Efficacy of Percutaneous Vertebral Augmentation and Use of Physical Therapy Intervention following Vertebral Compression Fractures in Older Adults: A Systematic Review : Journal of Geriatric Physical Therapy

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Efficacy of Percutaneous Vertebral Augmentation and Use of Physical Therapy Intervention following Vertebral Compression Fractures in Older Adults

A Systematic Review

Cahoj, Patricia A. PT, MS, DPT, GCS1; Cook, Jeanne L. PT, MSPT, CWS2; Robinson, Barbara S. PT, DPT3

Author Information

1 Instructor, Department of Physical Therapy, College of Health and Human Services, Missouri State University, Springfield, MO

2 Assistant Professor, Department of Physical Therapy, College of Health and Human Services, Missouri State University, Springfield, MO

3 Associate Professor, Department of Physical Therapy, College of Health and Human Services, Missouri State University, Springfield, MO

Address correspondence to: Patricia A. Cahoj, 901 S. National Ave., Springfield, MO 65897, Ph: 417-836-6626, Fax: 417-836-6229 ([email protected]).

Journal of Geriatric Physical Therapy 30(1):p 31-40, April 2007.
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Abstract

INTRODUCTION

Osteoporosis and Vertebral Compression Fractures

Osteoporosis affects 200 million individuals worldwide1 and is an especially common problem among elderly females, resulting in thoracic and lumbar vertebral compression fractures (VCF). It is estimated that 25% of women over age 50 will experience one or more VCF2,3 and there are 700,000 VCF annually4 with an enormous economic impact.5 According to the World Health Organization, osteoporosis is diagnosed when an individual's bone density t-score is 2.5 standard deviations below the mean as measured by a dual emission x-ray absorptiometry (DEXA) scan.6 Osteopenia, the precursor to osteoporosis, is characterized by a t-score of 1 to 2.5 standard deviations below the mean.6

The complications of osteoporosis and VCF include pain, postural deformities with related pulmonary compromise, impaired balance, decreased mobility and function, and more frequent and longer hospital stays.7–9 Additionally, these fractures may trigger a decline in health resulting in permanent disability or death of the older adult.9–11

Compression fractures may result from a fall or minor trauma.12 Sometimes VCF occur spontaneously with simple activities like coughing; turning or twisting; attempting to rise from a chair; stepping on or off a step; or picking up an object, pet, or grandchild.3,12 Vertebral compression fractures involving the anterior portion of the vertebral body are called anterior wedge fractures. These fractures are usually stable and do not result in neurological compromise. Burst fractures involve the entire vertebral body and may be unstable.13 Both types of VCF alter spinal postural alignment and support of the vertebral column.14 Changes in postural alignment may lead to pain, respiratory compromise, and impaired functional mobility.8,9,14 A single VCF may result in a 9% loss of forced vital capacity.15 Pain frequently increases with weight bearing, is most severe during the first few weeks, and decreases with rest and inactivity.12 Individual pain tolerance is variable, resulting in different levels of functional limitation.3

Conservative Intervention for VCF

Conservative, nonoperative intervention following VCF focuses on pain relief, strengthening, limiting motion of the spine, and maintaining functional activities within the individual's ability and tolerance.16,17 Bed rest, immobility, analgesics, and bracing are common nonsurgical interventions for VCF.18,19 Bracing provides support, decreases pain, and allows improved functional mobility.20,21

Surgical Intervention

When conservative intervention does not provide desired results within a few weeks or months, VCF can be treated surgically.4 Surgical intervention, known as percutaneous vertebral augmentation (PVA), following VCF includes surgical techniques called vertebroplasty and kyphoplasty.16,22 Other PVA terminology includes percutaneous vertebroplasty and balloon kyphoplasty.23 These procedures are being used with increased frequency in the United States.

