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Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness

This study has been terminated.
(Due to a lack of resources and the principal investigator leaving the institution, we stopped the study prior to reaching enrollment target.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01618227
First Posted: June 13, 2012
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
  Purpose

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).


Condition Intervention
Post-traumatic Stiff Wrists Device: Joint Active Systems (JAS) Static progressive splint Procedure: Rehabilitation without splinting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness

Resource links provided by NLM:


Further study details as provided by David C. Ring, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Wrist Range of Motion [ Time Frame: 2 months ]
    Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.


Secondary Outcome Measures:
  • Wrist Range of Motion [ Time Frame: 6 months ]
    Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.

  • Number of Physical/Occupational Therapy Visits [ Time Frame: 6 months ]
    Number of physical/occupational therapy visits will be collected from enrollment.

  • Number of Additional Surgeries [ Time Frame: 6 months ]
    The number of additional surgeries will be recorded and compared between groups.


Enrollment: 4
Study Start Date: September 2008
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: Rehabilitation without splinting Procedure: Rehabilitation without splinting
Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618227


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Responsible Party: David C. Ring, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01618227     History of Changes
Other Study ID Numbers: 2007P002509
First Submitted: June 7, 2012
First Posted: June 13, 2012
Results First Submitted: December 6, 2016
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017
Last Verified: February 2017