545416 research-article2014
POI0010.1177/0309364614545416Prosthetics and Orthotics InternationalDionyssiotis et al.
INTERNATIONAL SOCIETY FOR PROSTHETICS AND ORTHOTICS
Original Research Report
Prospective study of spinal orthoses in women
Prosthetics and Orthotics International 1–9 © The International Society for Prosthetics and Orthotics 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0309364614545416 poi.sagepub.com
Yannis Dionyssiotis, Georgios Trovas, Sofia Thoma, George Lyritis and Nikolaos Papaioannou
Abstract Background: There are not many clinical trials investigating the efficiency and compliance of using spinal orthoses in the management of osteoporosis. Objectives: The purpose of this study was to investigate the effect of long-term use and the compliance of spinal orthoses in postmenopausal women with vertebral fractures. Study design: Clinical trial of spinal orthoses in postmenopausal women. Methods: Women were separated into groups wearing different types of orthoses (Spinomed, Osteomed, Spinomed active, and Spine-X). Isometric maximum strength of trunk muscles (F/Wabdominals–extensors) was calculated and back pain was assessed in all women. In addition, women completed a compliance questionnaire about the use of the orthoses. Results: Spinomed decreased pain (p = 0.001) and increased trunk muscle strength (F/Wabdominals, p = 0.005 and F/Wextensors, p = 0.003, respectively). The compliance of wearing an orthosis for 6 months was 66%. Conclusion: The results suggest that orthoses could be an effective intervention for back pain and muscle strengthening in osteoporotic women. Clinical relevance In women with established osteoporosis, wearing Spinomed orthosis for at least 2 h/day for 6 months decreased back pain significantly and increased personal isometric trunk muscle strength. All spinal orthoses could be valuable instruments to help all requested rehabilitation programs like spine muscles’ strengthening and postural correct behavior, but only when used properly. Keywords Spinomed, Osteomed, orthosis, osteoporosis, women, compliance Date received: 17 May 2013; accepted: 1 July 2014
Background Spinal orthoses have been used in the management of thoracolumbar injuries treated with or without surgical stabilization. These orthoses, however, have never been tested under standardized conditions. Especially, no prospective, randomized, and controlled clinical trials are available to document efficacy according to the criteria of evidence-based medicine.1 Moreover, there is a lack of specific studies comparing various types of braces and orthoses. Even though it is widely accepted that spinal orthoses whether made of cloth, metal, or plastic, or whether rigid or flexible, relieve pain and promote the healing process by stabilizing the spine, that is, reducing
the load applied on the anterior column and vertebral body by restraining any attempt of forward flexion.2 Considering the body mechanics, the load of the spine is transferred by the vertebral body. But there are also other structures, that is, muscles, ligaments, and so on, in the
University of Athens, Athens, Greece Corresponding author: Yannis Dionyssiotis, University of Athens, Kifisia, Athens 14561, Greece. Email: [email protected]
Downloaded from poi.sagepub.com at UQ Library on August 16, 2015
2
Prosthetics and Orthotics International
region playing a regulatory role. In a kyphotic posture, the spinal kyphosis causes a forward and downward shift of the center of mass of the trunk in the sagittal plane. To maintain balance, the subject has to correct for this shift. This is impossible for some osteoporotic women because of muscle weakness. Anterior column fails resulting in compression while posterior column fails resulting in tension.3 The most broadly used types of spinal orthoses utilize a three-point pressure system.4 Different types of spinal orthoses are briefly discussed in the following: 1. The TLSO type (Knight–Taylor, Jewett, or cruciform anterior sternal hyperextension (CASH) brace, Boston): it provides support to the thoracolumbosacral spine. The CASH or Jewett brace has been favored for patients with acute thoracolumbar vertebral fractures. The goal of these braces is to provide forces to encourage hyperextension.5 However, a drawback to these orthoses in the treatment of compression fractures in osteoporotic elderly patients is controversial because it can exert excessive hyperextension forces on the lower lumbar vertebrae, which in turn can induce posterior element fractures or exacerbate a degenerative arthritis condition.6 2. The Posture Training Support (PTS) type, or the newer postural training support vest with weights (PTSW): these two orthoses are made of a softer material, gained popularity because of their improved comfort and increased compliance. The postural training support is worn over the shoulders similar to a mini-backpack and has a pocket into which small weights (total 1.75 lb) are added. The PTSW is similar to this type of orthosis except that it is fashioned as a vest with a Velcro attachment that fastens around the abdomen.7 3. Spinomed and Spinomed active: these are based on biofeedback theory.1,8 Spinomed consists of an abdominal pad, splint along the spine, back pad, and a system of belts with Velcro. The back orthosis consists of a back pad that is workable as a cold material and a system of belts with Velcro. This allows adjustments for individual sizes by an orthopedic technician. The orthosis weighs 450 g and is worn like a back pad. 4. Osteomed: it is based on the gate control theory of pain. The external appearance of the orthosis Osteomed resembles an item of clothing characterized by a constructively functional cut with Velcro tabs exerting pressure on the lumbosacral region. The air chamber pads, fixed in the paravertebral and lumbosacral areas, are filled with air to between 2/3 and 3/4 of their maximum capacity.9 The most widely held viewpoint is that the manual muscle strength is basically an attempt to assess the maximum