Vertebroplasty was developed in France in 1984.24 Although vertebroplasty was initially used to treat patients with cancer, it has gained popularity for other conditions and patient populations.23,24 Vertebroplasty is performed while a patient is prone and under local or general anesthesia. It involves fluoroscopic imaging to guide the injection of polymethylmethacrylate cement into the fractured vertebral body to hold and support the fractured bone.23,24

Kyphoplasty was first used in the United States in 1988.22 During kyphoplasty, the surgeon creates a space by expanding a ‘balloon’ in the vertebral body and then fills the space with bone cement.22,25 After the cement is inserted, the patient is placed in supine for approximately 1 hour while the cement hardens.24 Further procedural details related to PVA are described by Deen et al,11 Mathis et al,23 and Deramond et al.24

Both vertebroplasty and kyphoplasty provide pain relief and support the vertebral column. In addition, kyphoplasty restores vertebral height21,25–27 and has a decreased chance of cement leakage compared to vertebroplasty.22 However, Mathis et al report that kyphoplasty minimally improves vertebral height, involves greater risk due to the use of general anesthesia, and costs 10 to 20 times more than vertebroplasty.26 Neither vertebroplasty nor kyphoplasty has been compared to conservative treatment in a randomized trial.26

Purpose

The purpose of this systematic literature review was to provide the reader with information on the efficacy of PVA following VCF as well as the use of physical therapy intervention after PVA. It is hoped that this information will heighten awareness of the increasing use of surgical intervention for VCF and encourage physical therapists to identify the most appropriate interventions for the rehabilitation of individuals status post PVA.

METHODS

A search was conducted using Medline and the Cumulative Index of Nursing and Allied Health Literature (CINAHL) for the years between January 1990 and August 2005. Key words for the search included: vertebroplasty, kyphoplasty, physical therapy, rehabilitation, and outcomes. Additional searches were completed using the Physiotherapy Evidence Database (PEDro) and the Cochrane Database of Systematic Reviews (Cochrane Reviews), as well as the Agency for Healthcare Research and Quality (AHRQ): National Guideline Clearinghouse using key words vertebroplasty, kyphoplasty, and compression fracture.

Studies were initially reviewed by title and abstract. Inclusion criteria (Table 1) included whether the study was quantitative, available in English, and included physical therapy, rehabilitation, or functional outcomes compared over time following PVA secondary to osteoporotic VCF of the lumbar or thoracic spine in older adults.

T1-7
Table 1:
Quality Scoring Criteria and Percentage of Studies Satisfying the Criteria

Quality Scoring

A quality scoring system was developed to allow comparison of the articles. The quality scoring system was modeled after a study by Cleland and Durall28 and consisted of data present (point given) or not present (point not given). The greater the number of scoring criteria present, the higher the number of points received by that article. The quality score (percentage) was calculated by dividing each article's points by the 20 points possible. Table 1 lists the criteria of the quality scoring system, and the percentage of articles satisfying each criterion. Table 2 provides the quality score assigned to each article.

T2-7
Table 2:
Studies Included in this Systematic Review

RESULTS

No studies were found with searches on PEDro, Cochrane Reviews, or the AHRQ: National Guideline Clearinghouse. Searches in CINAHL and Medline resulted in 67 articles (21 and 53 respectively, with 7 duplicates) examining outcomes, rehabilitation, or physical therapy following PVA. After reviewing the title, description, abstract, or full text of the 67 articles, 36 were excluded because they were not research studies or lacked functional outcome measures. Seven studies were excluded because they focused on conditions other than VCF, and 6 were excluded because their focus was on surgical technique or specific surgical procedures. Three articles were excluded because they were case studies or literature reviews. One article was excluded because of the inconsistent use of assessments for subjects and another was excluded because only the abstract was available. Four additional articles, located through reference review, met the inclusion criteria and were used, bringing the total to 17 studies.

Of the 17 studies (Table 2), there were 10 prospective nonrandomized studies without a control group, 5 retrospective studies, and 2 prospective nonrandomized controlled trials. None of the studies was a randomized controlled trial. Table 3 provides data related to questions and variables, study design, sample size and profile, complications, and conclusions of each study.

T3A-7
Table 3:
Summary of Studies Reviewed (the articles are grouped according to study design and are listed in reverse chronological order)
T3B-7
Table 3:
Continued.

