Vertebral fractures are one of the most frequent and serious osteoporotic fractures. Rehabilitation plays an important role in these patients through its potential impact on pain and physical function, not only in the short-term, but also in the long term. The aim of this study is to assess the impact of a 10 days-rehabilitation program on quality of life in the long term. This study was an observational study conducted on patients with fragility vertebral fractures. At baseline and after 6 months the following parameters were evaluated: height and occiput wall distance, Visual Analogue Scale for dorsal and lumbar pain, 20 meters walk test for gait's performance. For quality of life assessment we used the Italian version of EuroQuol-5-dimensions-3-level. Patients were divided in two groups: 39 patients underwent a 10 days-rehabilitation program specific for fragility vertebral fractures, 15 patients did not receive any rehabilitation treatment. Patients who underwent a specific physiotherapy program had better quality of life-related outcomes after 6 months than patients did not perform any rehabilitation, in particular in EQ-Global Health and in the mobility and selfcare dimension of EQ-index. In conclusions this study shows that in the management of fragility vertebral fractures the exercises have an important role. © 2019 CIC Edizioni Internazionali s.r.l.. All rights reserve

Bottai, V.

Falossi, F

Mazzantini, M.

Raffaetà, G.

Falossi F

Mazzantini M.

Bottai V.

Raffaetà G.

