The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial

Karlijn J Barnhoorn, Rob A B Oostendorp, Robert T M van Dongen, Frank P Klomp, Han Samwel, Gert Jan van der Wilt, Eddy Adang, Hans Groenewoud, Henk van de Meent, Jan Paul M Frölke, Karlijn J Barnhoorn, Rob A B Oostendorp, Robert T M van Dongen, Frank P Klomp, Han Samwel, Gert Jan van der Wilt, Eddy Adang, Hans Groenewoud, Henk van de Meent, Jan Paul M Frölke

Abstract

Background: Pain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1.

Methods/design: This study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version.

Discussion: This is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.

Trial registration: ClinicalTrials.gov NCT00817128.

References

    1. Bruehl S, Harden RN, Galer BS, Saltz S, Bertram M, Backonja M, Gayles R, Rudin N, Bhugra MK, Stanton-Hicks M. External validation of IASP diagnostic criteria for Complex Regional Pain Syndrome and proposed research diagnostic criteria. International Association for the Study of Pain. Pain. 1999;81:147–154. doi: 10.1016/S0304-3959(99)00011-1.
    1. Vaneker M, Wilder-Smith OH, Schrombges P, Oerlemans HM. Impairments as measured by ISS do not greatly change between one and eight years after CRPS 1 diagnosis. Eur J Pain. 2006;10:639–644. doi: 10.1016/j.ejpain.2005.10.003.
    1. Van de Meent H, Oerlemans M, Bruggeman A, Klomp F, van Dongen R, Oostendorp R, Frölke JP. Safety of “pain exposure” physical therapy in patients with complex regional pain syndrome type 1. Pain. 2011;152(6):1431–1438. doi: 10.1016/j.pain.2011.02.032.
    1. Ek JW, van Gijn JC, Samwel H, van Egmond J, Klomp FP, van Dongen RT. Pain exposure physical therapy may be a safe and effective treatment for longstanding complex regional pain syndrome type 1: a case series. Clin Rehabil. 2009;23(12):1059–1066. doi: 10.1177/0269215509339875.
    1. Veldman PH, Reynen HM, Arntz IE, Goris RJ. Signs and symptoms of reflex sympathetic dystrophy: prospective study of 829 patients. Lancet. 1993;342:1012–1016. doi: 10.1016/0140-6736(93)92877-V.
    1. Oerlemans HM, Oostendorp RA, de Boo T, Goris RJ. Pain and reduced mobility in complex regional pain syndrome I: outcome of a prospective randomised controlled clinical trial of adjuvant physical therapy versus occupational therapy. Pain. 1999;83:77–83. doi: 10.1016/S0304-3959(99)00080-9.
    1. Oerlemans HM, Goris RJ, Oostendorp RA. Impairment level sumscore in reflex sympathetic dystrophy of one upper extremity. Arch Phys Med Rehabil. 1998;79(8):979–990. doi: 10.1016/S0003-9993(98)90098-3.
    1. De Mos M, de Bruijn AG, Huygen FJ, Dieleman JP, Stricker BH, Sturkenboom MC. The incidence of complex regional pain syndrome: a population-based study. Pain. 2007;129(1–2):12–20.
    1. Geertzen JH, Dijkstra PU, Groothoff JW, ten Duis HJ, Eisma WH. Reflex sympathetic dystrophy of the upper extremity- a 5.5-year follow up. Part II. Social life events, general health and changes in occupation. Acta Orthop Scand Suppl. 1998;279:19–23.
    1. Perez RS, Zollinger PE, Dijkstra PU, Thomassen-Hilgersom IL, Zuurmond WW, Rosenbrand KC. Geertzen JH; CRPS I task force: Evidence based guidelines for complex regional pain syndrome type 1. BMC Neurol. 2010;10:20. doi: 10.1186/1471-2377-10-20.
    1. Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006;42(3):241–256.
