Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01618227
First received: June 7, 2012
Last updated: June 12, 2012
Last verified: June 2012
  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: 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Wrist range of motion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of physical/occupational therapy visits will be collected from enrollment.

  • Number of additional surgeries [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of additional surgeries will be recorded and compared between groups.


Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: July 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618227

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

No publications provided

Responsible Party: David C. Ring, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01618227     History of Changes
Other Study ID Numbers: 2007P002509
Study First Received: June 7, 2012
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 27, 2014