1. OVERVIEW AND DESCRIPTION
Spinal orthoses are mechanical systems prescribed to apply external pressure at specific anatomical points to immobilize, support or correct spinal deformities. Numerous types of spinal orthoses are available for the cervical, thoraco-lumbar spine and sacrum. Because of the anatomical design of the spine, direct external application of pressure is limited to the central posterior spine. The cranium, rib cage and/or pelvis are used to exert indirect control.
- Soft tissue injuries, e.g., cervical whiplash, muscular strain, and metastatic cancer pain
- Post trauma in setting of stable spinal fractures
- Post-operative control of fractures
- Post-surgical care after spinal fusion or reconstruction
- To correct, control, or delay progression of spinal deformities such as scoliosis, kyphosis, or other neuromuscular caused deformities.1
- Stabilize spinal structures
- Maintain or correct spinal alignment
- Control spinal motion
- Off-load spinal elements
- Prevent or correct deformities/contractures
- Support weak muscles
- Aid in pain relief
- Provide biofeedback to correct posture/positioning
- Supportive orthoses are typically used for temporary pain control.
- Underlying principles of supportive spinal orthoses include limiting painful range of motion and providing kinesthetic feedback. Since pain is a common reason for prescribing a cervical orthosis (CO), many are supportive.
- Immobilization orthoses are primarily used for spinal trauma, with or without surgical intervention, as well as post-spinal reconstruction surgeries, including fusions.
- Corrective orthoses are frequently prescribed in pediatrics to address scoliosis or kyphosis that is idiopathic or secondary to neuromuscular disease.
Conditions potentially warranting orthotic treatment:
- Cervical or lumbar sprain/strain
- Degenerative disc disease
- Spondylolithesis, spondylolysis or spondylosis 2
- Stable fractures, post- surgical stabilization and/or fusion
- Kyphosis or scoliosis
- Arthritic conditions: inflammatory or non-inflammatory; osteoarthritis
- Paralysis from neuromuscular disease, tetraplegia
Potential Complications associated with Spinal Orthotic use:
- Loss of skin integrity
- Weakening of axial muscles
- Soft tissue contracture formation
- Physiological and/or psychological dependence 1
2. RELEVANCE TO CLINICAL PRACTICE
- Orthoses serve their purpose by applying force in the correct body areas. Contact between the orthosis and the patient’s body is proportional to control and pressure distribution.
- Forces can vary due to body habitus and patient movement or positioning. 3
- Fitting obese patients can be challenging, as the ability to control the spine through extensive soft tissue is limited
- Cachectic patients may have problems with fit due to limited soft tissue over pressure points and bony prominences. Skin irritation or even ulceration may occur; diligence in fit and monitoring is essential.
- No spinal orthosis achieves complete immobilization of the spine
- The halo achieves the best control, but “snaking”, or movement, in the cervical spine still occurs.
- The Philadelphia or similar cervical orthosis requires a thoracic extension for controlling C 6-7 and C6-T5 (cervicothoracic junction).
- Literature suggests to best immobilize the L4-L5 and L5-S1 levels, a unilateral thigh extension is required on a rigid lumbosacral orthoses.4
- As their main purpose is to immobilize and support the spine, it is important to remember that orthoses may interfere with mobility and activities of daily living
- Spinal orthoses should be prescribed judiciously, typically in conjunction with a rehabilitation treatment program fostering patient independence and minimizing the potential of their adverse effects
Choosing an orthosis:
- No specific criteria are available for determining when or which orthosis is indicated. The clinician must first diagnose the underlying condition and decide if orthotic treatment is required.
- If an orthosis is deemed appropriate, the goals need to be clear to the patient and the orthotist. Treatment goals can include: stabilizing spinal structures, limiting motion, off-loading spinal elements, correcting alignment, and/or providing support and pain relief or a combination of these.
- The various contraindications and the biomechanical effect of each orthosis need to be taken into account as well.
- Additionally, it is crucial to discuss the duration that the orthotic will be used.
- Consider flexible orthoses such as soft collars or corsets for pain control in a stable spine.
- Ideally, these devices are coupled with a rehabilitation plan that includes time-limited use, ROM, exercise and mobility.
- Soft flexible orthoses may be used for osteoarthritis, degenerative disc or spine disease, sprains, or inflammatory arthritis.
- Used for spinal stabilization; soft flexible orthoses are contraindicated in an unstable spine.
- The stability of the vertebral column must be ascertained in trauma or spinal fractures. If the fracture does not require surgical stabilization, a more rigid and motion-limiting orthosis is indicated.
- Halo orthosis is indicated for stable high cervical spinal fractures or unstable cervical spine fractures that do not require surgery. It is contraindicated in the presence of skull fractures or skull wounds that would be located near the site of pin placement.
- A thoraco-lumbosacral semi-rigid total contact orthosis (TLSO, “body jacket”, “turtle shell”) provides total contact and limits flexion, extension and rotation of the thoracolumbar spine, but does not provide control above C7.
- The cervical spine is the most mobile part of the spine with multiple planes of motion and degrees of freedom, which are relevant to the fitting, use and prescription of a cervical orthosis (CO). Additionally, the surface area is small and the amount of external force that can be applied is limited.