Nonrandomized Controlled Trials

The prospective nonrandomized controlled trials by Kasperk et al29 and Diamond et al30 had a mean quality score of 73% (Table 4). Both studies included a control group and had greater than 30 subjects. Both studies employed multiple outcome assessments that focused on pain, function, and use of pain medication. Both studies described complications following PVA and 1 study reported fracture status and discharge information. Neither study measured psychological outcomes. Conservative treatment was attempted in 1 study; however, neither study addressed physical therapy intervention following PVA.

T4-7
Table 4:
Scoring Criteria

Retrospective Studies

The mean quality score for the 5 retrospective studies31–35 was 63% (Table 4). All 5 studies had greater than 30 subjects, but lacked a control group. Four did not report psychological considerations, failed to mention discharge information, or did not include patients' fracture status. Three studies did not mention medication use or failed to identify who performed the outcome assessment. Two studies did not report study limitations. Only 3 studies completed multiple outcome assessments and included complications following PVA. Four studies reported use of conservative treatment prior to surgical intervention. None of the studies included physical therapy intervention following PVA.

Prospective Studies

The mean quality score for the 10 prospective nonrandomized studies without controls36–45 was 66% (Table 4). All of the prospective studies measured pain, function, and described complications following PVA but lacked a control group. Four studies had less than 30 subjects. Eight studies did not mention who performed the outcome assessments and 7 studies did not report study limitations. Only 7 studies included multiple outcome assessments. Five studies did not mention medication use or include fracture status, and 2 had no information related to psychological assessments. Seven studies reported discharge information, and 9 studies used conservative treatment prior to surgical intervention; however, none of the studies included physical therapy intervention following PVA.

Outcomes of PVA

Based upon the 17 studies in this systematic literature review, overall outcomes following PVA are favorable. After PVA, patients reported decreased pain29–33,35–45 and medication use,31,35,38,44 increased function,29–33,35,36,39,40,43–45 and improved quality of life.33,34,37–39,41 Decreased hospital stay33 and fewer physician visits29 were also reported. Mean hospital stay was 1.7 days for kyphoplasty with 82% of patients discharged to home, 11% to rehabilitation facilities, and 5% to skilled care centers.33 Diamond et al described a 40% decrease in hospital stay for patients with vertebroplasty compared to those treated conservatively.30 Most of the studies reported decreased pain following PVA29–33,35–45 that was sustained over time.36,40 The amount and type of medication used changed post PVA.31,35,38,44 Medications typically used prior to PVA included narcotics and prescription non-narcotics, while medications used post PVA included fewer prescription non-narcotics and over-the-counter medications such as aspirin, acetaminophen, and nonsteroidal anti-inflammatory drugs.38 Evans et al reported a substantial decrease in scheduled oral narcotics and other medications following PVA.31 Diamond et al found that 25% of patients stopped all pain medications within 24 hours following vertebroplasty compared to no decease in pain medication for the control group.30

Kyphoplasty was reported to restore vertebral body height (VBH) by as much as 12% compared to an 8% decrease in VBH for individuals treated conservatively.29 Lieberman et al reported that VBH was restored by an average of 35% following PVA.43 Significant changes in VBH were also noted when measured radiographically, showing an average anterior VBH increase of 4.6 mm.34 Even 1 year post PVA, anterior VBH remained at 85% of predicted levels, while midline VBH remained at 89% of predicted levels.33

Ambulation, physical function, and quality of life improved following PVA.29–41,43–45 Evans et al reported that 18% of patients were bedridden and 55% were in wheelchairs or had limitations in ambulation prior to PVA.31 Following PVA, 70% of patients had normal ambulation, and 63% were able to perform activities of daily living with little or no pain.31 Improved physical function44 and quality of life41 were sustained 6 months post PVA. Diamond et al reported a 29% increase in physical function following vertebroplasty compared to no improvement in the control group.30

Fourteen studies reported complications following PVA.29–31,33,34,36,37,39,40–45 Two studies did not address complications32,35 and Do et al reported that no complications occurred as a result of PVA.38 Cement leakage was the most common complication following PVA.29,31,34,36,37,39–44 Results of cement leakage varied from no symptoms,34,36,37,39,41,43 to radiculopathy,31,40,44 and lower limb paresis.29 Chen et al reported the need for surgical decompression due to cement leakage.42 Additional fractures were noted in 4 studies30,31,34,41 including vertebral compression fractures, and fractures of transverse processes and ribs. Other medical complications, not directly related to PVA, included myocardial infarction,39,43,45 pulmonary embolism,33,36 and exacerbation of medical conditions such as congestive heart failure and pulmonary edema.43,45