force a muscle can generate.10 In our view, the manual muscle testing is particularly suitable in the rehabilitation phase when muscles or muscle groups with a lack of contraction to weak muscles or muscle groups are examined. However, the manual muscle testing method that primarily measures force in the final stages of rehabilitation or in subjects with muscular fitness appears unsuitable to identify deficiencies and imbalances. For these reasons, the use of a precise and apparatus-based device having diagnostic power is recommended. The extension of classic muscle function test on the maximum isometric force capability takes into account that it is not individual muscles but functional groups of muscles are to be examined. The functionality of the muscle groups is based on the respective joints that are associated with different patterns of movement, such as flexion and extension of the trunk. The purpose of this study was to investigate the effect of long-term use of modern spinal orthoses (semi-rigid and elastic) to alleviate back pain by exerting force on the trunk (extensors–abdominal) muscles in postmenopausal women with vertebral fractures in thoracic and lumbar spine and the compliance with the use of such spinal orthoses.
Methods Fifty socially active women aged above 60 years, referred to the University from various departments for routine osteoporosis examinations, were enrolled in this study. Study entry criteria were as follows: established spinal osteoporosis defined by the presence of at least one vertebral fracture in the thoracic or lumbar spine not caused by serious injury or accident, radiographic (x-ray) evidence of morphometry-based fracture of the vertebra with a reduction in vertebral height of at least 20%, and women with a kyphosis angle more than 55° measured in lateral view x-ray of dorsal spine. The standard (Cobb) measuring technique for the quantification of thoracic kyphosis was used, which has the advantage of being part of a global non-invasive postural evaluation, although the precision of the resulting measurement is not very high.11,12 All measurements were performed by the same physiatrist (Y.D.) Women with disorders affecting bone metabolism (hyperthyroidism, primary hyperparathyroidism, and osteomalacia) and also women with serious degenerative diseases such as severe osteoarthritis, scoliosis, and tumors were excluded. Causes of secondary osteoporosis were excluded from the history and biochemical tests of serum blood and urine. We adopted our inclusion and exclusion criteria from the study of Pfeifer et al.7 Their study introduced the thoracolumbar orthosis Spinomed (Medi Bayreuth, Bayreuth, Germany) in a scientific evidence-based manner. Our purpose was to repeat a clinical trial using similar methods but various orthoses in order to determine generalizability. This was planned as a randomized clinical trial prospective study to be completed in 6 months. Women were separated into
Downloaded from poi.sagepub.com at UQ Library on August 16, 2015
3
Dionyssiotis et al.
Figure 1. Digimax ISO-Rack (Digimax Systems, Hamm, Germany) system is a low-cost versatile isometric measuring station. The basis of the automated supplement is a digital, microprocessor-controlled instrument from Digimax Systems. The meter consists first of a force sensor, which operates on the basis of strain gauges, and the other composed of a display unit in the form of a handheld device, which is also equipped with an interface to the PC. For an optimal reproduction of the measurement situation, there are numbers printed across the Rack and on the surface of a floor mat. This floor mat is completed in a chest-type pattern with reference numbers and stands in the floor beside the Rack device.
group A (n = 20, using semi-rigid orthosis Spinomed or Spine-X), group B (n = 20, using elastic multifunctional orthosis Osteomed, Spinomed active), and the control group (n = 10), which included women of similar age with fractures. Women were referred to our department with their own orthosis (bought with their own expenses) as prescribed by their physician. All were ready made not custom handmade orthoses, according to subjects’ size and shape. After trying the orthosis, a qualified technician adjusted and modified the device to ensure a perfect fit. All orthoses used during this study were manufactured abroad (in Germany) and imported. Women were assigned in groups immediately (according to the prescribed orthosis) after screening by the physiatrist (Y.D.) to determine whether they met the inclusion criteria. As controls, women who denied wearing the prescribed orthosis were enrolled. Participants were required to wear the provided orthosis at least 2 h/day and keep a dairy (proof of compliance to treatment). All participants received various medications for osteoporosis including calcium and vitamin D. All were recruited from various departments around Athens (Rehabilitation, Orthopaedic, and Rheumatology Departments) after announcement for participation in a clinical research of Athens University. The protocol was designed according to the Declaration of Helsinki, and all subjects agreed to take part voluntarily. We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research.