    1. De Rooij AM, Florencia Gosso M, Haasnoot GW, Marinus J, Verduijn W, Claas FH, van den Maagdenberg AM, van Hilten JJ. HLA-B62 and HLA-DQ8 are associated with Complex Regional Pain Syndrome with fixed dystonia. Pain. 2009;145:82–85. doi: 10.1016/j.pain.2009.05.015.
    1. Heerschap A, den Hollander JA, Reynen H, Goris RJ. Metabolic changes in reflex sympathetic dystrophy: a 31P NMR spectroscopy study. Muscle Nerve. 1993;16(4):367–373. doi: 10.1002/mus.880160405.
    1. Oyen WJ, Arntz IE, Claessens RM, van der Meer JW, Corstens FH, Goris RJ. Reflex sympathetic dystrophy of the hand: an excessive inflammatory response? Pain. 1993;55(2):151–157. doi: 10.1016/0304-3959(93)90144-E.
    1. Huygen FJ, de Bruijn AG, de Bruin MT, Groeneweg JG, Klein J, Zijlstra FJ. Evidence for local inflammation in complex regional pain syndrome type 1. Mediators Inflamm. 2002;11(1):47–51. doi: 10.1080/09629350210307.
    1. Huygen FJ, Ramdhani N, van Toorenenbergen A, Klein J, Zijlstra FJ. Mast cells are involved in inflammatory reactions during Complex Regional Pain Syndrome type 1. Immunol Lett. 2004;91(2–3):147–154.
    1. Calder JS, Holten I, McAllister RM. Evidence for immune system involvement in reflex sympathetic dystrophy. J Hand Surg Br. 1998;23(2):147–150. doi: 10.1016/S0266-7681(98)80162-9.
    1. Schinkel C, Gaertner A, Zaspel J, Zedler S, Faist E, Schuermann M. Inflammatory mediators are altered in the acute phase of posttraumatic complex regional pain syndrome. Clin J Pain. 2006;22:235–239. doi: 10.1097/01.ajp.0000169669.70523.f0.
    1. Birklein F, Weber M, Ernst M, Riedl B, Neundörfer B, Handwerker HO. Experimental tissue acidosis leads to increased pain in complex regional pain syndrome (CRPS) Pain. 2000;87(2):227–234. doi: 10.1016/S0304-3959(00)00286-4.
    1. Birklein F, Weber M, Neundörfer B. Increased skin lactate in complex regional pain syndrome: evidence for tissue hypoxia? Neurology. 2000;55(8):1213–1215. doi: 10.1212/WNL.55.8.1213.
    1. Koban M, Leis S, Schultze-Mosgau S, Birklein F. Tissue hypoxia in complex regional pain syndrome. Pain. 2003;104(1–2):149–157.
    1. Birklein F, Riedl B, Sieweke N, Weber M, Neundörfer B. Neurological findings in complex regional pain syndromes–analysis of 145 cases. Acta Neurol Scand. 2000;101(4):262–269.
    1. Kurvers HA, Jacobs MJ, Beuk RJ, van den Wildenberg FA, Kitslaar PJ, Slaaf DW, Reneman RS. Reflex sympathetic dystrophy: result of autonomic denervation? Clin Sci. 1994;87(6):663–669.
    1. Galer BS, Jensen M. Neglect-like symptoms in complex regional pain syndrome: results of a self-administered survey. J Pain Symptom Manage. 1999;18(3):213–217. doi: 10.1016/S0885-3924(99)00076-7.
    1. Nickel FT, Maihöfner C. Current concepts in pathophysiology of CRPS I. Handchir Mikrochir Plast Chir. 2010;42:8–14. doi: 10.1055/s-0029-1246211.
    1. Juottonen K, Gockel M, Silén T, Hurri H, Hari R, Forss N. Altered central sensorimotor processing in patients with complex regional pain syndrome. Pain. 2002;98(3):315–323. doi: 10.1016/S0304-3959(02)00119-7.
