. There have been several randomized controlled trials (RCTs) examining a relationship between the correction of inherent LLD with insole inserts and lower back pain. Furthermore, there has been a past RCT and there is a current RCT examining a relationship between the use of the EVENup orthotic shoe lift to correct CAM walker boot simulated LLD and pain at sites other than the extremity being treated. However, these studies were not conducted with patient populations with uniform injuries. To the best of our knowledge, an RCT has not been conducted with the EVENup orthotic shoe lift to examine this relationship in a uniform patient population with nonoperative ankle fractures. This RCT aims to assess the efficacy of the EVENup orthotic shoe lift, towards reducing and even preventing such pain that may be associated with this common course of treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-operative Treatment of Ankle Fracture

• CAM boot as treatment for injury

• Weight bearing ad lib

Exclusion Criteria:

• Pregnancy

• Non-English speaking

• Recent surgery for lower extremity or back

• Recent other injury to lower extremity or back

• Restricted weight bearing

Related Conditions & MeSH terms

• Ankle Fractures
• Arthralgia
• Trouble Balancing

Intervention

Device:
• Even-Up
Orthotic shoe lift worn on contralateral foot to increase leg length

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (13)

Defrin R, Ben Benyamin S, Aldubi RD, Pick CG. Conservative correction of leg-length discrepancies of 10mm or less for the relief of chronic low back pain. Arch Phys Med Rehabil. 2005 Nov;86(11):2075-80. — View Citation

DiGiovanni BF, Moore AM, Zlotnicki JP, Pinney SJ. Preferred management of recalcitrant plantar fasciitis among orthopaedic foot and ankle surgeons. Foot Ankle Int. 2012 Jun;33(6):507-12. doi: 10.3113/FAI.2012.0507. — View Citation

Keene DJ, Willett K, Lamb SE. The Immediate Effects of Different Types of Ankle Support Introduced 6 Weeks After Surgical Internal Fixation for Ankle Fracture on Gait and Pain: A Randomized Crossover Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):157-67. doi: 10.2519/jospt.2016.6212. Epub 2016 Jan 26. — View Citation

Kipp D, Village D, Edwards KJ. Effectiveness of Evenup™ Shoe-Lift Use Among Individuals Prescribed a Walking Boot. J Allied Health. 2017 Summer;46(2):104-110. — View Citation

Mittal R, Harris IA, Adie S, Naylor JM; CROSSBAT Study Group. Surgery for Type B Ankle Fracture Treatment: a Combined Randomised and Observational Study (CROSSBAT). BMJ Open. 2017 Mar 27;7(3):e013298. doi: 10.1136/bmjopen-2016-013298. — View Citation

O'Toole GC, Makwana NK, Lunn J, Harty J, Stephens MM. The effect of leg length discrepancy on foot loading patterns and contact times. Foot Ankle Int. 2003 Mar;24(3):256-9. — View Citation

Rannisto S, Okuloff A, Uitti J, Paananen M, Rannisto PH, Malmivaara A, Karppinen J. Correction of leg-length discrepancy among meat cutters with low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2019 Mar 14;20(1):105. doi: 10.1186/s12891-019-2478-3. — View Citation

Ready LV, Fisk EG, Ciurylo W, Chiodo CP, Bluman EM, Smith JT. Associated Joint Pain With Controlled Ankle Movement Walker Boot Wear. J Am Acad Orthop Surg Glob Res Rev. 2018 Nov 27;2(12):e044. doi: 10.5435/JAAOSGlobal-D-18-00044. eCollection 2018 Dec. — View Citation

Simpson MR, Howard TM. Tendinopathies of the foot and ankle. Am Fam Physician. 2009 Nov 15;80(10):1107-14. Review. — View Citation

Subotnick SI. Limb length discrepancies of the lower extremity (the short leg syndrome). J Orthop Sports Phys Ther. 1981;3(1):11-6. — View Citation

Vulcano E, Deland JT, Ellis SJ. Approach and treatment of the adult acquired flatfoot deformity. Curr Rev Musculoskelet Med. 2013 Dec;6(4):294-303. doi: 10.1007/s12178-013-9173-z. — View Citation

Waverly BJ, Sorensen MD, Sorensen TK. Early Weightbearing Protocol in Operative Fixation of Acute Jones Fractures. J Foot Ankle Surg. 2018 May - Jun;57(3):489-493. doi: 10.1053/j.jfas.2017.11.005. — View Citation

White SC, Gilchrist LA, Wilk BE. Asymmetric limb loading with true or simulated leg-length differences. Clin Orthop Relat Res. 2004 Apr;(421):287-92. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Reported Pain (VAS)	Visual Analog Scale (0 - 100) to assess pain at various musculoskeletal sites. Patients are presented with a slider on a scale to indicate the degree to which they are experiencing pain on a scale from "No Pain" at the far left to "Worst Pain" at the far right. The position on the scale is then translated into a number from 0 (no pain) to 100 (worst pain).	0-24 weeks
Primary	Patient Reported Outcome (FAAM-ADL, 0 - 100)	FAAM-ADL (Foot and Ankle Ability Measure - Activities of Daily Living, [0 -100]).The FAAM-ADL consists of 21 questions, with a maximum score of 4 per question. The sum of the scores of answered questions is divided by the highest potential score (84 if all 21 questions are answered) and converted to a total score out of 100, with a minimum score of 0. Higher scores indicate better function. Total score range is 0 to 100.	0-24 weeks

External Links

•   Study of an Orthotic Designed to Equalize Leg Lengths for Patients with Injuries Managed in Walking Boots