Measurements and questionnaires Anthropometric values of height and weight of the subjects were measured in standing position. Weight, W (kg) was recorded on Leonardo™ Mechanography Ground Reaction Force Platform (Novotec Medical GmbH, Pforzheim, Germany). This system measures forces, F (N) applied to the plate over time including stationary forces. Height (m) was measured with a wall-mounted ruler. Body mass index (BMI) was also calculated for each subject (BMI = weight (kg)/height2 (m)). We calculated the maximum personal isometric strength of trunk muscles (Force/Weightabdominals and Force/ Weightextensors) in a seated position with knees and hips bent at 90° with the system Digimax ISO-Rack (Digimax Systems, Hamm, Germany). This system is a low-cost versatile isometric measuring station. The basis of the automated supplement is a digital, microprocessor-controlled instrument from Digimax Systems. The meter consists first of a force sensor, which operates on the basis of strain gauges, and the other composed of a display unit in the form of a handheld device, which is also equipped with an interface to the PC. We used a lower filtering setting for acquired signals from ISO-Rack to ensure harmonious and more accurate curves with the cut-off frequency of 5 (filter interval) according to the manufacturer’s instructions. For an optimal reproduction of the measurement situation, there are numbers printed across the Rack and on the surface of a floor mat. This floor mat is completed in a chesttype pattern with reference numbers and stands in the floor beside the Rack device (Figure 1). The average force from
Downloaded from poi.sagepub.com at UQ Library on August 16, 2015
4
Prosthetics and Orthotics International (SD) and qualitative data by the number of patients (n) and percentage (%). Qualitative variables were analyzed using chi-square (χ2) test and Fisher’s exact test. All tests are two-sided with 95% significance level. Statistical analysis was performed using the SPSS version 12.00. Significance was set at 0.05 level.
Figure 2. Greek version of VAS. VAS: Visual Analog Scale.
three trials was recorded. The maximum strength in each trial was measured, and these values showed high reproducibility (r = 0.990, p
POI0010.1177/0309364614545416Prosthetics and Orthotics InternationalDionyssiotis et al.
INTERNATIONAL SOCIETY FOR PROSTHETICS AND ORTHOTICS
Original Research Report
Prospective study of spinal orthoses in women
Prosthetics and Orthotics International 1–9 © The International Society for Prosthetics and Orthotics 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0309364614545416 poi.sagepub.com
Yannis Dionyssiotis, Georgios Trovas, Sofia Thoma, George Lyritis and Nikolaos Papaioannou
Abstract Background: There are not many clinical trials investigating the efficiency and compliance of using spinal orthoses in the management of osteoporosis. Objectives: The purpose of this study was to investigate the effect of long-term use and the compliance of spinal orthoses in postmenopausal women with vertebral fractures. Study design: Clinical trial of spinal orthoses in postmenopausal women. Methods: Women were separated into groups wearing different types of orthoses (Spinomed, Osteomed, Spinomed active, and Spine-X). Isometric maximum strength of trunk muscles (F/Wabdominals–extensors) was calculated and back pain was assessed in all women. In addition, women completed a compliance questionnaire about the use of the orthoses. Results: Spinomed decreased pain (p = 0.001) and increased trunk muscle strength (F/Wabdominals, p = 0.005 and F/Wextensors, p = 0.003, respectively). The compliance of wearing an orthosis for 6 months was 66%. Conclusion: The results suggest that orthoses could be an effective intervention for back pain and muscle strengthening in osteoporotic women. Clinical relevance In women with established osteoporosis, wearing Spinomed orthosis for at least 2 h/day for 6 months decreased back pain significantly and increased personal isometric trunk muscle strength. All spinal orthoses could be valuable instruments to help all requested rehabilitation programs like spine muscles’ strengthening and postural correct behavior, but only when used properly. Keywords Spinomed, Osteomed, orthosis, osteoporosis, women, compliance Date received: 17 May 2013; accepted: 1 July 2014
Background Spinal orthoses have been used in the management of thoracolumbar injuries treated with or without surgical stabilization. These orthoses, however, have never been tested under standardized conditions. Especially, no prospective, randomized, and controlled clinical trials are available to document efficacy according to the criteria of evidence-based medicine.1 Moreover, there is a lack of specific studies comparing various types of braces and orthoses. Even though it is widely accepted that spinal orthoses whether made of cloth, metal, or plastic, or whether rigid or flexible, relieve pain and promote the healing process by stabilizing the spine, that is, reducing