- Types of COs include: cervical collars, cervicothoracic orthoses, halo or similar type of orthoses. COs achieve the previously mentioned goals, but some are designed to redistribute the weight of the head to the trunk.
- These biomechanical goals are achieved through obtaining purchase of the trunk and/or head, controlling spinal motion, and aligning the spine. The direction and magnitude of applied forces and the forces exerted by the body in return provide the biomechanical therapeutic intervention.
- Examples of COs include: soft collar, Philadelphia, Aspen, Miami J, Minerva, SOMI, Halovest.1
- Although soft COs are commonly used in clinical practice, there is no evidence that supports their use for axial neck pain or whiplash injury. In acute whiplash, using a soft CO delays return to work, when compared to patients who were prescribed exercise only. 5 Early mobilization was superior to soft collar immobilization in cervical soft tissue injuries. 6
Thoracic and Thoraco-lumbosacral Orthoses (TLSO)
- Generally categorized into either corsets, jackets, hyperextension, hyper-flexion, or rigid braces.
- These are 3-point force control systems coupled with compression of the abdomen. The 3-point system is composed of two anterior supports and the abdominal support, which are counterbalanced by a rigid posterior support. Abdominal compression reduces the longitudinal spinal forces, lumbar lordosis, and intervertebral joint motion, thereby off-loading the intervertebral discs. The pelvis serves as the base of alignment. Pressure over the bony prominences provides a kinesthetic reminder to maintain or correct posture.
- In contrast, hyperextension orthoses allows extension and limited rotation. Since abdominal support is not needed, these orthoses have forces at the sternum, hypogastrium and upper lumbar spine.
Milwaukee brace – cervicothoracolumbosacral orthosis (CTLSO)
- Used primarily for correction of deformity due to idiopathic scoliosis. It is indicated in a skeletally immature child with a Cobb angle of 20 degrees or greater.
- Periodic X-rays are used to monitor change in the spinal curvature. In one meta-analysis, the weighted mean proportion of success was 0.93, 0.62, and 0.60 for 23, 16, and 8 hours of wear per day, respectively.7
- It immobilizes the thoracolumbar spine and provides corrective forces to the spine. Using the ribs as stabilizers, thoracic forces are applied superiorly and medially with thoracic pads.
- The efficacy of bracing appears to be directly related to the number of hours/day that the brace is worn.8
- Patient compliance is a problem because of bulk, size, and unattractiveness of the orthosis. Patients often overestimate the time they actually spend in an orthosis. The efficacy also appears to be related to sex (decreased in males), and weight, with decreased efficacy in overweight patients.8
Sacral and Sacroiliac Orthoses
- Trochanteric band and sacroiliac corsets are most commonly used.
- They offer minimal support but may provide sufficient proprioceptive feedback to avoid painful motions and reduce fear of motion.
- Prescribed in the setting of sacroiliac dysfunction or low back pain during pregnancy.5
Social and Economic Factors
- Wearing orthoses have potential interference with ADLs, school or work. Many devices are cumbersome and unattractive, which negatively impacts patient compliance.
- Some patients become psychologically dependent on the device, and wear the orthosis long after it is no longer needed
- Spinal orthoses may not be well tolerated in some conditions, such as hot, humid climates.
- One study showed an increase in compliance if there was an electronic monitoring device within the 11
- Efforts have been geared towards improving the comfort of the material and reducing the weight of the orthosis, while maintaining stability. 12
- Most commercially available spinal orthoses in the United States have not been tested in a standardized fashion. The Food and Drug Administration (FDA) classifies spinal orthoses as Class I devices, meaning that the use of the device has been deemed “low risk” and thus has low regulatory control. FDA clearance is not required before production or sales in the medical device market.
- Commercial pre-fabricated orthoses may be more economical, however they may have limitations of less intimate fit, less control, and need for modifications. They are often more complex in design, e.g. more strapping to accommodate various body shapes.
3. CUTTING EDGE/UNIQUE CONCEPTS/EMERGING ISSUES
Studies are in their early stages utilizing spinal imaging (MRI or CT scans), typically done at the time of injury, to design and fit a custom orthosis for the individual.
There is a growing movement in the orthotics industry to employ laser scanners, computer-aided design and manufacturing (CAD/CAM), coupled with advanced software to measure and fabricate orthoses, thereby increasingly eliminating casting and other labor-intensive approaches.8,13
4. GAPS IN KNOWLEDGE/EVIDENCE BASE
In general, research is lacking in regards to indications when to use and when not to use spinal orthoses. Furthermore, the research that is available shows significant contradictory stances.
