MILITARY MEDICINE, 174, 3:270, 2009 Preliminry Findings of Rndomized Controlled Tril of n Interdisciplinry Militry Pin Progrm Robert J. Gtchel, PhD * ; Donld D. McGery, PhD ; Aln Peterson, PhD ; Mysti Moore, MS PT * ; Kren LeRoy, RN * ; Mj Willim C. Isler ; Lt Col Ann S. Hryshko-Mullen ; Tom Edell, MD ABSTRACT Chronic pin relted to musculoskeletl conditions is the leding cuse of medicl dischrge from ctive duty militry service. The present study is the first rndomized controlled tril of n interdisciplinry pin tretment progrm (functionl restortion, FR) to decrese chronic musculoskeletl pin nd increse functioning in n ctive duty militry popultion. Sixty-six militry prticipnts were rndomly ssigned to either n FR tretment group or stndrd nesthesi pin clinic tretment comprison group. A repeted mesures design ws employed nd dt were nlyzed for pre- to post-tretment differences, s well s for 6-months nd 1-yer post-tretment outcomes. Findings reveled significntly greter improvements for the FR group on self-reported pin, disbility, functionl sttus, nd fitness for militry duty t the post-tretment nd follow-up points, reltive to the comprison group. These results clerly demonstrte the efficcy nd militry relevnce of FR progrm for ctive duty militry personnel who hve chronic musculoskeletl pin disorders. Chronic pin relted to musculoskeletl disorders is of significnt concern in the U.S. Armed Forces. This is prticulrly true considering the physicl requirements of mny militry personnel nd the high-risk environments in which they work. Indeed, musculoskeletl system conditions re the leding cuse of hospitliztion nd disbility for the U.S. Armed Forces. The Deprtment of Defense pys over $1.5 billion per yer to disbled service members, nd musculoskeletl conditions ccount for 40 50% of this mount. 1 4 For exmple, the medicl dischrge of one ctive duty U.S. militry member in his or her twenties hs been estimted to cost the government pproximtely $250,000 in lifetime disbility costs, excluding helth cre costs. 5 For Specil Opertions or other highly trined militry personnel (e.g., pilots), the finncil cost of mediclly bording just one individul nd then retrining replcement cn exceed $1,000,000. 6 Despite continuous dvnces in militry medicine, the rtes of disbility cses within the U.S. militry hve been incresing t n lrming rte, nd nerly doubled between 1985 nd 1994. 5 They re continuing to increse becuse of militry deployments nd relted injuries in support of Opertion Irqi Freedom (OIF) nd Opertion Enduring Freedom (OEF). Recent dt on wound ptterns for U.S. Mrines nd Silors *The University of Texs t Arlington, 501 S. Neddermn Drive, No. 313, Arlington, TX 76019. The University of Texs, Helth Science Center t Sn Antonio, 7703 Floyd Curl Drive, Sn Antonio, TX 78229-3900. Wilford Hll Medicl Center, 59 MDW/2200 Berquist Drive, Ste. 1, Lcklnd AFB, TX 78236-5300. The views expressed in this rticle re those of the uthors nd re not the officil policy of the Deprtment of Defense or the United Sttes Air Force. This mnuscript ws received for review in August 2007. The revised mnuscript ws ccepted for publiction in December 2008. Reprint & Copyright by Assocition of Militry Surgeons of U.S., 2009. serving in Irq 7 indicted tht upper nd lower extremity musculoskeletl injuries ccounted for lmost 70% of ll injuries, nd tht, therefore, orthopedic surgery ws the most commonly needed medicl specilty. Another study found tht 53% of ptients mediclly evcuted from OIF nd evluted t two militry pin mngement centers hd lower bck pin. 6 It is nticipted tht the injuries sustined in militry personnel deployed to OIF/OEF will lso result in significnt increse in chronic pin in the future. Without chnges in the current pproch to tretment, the trends of incresing disbility rtes nd ssocited costs will very likely continue in the militry. Thus, there is cler need for clinicl reserch to develop evidence-bsed tretment pproches to decrese the enormous costs ssocited with chronic musculoskeletl conditions within the U.S. Armed Forces. The functionl restortion pproch involves n interdisciplinry tem pproch consisting of three mjor components physicl therpy, occuptionl therpy, nd psychosocil intervention which is guided by supervising nurse nd physicin tem. It is bsed upon the ssumption tht lmost ll ptients suffering from occuptionl musculoskeletl pin nd disbility cn be returned to productive lifestyle through pproprite reconditioning nd coping skills trining. This progrm is ccomplished through n ggressive psychosocil nd physicl reconditioning progrm, not through trditionl pssive physicl tretment modlities. Tretment is initilly guided by quntified mesurements of function, which not only llows the reconditioning to proceed sfely, but lso provides quntifible documenttion of complince, effort, nd eventul success. Psychosocil issues nd return-to-work issues re simultneously ddressed by the psychology nd occuptionl therpy components of the progrm. Such issues cn be effectively delt with using psychosocil pproches. 8 We hve described this pproch in detil in number of publictions. 9,10 It should lso be noted 270 MILITARY MEDICINE, Vol. 174, Mrch 2009