    1. Maihöfner C, Nickel FT, Seifert F. Neuropathic pain and neuroplasticity in functional imaging studies. Schmerz. 2010;24(2):137–145. doi: 10.1007/s00482-010-0902-6.
    1. Moseley GL. Why do people with complex regional pain syndrome take longer to recognize their affected hand? Neurology. 2004;62(12):2182–2186. doi: 10.1212/01.WNL.0000130156.05828.43.
    1. Flor H. [Visualisation of phantom- and backpain using imaging techniques. Implication for treatment] Orthopade. 2004;33(5):553–557. doi: 10.1007/s00132-003-0614-z.
    1. Bruehl S, Chung OY. Psychological and behavioral aspects of complex regional pain syndrome management. Clin J Pain. 2006;22:430–437. doi: 10.1097/01.ajp.0000194282.82002.79.
    1. Daly AE, Bialocerkowski AE. Does evidence support physiotherapy management of adult Complex Regional Pain Syndrome Type One? A systematic review. Eur J Pain. 2009;13(4):339–353. doi: 10.1016/j.ejpain.2008.05.003.
    1. Stanton-Hicks M, Baron R, Boas R, Gordh T, Harden N, Hendler N, Koltzenburg M, Raj P, Wilder R. Complex Regional Pain Syndromes: guidelines for therapy. Clin J Pain. 1998;14(2):155–166. doi: 10.1097/00002508-199806000-00012.
    1. Stanton-Hicks MD, Burton AW, Bruehl SP, Carr DB, Harden RN, Hassenbusch SJ, Lubenow TR, Oakley JC, Racz GB, Raj PP, Rauck RL, Rezai AR. An updated interdisciplinary clinical pathway for CRPS: report of an expert panel. Pain Pract. 2002;2(1):1–16. doi: 10.1046/j.1533-2500.2002.02009.x.
    1. Raja SN, Grabow TS. Complex regional pain syndrome I (reflex sympathetic dystrophy) Anesthesiology. 2002;96(5):1254–1260. doi: 10.1097/00000542-200205000-00031.
    1. Rico H, Merono E, Gomez-Castresana F, Torrubiano J, Espinos D, Diaz P. Scintigraphic evaluation of reflex sympathetic dystrophy: comparative study of the course of the disease under two therapeutic regimens. Clin Rheumatol. 1987;6(2):233–237. doi: 10.1007/BF02201029.
    1. Harke H, Gretenkort P, Ladleif HU, Rahman S, Harke O. The response of neuropathic pain and pain in complex regional pain syndrome I to carbamazepine and sustained-release morphine in patients pretreated with spinal cord stimulation: a double-blinded randomized study. Anesth Analg. 2001;92(2):488–495. doi: 10.1213/00000539-200102000-00039.
    1. Connelly NR, Reuben S, Brull SJ. Intravenous regional anesthesia with ketorolac-lidocaine for the management of sympathetically-mediated pain. Yale J Biol Med. 1995;68(3–4):95–99.
    1. Azad SC, Beyer A, Römer AW, Galle-Röd A, Peter K, Schöps P. Continuous axillary brachial plexus analgesia with low dose morphine in patients with complex regional pain syndromes. Eur J Anaesthesiol. 2000;17(3):185–188.
    1. Price DD, Long S, Wilsey B, Rafii A. Analysis of peak magnitude and duration of analgesia produced by local anesthetics injected into sympathetic ganglia of complex regional pain syndrome patients. Clin J Pain. 1998;14(3):216–226. doi: 10.1097/00002508-199809000-00008.
    1. Zuurmond WW, Langendijk PN, Bezemer PD, Brink HE, de Lange JJ, van Loenen AC. Treatment of acute reflex sympathetic dystrophy with DMSO 50% in a fatty cream. Acta Anaesthesiol Scand. 1996;40(3):364–367. doi: 10.1111/j.1399-6576.1996.tb04446.x.
