CLINICIAN INSTRUCTIONS Dynasplint Supination/Pronation Forearm System Corporate Headquarters: 800.638.6771 toll-free 800.380.3784 fax Canada: 800.668.9139 toll-free 905.851.3494 fax Europe: 00131.455 230 418 phone 00131.455 231 303 fax www.dynasplint.com INDICATION: Dynasplint Supination/Pronation Forearm Systems are used for the treatment of joint stiffness and limited range of motion due to: Barton s fracture Colles fracture Fractures/dislocations involving wrist, forearm or elbow Mid shaft, distal or proximal radial fractures Mid shaft, distal or proximal humeral fractures Post surgical cases Radial head fractures Radiohumeral dislocations Smith FX DYNASPLINT and Dynasplint Systems are registered trademarks of Dynasplint Systems, Inc. Stretch Beyond Your Expectations.
Indications and Brief Introduction The Dynasplint Supination/Pronation System is designed to treat limited range of motion in the wrist and forearm caused by shortened connective tissue. This condition is most often the result of the elbow or wrist necessarily being immobilized for several days or weeks following an injury, illness or surgery. Frequently, elbow and wrist fractures, dislocations, burns and surgical repairs of torn ligaments are the primary conditions requiring immobilization at the elbow or wrist. The ability to fully supinate or pronate the forearm can then be lost. The Dynasplint Supination/Pronation System uses the same remarkably effective treatment as Dynasplint s other systems. Low-force applied to the restricted tissue for prolonged periods each 24-hour day is commonly referred to as low-load, prolongedduration stretch (LLPS), and is the basis of treatment when using the Dynasplint Supination/Pronation System to promote permanent connective tissue elongation in a safe, time-efficient means. The optimal time to start treatment with the Dynasplint Supination/Pronation System is 2 3 weeks after the immobilization period ends. For instance, if a patient suffered a Colles or radial head fracture, they may need 3 6 weeks in a cast or some other type of immobilizer. When the immobilizer is removed, they need to begin actively moving the wrist, forearm and elbow to restore the tissues to their normal length, which in turn allows full Supination/Pronation. Frequently, range of motion still lacks sufficient progress despite even more aggressive treatment using exercise and joint mobilization. If at the 2 3 week post-immobilization period the patient s supination and/or pronation is significantly deficient, then LLPS treatment using the Dynasplint Supination/Pronation System will greatly enhance t he patient s return to full range of motion. Just as in all other Dynasplint peripheral body joint devices, the Supination/Pronation System employs in-line axis, spring adjustable technology for accurate, reproducible tension thus allowing daily settings of time and intensity for consistent treatment day-to-day. Depending on many factors, including patient history, diagnosis, compliance levels, degree and severity of condition being treated; the total time required from onset of treatment to completion of the program, using the Dynasplint Supination/Pronation System, can range from three weeks to three months and occasionally longer. 1
FITTING INSTRUCTIONS STANDARD FITTING INSTRUCTIONS FOR SUPINATION: STEP 1: Loosen side bar set screws to allow telescoping of arms for appropriate biomechanical line up. STEP 2: With the mobile pin (See Figure 2) removed and the Dynasplint System reading Supination when looking from the wrist stabilizer to the mechanical joint centered just outside the distal-most ring, slip the patient s arm into the system so that their thumb is seated all the way through in the wrist stabilizer. Secure the hook and loop fasteners (See Figure 2) around the wrist and upper arm. See Figure 1. FIGURE 1. Black Tension Knob Joint Rod Distal Inner Ring Wrist Stabilizer FIGURE 2. Mobile Pin Read Supination from this Side Side Bar Set Screw *See Note Mechanical Elbow Upper Arm Cuff STEP 3: Adjust the forearm length in or out to have the mechanical elbow line up with the anatomical elbow. Snug the set screws to prevent further telescoping. STEP 4: With the tension set at 0, while the patient remains in the unit, hold their forearm at the available end-range point for supination. Place the mobile pin in the colored (red or black) receiving hole which is located on the distal inner ring at a point immediately away from the flat side of the joint rod extending from the joint housing. See Figure 1. Let go of the patient s forearm. STEP 5: Follow the instructions in the Protocol section. *NOTE: Additional counterforce strap may be used on top of forearm for stabilization. 2