tht ll of these ptients were initilly seen t the Anesthesi Pin Clinic (to be described lter), where they received ny stndrd tretment deemed necessry to mnge their pin (e.g., medictions, injections, etc.). Fortuntely, numerous studies with civilin popultions hve demonstrted the effectiveness of functionl restortion progrm t fcilitting return to work in civilin ptients with occuptionl musculoskeletl disorders. Return-to-work rtes with these popultions often pproch 80 85% t 1 yer, compred to no-tretment or stndrd cre comprison groups tht demonstrte only roughly 40% return-to-work rte, when ptients re treted through n interdisciplinry pproch. 11 13 The purpose of this present study ws to conduct the first systemtic evlution of the efficcy of functionl restortion progrm designed to decrese chronic musculoskeletl pin, increse functioning, nd retin militry members on ctive duty. The mjor guiding hypothesis ws tht such progrm would significntly increse the likelihood tht militry personnel suffering from musculoskeletl disorders would remin on ctive duty nd be fully qulified to perform ll of their militry duties, s well s beneficilly impct outcomes like mediction use for pin nd helth cre utiliztion rtes for pin tretment. For the study, prticipnts were ctive duty militry members recruited from ll four brnches of the militry nd treted t Wilford Hll Medicl Center t Lcklnd Air Force Bse, Texs. A repeted mesures (pre- to post-tretment evlution) design ws employed to determine differentil outcomes on vribles such s: return to full duty sttus; retention of duty sttus for t lest 6 months; helth cre utiliztion rtes for pin tretment; ptient-reported pin symptoms; nd number of militry members on medicl profile, disbility, or seprted from ctive duty. Additionl ims included improving functioning, incresing the number of militry members remining fit for duty nd worldwide qulified, nd incresing militry members bility to pss their physicl fitness test for their respective militry service. In summry, this investigtion ws designed to ddress the cler need for clinicl reserch to develop evidence-bsed ssessment nd tretment pproches to decrese the enormous costs ssocited with chronic musculoskeletl conditions within the U.S. Armed Forces. METHODS Subjects After signing n informed consent document, totl of 66 prticipnts were ssessed individully to determine pretretment bseline for ll mesures. They were then rndomly ssigned to either one of two tretment groups: (1) Stndrd Tretment Comprison Group (stndrd nesthesi pin clinic medicl cre; n = 36) or (2) Functionl Restortion ( n = 30). The two groups were mtched for ge, gender, rce, nd time since originl injury or onset of pin, on the bsis of n urn rndomiztion procedure. 14,15 This is n dptive rndomiztion procedure to ensure creful, ongoing mtching on importnt vribles. An independent individul, who ws not responsible for determining the eligibility of ptients for the study, ws responsible for the rndomiztion ssignment. Tble I presents the demogrphic vribles for these two groups. There were no initil sttisticlly significnt differences found between groups for ny of the vribles. All of these subjects were recruited from ctive duty militry personnel who were routinely referred to Wilford Hll Medicl Center (WHMC) nd Brooke Army Medicl Center (BAMC) for the tretment of musculoskeletl disorders. Both WHMC nd BAMC evlute severl hundred ctive duty militry ptients per yer with musculoskeletl pin conditions who were potentil cndidtes for the study. To be eligible for the study, ptients hd to meet the following criteri: Dignosed musculoskeletl disorder (e.g., chronic low bck pin) Pin durtion greter thn 3 months Active duty militry; ll four services were eligible to prticipte At lest 18 months retinbility on ctive duty (to ensure vilbility for follow-up) No Medicl Evlution Bord in progress Decresed bility to perform duty requirements becuse of pin nd disbility No current pln for surgery, morphine pump, or spinl cord stimultor. Mesures Before the tretment intervention, subjects in both groups were dministered stndrd ssessment bttery tht included the following: 1. Pin Drwing nd Visul Anlog Scle (VAS). The Pin Drwing16 is self-report ssessment of pin loction nd severity expressed freely on front nd bck drwing of person. A 10-cm line visul nlog scle (VAS) is prt of the drwing. This ltter VAS mesure ws used in the present study. 