    1. Perez RS, Zuurmond WW, Bezemer PD, Kuik DJ, van Loenen AC, de Lange JJ, Zuidhof AJ. The treatment of complex regional pain syndrome type I with free radical scavengers: a randomized controlled study. Pain. 2003;102(3):297–307. doi: 10.1016/S0304-3959(02)00414-1.
    1. Serpell MG. Gabapentin in neuropathic pain syndromes: a randomised, double-blind, placebocontrolled trial. Pain. 2002;99:557–566. doi: 10.1016/S0304-3959(02)00255-5.
    1. Van de Vusse AC, Stomp-van den Berg SG, Kessels AH, Weber WE. Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type I [ISRCTN84121379] BMC Neurol. 2004;4:13. doi: 10.1186/1471-2377-4-13.
    1. Van Hilten JJ. Movement disorders in complex regional pain syndrome. Pain Med. 2010;11(8):1274–1277. doi: 10.1111/j.1526-4637.2010.00916.x.
    1. Van Rijn MA, Munts AG, Marinus J, Voormolen JH, de Boer KS, Teepe-Twiss IM, van Dasselaar NT, Delhaas EM, van Hilten JJ. Intrathecal baclofen for dystonia of complex regional pain syndrome. Pain. 2009;143:41–47. doi: 10.1016/j.pain.2009.01.014.
    1. Raja SN. Motor dysfunction in CRPS and its treatment. Pain. 2009;143:3–4. doi: 10.1016/j.pain.2009.01.024.
    1. Muizelaar JP, Kleyer M, Hertogs IA, DeLange DC. Complex regional pain syndrome (reflex sympathetic dystrophy and causalgia): management with the calcium channel blocker nifedipine and/or the alpha-sympathetic blocker phenoxybenzamine in 59 patients. Clin Neurol Neurosurg. 1997;99(1):26–30. doi: 10.1016/S0303-8467(96)00594-X.
    1. Murray CS, Cohen A, Perkins T, Davidson JE, Sills JA. Morbidity in reflex sympathetic dystrophy. Arch Dis Child. 2000;82(3):231–233. doi: 10.1136/adc.82.3.231.
    1. Sherry DD, Wallace CA, Kelley C, Kidder M, Sapp L. Short- and long-term outcomes of children with complex regional pain syndrome type I treated with exercise therapy. Clin J Pain. 1999;15:218–223. doi: 10.1097/00002508-199909000-00009.
    1. Stanton RP, Malcolm JR, Wesdock KA, Singsen BH. Reflex sympathetic dystrophy in children: an orthopedic perspective. Orthopedics. 1993;16(7):773–779.
    1. Watson HK, Carlson L. Treatment of reflex sympathetic dystrophy of the hand with an active “stress loading” program. J Hand Surg Am. 1987;12(5 Pt 1):779–785.
    1. Perez RS, Keijzer C, Bezemer PD, Zuurmond WW, de Lange JJ. Predictive value of symptom level measurements for complex regional pain syndrome type I. Eur J Pain. 2005;9:49–56. doi: 10.1016/j.ejpain.2004.04.003.
    1. Frölke JP, van Rumund A, de Waardt D, van Dongen RT, Klomp FP, Verbeek AL, van de Meent H. Complex regional pain syndrome type 1? In 77% of people had a different diagnosis. Ned Tijdschr Geneeskd. 2009;153(12):550–553.
    1. Breivik EK, Björnsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain. 2000;16(1):22–28. doi: 10.1097/00002508-200003000-00005.
    1. Vanderiet K, Adriaensen H, Carton H, Vertommen H. The McGill Pain Questionnaire constructed for the Dutch language (MPQ-DV). Preliminary data concerning reliability and validity. Pain. 1987;30(3):395–408. doi: 10.1016/0304-3959(87)90027-3.
    1. Norkin CC, White DJ. Measurement of joint motion. A guide to goniometry. Philadelphia: F.A: Davis Company; 2009.
    1. Bruggeman AW, Oerlemans MH, Frölke JP. Warm and cold complex regional pain syndromes: differences beyond skin temperature? Neurology. 2009;73(20):1711. doi: 10.1212/WNL.0b013e3181bd6b0d.
