Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness

NCT ID: NCT01618227

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2015-01-31

Brief 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).

Detailed Description

Upon enrollment, a form containing demographic and injury-related information will be completed, and the subjects will fill out the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Subjects will be evaluated for negative pain thoughts, pain anxiety, and depression. Study staff will supervise and assist with the questionnaires. Subjects will be evaluated at 2 and 6 months after enrollment during their routine office visits. The DASH questionnaire will be filled out and active wrist motion will be measured using a standard goniometer by a research assistant who will not be involved in the care of the patient. The number of physical/occupational therapy visits, additional surgeries, ease of splint application and use, and splint protocol compliance will be recorded.

The investigators intend to study the effectiveness rather than the efficacy of the splint, which means subjects will be free at all times to pursue an alternative treatment course and discontinue splint wear. The investigators will use intention to treat analysis.

Radiographs and other diagnostic studies will be obtained at the discretion of the treating surgeon and will not differ from routine clinical care.

Conditions

Post-traumatic Stiff Wrists

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rehabilitation with static progressive splinting

Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.

Group Type: EXPERIMENTAL

Joint Active Systems (JAS) Static progressive splint

Intervention Type: DEVICE

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.

Rehabilitation without splinting

Group Type: EXPERIMENTAL

Rehabilitation without splinting

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

Rehabilitation without splinting

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Less than 45 degrees of wrist extension, flexion, or both.
• Between two weeks and six months after a wrist or forearm fracture

Exclusion Criteria

• Active infection
• Wound problems
• Inability to comply with a structured rehabilitation protocol
• Burn-related contractures
• Primary osteoarthritis
• Clinically significant anatomic deformity, implants, or heterotopic bone hindering motion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

David C. Ring, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2007P002509

Identifier Type: -

Identifier Source: org_study_id