the load applied on the anterior column and vertebral body by restraining any attempt of forward flexion.2 Considering the body mechanics, the load of the spine is transferred by the vertebral body. But there are also other structures, that is, muscles, ligaments, and so on, in the
University of Athens, Athens, Greece Corresponding author: Yannis Dionyssiotis, University of Athens, Kifisia, Athens 14561, Greece. Email: [email protected]
Downloaded from poi.sagepub.com at UQ Library on August 16, 2015
2
Prosthetics and Orthotics International
region playing a regulatory role. In a kyphotic posture, the spinal kyphosis causes a forward and downward shift of the center of mass of the trunk in the sagittal plane. To maintain balance, the subject has to correct for this shift. This is impossible for some osteoporotic women because of muscle weakness. Anterior column fails resulting in compression while posterior column fails resulting in tension.3 The most broadly used types of spinal orthoses utilize a three-point pressure system.4 Different types of spinal orthoses are briefly discussed in the following: 1. The TLSO type (Knight–Taylor, Jewett, or cruciform anterior sternal hyperextension (CASH) brace, Boston): it provides support to the thoracolumbosacral spine. The CASH or Jewett brace has been favored for patients with acute thoracolumbar vertebral fractures. The goal of these braces is to provide forces to encourage hyperextension.5 However, a drawback to these orthoses in the treatment of compression fractures in osteoporotic elderly patients is controversial because it can exert excessive hyperextension forces on the lower lumbar vertebrae, which in turn can induce posterior element fractures or exacerbate a degenerative arthritis condition.6 2. The Posture Training Support (PTS) type, or the newer postural training support vest with weights (PTSW): these two orthoses are made of a softer material, gained popularity because of their improved comfort and increased compliance. The postural training support is worn over the shoulders similar to a mini-backpack and has a pocket into which small weights (total 1.75 lb) are added. The PTSW is similar to this type of orthosis except that it is fashioned as a vest with a Velcro attachment that fastens around the abdomen.7 3. Spinomed and Spinomed active: these are based on biofeedback theory.1,8 Spinomed consists of an abdominal pad, splint along the spine, back pad, and a system of belts with Velcro. The back orthosis consists of a back pad that is workable as a cold material and a system of belts with Velcro. This allows adjustments for individual sizes by an orthopedic technician. The orthosis weighs 450 g and is worn like a back pad. 4. Osteomed: it is based on the gate control theory of pain. The external appearance of the orthosis Osteomed resembles an item of clothing characterized by a constructively functional cut with Velcro tabs exerting pressure on the lumbosacral region. The air chamber pads, fixed in the paravertebral and lumbosacral areas, are filled with air to between 2/3 and 3/4 of their maximum capacity.9 The most widely held viewpoint is that the manual muscle strength is basically an attempt to assess the maximum
force a muscle can generate.10 In our view, the manual muscle testing is particularly suitable in the rehabilitation phase when muscles or muscle groups with a lack of contraction to weak muscles or muscle groups are examined. However, the manual muscle testing method that primarily measures force in the final stages of rehabilitation or in subjects with muscular fitness appears unsuitable to identify deficiencies and imbalances. For these reasons, the use of a precise and apparatus-based device having diagnostic power is recommended. The extension of classic muscle function test on the maximum isometric force capability takes into account that it is not individual muscles but functional groups of muscles are to be examined. The functionality of the muscle groups is based on the respective joints that are associated with different patterns of movement, such as flexion and extension of the trunk. The purpose of this study was to investigate the effect of long-term use of modern spinal orthoses (semi-rigid and elastic) to alleviate back pain by exerting force on the trunk (extensors–abdominal) muscles in postmenopausal women with vertebral fractures in thoracic and lumbar spine and the compliance with the use of such spinal orthoses.