STANDARD FITTING INSTRUCTIONS FOR PRONATION: STEP 1: Loosen side bar set screws to allow telescoping of arms for appropriate biomechanical line up. STEP 2: With the mobile pin removed and the Dynasplint System reading Pronation when looking from the wrist stabilizer to the mechanical joint centered just outside the distal-most ring, slip the patient s arm into the system so that their thumb is seated all the way through in the wrist stabilizer. Secure the hook and loop fasteners around the wrist and upper arm. See Figure 3. FIGURE 3. Upper Arm Cuff Mechanical Elbow Alignment with Anatomical Elbow *See Note Side Bar Hook and Loop Fastener Wrist Stabilizer Distal Inner Ring Black Tension Knob Joint Rod Mobile Pin STEP 3: Adjust the forearm length in or out to have the mechanical elbow line up with the anatomical elbow. Snug the set screws to prevent further telescoping. STEP 4: With the tension set at 0, while the patient remains in the unit, hold their forearm at the available end-range point for pronation. Place the mobile pin in the colored (red or black) receiving hole which is located on the distal inner ring at a point immediately away from the flat side of the joint rod extending from the joint housing. See Figure 3. Let go of the patient s forearm. STEP 5: Follow the instructions in the Protocol section. * NOTE: Additional counterforce strap may be used on top of forearm for stabilization Give the patient the Patient Instruction Booklet to take home with the Dynasplint Supination/Pronation System. 3
Protocol The guiding principle in all protocols using low-load, prolonged-duration stretch (LLPS) is to achieve the following: 1. First, and of utmost importance, is to have the wearing time be the longest cumulative possible each 24-hour day up to but not exceeding 12 hours per day in any one direction. This time period achieved will be referred to as the optimal application time. In other words, wearing time of 12 hours per day will produce better results clinically, but it may be impractical to wear the device that long. On the other hand, 30 minutes may not be long enough to achieve desired tissue elongation. Around 6 8 hours while sleeping or daytime use may be optimal. 2. Second, once the optimal time of wear is achieved, then, without reducing wearing time it is preferred to have the force be such that after removal, the patient should experience some degree of post-removal discomfort in the form of transient stiffness or aching in the forearm. This will indicate tissue stress producing elongation, which leads to range-of-motion improvement. Discomfort or aching beyond one hour is too much and the next scheduled wearing should be done with slightly less tension in the Dynasplint spring. Specifically follow these steps: a. For the first day, turn the black tension knob clockwise the number of revolutions required to have the joint rod just begin to slightly push the pin to a position of rotation which just meets the end range position available for the patient based on where their range of motion restriction begins. For instance, if the patient s range of motion is restricted to 60 supination (90 is desired), the beginning tension level will approximate 2 on the scale. b. Wear the Dynasplint System for up to 2 cumulative hours the first day. c. On the 2nd day, try to extend the time beyond 2 hours by wearing the splint while sleeping or through multiple daytime applications. The most common wearing schedule reporting clinical results is 2-3 sessions per day, 20-30 minutes per session. Despite reported success with as little as 1 hour cumulative per day, it may be in the patient s best interest to have significantly longer wearing time each day. Studies show that longer periods of low-force stretch produce greater permanent elongation of connective tissue. This leads to faster improvement in your range of motion. d. After several days, the optimal wearing schedule will be achieved and the tension setting can be advanced very gradually day-to-day until a tension level is achieved which both allows the patient to wear the system for the entire optimal time period while at the same time, producing some degree of post-wear discomfort (not lasting longer than 1 hour). e. If no post-wear discomfort is sensed, without sacrificing any time of wear, advance the tension each day by ½ turn of the tension knob. f. As range of motion improves, it will become necessary to change the quick-release pin location to the next adjacent colored hole. (First, de- 4