Archivio della Ricerca - Università di Pisa

66 Clinical Cases in Mineral and Bone Metabolism 2019; 16(1):66-70Francesca Falossi1 Maurizio Mazzantini2Vanna Bottai3 Gloria Raffaetà1 1 Departmental Section of Orthopedic Rehabilitation, University of Pisa, Pisa, Italy2 Rheumatology Clinic, University of Pisa, Italy3 Second Orthopedic and Traumatologic Clinic, University of Pisa, Pisa, ItalyAddress for correspondence:Francesca FalossiDepartmental Section of Orthopedic Rehabilitation University of Pisa, Pisa, ItalyE-mail: france.falossi@gmail.comSummaryVertebral fractures are one of the most frequent and serious osteoporotic fractures. Rehabilitation play an important role in these patients through its potential impact on pain and physical function, not only in the short-term, but also in the long term. The aim of this study is to assess the impact of a 10 days-rehabilitation program on quality of life in the long term. This study was an observational study conducted on pa-tients with fragility vertebral fractures. At baseline and after 6 months the following parameters were evaluated: height and occiput wall distance, Visual Analogue Scale for dorsal and lumbar pain; 20 meters walk test for gait’s performance. For quality of life assessment we used the Italian version of EuroQuol-5-dimensions-3-level. Patients were divided in two groups: 39 patients underwent a 10 days-rehabili-tation program specific for fragility vertebral fractures, 15 patients did not receive any rehabilitation treatment.Patients who underwent a specific physiotherapy pro-gram had better quality of life-related outcomes after 6 months than patients did not perform any rehabilita-tion, in particular in EQ-Global Health and in the mobil-ity and selfcare dimension of EQ-index.In conclusions this study shows that in the manage-ment of fragility vertebral fractures the exercises have an important role.KEY WORDS: quality of life; vertebral fractures; exercises; rehabilitation pro-gram; osteoporosis.IntroductionOsteoporotic fractures have a great impact on global pub-lic health (1). They are one of the commonest causes of disability and represent a considerable cost in health care system (2). Vertebral fractures are one of the most frequent and seri-ous osteoporotic fractures. They have many consequences about posture like thoracic hyper kyphosis, lumbar hyper lordosis, protrusion of the head and in worst cases flec-tion of the knees. Other important consequences are pain, restriction of activities and of social participation, altered psychological state, and increased risk of falls. All these alterations have a great impact on the quality of life.There is a great body of literature that shows a strict as-sociation between vertebral fractures and impaired quality of life (3-9). Waterloo et al. in 2013 found that women with prevalent vertebral fractures reported more often back pain and had poorer EuroQuol-5-dimensions-3-level (EQ-5D-3L) and EuroQol Visual Analogue Scale (EQ VAS) scores than did women without vertebral fractures; number and severity of fracture influenced the scores in women (10). In a study by Cockerill et al., recent vertebral fractures were associat-ed with impairment in quality of life (11).Furthermore, Nuti et al. found that the presence of an un-diagnosed osteoporotic vertebral fracture was an indepen-dent risk factor for poor quality-of-life (12). Little is known about the impact of a rehabilitation program in patients with subacute or cronic vertebral fractures (13-16). Rehabili-tation play an important role in these patients through its potential impact on pain and physical function, not only in the short-term, but also in the long term. However in these previous studies the rehabilitation program included home exercises or program’s exercises lasting several weeks.The aim of this study is to assess the impact of a 10 days-re-habilitation program on quality of life in the long term.Methods This study was an observational study conducted on female patients who were referred to the multidisciplinary outpa-tient clinic for “Diagnosis, therapy, rehabilitation of patients with fragility vertebral fracture” of “Azienda Ospedaliera Universitaria di Pisa”, Italy.Age, Body Mass Index (BMI), Barthel index (17), number, level and severity of vertebral fractures (Genant’s score), bone densitometric values at lumbar and femur sites (mea-sured by DXA) were obtained at the baseline assessment.At baseline and after 6 months the following parameters were evaluated: height and occiput wall distance, Visu-al Analogue Scale (VAS) for dorsal and lumbar pain; 20 meters walk test for gait’s performance. For quality of life assessment we used the Italian version of EuroQuol-5-di-mensions-3-level (EQ-5D-3L) (18). The EQ-5D-3L consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale. The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activ-ities, pain/discomfort