2. Dlls Pin nd Disbility Questionnire. This questionnire ws derived from the Million Visul Anlog Scle. 17 It is 15-item VAS mesure of pin disbility, producing totl functionl disbility score rnging from 0 to 150 (focusing on pin disbility nd function versus just self-reported pin). All questions relted to the ptient s bility to perform ctivities of dily living. In ddition, this instrument hs the dvntge of visul nlog formt, which is typiclly considered more effective thn other commonly used self-report formts. 3. Oswestry Disbility Questionnire. This self-report scle18 evlutes the degree of functionl impirment the ptient is experiencing. It consists of 10 questions, with responses for ech scored from 0 to 5 (higher scores indicting greter impirment). MILITARY MEDICINE, Vol. 174, Mrch 2009 271
TABLE I. Demogrphic Vribles for the Two Tretment Groups Functionl Restortion, No. (%) Stndrd Tretment, No. (%) Significnce Brnch of Service Army 7 (23%) 9 (25%) Air Force 23 (77%) 26 (72%) Nvy 0 (0%) 1 (3%) Gender Mle 21 (70%) 23 (64%) Femle 9 (30%) 13 (36%) Rce Asin 1 (3%) 2 (6%) Africn-Americn 5 (17%) 7 (19%) Cucsin, Non-Hispnic 19 (63%) 24 (67%) Hispnic 4 (13%) 3 (8%) Other 1 (3%) 0 (0%) Rnk Enlisted 25 (83%) 31 (80%) Officer 5 (17%) 5 (14%) Site of Pin Lumbr 21 (70%) 27 (75%) Thorcic 2 (7%) 3 (8%) Cervicl 3 (10%) 1 (3%) Multiple Spinl 1 (3%) 2 (6%) Upper Extremity 2 (7%) 0 (0%) Lower Extremity 1 (3%) 3 (8%) Age 36.9 (7.5) 34.4 (6.9) Time Since Injury (in months) 67.8 (69.0) 63.4 (61.5), not sttisticlly significnt. c 2 nlyses. 4. 36-Item Short Form Helth Survey Summry (SF-36). This is 36-item questionnire mesuring 8 dimensions tht contribute to 2 summry scles the Physicl Composite nd Mentl Composite Summry Scles. 19 It is mesure of physicl nd socil functioning, including generl helth nd helth perceptions, with higher scores indicting higher levels of functioning. 5. Beck Depression Inventory (BDI-2). The BDI-220 consists of 21 items focusing on symptoms such s sleep disturbnce, weight chnge, nd chnges in interest in ctivities previously enjoyed. It ws originlly developed by Beck 21 s mens of ssessing the cognitive component of depression. Any prticipnt who endorsed suicidl idetion on the BDI-2 ws further ssessed by n on-site stff psychologist, who followed the locl policy for the ssessment of suicidl ptients t WHMC nd BAMC. In the current study, no subjects needed further evlution fter screening by the stff psychologist. 6. The Multidimensionl Pin Inventory (MPI). The MPI 22 is self-report mesure of the impct of pin on vrious spects of one s life. Turk nd Rudy lso developed system of clssifying MPI score profiles into ctegories of coping, such s Interpersonlly Distressed Copers, Adptive Copers, nd Dysfunctionl Copers. 23 The MPI hs been widely used in studies of chronic pin nd chronic pin tretment, nd hs been shown to hve good psychometric properties. 22 A vriety of subscles for pin ssessment re vilble through the MPI, including mesures of pin severity (MPI-PS), ffective distress (MPI-AD), interference of pin on functioning (MPI-I), perceived support from others (MPI-S), nd generl physicl ctivity level (MPI-GA). 7. Fer Avoidnce Beliefs Questionnire (FABQ). The FABQ 24 hs two components one tht ssesses generl fer of ctivity becuse of concerns bout hrm or worsening pin (FABQ-PA) nd the other ssessing fer of work-relted ctivities (FABQ-W). 8. Functionl Cpcity Evlution. The interdisciplinry functionl restortion progrm relies hevily on the objective quntifiction of function to determine the extent of ptient s musculoskeletl disbility, s well s to guge rehbilittion progress. 25 The Cliforni Functionl Cpcity Protocol, e.g., 26 ws used to evlute humn performnce, including rnge of motion, functionl strength, endurnce nd dexterity, using stndrdized tsks. Procedure The bove stndrd ssessment bttery ws dministered to both the functionl restortion nd comprison group subjects before the strt of tretment (during the bseline ssessment) nd immeditely fter tretment completion, s well s 6- nd 12-month follow-ups fter tretment completion. The following socioeconomic outcome vribles were trcked (using stndrdized outcome trcking protocol developed by Myer, 272 MILITARY MEDICINE, Vol. 174, Mrch 2009