crease the tension for the right forearm. Move it clockwise for supination and counterclockwise for pronation viewing from the outside of the front section of the distal rings. For the left forearm, move the pin in the opposite direction as just stated.) When you do this, you will need to reset the tension back down to the level the patient started with during the initial stages of treatment with the Supination/Pronation, i.e., from 6 back down to 1 or 2. After resetting the tension, proceed to increase it gradually just as before. NEUROLOGICAL Protocol Neurological patients being fit in a standard unit that is neurologically dressed should follow the NEUROLOGICAL protocol. NOTE: Tension settings are different for the standard and neurological systems. If patient is transferring from a NEUROLOGICAL unit to a STANDARD unti that is neurologically dressed, please see the tension scales to adjust tension properly. Specifications Range of Motion of Unit Stem Rod: 90 Weight: Adult - 3.9 lbs. Range: Standard: 0 to 180 Telescopic Range: 8 3 / 4-15 3 / 4 (measured from web of thumb to the joint axis of the elbow) SUPINATION/PRONATION SCALE SETTING 0 1 2 3 4 5 6 7 8 9 FT. LBS. KG. CMS. 0.0 0.38 0.81 1.27 1.73 1.94 2.08 2.22 2.23 2.29 0.0 5.25 11.20 17.56 23.93 26.83 28.76 30.70 30.84 31.67 Setting Angle of Stem Rod Spring Tube 60º 45º 32º 18º 7º Hyper 5º Torque values expressed in foot pounds. 5
TROUBLESHOOTING Instruct patient to remove the Dynasplint System immediately if pain or numbness occurs. No tension felt. Be certain the mobile pin is placed at a point both on the flat side of the joint rod and in the receiving hole which best approximates a position of the patient s end range available (their pathological limit) with zero tension dialed into the Dynasplint Supination/Pronation System. Wrist slips in wrist stabilizer. After determining the first strap is snug and slippage continues to occur, have a second strap adhered to the wrist stabilizer either distal to or proximal to the existing strap. If this fails to correct the slippage, try a different sized wrist stabilizer. Pain. Decrease the tension by increments of 0.5 until the unit is tolerated. Unless absolutely necessary, do not decrease wearing time. Some patients may have to resort to daytime/evening use and/or multiple sessions, i.e., two, four-hour daytime/evening sessions. Numbness. Check cuffs for over-tightness and decrease wearing tension by increments of 0.5. Check upper arm cuffs. Be careful not to cause too much tension and/or pressure to brachial plexus (arm pit region). The inside material in the wrist stabilizer peels off. Add appropriate size piece of terry cloth to line the entire stabilizer. CONTRAINDICATIONS: Although Dynasplint Systems can provide unusually conservative stretching force, these devices are contraindicated where range of motion therapy is inappropriate. PRECAUTIONS: Carpal tunnel syndrome, osteoporosis, thrombophlebitis, spasticity, edema, gross ligament instability, circulatory impairment, RSD, and Fibromyalgia. NOTE: This device is restricted to use on the order of a licensed health care practitioner. 6
1996 Dynasplint Systems, Inc. Dynasplint Systems, Inc. products are covered by one or more of the following U.S.A. patents: 5,558,624; 5,645,521; 6,413,231; 6,506,172; 6,740,051; 6,908,475; 6,942,629; 6,942,631; 4,485,808; 4,508,111; 4,538,600; 4,944,290; 4,947,835; and 5,070,868. Other patents issued and/or pending in the U.S.A. and internationally. The product described in the enclosed literature is intended for the specific purpose as per the instructions attached. Any use of this product outside of its intended purpose on any body part or in a manner outside the protocol established by Dynasplint Systems, Inc., is a use of the product for which it, its divisions and employees cannot be held responsible. All implied warranties of fitness for use for any other purpose (or purposes) are expressly disclaimed.