- For example, it is generally accepted that stable thoracolumbar burst fractures should be treated conservatively with spinal bracing and physical therapy, rather than surgical fixation. A study with a 16 to 22 year follow up shows evidence to support this treatment plan despite other studies that are shown to favor surgical fixation.12,14 Additionally, in the same subset of stable fractures there have been trials that support no bracing and early ambulation, rather than with just bracing.15,16
- The literature also has conflicting results about the deconditioning effects of orthoses on the paraspinal muscles: some studies suggest the muscles get stronger, while others suggest that they get weaker, and even other suggest that there is no change in the strength of the supportive musculature.12,17,18
- Other studies have looked at the effect of post-operative bracing after surgical fixation. Again, these have yielded results that either recommend against bracing or find no difference in outcomes between those with bracing and those without following surgery.12,19
In spite of the growing field of cancer rehabilitation, evidence-based guidance around how to correctly position and when to mobilize patients with metastatic spine disease is lacking. It is unknown if spinal orthoses are effective for pain control and improving quality of life in metastatic disease.
Few randomized control trials (RCTs) are published to document efficacy of spinal orthoses according to evidence-based medicine criteria. Areas of needed study include: 1) determining the efficacy of cervical and upper thoracic immobilization after surgery; 2) development of more effective non-invasive immobilization of the unstable cervical spine; 3) efficacy in the treatment of osteoporosis; and 4) developing guidelines with indications for and against use of spinal orthoses.
- O’Young B, Young MA, Stiens SA. Physical Medicine and Rehabilitation Secrets. Mosby; 2008.
- Panteliadis P, Nagra NS, Edwards KL, Behrbalk E, Boszczyk B. Athletic Population with Spondylolysis: Review of Outcomes following Surgical Repair or Conservative Management. Global Spine J. 2016;6(6):615-25.
- Rohlmann A, Zander T, Graichen F, Bergmann G. Effect of an orthosis on the loads acting on a vertebral body replacement. Clin Biomech (Bristol, Avon). 2013;28(5):490-4.
- Fidler MW, Plasmans CM. The effect of four types of support on the segmental mobility of the lumbosacral spine. J Bone Joint Surg Am. 1983;65(7):943-947.
- Crawford JR, Khan RJ, Varley GW. Early management and outcome following soft tissue injuries of the neck: a randomized control trial. Injury. 2004;35(9):891-895.
- Zarghooni K, Beyer F, Siewe J, Eysel P. The orthotic treatment of acute and chronic disease of the cervical and lumbar spine. Dtsch Arztebl Int. 2013;110(44):737-42.
- Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis. A prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society. 1995;77(6):815.
- O’Neill PJ, Karol LA, Shindle MK, et al. Decreased orthotic effectiveness in overweight patients with adolescent idiopathic scoliosis. J Bone Joint Surg Am. 2005;87:1069.
- DiRaimondo CV, Green NE. Brace-wear compliance in patients with adolescent idiopathic scoliosis. J Pediatr Orthop. 1988;8:143.
- Hammer N, Möbius R, Schleifenbaum S, et al. Pelvic Belt Effects on Health Outcomes and Functional Parameters of Patients with Sacroiliac Joint Pain. PLoS ONE. 2015;10(8):e0136375.
- Miller DJ, Franzone JM, Matsumoto H, et al. Electronic monitoring improves brace-wearing compliance in patients with adolescent idiopathic scoliosis: a randomized clinical trial. Spine. 2012;37(9):717-21.
- Rizza R, Liu X, Thometz J, Tassone C. Comparison of biomechanical behavior between a cast material torso jacket and a polyethylene based jacket. Scoliosis. 2015;10(Suppl 2):S15.
- Cobetto N, Aubin CE, Parent S, et al. Effectiveness of braces designed using computer-aided design and manufacturing (CAD/CAM) and finite element simulation compared to CAD/CAM only for the conservative treatment of adolescent idiopathic scoliosis: a prospective randomized controlled trial. Eur Spine J. 2016;.
- Wood KB, Buttermann GR, Phukan R, et al. Operative compared with nonoperative treatment of a thoracolumbar burst fracture without neurological deficit: a prospective randomized study with follow-up at sixteen to twenty-two years. J Bone Joint Surg Am. 2015;97(1):3-9.
- Kim HJ, Yi JM, Cho HG, et al. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014;96(23):1959-66.
- Bailey CS, Urquhart JC, Dvorak MF, et al. Orthosis versus no orthosis for the treatment of thoracolumbar burst fractures without neurologic injury: a multicenter prospective randomized equivalence trial. Spine J. 2014;14(11):2557-64.
- Schwab F. Treatment with or without an Orthosis is Equivalent for Thoracolumbar Burst Fracture without Neurologic Injury. J Bone Joint Surg Am. 2015;97(16):1374.
- Valentin GH, Pedersen LN, Maribo T. Wearing an active spinal orthosis improves back extensor strength in women with osteoporotic vertebral fractures. Prosthet Orthot Int. 2014;38(3):232-8.
- Skoch J, Zoccali C, Zaninovich O, et al. Bracing After Surgical Stabilization of Thoracolumbar Fractures: A Systematic Review of Evidence, Indications, and Practices. World Neurosurg. 2016;93:221-8.
Original Version of the Topic
Mary Catherine Spires, MD. Cervical, Thoracic and Lumbosacral Orthoses. 11/05/2012
Jennifer Yang, MD
Nothing to Disclose
Erika Gosai, MD
Nothing to Disclose
Steven Avers, DO
Nothing to Disclose