Prescott nd Gtchel) 25 immeditely following tretment, nd t 6 months nd 12 months following tretment: removl of duty restrictions becuse of pin; retention of ctive duty sttus; dditionl helth cre visits relted to the originl musculoskeletl disorders; ny surgicl procedures or hospitliztion relted to the originl musculoskeletl disorder; ny recurrent injury; pin nd disbility rtings; nd tretment stisfction. We chieved 100% follow-up for ll militry subjects in the present study. Stndrd Tretment (ST) Comprison Group The ST Comprison Group (stndrd tretment in the nesthesi pin clinic) received tretment similr to specilty pin tretment vilble t mny of the lrger militry medicl tretment fcilities with stffing commensurte to tht of WHMC. This tretment is more thn the usul medicl cre tht most ptients with chronic musculoskeletl pin conditions receive by their primry medicl provider or primry cre mnger. Physicins working t WHMC nd BAMC re nesthesiologists with fellowship trining in pin mngement or pin medicine. Of the five providers in these loctions, ll were bord certified in nesthesiology, four were bord certified in pin mngement, nd the other ws bord eligible in pin mngement. These providers hd extensive experience in the ssessment nd tretment of chronic pin conditions, including musculoskeletl pin disorders. Common tretments in this setting include mngement of pin medictions, proper use of ntidepressnt medictions s pproprite, nerve blocks nd steroid injections, nd bsic exercise progrm when pproprite. RESULTS The mjor preliminry results presented in the current study re the pre- to post-tretment chnges gthered for ll 66 subjects. In ddition, to dte, there re 6-month ( n = 45) nd 1-yer ( n = 24) outcomes now vilble for prt of this cohort, tht re lso presented. These re ll consecutive subjects, with no dropouts. These longer-term outcomes for the entire cohort (N = 90) will be reported in the future when ll hve been collected. Institutionl Review Bords (IRB) of record included: WHMC (which covered both WHMC nd BAMC), The University of Texs t Arlington (where the PI ws bsed), nd Fort Detrick (representing the Peer Reviewed Medicl Reserch Progrm). Psychosocil Mesures Tble II presents the pre- nd post-tretment psychosocil mesures for the two groups. As cn be seen, there were significntly greter tretment gins mde by the FR group t the post-tretment follow-up. A series of one-between (groups) nd one-within (pre- versus post-tretment) repeted mesures nlyses of vrince sttisticlly confirmed these findings, s evidenced by the significnt interction effects. It should lso be noted tht, t pre-tretment, independent smples t-tests reveled no significnt bseline differences between the two groups on ny of these mesures. Thus, the two groups were comprble t the pre-tretment mesurement period, but only the FR group displyed positive chnge t post-tretment. Physicl Mesures Tble III presents the pre- nd post-tretment physicl mesures for the two groups. Agin, there were significntly greter tretment gins mde by the FR group t the posttretment follow-up. Logistic Regression Anlyses Psychosocil nd physicl vribles were lso included in binry logistic regression nlysis to determine sensitivity nd specificity of these vribles in predicting tretment group membership. Predictor vribles were chosen on the bsis of zero-order correltion mtrix nd were entered into the regression eqution using n Enter method (becuse predictors were selected on the bsis of theory nd the correltion mtrix). The results of the nlysis, shown in Tble IV, reveled significnt predictive model, with over 93% sensitivity nd specificity. The Ngelkerke R 2 shows tht the regression model ccounted for lmost 91% of the vrince in group membership. The criterion vribles were lso subjected to discriminnt function TABLE II. Comprison of the Two Tretment Groups on the Pre- nd Post-tretment Psychosocil Mesures Functionl Restortion Stndrd Tretment Pre b Post Pre b Post Significnce Pin Visul Anlog Scle 6.1 (2.1) 3.8 (2.3) 6.1 (1.8) 6.0 (2.1) 0.008 Pin Disbility Questionnire 76.1 (23.3) 54.3 (21.8) 79.1 (21.1) 76.6 (21.2) 0.003 Beck Depression Inventory 11.3 (8.1) 5.5 (4.1) 13.8 (9.4) 10.5 (8.2) 0.048 Short Form-36 Physicl Composite Scle 32.5 (9.5) 43.5 (8.6) 35.6 (9.0) 34.3 (7.6) <0.001 Short Form-36 Mentl Composite Scle 51.6 (9.1) 53.5 (5.9) 48.3 (8.8) 50.6 (8.4) Multidimensionl Pin Inventory, Interference 37.7 (11.1) 30.1 (10.6) 36.7 (8.4) 39.5 (9.3) <0.001 Multidimensionl Pin Inventory, Affective Distress 39.4 (9.5) 34.4 (8.6) 40.5 (9.0) 44.0 (11.1) 0.002 Oswestry Disbility Scle 18.1 (8.6) 11.0 (5.4) 18.9 (6.1) 17.8 (4.5) 0.002 Fer Avoidnce Beliefs Questionnire, Physicl Activity 14.9 (5.5) 7.2 (4.2) 16.2 (5.6) 15.5 (5.5) 0.001 ANOVA Group X time interction effects. b No significnt pre-tretment differences between groups (bsed on independent smples t-tests). MILITARY MEDICINE, Vol. 174, Mrch 2009 273