While the 17 studies demonstrated the effectiveness of PVA, there was little consistency in discharge criteria following the procedure. In some studies, patients were discharged based upon a specific time frame.29,36,37,39,42,44 Two studies based discharge upon patient status.31,38 Evans et al reported immobilization for 1 hour following PVA with discharge once patients could ambulate31 and Do et al discharged patients when medically stable.38 McGraw et al used positioning and time as a reference for progressing the patient prior to discharge.40 They observed the patient in supine for 1 hour, in sitting for 1 hour, and then allowed the patient to stand; however, did not specify a time frame for discharge.40 Chen et al discharged patients with a thoracolumbar support within 24 hours following PVA.42 Other authors described discharge based upon time including 3 hours,36 overnight observation,44,45 or 48 hours29 as the guide. One study kept patients supine for 24 hours and discharged them 3 days after PVA.37

None of the 17 studies mentioned physical therapy intervention following PVA; however, patients may have received physical therapy intervention prior to discharge. Nine studies described discharge information; although there was no consistency between studies, nor was there a reference to physical therapy intervention that may have affected the outcomes of PVA.29,31,36–40,42,44 One study required that patients attain a predetermined functional level prior to discharge but did not indicate that physical therapy intervention was provided.31

DISCUSSION

The purpose of this systematic literature review was to present a summary of research findings regarding the efficacy of PVA and the incorporation of physical therapy intervention following PVA. All of the studies in this systematic review supported the use of kyphoplasty or vertebroplasty; however, none recommended PVA be used in place of conservative treatment. None of the studies evaluated discussed the incorporation of physical therapy intervention following PVA.

Efficacy of PVA

Conservative treatment for VCF may be effective; however, when bed rest, bracing, and analgesics do not provide pain relief, there is growing evidence to support PVA. Fourteen studies attempted conservative treatment but when conservative treatment failed to provide symptom relief, PVA was performed.29,31–34,36–38,40–45 Patients with limited progress following conservative treatment may find pain relief following PVA, thus improving functional mobility and quality of life. Two studies, excluded from this review because they did not examine functional outcomes, reported that PVA decreased pain and was a safe and effective procedure.46,47 These results are consistent with the studies included in this review. Lower levels of pain may lead to decreased medication use, encouraging earlier return to function and preventing further debilitation and secondary complications of immobility.9,10,12

Although the evaluated studies supported the use of PVA, some concerns were noted when PVA was used during the acute stage following VCF. Treating acute fractures with PVA increased the risk for cement leakage; therefore, it was recommended that surgical intervention be withheld until the subacute stage.48,49 However, the time necessary for conservative treatment may lead to secondary complications from bed rest and immobility.18,19,24 Prolonged pain, immobility, and limited function present during conservative treatment can lead to molecular changes in bone and cardiorespiratory compromise.9,50 When PVA is finally performed, the patient's status may have already deteriorated.

The complications following PVA described in this systematic review were similar to complications reported in studies that did not meet our inclusion criteria. The most commonly reported complication following vertebroplasty and kyphoplasty was cement leakage.51 Deramond et al reported increased incidence of cement leakage that was related to destruction of the vertebral body.24 According to Gafin et al, there is more risk of leakage with vertebroplasty than kyphoplasty.51 Bone cement leakage was reported in 30% to 67% of patients following vertebroplasty but less than 1% to 10% leakage with kyphoplasty.51,52 Few patients were found to be symptomatic with either procedure.46,51

Additional complications, identified in the literature describing surgical techniques, were not reported in the 17 studies evaluated in this systematic review. In addition to complications of PVA such as increased pain and rib or vertebral fracture, other studies identified hemorrhage, fever, and infection as complications.4,46,47,51 While PVA is reported to be a safe and effective treatment, it is important to note that serious complications, such as pneumothorax, radiculopathy or spinal cord compression, and cement pulmonary embolism, have occurred in 1% to 10% of cases.4,7,24,51,53,54 Uppin et al reported an increased incidence of VCF following PVA, with 22 of 177 patients (12.4%) experiencing additional VCF.55 Two-thirds of these fractures occurred in vertebrae adjacent to cemented vertebrae.55