Methods Fifty socially active women aged above 60 years, referred to the University from various departments for routine osteoporosis examinations, were enrolled in this study. Study entry criteria were as follows: established spinal osteoporosis defined by the presence of at least one vertebral fracture in the thoracic or lumbar spine not caused by serious injury or accident, radiographic (x-ray) evidence of morphometry-based fracture of the vertebra with a reduction in vertebral height of at least 20%, and women with a kyphosis angle more than 55° measured in lateral view x-ray of dorsal spine. The standard (Cobb) measuring technique for the quantification of thoracic kyphosis was used, which has the advantage of being part of a global non-invasive postural evaluation, although the precision of the resulting measurement is not very high.11,12 All measurements were performed by the same physiatrist (Y.D.) Women with disorders affecting bone metabolism (hyperthyroidism, primary hyperparathyroidism, and osteomalacia) and also women with serious degenerative diseases such as severe osteoarthritis, scoliosis, and tumors were excluded. Causes of secondary osteoporosis were excluded from the history and biochemical tests of serum blood and urine. We adopted our inclusion and exclusion criteria from the study of Pfeifer et al.7 Their study introduced the thoracolumbar orthosis Spinomed (Medi Bayreuth, Bayreuth, Germany) in a scientific evidence-based manner. Our purpose was to repeat a clinical trial using similar methods but various orthoses in order to determine generalizability. This was planned as a randomized clinical trial prospective study to be completed in 6 months. Women were separated into
Downloaded from poi.sagepub.com at UQ Library on August 16, 2015
3
Dionyssiotis et al.
Figure 1. Digimax ISO-Rack (Digimax Systems, Hamm, Germany) system is a low-cost versatile isometric measuring station. The basis of the automated supplement is a digital, microprocessor-controlled instrument from Digimax Systems. The meter consists first of a force sensor, which operates on the basis of strain gauges, and the other composed of a display unit in the form of a handheld device, which is also equipped with an interface to the PC. For an optimal reproduction of the measurement situation, there are numbers printed across the Rack and on the surface of a floor mat. This floor mat is completed in a chest-type pattern with reference numbers and stands in the floor beside the Rack device.
group A (n = 20, using semi-rigid orthosis Spinomed or Spine-X), group B (n = 20, using elastic multifunctional orthosis Osteomed, Spinomed active), and the control group (n = 10), which included women of similar age with fractures. Women were referred to our department with their own orthosis (bought with their own expenses) as prescribed by their physician. All were ready made not custom handmade orthoses, according to subjects’ size and shape. After trying the orthosis, a qualified technician adjusted and modified the device to ensure a perfect fit. All orthoses used during this study were manufactured abroad (in Germany) and imported. Women were assigned in groups immediately (according to the prescribed orthosis) after screening by the physiatrist (Y.D.) to determine whether they met the inclusion criteria. As controls, women who denied wearing the prescribed orthosis were enrolled. Participants were required to wear the provided orthosis at least 2 h/day and keep a dairy (proof of compliance to treatment). All participants received various medications for osteoporosis including calcium and vitamin D. All were recruited from various departments around Athens (Rehabilitation, Orthopaedic, and Rheumatology Departments) after announcement for participation in a clinical research of Athens University. The protocol was designed according to the Declaration of Helsinki, and all subjects agreed to take part voluntarily. We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research.
Measurements and questionnaires Anthropometric values of height and weight of the subjects were measured in standing position. Weight, W (kg) was recorded on Leonardo™ Mechanography Ground Reaction Force Platform (Novotec Medical GmbH, Pforzheim, Germany). This system measures forces, F (N) applied to the plate over time including stationary forces. Height (m) was measured with a wall-mounted ruler. Body mass index (BMI) was also calculated for each subject (BMI = weight (kg)/height2 (m)). We calculated the maximum personal isometric strength of trunk muscles (Force/Weightabdominals and Force/ Weightextensors) in a seated position with knees and hips bent at 90° with the system Digimax ISO-Rack (Digimax Systems, Hamm, Germany). This system is a low-cost versatile isometric measuring station. The basis of the automated supplement is a digital, microprocessor-controlled instrument from Digimax Systems. The meter consists first of a force sensor, which operates on the basis of strain gauges, and the other composed of a display unit in the form of a handheld device, which is also equipped with an interface to the PC. We used a lower filtering setting for acquired signals from ISO-Rack to ensure harmonious and more accurate curves with the cut-off frequency of 5 (filter interval) according to the manufacturer’s instructions. For an optimal reproduction of the measurement situation, there are numbers printed across the Rack and on the surface of a floor mat. This floor mat is completed in a chesttype pattern with reference numbers and stands in the floor beside the Rack device (Figure 1). The average force from
Downloaded from poi.sagepub.com at UQ Library on August 16, 2015
4
Prosthetics and Orthotics International (SD) and qualitative data by the number of patients (n) and percentage (%). Qualitative variables were analyzed using chi-square (χ2) test and Fisher’s exact test. All tests are two-sided with 95% significance level. Statistical analysis was performed using the SPSS version 12.00. Significance was set at 0.05 level.
Figure 2. Greek version of VAS. VAS: Visual Analog Scale.
three trials was recorded. The maximum strength in each trial was measured, and these values showed high reproducibility (r = 0.990, p