TABLE III. Pre- nd Post-tretment Physicl Mesures for the Two Tretment Groups Functionl Restortion Stndrd Tretment Pre b Post Pre b Post Significnce Lifting, Floor to Wist 49.4 (21.6) 79.2 (24.6) 40.9 (18.4) 52.5 (14.4) <0.001 c Lifting, Wist to Ers 40.6 (17.0) 67.1 (20.4) 32.5 (14.5) 40.8 (11.3) <0.001 c Tredmill 07:14 (1:43) 9:40 (1:38) 5:51 (2:04) 6:44 (2:19) 0.002 c Metbolic Equivlents (METS) 9.3 (1.3) 11.9 (2.4) 8.0 (2.2) 8.0 (3.7) 0.009 c Oxygen Consumption (VO 2 ) 32.7 (4.7) 41.6 (8.4) 27.6 (7.9) 29.8 (10.1) <0.001 c Lumbr Flexion 42.6 (16.4) 52.0 (12.4) 47.3 (16.0) 43.1 (13.4) 0.016 d Lumbr Extension 15.3 (9.6) 18.6 (12.2) 18.6 (26.2) 12.9 (7.0) d Significnt nlysis of vrince group X time interction effects. b No significnt pre-tretment differences between groups (bsed on independent smples t-tests). c Between-group differences t pre-tretment were nonsignificnt. However, n nlysis of covrince, controlling for pre-tretment differences, continued to revel significnt difference t post-tretment. d Results were bsed on nlysis of dt only for those with lumbr injury (73% of smple). TABLE IV. Summry of Logistic Regression Anlysis Results Vrible Wld Sttistic df P Multidimensionl Pin Inventory, 5.388 1 0.020 Support Pin Disbility Questionnire 16.187 1 <0.001 Pin Visul Anlog Scle 10.831 1 0.001 Fer Avoidnce Beliefs 18.072 1 <0.001 Questionnire, Physicl Activity Short Form-36, Physicl Composite 8.817 1 0.003 Score Dynmic Lift, Floor to Wist 13.897 1 <0.001 Full Model Test: χ 2 (6, N = 66) = 43.7, p < 0.001. Sensitivity = 95.7%; specificity = 93.8%; Model R 2 (Ngelkerke R 2 ) = 0.908. Discriminnt function nlysis of bove model: Wilks L= 0.343, χ 2 (6, N = 66) = 36.4, p < 0.001; κ = 0.792, p < 0.001, 89.7% of ll cses correctly clssified; 87.2% clssified using leve-one-out method. nlysis to further test the bility of the model to discriminte between the tretment nd comprison groups. This nlysis proved significnt, correctly clssifying lmost 90% of cses. In ddition, leve-one-out method ws used to estimte function discrimintion if used with different dt set, yielding correct-clssifiction rte of more thn 87%. Six-Month Psychosocil Outcomes As indicted erlier, only 45 subjects hd reched the 6-month follow-up evlution period. At this point in follow-up, only psychosocil vribles were formlly mesured. These results re presented in Tble V. It is cler, even t 6-month follow-up, tht the FR tretment prticipnts were significntly improved compred to their ST counterprts on vriety of psychosocil mesures. Within-subjects nlyses (pired t -tests), for both the FR nd ST groups, reveled tht neither group chnged significntly over 6 months, reltive to post-tretment levels. Socioeconomic Outcomes t Six-Month Follow-up Socioeconomic outcomes dt were gthered through structured interview nd ptient records. Agin, informtion ws vilble for only the 45 prticipnts who hd reched 6 months post-tretment. Odds rtio nd Student s t -test dt re presented in Tble VI. Once more, FR subjects demonstrted significntly better outcomes ssocited with helth cre utiliztion nd mediction use thn their ST counterprts. Dt on work retention were not presented here becuse no subject hd been mediclly seprted from the militry becuse of pin in either group. One-Yer Outcomes Twenty-four subjects (12 in ech group) hd completed the 1-yer follow-up evlution period. As is redily pprent in Tble VII, even though these comprisons re somewht sttisticlly underpowered, the FR group is gin displying significntly better outcomes thn the ST group on number of importnt vribles relted to ctive duty sttus nd work rediness. One of the most significnt trends is tht individuls in the ST group hd over four times s mny medicl ppointments (23.1 vs. 5.1, p = 0.09) during the 12-month follow-up period s compred to the FR group. DISCUSSION The results of the present study hve significnt militry relevnce. The findings reveled mrked improvement in both psychosocil nd physicl outcomes t