Physical Therapy Intervention Following PVA

With limited data available regarding discharge criteria and rehabilitation following PVA, evidence-based practice guidelines have not been developed. Physical therapists are specifically qualified to develop guidelines for patients with VCF, whether or not they have undergone PVA. Specific practice patterns supporting intervention after PVA already exist in the Guide to Physical Therapist Practice and include Musculoskeletal Patterns: 4B- Impaired Posture and 4G- Impaired Joint Mobility, Muscle Performance, and Range of Motion Associated with Fracture.56

While physical therapy intervention following PVA was not discussed in the literature, studies were found that provide a framework for program development.4,10,12 In some studies, movement and physical activity were allowed between 2 and 24 hours post PVA.4,10 Larsen reported that dressings could be removed 24 hours after PVA and patients could bathe or shower the following day.12 According to Spivak and Johnson, intervention following PVA should include exercises for spinal extension once pain allows.57 Specific exercises for postural improvement through strengthening trunk extension are reported in the literature.58,59

Implications for Research

Of the 17 studies included in this systematic review, only 2 had a control group.29,30 Both control groups consisted of individuals who declined surgical intervention. Although the control and intervention groups were not matched, both studies described characteristics that were similar between groups. Because of the limited number of studies and the absence of randomized controlled trials related to outcomes following PVA, the results and conclusions of the studies in this systematic review may be limited. Randomized controlled trials should be developed to examine the difference between conservative treatment and PVA. The long-term effects of PVA are not yet known. The longest follow-up study was completed by Perez-Higueras et al who found that pain reduction was still significant 5 years postsurgical intervention.46 Longitudinal studies should be completed to determine the long-term efficacy of PVA.

Studies should compare the outcomes of patients receiving physical therapy intervention following VCF, whether treated conservatively or with PVA, with those receiving no physical therapy intervention. Outcome measures could include measures of spinal posture as well as pain, physical function, medication use, and quality of life. Kyphotic posture negatively affects patients' balance, respiratory status, and risk for falls and future VCF.8,9 Using a reliable device to measure posture would allow comparison of posture before and after PVA, as well as before and after conservative treatment for VCF. Kyphotic curve could be measured using the flexi-curve,60–63 index of kyphosis,61 curviscope,64 Arcometer,65 or mid-sagittal contour gauge.66 Respiratory status could be assessed by measuring vital capacity and forced expiratory volume using a portable spirometer, allowing correlation between PVA, posture, and respiratory function.

Limitations

This systematic review has several limitations. The search was limited to articles in English and only included 5 databases (Cochrane Reviews, AHRQ: National Guideline Clearinghouse, PEDro, Medline, and CINAHL). While a meta-analysis would be the ideal statistical tool to compare studies, it was not used in this systematic review due to differences and variability in outcomes measured. Another limitation was the use of a quality scoring system to rank the studies. Such a system has been used by other authors to compare studies with variable outcomes or interventions.28,67 The quality scoring system used in this review allowed the 17 studies to be scored and compared. In order to improve consistency, the same investigator determined the absence or presence of scoring criteria for all studies. Additionally, all criteria were weighted equally, thus the importance of each criterion was not quantified. For example, even though 2 studies had control groups, with assigned quality scores of 65%30 and 80%,29 other studies36–38 scored 80% without the inclusion of a control group. The use of a weighted quality scoring system may be useful in future reviews.

CONCLUSION

Although PVA appears to be an effective treatment option for individuals with VCF, further research regarding the use and long term outcomes of PVA would be beneficial. Presently physical therapy is not a standard treatment intervention following PVA. Whether outcomes following PVA might be enhanced with the provision of physical therapy intervention warrants investigation.

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Keywords:

vertebroplasty; kyphoplasty; physical therapy; rehabilitation; outcomes

© 2007 Lippincott Williams & Wilkins, Inc.