and anxiety/depression. Each dimen-Case reportThe impact of rehabilitation on the health-related quality of life in patients with vertebral fragility fracturesThe impact of rehabilitation on the health-related quality of life in patients with vertebral fragility fractures67Clinical Cases in Mineral and Bone Metabolism 2019; 16(1):66-70sion has 3 levels: no problems, some problems, extreme problems. The EQ-5D descriptive system, may be convert-ed into a single summary index by applying a formula that essentially attaches values to each of the levels in each di-mension (EQ-index). The EQ visual analogue scale records the respondent’s self-rated health on a vertical, visual ana-logue scale where the endpoints are labelled ‘Best imagin-able health state’ and ‘Worst imaginable health state’ This information can be used as a quantitative measure of global health as judged by the individual respondents (EQ-GH). Exclusion criteria were: uncooperative patients, patients with recent fracture (< 3 months) or with corset and the patients unable to walk independently. Patients selected were 54, divided  in  two groups. Patients of group A (39) underwent a 10 days-rehabilitation program specific for fragility vertebral fractures. Patients of group B (15) did not receive any rehabilitation treatment (they were patients who could not perform rehabilitation for logistical reasons). All patients underwent treatment for osteoporosis and appropriate analgesic therapy. Primary endpoint was to evaluate the differences in EQ-GH and EQ-index after 6 months in the two groups.Physiotherapy programThe physiotherapy protocol includes 10 treatment sessions lasting 40 minutes each. The sessions were performed in the morning (from Monday to Friday for two weeks). The exercises were applied by the same physical therapist. The protocol provided exercises supine with lower limbs flexed to 90° and supported on a cube, exercises in seated posi-tion with hip and knee flexed to 90°, exercises in upright position in support to the wall.Exercises supine with lower limbs flexed to 90° and sup-ported on a cube• Respiratory exercises• Retropulsion and antepulsion shoulder exercises• Abduction of upper limb on frontal plan with elbows flexed at 90°• Strengthening of the abdominal muscles• Retroversion, anteversion and lateralization of the pel-vis on the proprioceptive pillowExercises in seated position with hip and knee flexed to 90°• Alignment of spine• Elevation of the shoulders with upper limbs adducts• Retropulsion shoulder exercises• Retroversion, anteversion and lateralization of the pel-vis on the proprioceptive pillowExercises in upright position in support to the wall with feet apart• Extension upper limb against resistance• Retropulsion shoulder exercises• Antepulsion shoulder exercises up to 90°Data analysisFor anthropometric and functional outcomes measured us-ing continuous scale, differences in mean changes were compared between groups using the Student’s T-test. The p value was set at p < 0.05.ResultsTable 1 shows the characteristics and clinical parameters of group A and B at baseline. No difference was found between two groups. All patients of group A and B were female.Table 2 shows changes in clinical parameters after 6 months between group A and B. After 6 months, although there were an improvement in the parameters, only the per-Table 1 - Characteristics and clinical parameters group A and B at baseline.mean Group A Group B Pstd.dev.± Mean std.dev. ±Age 71,1 7,1 73,6 7,6 0,284BMI 26,7 4,7 26,22 4,3 0,745DXA t-score L -2,4 1,0 -2,7 0,8 0,58DXA t-score FN -2,4 0,8 -2,1 0,9 0,366DXA t-score FT -2,2 0,9 -1,7 1,2 0,151N° vertebral fratures 2,95 1,8 2,87 1,8 0,971Genant’s score 4,3 2,9 4,2 3,3 0,878Barthel 93 10,9 89 8,7 0,209Dorsal VAS 3,6 2,6 3,7 3,1 0,858Lumbar VAS 5,1 3,0 4,7 3,5 0,661EQ-index 0,72 0,2 0,73 0,2 0,954EQ-GH 56,7 17,5 48,7 26,0 0,19720 meters walk test (sec) 28,65 8,4 30,77 16,4 0,261Occiput wall distance (cm) 9,13 4,3 8,12 4,0 0,391Height (m) 1,56 0,1 1,57 0,1 0,765Lumbar spine bone mineral density (DXA-t-score L); femoral neck bone mineral density (DXA t-score FN); total hip bone mineral density (DXA t-score FT); standard deviation (std.dev.); * P<0,005F. Falossi et al.68 Clinical Cases in Mineral and Bone Metabolism 2019; 16(1):66-70did not perform any rehabilitation, in particular in EQ-Global Health and in the mobility and self-care dimension of EQ-in-dex. After 6 months the antropometric and functional out-comes are sensible better both group A and B, but there were no difference between groups. In fact all patients un-derwent treatment for osteoporosis and appropriate analge-sic therapy and also practical advice for daily life. EQ-Global Health and Eq index (mobility and self-care) although also improved in group B, showed a significant difference in the group that performed physiotherapy. A number of RCTs of exercise interventions