    1. Veehof MM, Sleegers EJ, van Veldhoven NH, Schuurman AH, van Meeteren NL. Psychometric qualities of the Dutch language version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH-DLV) J Hand Ther. 2002;15(4):347–354. doi: 10.1016/S0894-1130(02)80006-0.
    1. Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2011;14(2):128–146.
    1. McNair PJ, Prapavessis H, Collier J, Bassett S, Bryant A, Larmer P. The lower-limb tasks questionnaire: an assessment of validity, reliability, responsiveness, and minimal important differences. Arch Phys Med Rehabil. 2007;88(8):993–1001. doi: 10.1016/j.apmr.2007.05.008.
    1. Inrig T, Amey B, Borthwick C, Beaton D. Validity and Reliability of the Fear-Avoidance Beliefs Questionnaire (FABQ) in Workers with Upper Extremity Injuries. J Occup Rehabil. 2009;19:142–154. doi: 10.1007/s10926-009-9171-6.
    1. Ware JE. Sherbourne CD: The MOS 36-iten Short-Form Health Survey (SF-36). I. Conceptual Framework and Item Selection. Med Care. 1992;30(6):473–483. doi: 10.1097/00005650-199206000-00002.
    1. Bohannon RW. Test-retest reliability of hand-held dynamometry during a single session of strength assessment. Phys Ther. 1986;66(2):206–209.
    1. Bohannon RW, Andrews AW. Interrater reliability of hand-held dynamometry. Phys Ther. 1987;67(6):931–933.
    1. Rossier P, Wade DT. Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment. Arch Phys Med Rehabil. 2001;82(1):9–13. doi: 10.1053/apmr.2001.9396.
    1. Schoppen T, Boonstra A, Groothoff JW, de Vries J, Göeken LN, Eisma WH. The Timed “up and go” test: reliability and validity in persons with unilateral lower limb amputation. Arch Phys Med Rehabil. 1999;80(7):825–828. doi: 10.1016/S0003-9993(99)90234-4.
    1. Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002;82(2):128–137.
    1. Adherence to long-term therapies - evidence for action.
    1. Blair SN, Haskell WL, Ho P, Paffenbarger RS, Vranizan KM, Farquhar JW, Wood PD. Assessment of habitual physical activity by a seven-day recall in a community survey and controlled experiments. Am J Epidemiol. 1985;122:794–804.
    1. Sallis JF, Buono MJ, Roby JJ, Micale FG, Nelson JA. Seven-day recall and other physical activity self-reports in children and adolescents. Med Sci Sports Exerc. 1993;25(1):99–108. doi: 10.1249/00005768-199301000-00014.
    1. Sjostrom M, Bull F, Craig C. Towards standardized global assessment of health-related physical activity the International Physical Activity Questionnaire (IPAQ) Med Sci Sports Exerc. 2002;34(5):S202.
    1. Sullivan MJ, Bishop SR, Pivik J. The Pain Catastrophizing Scale: development and validation. Psychol Assess. 1995;7:524–532.
    1. Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984;59(3):974. doi: 10.2466/pms.1984.59.3.974.
    1. Slootmaker SM, Chin A, Paw MJ, Schuit AJ, van Mechelen W, Koppes LL. Concurrent validity of the PAM accelerometer relative to the MTI Actigraph using oxygen consumption as a reference. Scand J Med Sci Sports. 2009;19(1):36–43.
    1. Lamers LM, Stalmeier PF, McDonnell J, Krabbe PF, van Busschbach JJ. Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff. Ned Tijdschr Geneeskd. 2005;149(28):1574–1578.
    1. Hakkaart-van Roijen L, Tan SS, Bouwmans CAM. Handleiding voor kostenonderzoek, methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. College voor zorgverzekeringen. Geactualiseerde versie. 2010.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel