Post-traumatic Stiff WristsNCT01618227
Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness
A study testing Joint Active Systems (JAS) Static progressive splint and Rehabilitation without splinting in people with Post-traumatic Stiff Wrists, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stiff Wrists
- What is being tested?
- Joint Active Systems (JAS) Static progressive splint and Rehabilitation without splinting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Prospective Randomized Trial of Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness
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:
Read more
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:
- Six months after study enrollment, subjects that use static progressive splinting have better wrist flexion and extension than those that use standard therapy techniques.
- Motion at enrollment, 2 months and 6 months after enrollment correlates with negative pain thoughts, pain anxiety, and depression.
- 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.
- 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).
Read the 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
- Being tested
- Joint Active Systems (JAS) Static progressive splint, Rehabilitation without splinting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint Active Systems (JAS) Static progressive splintDevice
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 splintingProcedure or surgery
Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation with static progressive splinting | Experimental | 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. Receives: Device: Joint Active Systems (JAS) Static progressive splint |
| Rehabilitation without splinting | Experimental | Not described Receives: Procedure: Rehabilitation without splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist Range of Motion
Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.
Measured: 2 months
Secondary outcomes (3)
Wrist Range of Motion
Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.
Measured: 6 months
Number of Physical/Occupational Therapy Visits
Number of physical/occupational therapy visits will be collected from enrollment.
Measured: 6 months
Number of Additional Surgeries
The number of additional surgeries will be recorded and compared between groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startSep 2008
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Due to a lack of resources and the principal investigator leaving the institution, we stopped the study prior to reaching enrollment target.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic Stiff WristsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618227
- Sponsor's protocol ID
- 2007P002509
- Status last verified
- Feb 2017
- First submitted
- 7 Jun 2012
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness
- ClinicalTrials.gov ID
- NCT01618227
- Acronym / sponsor ID
- 2007P002509
- Conditions
- Post-traumatic Stiff Wrists
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a lack of resources and the principal investigator leaving the institution, we stopped the study prior to reaching enrollment target.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Six months after study enrollment, subjects that use static progressive splinting have better wrist flexion and extension than those that use standard therapy techniques.
- Motion at enrollment, 2 months and 6 months after enrollment correlates with negative pain thoughts, pain anxiety, and depression.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with static progressive splinting | Experimental | Device: Joint Active Systems (JAS) Static progressive splintStatic 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. |
| Rehabilitation without splinting | Experimental | Procedure: Rehabilitation without splinting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Active infection
- Wound problems
- Inability to comply with a structured rehabilitation protocol
- Burn-related contractures
- Primary osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint Active Systems (JAS) Static progressive splintSubjects 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. | Device | Rehabilitation with static progressive splinting |
| Rehabilitation without splintingSubjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting. | Procedure or surgery | Rehabilitation without splinting |
Primary outcome
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.
3 secondary outcomes
Wrist Range of Motion
Time frame: 6 months
Number of Physical/Occupational Therapy Visits
Time frame: 6 months
Number of Additional Surgeries
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Active Systems (JAS) Static progressive splint and Rehabilitation without splinting in people with Post-traumatic Stiff Wrists, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist Range of Motion (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.