Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness

Summary

Loss of wrist flexion and extension is a common problem after wrist and forearm fractures that may lead to disability and unsatisfactory outcomes after fracture treatment. In many patients, this range of motion loss is caused by stiffness of the soft tissues. Such stiffness may loosen up and improve with rehabilitation. Static progressive splints apply a constant stretch upon the wrist resulting in a stretch relaxation and plastic deformation of the soft tissues. By altering the splint's bending angle, one can incrementally increase the force applied on either wrist flexion or extension. There are no data comparing rehabilitation with static-progressive splinting to rehabilitation without static-progressive splinting for the restoration of wrist flexion and extension after wrist or forearm fractures.

Primary study hypothesis:

Two months after study enrollment patients that use static progressive splinting have better wrist flexion and extension than patients that use standard therapy techniques.

Secondary study hypotheses:

1. Six months after study enrollment, subjects that use static progressive splinting have better wrist flexion and extension than those that use standard therapy techniques.
2. Motion at enrollment, 2 months and 6 months after enrollment correlates with negative pain thoughts, pain anxiety, and depression.
3. Six months after study enrollment, subjects that use static progressive splinting have had fewer physical/occupational therapy visits than those that use standard therapy techniques.
4. Six months after study enrollment patients that use static progressive splinting have had fewer additional surgeries than patients that use standard therapy techniques.

This study will employ a prospective randomized design. Subjects will be invited to enroll during their routine office follow-up visit. Informed consent will be obtained. Subjects will be randomized on a 1:1 ratio to rehabilitation with or without static progressive splinting.

All subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. The static progressive splint will be prescribed according to the randomization sequence. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer. Use of the splints will be discontinued at the patient's discretion or when a plateau phase in active range of motion is achieved (defined as no measurable gains in active range of motion achieved in a 30-day period).

Conditions

• Post-traumatic Stiff Wrists

Interventions

DEVICE

Joint Active Systems (JAS) Static progressive splint

Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer.

PROCEDURE

Rehabilitation without splinting

Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.

Sponsors & Collaborators

• Massachusetts General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• United States

Study Locations