vrious intervls by the FR group. Psychosocilly, FR group subjects reported significnt improvements in self-reported pin intensity, perceived disbility, nd emotionl distress immeditely fter tretment reltive to their pre-tretment functioning levels, s well s compred to the ST comprison group subjects t post-tretment. There were lso few chnges in psychosocil vribles for ST group prticipnts between the pre- nd post-tretment ssessment vribles. A lck of chnge over the 3-week tretment intervl for this group is understndble considering tht the men durtion of pin for ll subjects in the study ws pproximtely 5 yers, nd ll prticipnts enrolled in the study initilly presented with reltively stble pin symptomtology. This considertion, however, mkes the improvement of FR subjects tht much more remrkble. Specificlly, FR group subjects experienced significnt 274 MILITARY MEDICINE, Vol. 174, Mrch 2009
TABLE V. Six-Month Outcome Results for the Two Tretment Groups ( n = 45) Vrible Functionl Restortion Men (SD) Stndrd Tretment Men (SD) P Beck Depression Inventory 6.4 (7.3) 13.8 (8.3) 0.008 Short Form-36 Physicl Functioning 46.4 (9.0) 36.3 (11.2) 0.006 Short Form-36 Role Physicl 47.1 (11.7) 35.9 (12.1) 0.009 Short Form-36 Bodily Pin 44.1 (8.6) 35.2 (4.6) 0.002 Short Form-36 Vitlity 48.4 (9.8) 36.1 (10.3) 0.002 Short Form-36 Mentl Helth 53.8 (7.2) 45.5 (10.9) 0.009 Short Form-36 Physicl Composite Score 43.3 (8.6) 35.1 (7.6) 0.006 Short Form-36 Mentl Composite Score 52.0 (8.1) 45.5 (10.2) 0.031 Multidimensionl Pin Inventory, Pin Severity 30.0 (11.6) 44.8 (11.5) 0.002 Multidimensionl Pin Inventory, Interference 28.1 (10.0) 38.4 (13.9) 0.015 Multidimensionl Pin Inventory, Life Control 58.7 (4.2) 53.2 (6.1) 0.004 Multidimensionl Pin Inventory, Affective Distress 37.5 (8.6) 46.4 (14.0) 0.039 Multidimensionl Pin Inventory, Support 44.6 (10.9) 51.7 (5.1) 0.040 Multidimensionl Pin Inventory, Activities wy from Home 60.6 (8.3) 55.0 (7.3) 0.040 Multidimensionl Pin Inventory, Socil Activities 56.5 (10.4) 47.1 (8.3) 0.0 10 Multidimensionl Pin Inventory, Generl Activity Level 61.9 (8.2) 55.9 (9.1) 0.040 Pin Visul Anlog Scle 4.0 (2.3) 6.6 (2.0) 0.002 Oswestry Disbility Scle 10.3 (7.7) 19.5 (5.5) <0.001 Pin Disbility Questionnire 51.3 (24.3) 81.7 (19.7) <0.001 Bsed on Student s t-test. TABLE VI. Socioeconomic Outcomes for the Two Tretment Groups t 6 Months Functionl Restortion ( n = 22) Stndrd Tretment ( n = 23) Significnce Helthcre Utiliztion OR (95% CI) Pin Clinic 77% 87% 2.0 (0.3 12.5) Physicl Therpy 9% 22% 2.5 (0.4 16.1) Primry Cre 18% 57% 5.0 (1.2 21.0) Behviorl Helth 41% 17% 3.3 (0.7 15.4) Continued Tking Pin Mediction 6 Months fter Tretment Men No. of Medictions Tken (SD) 1.9 (1.7) Men No. of Medictions Tken (SD) 3.1 (2.3) P = 0.043 OR (95% CI) Nrcotic 18% 52% 4.6 (1.0 20.3) Nonsteroidl Anti-inflmmtory 50% 83% 4.3 (0.9 20.0) Muscle Relxnt 14% 43% 4.4 (0.9 21.3) Acetminophen 5% 13% 2.7 (0.2 33.0) OR, odds rtio; 95% CI = 95% confidence intervl; Student s t -test; independent smples. relief of psychosocil distress indices, including n improved sense of control over their pin, decresed concern bout the impct of physicl ctivity on pin, nd significntly reduced reports of functionl disbility. Of prticulr note mong the FR post-tretment outcomes is significnt decrese in selfreport pin intensity from pre- to post-tretment. This outcome is especilly importnt becuse the primry gols of the FR tretment were improved physicl functioning nd qulity of life, lthough decresing reported pin ws of secondry importnce. This is understndble considering tht reserch on pin intensity rtings 27 suggests tht visul nlog pin rtings mesure more holistic functioning (e.g., disbility nd psychosocil functioning) rther thn merely nociception. Physicl function ssessments lso reveled significnt improvements ttributble to FR immeditely fter tretment. As with psychosocil testing, beneficil tretment effects were noted both within the FR group (from pre- to post-tretment), s well s between the FR nd ST groups t post-tretment. Agin, these gins were expected becuse of the intensive physicl therpy bsed on quntifible, objective functionl ssessment inherent in the FR pproch, lthough physicl therpy lone might not be solely responsible for these improvements. Indeed, functionl restortion tretment is bsed on the perspective tht chronic pin is complex phenomenon involving multiple domins of functioning, including physicl, psychosocil, nd socioculturl components. These components interct with one nother to contribute to the complex chronic musculoskeletl pin syndrome. To more fully explore the reltionship between psychosocil nd physicl vribles in FR tretment, post-tretment vribles in those domins were entered into logistic regression nlysis to develop model to predict FR versus ST group membership. As expected, the resulting regression model indicted vst physicl nd psychosocil differences between the tretment nd comprison groups (s seen in Tble IV ). Discriminnt function nlysis ws lso ble to discriminte group membership with more thn 87% ccurcy, further emphsizing the significnt physicl nd psychosocil MILITARY MEDICINE, Vol. 174, Mrch 2009 275
