期刊论文详细信息
Trials
Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial
John D Bennett2  Pamela A Duffy3  Daniel Pinto6  Thomas G McPoil4  Bryan C Heiderscheit7  Timothy W Flynn1  Shane M McClinton5 
[1] Department of Physical Therapy, Rocky Mountain University of Health Professions, 561 East 1860 South, Provo, Utah 84606, USA;Podiatric Medicine Program, Des Moines University, 3200 Grand Avenue, Des Moines, Iowa 50312, USA;Public Health Program, Des Moines University, 3200 Grand Avenue, Des Moines, Iowa 50312, USA;School of Physical Therapy, Rueckert-Hartman College of Health Professions, Regis University, 3333 Regis Boulevard, Denver, Colorado 80221, USA;Department of Physical Therapy, Des Moines University, 3200 Grand Avenue, Des Moines, IA 50312, USA;Department of Physical Therapy and Human Movement Sciences/Center for Healthcare Studies, Feinberg School of Medicine, Northwestern University, 645 North Michigan Avenue, Suite 1100, Chicago, Illinois 60611, USA;Department of Orthopedics and Rehabilitation, University of Wisconsin – Madison, 1300 University Avenue, Madison, Wisconsin 53706, USA
关键词: Podiatry;    Plantar fasciitis;    Musculoskeletal manipulations;    Exercise therapy;    Cost;   
Others  :  807852
DOI  :  10.1186/1745-6215-14-414
 received in 2013-09-22, accepted in 2013-11-18,  发布年份 2013
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【 摘 要 】

Background

A significant number of individuals suffer from plantar heel pain (PHP) and many go on to have chronic symptoms and continued disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed. Currently, there is a wide variation in treatment, cost, and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches. Two practice guidelines and recent evidence of effective physical therapy intervention are available to direct treatment but the timing and influence of physical therapy intervention in the multidisciplinary management of PHP is unclear. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy intervention (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP.

Methods

A parallel-group, block-randomized clinical trial will compare ePT and uPOD. Both groups will be seen initially by a podiatrist before allocation to a group that will receive physical therapy intervention consisting primarily of manual therapy, exercise, and modalities, or podiatric care consisting primarily of a stretching handout, medication, injections, and orthotics. Treatment in each group will be directed by practice guidelines and a procedural manual, yet the specific intervention for each participant will be selected by the treating provider. Between-group differences in the Foot and Ankle Ability Measure 6 months following the initial visit will be the primary outcome collected by an independent investigator. In addition, differences in the European Quality of Life – Five Dimensions, Numeric Pain Rating Scale, Global Rating of Change (GROC), health-related costs, and cost-effectiveness at 6 weeks, 6 months, and 1 year will be compared between groups. The association between successful outcomes based on GROC score and participant expectations of recovery generally, and specific to physical therapy and podiatry treatment, will also be analyzed.

Discussion

This study will be the first pragmatic trial to investigate the clinical outcomes and cost-effectiveness of ePT and uPOD in individuals with PHP. The results will serve to inform clinical practice decisions and management guidelines of multiple disciplines.