in people with vertebral osteoporosis reported reduced pain and improved quality of life (13-16, 19-21). There are only few studies that examined exercise in osteoporotic populations with vertebral fracture. Papaio-annou et al. in a RCT of 2003 found that a home exercise program improved quality of life in symptoms, emotion, lei-sure and social activity over 6 months (16). In this study  pa-tients were instructed to complete 60 min of exercise over the course of the day on 3 days each week for 6 months. Bergland et al. in 2010 found that exercise improves mo-bility as well as the health-related quality of life in elderly women with a history of vertebral fractures measured at 3 months after baseline as well as at 12 months (13). Malm-ceived quality of life had a significant difference between group A and B. In particular EQ-index doesn’t show differ-ence after 6 months between two groups (P-value 0,4342). Instead there is a significant difference between group A and B after 6 months on EQ-GH with a significantly higher result in group A than group B (Figure 1).The EQ-index doesn’t show difference between group A and B after 6 months. About the 5 dimensions of EQ-5D de-scriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) there is a significant difference between group A and B after 6 months on mobil-ity and self-care. Usual activities, pain/discomfort, anxiety/depression doesn’t show difference (Table 3).VAS (dorsal and lumbar), 20 meters walk test, height and the occiput wall distance doesn’t show significant difference between two groups after 6 months.DiscussionThe results of this observational  study show that patients who underwent a specific physiotherapy program (group A) had better quality of life-related outcomes than patients Table 2 - Clinical parameters group A and B after 6 months. Group A Group B PBaseline After 6 months Baseline After 6 monthsMean Mean std.dev. Mean Mean std.dev.EQ-index 0,72 0,8 0,14 0,73 0,8 0,2 0,434EQ-GH 56,7 63,5 17,8 48,7 49,3 20 0,014*Dorsal VAS 3,6 2,6 2,53 3,7 3,3 2,9 0,401Lumbar VAS 5,1 4,7 2,9 4,7 5,1 2,4 0,68520 meters walk test (sec) 28,65 26,1 8,7 30,77 26,99 9,2 0,755Occiput wall distance (cm) 9,13 8,2 3,8 8,12 7,2 2,5 0,366Height (m) 1,56 1,6 0,1 1,57 1,6 0,1 0,731* P<0,005Figure 1 - Box plot EQ-GH after 6 months.The impact of rehabilitation on the health-related quality of life in patients with vertebral fragility fractures69Clinical Cases in Mineral and Bone Metabolism 2019; 16(1):66-703. Lips P, van Schoor NM. Quality of life in patients with osteoporosis. Osteoporos Int. 2005:16(5):447-455.4. Cockerill W, Lunt M, Silman AJ, Cooper C, Lips P, Bhalla AK, Can-nata JB, Eastell R, Felsenberg D, Gennari C, et al. Health-related quality of life and radiographic vertebral fracture. Osteoporos Int. 2004;15(2):113-119.5. Fechtenbaum J, Cropet C, Kolta S, Horlait S, Orcel P, Roux C. The severity of vertebral fractures and health-related quality of life in oste-oporotic postmenopausal women. Osteoporos Int. 2005;16(12):2175-2179.6. Ström O, Borgström F, Zethraeus N, Johnell O, Lidgren L, Ponzer S, Svensson O, Abdon P, Ornstein E, Ceder L, et al. Long-term cost and effect on quality of life of osteoporosis-related fractures in Sweden. Acta Orthop. 2008;79(2):269-280.7. Silverman SL, Shen W, Minshall ME, Xie S, Moses KH. Prevalence of depressive symptoms in postmenopausal women with low bone mineral density and/or prevalent vertebral fracture: results from the Multiple Outcomes of Raloxifene Evaluation (MORE) study. J Rheu-matol. 2007;34(1):140-144.8. Pasco J, Henry M, Korn S, Nicholson G, Kotowicz M. Morphometric vertebral fractures of the lower thoracic and lumbar spine, physical function and quality of life in men. Osteoporos Int. 2009;20(5):787-792.9. Salaffi F, Cimmino MA, Malavolta N, Carotti M, Di Matteo L, Scendoni P, Grassi W, Group IMOFS. The burden of prevalent fractures on healthrelated quality of life in postmenopausal women with osteopo-rosis: the IMOF study. J Rheumatol. 2007;34(7):1551-1560.10. Waterloo S, Søgaard AJ, Ahmed LA, Damsgård E, B. Morseth B, N. Emaus N. Vertebral fractures and self-perceived health in elder-ly women and men in a population-based cross-sectional study: the Tromsø Study 2007-08. BMC Geriatrics. 2013;13:102.11. Cockerill W, Lunt M, Silman AJ, Cooper C, Lips P, Bhalla AK, Can-nata JB, Eastell R, Felsenberg D, Gennari C, et al. Health-related quality of life and radiographic vertebral fracture. Osteoporos Int. 2004;15(2):113-119.12. Nuti R, Caffarelli C, Guglielmi G, Gennari L, Gonnelli S. Undiagnosed Vertebral Fractures Influence Quality of Life in Postmenopausal Women With Reduced Ultrasound Parameters. Clin Orthop Relat Res. 2014;472:2254-2261. DOI 10.1007/s11999-014-3588-8.13. Bergland A, Thoresen H, Karesen R. Effect of exercise on mobility, balance, and health-related quality of life in osteoporotic women with a history of vertebral fracture: a randomised controlled trial. Osteopo-ros Int. 2010;22:1863-1871.14. Gold DT, Shipp KM, Pieper CF, Duncan PW, Martinez S, Lyles KW. Group treatment improves trunk strength and psychological status in older women with vertebral fractures: results of a randomized clini-cal trial. J Am Geriatr Soc. 2004;52:1471-1478. doi: 10.1111/j.1532-5415.2004.52409.x.15. Malmros B, Mortensen L, Jensen MB, Charles P. Positive effects of physiotherapy on chronic pain and performance in osteoporosis. Os-teoporos Int. 1998;8:215-221. doi: 10.1007/s001980050057. 