TABLE VII. One-Yer Outcome Results for the Two Tretment Groups Functionl Restortion ( n = 12) Stndrd Tretment ( n = 12) Significnce Met Medicl Bord within 1 Yer n = 0 n = 2 OR = 1.8 95% CI, 1.2 2.7 Continued Seeking Medicl Cre for Pin n = 7 n = 11 OR = 3.1 95% CI, 0.2 41.5 1 Yer fter Tretment Continued Tking Pin Mediction n = 9 n = 10 OR = 2.0 95% CI, 0.2 12.3 1 Yer fter Tretment New Surgicl Procedures for Pin n = 4 n = 6 OR = 2.0 95% CI, 0.4 10.4 1 Yer fter Tretment Totl No. of MD nd/or ER Visits for Pin 5.1 (7.8) 23.1 (56.3) P = 0.09 Cre 1 Yer fter Tretment Totl No. of Different Helth Cre Providers 1.8 (1.5) 2.8 (1.4) P = 0.07 Seen for Pin 1 Yer fter Tretment Averge Pin VAS Rting 1 Yer fter Tretment 3/10 5/10 P = 0.05 Becuse of the smll number of cses, dt were nlyzed using Mnn-Whitney U-test. differences between those subjects who completed functionl restortion tretment versus those rndomized to the comprison group. It must lso be stted tht one notble component of the model/function reviewed bove ws the conspicuous bsence of vribles ssocited with emotionl distress. Those who work with chronic musculoskeletl pin know how integrl emotionl distress (e.g., depression, nxiety, etc.) is to the chronic pin experience. Exmintion of the zero-order correltion mtrix (from which predictors were chosen) reveled tht the emotionl vribles my hve been omitted becuse of significnt correltions with mny (if not ll) of the finl predictor vribles chosen. Thus, it is likely tht emotionl distress ws not necessrily removed from the model entirely, but ctully ws represented through the remining vribles s surrogtes. More work in future chronic pin reserch will ultimtely be needed to further unrvel this phenomenon. As with ll reserch endevors of this scope, the considertion of long-term outcomes is of primry importnce. We hve preliminrily reviewed long-term outcomes dt from 6- nd 12-month follow-ups fter tretment to quntify the persistence of the post-tretment effects. Despite the lck of gret sttisticl power ccompnying fewer long-term follow-up dt points, outcomes pper to lredy show significnt differences between the FR nd ST groups. At 6-month follow-up, neither of the two groups demonstrted significnt chnge in physicl or psychosocil performnce. Thus, FR subjects continued to show symptom improvement, reltive to the ST subjects (who showed no chnge) t long-term follow-up. Anlyses of the socioeconomic vribles further reveled tht FR subjects were significntly less likely to seek helth cre services (in vriety of specilties) compred to their ST counterprts 6 months fter tretment, nd were less likely to rely on mediction for pin mngement. One somewht unexpected result of these dt ws n indiction tht FR subjects were more likely to utilize behviorl helth services for pin mngement fter FR tretment. This incresed behviorl helth cre utiliztion my be ttributble to incresed wreness of behviorl helth services in pin tretment fter FR prticiption. Socioeconomic outcomes t 1-yer post-tretment continued to support the mintennce of tretment benefit for FR subjects compred to those who did not receive the intervention. The results of the present study hve significnt militry relevnce. Currently, there is no frme of reference by which to mesure tretment success in specilty pin center ctering to militry personnel wounded in combt. A recent epidemiologicl study of OIF veterns indicted tht over one-hlf of those mediclly evcuted out of the combt theter were for musculoskeletl pin conditions. 6 A key finding ws tht only 24% of the soldiers experienced greter thn 50% pin reduction fter tretment, nd only 2% were ble to return to deployed duty in Irq. These finding suggest tht dditionl tretment pproches, such s FR, my be needed to mintin fitness for militry duty nd to be mediclly qulified for deployment. ACKNOWLEDGMENTS The writing of this mnuscript ws supported in prt by grnts to Dr. Robert Gtchel from the Congressionlly Directed Medicl Reserch Progrm s Peer Review Medicl Reserch Progrm (DAMD 17-03-1-0055), nd from the Ntionl Institutes of Helth (1K05 MH071892 nd 3R01 MH 046452. REFERENCES 1. Berkowitz SM, Feuerstein M, Lopez MS, Peck CA : Occuptionl bck disbility in U.S. Army personnel. Milit Med 1999 ; 164 : 421 8. 