Trial registration

ClinicalTrials.gov: NCT01865734

【 授权许可】

   
2013 McClinton et al.; licensee BioMed Central Ltd.

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【 参考文献 】
  • [1]Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C, Herrick R, Myerson M, Sammarco J, Janecki C, Ross S, Bowman M, Smith R: Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot Ankle Int 1999, 20(4):214-221.
  • [2]Riddle DL, Schappert SM: Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int 2004, 25(5):303-310.
  • [3]Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF: Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis: a prospective clinical trial with two-year follow-up. J Bone Joint Surg Am 2006, 88(8):1775-1781.
  • [4]Wolgin M, Cook C, Graham C, Mauldin D: Conservative treatment of plantar heel pain: long-term follow-up. Foot Ankle Int 1994, 15(3):97-102.
  • [5]Beyzadeoglu T, Gokce A, Bekler H: The effectiveness of dorsiflexion night splint added to conservative treatment for plantar fasciitis. Acta Orthop Traumatol Turc 2007, 41(3):220-224.
  • [6]Martin RL, Irrgang JJ, Conti SF: Outcome study of subjects with insertional plantar fasciitis. Foot Ankle Int 1998, 19(12):803-811.
  • [7]Tong KB, Furia J: Economic burden of plantar fasciitis treatment in the United States. Am J Orthop 2010, 39(5):227-231.
  • [8]Yi TI, Lee GE, Seo IS, Huh WS, Yoon TH, Kim BR: Clinical characteristics of the causes of plantar heel pain. Ann Rehabil Med 2011, 35(4):507-513.
  • [9]Wearing SC, Smeathers JE, Urry SR, Hennig EM, Hills AP: The pathomechanics of plantar fasciitis. Sports Med 2006, 36(7):585-611.
  • [10]Cleland JA, Abbott JH, Kidd MO, Stockwell S, Cheney S, Gerrard DF, Flynn TW: Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther 2009, 39(8):573-585.
  • [11]Riddle DL, Pulisic M, Pidcoe P, Johnson RE: Risk factors for plantar fasciitis: a matched case–control study. J Bone Joint Surg Am 2003, 85-A(5):872-877.
  • [12]Kibler WB, Goldberg C, Chandler TJ: Functional biomechanical deficits in running athletes with plantar fasciitis. Am J Sports Med 1991, 19(1):66-71.
  • [13]Irving DB, Cook JL, Young MA, Menz HB: Obesity and pronated foot type may increase the risk of chronic plantar heel pain: a matched case–control study. BMC Musculoskelet Disord 2007, 8:41. BioMed Central Full Text
  • [14]Hendrix CL, Jolly GP, Garbalosa JC, Blume P, DosRemedios E: Entrapment neuropathy: the etiology of intractable chronic heel pain syndrome. J Foot Ankle Surg 1998, 37(4):273-279.
  • [15]Johnston MR: Nerve entrapment causing heel pain. Clin Podiatr Med Surg 1994, 11(4):617-624.
  • [16]Schon LC, Glennon TP, Baxter DE: Heel pain syndrome: electrodiagnostic support for nerve entrapment. Foot Ankle 1993, 14(3):129-135.
  • [17]Diers DJ: Medial calcaneal nerve entrapment as a cause for chronic heel pain. Physiother Theory Pract 2008, 24(4):291-298.
  • [18]Orchard J: Plantar fasciitis. BMJ 2012, 345:e6603.
  • [19]McPoil TG, Martin RL, Cornwall MW, Wukich DK, Irrgang JJ, Godges JJ: Heel pain–plantar fasciitis: clinical practice guildelines linked to the international classification of function, disability, and health from the Orthopaedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther 2008, 38(4):A1-A18.
  • [20]Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS Sr, Zlotoff HJ, Bouche R, Baker J, American College of Foot and Ankle Surgeons heel pain committee: The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg 2010, 49(3):S1-19.
  • [21]Martin JE, Hosch JC, Goforth WP, Murff RT, Lynch DM, Odom RD: Mechanical treatment of plantar fasciitis: a prospective study. J Am Podiatr Med Assoc 2001, 91(2):55-62.
  • [22]Al Fischer Associates, Inc: 2002 Podiatric practice survey: statistical results. J Am Podiatr Med Assoc 2003, 93(1):67-86.
  • [23]Reischl S: Physical therapist foot care survey. Orthop Pract 2001, 13:27.
  • [24]Agency for Healthcare Research and Quality: Guideline Comparison. [http://www.guideline.gov/compare/index.aspx webcite]
  • [25]Looney B, Srokose T, Fernandez-de-Las-Peñas C, Cleland JA: Graston instrument soft tissue mobilization and home stretching for the management of plantar heel pain: a case series. J Manipulative Physiol Ther 2011, 34:138-142.
  • [26]Renan-Ordine R, Alburquerque-Sendin F, de Souza DP, Cleland JA, Fernandez-de-Las-Peñas C: Effectiveness of myofascial trigger point manual therapy combined with a self-stretching protocol for the management of plantar heel pain: a randomized controlled trial. J Orthop Sports Phys Ther 2011, 41(2):43-50.
  • [27]Wand BM, Bird C, McAuley JH, Doréf CJ, MacDowell M, De Souza LH: Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise. Spine 2004, 29:2350-2356.
  • [28]Gellhorn AC, Chan L, Martin B, Friedly J: Management patterns in acute low back pain: the role of physical therapy. Spine 2012, 37(9):775-782.
  • [29]Fritz JM, Childs JD, Wainner RS, Flynn TW: Primary care referral of patients with low back pain to physical therapy: impact on future healthcare utilization and costs. Spine 2012, 37(25):2114-2121.
  • [30]Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM: Evidence of validity for the foot and ankle ability measure (FAAM). Foot Ankle Int 2005, 26(11):968-983.