16. Papaioannou A, Adachi JD, Winegard K, Ferko N, Parkinson W, Cook RJ, Webber C, McCartney N. Efficacy of home-based exer-cise for improving quality of life among elderly women with symp-tomatic osteoporosis-related vertebral fractures. Osteoporos Int. ros et al. found that a 10-week exercise program improved balance, quality of life, level of daily function and decreased pain (15). Gold et al. found that group exercises and coping classes for 6 months delivered by a physiotherapist and so-cial worker led to improvements in back extensor strength and psychological impairment but not in pain levels (14). In our study patients performed a physiotherapy protocol which included 10 daily sessions lasting 40 minutes each, so the treatment lasted a shorter period. Nonetheless im-provement of the perceived quality of life is maintained over 6 months, in particular the improvement in global health and in mobility and self-care dimension. These results support the benefits of exercises in the clinical management of pa-tients with osteoporotic vertebral fractures. The limits of this study are: the sample has a limited number, the two group are heterogeneous in the number of participants, it was not possible exclude physiological musculoskeletal differences between two groups that could affect the results. This is only an observational study on female who were referred to the multidisciplinary outpatient clinic for “Diagnosis, thera-py, rehabilitation of patients with fragility vertebral fracture” of “Azienda Ospedaliera Universitaria di Pisa”, Italy, without the possibility to create groups blinded randomized certain-ly would strengthen further results.ConclusionsThis study shows that in the management of fragility ver-tebral fractures the exercises have an important role. In fact a physiotherapy protocol of 10 daily sessions lasting 40 minutes each associated to analgesic therapy and an-tiresorptive treatment can improve quality of life in the long term. So, a global care of patients with fragility vertebral fractures, including correct drug treatment and physiother-apy, helps to improve their perceived quality of life.Written informed consent was obtained from patients. With this consent the patients authorize the collection and pub-lication of clinical data about their case for scientific and educational purposes even outside the institution.References1. Cole ZA, Dennison EM, Cooper C. The impact of methods for esti-mating bone health and the global burden of bone disease. Salud Publica Mex. 2009;51(Suppl. 1):S38-45.2. Cummings SR, Melton LJ. Epidemiology and outcomes of osteopo-rotic fractures. Lancet. 2002;359:1761-7.Table 3 - T-test for 5 dimensions of EQ after 6 months.Group A Group BPmean Std.dev. mean Std.dev.Mobility 1,5 0,5 1,9 0,5 0,0092*Self-care 1,2 0,4 1,5 0,5 0,0208*Usual activities 1,7 0,5 2,0 0,5 0,0980Pain/discomfort 2,1 0,4 2,1 0,3 0,6194Anxiety/depression 1,7 0,5 1,9 0,6 0,4376* P<0,005.F. Falossi et al.70 Clinical Cases in Mineral and Bone Metabolism 2019; 16(1):66-7020. Hongo M, Itoi E, Sinaki M, Miyakoshi N. Effect of low-intensity back exercise on quality of life and back extensor strength in patients with osteoporosis: a randomized controlled trial. Osteoporos Int. 2007;18:1389-1395. doi: 10.1007/s00198-007-0398-9.21. Madureira MM, Takayama L, Gallinaro AL, Caparbo VF, Costa RA, Pereira RM. Balance training program is highly effective in improv-ing functional status and reducing the risk of falls in elderly wom-en with osteoporosis: a randomized controlled trial. Osteoporos Int. 2007;18:419-425. doi: 10.1007/s00198-006-0252-5.2003;14:677-682. doi: 10.1007/s00198-003-1423-2.17. Mahoney FI, Barthel DW. The Barthel Index. Mar St Med J. 1965;14:61-65.18. EuroQol; Available from: URL: http://www.euroqol.org/. Accessed febrary 2014.19. Chien YC, Yang RS, Tsauo JY. Home-based trunk-strengthening exercise for osteoporotic and osteopenic postmenopausal women without fracture - a pilot study. Clin Rehabil. 2005;19:28-36. doi: 10.1191/0269215505cr844oa. 

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The impact of rehabilitation on the health-related quality of life in patients with vertebral fragility fractures

The impact of rehabilitation on the health-related quality of life in patients with vertebral fragility fractures

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