2. Feuerstein M, Berkowitz SM, Pstel R, Hung GD : The Secondry Prevention Progrm for Occuptionl Low Bck Pin-Relted Disbility. Presented t the Workers Compenstion Reserch Group; New Brunswick, NJ, July 1999. 3. Hung GD, Berkowitz SM, Feuerstein M, Peck CA : Occuptionl upperextremity-relted disbility: demogrphic, physicl, nd psychosocil fctors. Milit Med 1998 ; 163 : 552 8. 4. Jones BH, Amoroso PJ, Cnhm ML : Atls of injuries in the U.S. rmed forces militry medicine. Milit Med 1999 ; Supp(164) : 9-1 9-26. 5. Amoroso PJ, Cnhm ML : Disbilities relted to the musculoskeletl system: physicl evlution bord dt. In: Atls of Injuries in the U.S. Armed Forces, pp 4-1 to 4-73. Edited by Jones PJ, Amoroso PJ, Cnhm ML. Bethesd, MD, AMSUS, 1999. 276 MILITARY MEDICINE, Vol. 174, Mrch 2009
6. Cohen SP, Griffith S, Lrkin TM, Villen F, Lrkin R : Presenttion, dignoses, mechnisms of injury, nd tretment of soldiers injured in Opertion Irqi Freedom: n epidemiologicl study conducted t two militry pin mngement centers. Anesth Anlg 2005 ; 101 : 1098 103. 7. Zouris JM, Wlker GJ, Dye J, Glerneu M : Wounding ptterns for U.S. mrines nd silors during Opertion Irqi Freedom, mjor combt phse. Milit Med 2006 ; 171 : 246 52. 8. Gtchel RJ, Turk DC : Psychologicl Approches to Pin Mngement: A Prctitioner s Hndbook. New York, Guilford Publictions, Inc., 1996. 9. Myer TG, Gtchel RJ : Functionl Restortion for Spinl Disorders: The Sports Medicine Approch. Phildelphi, PA, Le & Febiger, 1988. 10. Gtchel RJ, Myer TG : Functionl restortion for chronic low bck pin, prt II: multimodl disbility mngement. Pin Mngement. 1989 ; 2 : 136 40. 11. Myer TG, Gtchel RJ, Myer H, Kishino N, Keeley J, Mooney V : A prospective two-yer study of functionl restortion in industril low bck injury. JAMA 1987 ; 258 : 1181 2. 12. Gtchel RJ, Okifuji A : Evidence-bsed scientific dt documenting the tretment- nd cost-effectiveness of comprehensive pin progrms for chronic nonmlignnt pin. J Pin 2006 ; 7 (11) : 779 93. 13. Gtchel RJ : Clinicl Essentils of Pin Mngement. Wshington, DC, Americn Psychologicl Assocition, 2005. 14. Lchin JM, Mtts JP, Wei LJ : Rndomiztion in clinicl trils: conclusions nd recommendtions. Control Clin Trils 1988 ; 9 (4) : 365 74. 15. Stout RL, Wirtz PW, Crbonri JP, Del Boc FK : Ensuring blnced distribution of prognostic fctors in tretment outcome reserch. J Stud Alcohol 1994 ; 12 (Supplement) : 70 5. 16. Mooney V, Cirns D, Robertson J : A system for evluting nd treting chronic bck disbility. West J Med 1976 ; 124 (5) : 370 6. 17. Million S, Hll W, Hvik NK, Bker RD, Jyson MIV : Assessment of the progress of the bck-pin ptient. 1981 Volvo Awrd in Clinicl Science. Spine 1982 ; 7 : 204 12. 18. Firbnks JC, Couper J, Dvies JB, O Brien JP : The Oswestry low bck pin disbility questionnire. Physiotherpy 1980 ; 66 : 271 3. 19. Wre JE, Sherbourne CD : The MOS 36-Item Short-Form Helth Survey (SF-36). I. Conceptul frmework nd item selection. Med Cre 1992 ; 30 : 473 83. 20. Beck AT, Steer RA, Brown GK : Beck Depression Inventory Mnul, Ed 2, Sn Antonio, TX, Psychologicl Corportion, 1996. 21. Beck A : Depression: Clinicl, Experimentl, nd Theoreticl Aspects. New York, Hrper & Rowe, 1967. 22. Kerns RD, Turk DC, Rudy TE : The West Hven-Yle Multidimensionl Pin Inventory. Pin 1985 ; 23 : 345 56. 23. Turk D, Rudy T : Towrd n empiriclly derived txonomy of chronic pin ptients: integrtion of psychologicl ssessment dt. J Consult Clin Psychol 1988 ; 56 : 233 8. 24. Wddell G, Newton M, Henderson I, Somerville D, Min CJA : Fer-Avoidnce Beliefs Questionnire (FABQ) nd the role of fervoidnce beliefs in chronic low bck pin nd disbility. Pin 1993 ; 52 : 157 8. 25. Myer TG : Quntittive physicl nd functionl cpcity ssessment. In: Occuptionl Musculoskeletl Disorders: Function, Outcomes & Evidence. Edited by Myer TG, Gtchel RJ, Poltin PB. Phildelphi, PA, Lippincott, Willims & Wilkins, 2000. 26. Mtheson LN, Mooney VA, Grnt V, Leggett S, Kenny K : Stndrdized evlution of work cpcity. J Bck Musculoskeletl Rehbil 1996 ; 6 : 249 64. 27. McGery DD, Myer TG, Gtchel RJ : High pin rtings predict tretment filure in chronic occuptionl musculoskeletl disorders. J Bone Joint Surg Am 2006 ; 88 (2) : 317 25. MILITARY MEDICINE, Vol. 174, Mrch 2009 277