  • [31]Irving DB, Cook JL, Menz HB: Factors associated with chronic plantar heel pain: a systematic review. J Sci Med Sport 2006, 9(1–2):11-22.
  • [32]Faul F, Erdfelder E, Lang AG, Buchner A: G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007, 39(2):175-191.
  • [33]Childs JD, Piva SR, Fritz JM: Responsiveness of the numeric pain rating scale in patients with low back pain. Spine 2005, 30(11):1331-1334.
  • [34]Jaeschke R, Singer J, Guyatt GH: Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials 1989, 10(4):407-415.
  • [35]Cleland JA, Childs JD, Fritz JM, Whitman JM, Eberhart SL: Development of a clinical prediction rule for guiding treatment of a subgroup of patients with neck pain: use of thoracic spine manipulation, exercise, and patient education. Phys Ther 2007, 87(1):9-23.
  • [36]Brooks R: EuroQol: the current state of play. Health Policy 1996, 37:53-72.
  • [37]Shaw JW, Johnson JA, Coons SJ: US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 2005, 43(3):203-220.
  • [38]Redmond AC, Crosbie J, Ouvrier RA: Development and validation of a novel rating system for scoring standing foot posture: the foot posture index. Clin Biomech 2006, 21(1):89-98.
  • [39]Bolívar YA, Munuera PV, Padillo JP: Relationship between tightness of the posterior muscles of the lower limb and plantar fasciitis. Foot Ankle Int 2013, 34(1):42-48.
  • [40]Labovitz JM, Yu J, Kim C: The role of hamstring tightness in plantar fasciitis. Foot Ankle Spec 2011, 4(3):141-144.
  • [41]Harty J, Soffe K, O’Toole G, Stephens MM: The role of hamstring tightness in plantar fasciitis. Foot Ankle Int 2005, 26(12):1089-1092.
  • [42]Jung DY, Kim MH, Koh EK, Kwon OY, Cynn HS, Lee WH: A comparison in the muscle activity of the abductor hallucis and the medial longitudinal arch angle during toe curl and short foot exercises. Phys Ther Sport 2011, 12(1):30-35.
  • [43]Jung DY, Koh EK, Kwon OY: Effect of foot orthoses and short-foot exercise on the cross-sectional area of the abductor hallucis muscle in subjects with pes planus: a randomized controlled trial. J Back Musculoskelet Rehabil 2011, 24(4):225-231.
  • [44]Fiolkowski P, Brunt D, Bishop M, Woo R, Horodyski M: Intrinsic pedal musculature support of the medial longitudinal arch: an electromyography study. J Foot Ankle Surg 2003, 42(6):327-333.
  • [45]Lynn SK, Padilla RA, Tsang KK: Differences in static- and dynamic-balance task performance after 4 weeks of intrinsic-foot-muscle training: the short-foot exercise versus the towel-curl exercise. J Sport Rehabil 2012, 21(4):327-333.
  • [46]Chang R, Kent-Braun JA, Hamill J: Use of MRI for volume estimation of tibialis posterior and plantar intrinsic foot muscles in healthy and chronic plantar fasciitis limbs. Clin Biomech 2012, 27(5):500-505.
  • [47]Allen RH, Gross MT: Toe flexors strength and passive extension range of motion of the first metatarsophalangeal joint in individuals with plantar fasciitis. J Orthop Sports Phys Ther 2003, 33(8):468-478.
  • [48]Bullock-Saxton JE, Janda V, Bullock MI: The influence of ankle sprain injury on muscle activation during hip extension. Int J Sports Med 1994, 15(6):330-334.
  • [49]Friel K, McLean N, Myers C, Caceres M: Ipsilateral hip abductor weakness after inversion ankle sprain. J Athl Train 2006, 41(1):74-78.
  • [50]Meyer J, Kulig K, Landel R: Differential diagnosis and treatment of subcalcaneal heel pain: a case report. J Orthop Sports Phys Ther 2002, 32(3):114-122.
  • [51]Alshami AM, Souvlis T, Coppieters MW: A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther 2008, 13(2):103-111.
  • [52]Vicenzino B: Foot orthotics in the treatment of lower limb conditions: a musculoskeletal physiotherapy perspective. Man Ther 2004, 9:185-196.
  • [53]Louw A, Diener I, Butler DS, Puentedura EJ: The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil 2011, 92(12):2041-2056.
  • [54]Louw A, Puentedura EL, Mintken P: Use of an abbreviated neuroscience education approach in the treatment of chronic low back pain: a case report. Physiother Theory Pract 2012, 28(1):50-62.
  • [55]Henry KD, Rosemond C, Eckert LB: Effect of number of home exercises on compliance and performance in adults over 65 years of age. Phys Ther 1999, 79(3):270-277.
  • [56]Kulig K, Lederhaus ES, Reischl S, Arya S, Bashford G: Effect of eccentric exercise program for early tibialis posterior tendinopathy. Foot Ankle Int 2009, 30(9):877-885.
  • [57]Fergusson D, Aaron SD, Guyatt G, Hébert P: Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ 2002, 325(7365):652-654.
  • [58]Glick HA, Doshi JA, Sonnad SS, Polksy D: Economic Evaluation in Clinical Trials. New York: Oxford University Press Inc.; 2007.
  • [59]Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL: Methods for the Economic Evaluation of Health Care Programmes. 3rd edition. New York: Oxford University Press Inc.; 2005.
  • [60]Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E: Consolidated health economic evaluation reporting standards (CHEERS)–explanation and elaboration: a report of the ISPOR health economic evaluation publication guidelines good reporting practices task force. Value Health 2013, 16(2):231-250.
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