The Effect of Functional Task Training Combined With Therapeutic Ultrasound on Adults With Hip Osteoarthritis

NCT02798900 | Withdrawn DMC

• 1 other identifier: SAP1388
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of a functional task-training program combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality in adults with hip osteoarthritis.

Conditions

Osteoarthritis, Hip

Keywords

Task-specific exercise; Ultrasonic Waves; Biomechanics; Gait; Rehabilitation; Exercise therapy

Outcome Measures

Primary Outcomes (8)

• Visual Analog Scale for pain

  To measure the pain intensity

  within the first 2 weeks before the intervention

• Change from Baseline Visual Analog Scale for pain at 16th session of intervention

  within the first 2 weeks after the intervention

• Muscle strength

  It is the muscle strength of gluteus maximus, medium, quadriceps and hamstrings measured using a manual muscle dynamometer.

  within the first 2 weeks before the intervention

• Change from Baseline Muscle strength at 16th session of intervention

  Change of the muscle strength of gluteus maximus, medium, quadriceps and hamstrings after the intervention.

  within the first 2 weeks after the intervention

• Gait biomechanics

  Assess the speed, hip range of motion, and peak hip flexion/extension in the gait phases by using motion analysis system BTS SmartDX100 Brand.

  within the first 2 weeks before the intervention

• Change from Baseline Gait biomechanics at 16th session of intervention

  within the first 2 weeks after the intervention

• Six minute walk test (To measure the physical function in terms of the basic mobility)

  within the first 2 weeks before the intervention

• Change from Baseline Six minute walk test at 16th session of intervention

  within the first 2 weeks after the intervention

Secondary Outcomes (4)

• Change from Baseline Visual Analog Scale for pain at 5th session of intervention

  After finishing the 5th session of intervention

• Change from Baseline Visual Analog Scale for pain at 10th session of intervention

  After finishing the 10th session of intervention

• Change from Baseline Six minute walk test at 5th session of intervention

  After finishing the 5th session of intervention

• Change from Baseline Six minute walk test at 10th session of intervention

  After finishing the 10th session of intervention

Study Arms (2)

Functional task-training and Ultrasound

EXPERIMENTAL

This group will receive 16 sessions of functional task-training program and therapeutic ultrasound will be applied prior to functional task-training.

Other: Functional task-training; Device: Therapeutic Ultrasound

Functional task-training

ACTIVE COMPARATOR

This group will receive 16 sessions of functional task-training program.

Other: Functional task-training

Interventions

Functional task-training OTHER

The functional task-training program includes warming up followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching.

Functional task-training; Functional task-training and Ultrasound

Therapeutic Ultrasound DEVICE

Therapeutic pulsed ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes on the anterior, medial and lateral hip area.

Functional task-training and Ultrasound

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of hip osteoarthritis

You may not qualify if:

• Musculoskeletal disability in other lower extremity joints or trunk
• Acute injuries of lower extremity and trunk in past three months
• Arthroscopic surgery
• An intra-articular injection in past three months
• Candidate for surgery
• Patients with fibromyalgia
• Patients with neurologic disease
• Participation in a structured physical activity program in past three months

Sponsors & Collaborators

• Universidad del Rosario: lead
• CORPORACION HOSPITALARIA JUAN CIUDAD, MEDERI: collaborator

Study Sites (1)

Universidad del Rosario

Bogotá, Colombia

Location

Related Publications (43)

• Oakley EM. Application of continuous beam ultrasound at therapeutic levels. Physiotherapy. 1978 Jun;64(6):169-72. No abstract available.

  PMID: 674399 BACKGROUND

• Farcic TS, Baldan CS, Cattapan CG, Parizotto NA, Joao SM, Casarotto RA. Treatment time of ultrasound therapy interferes with the organization of collagen fibers in rat tendons. Braz J Phys Ther. 2013 May-Jun;17(3):263-71. doi: 10.1590/s1413-35552012005000090.

  PMID: 23966143 BACKGROUND

• CARTER EF Sr, HARRISS RR, PHILLIPS K, ROBINSON LF. Therapeutic application of ultrasound energy; results of broad clinical survey. J Fla Med Assoc (1914). 1956 Oct;43(4):341-6. No abstract available.

  PMID: 13367362 BACKGROUND

• Chan AK, Myrer JW, Measom GJ, Draper DO. Temperature changes in human patellar tendon in response to therapeutic ultrasound. J Athl Train. 1998 Apr;33(2):130-5.

  PMID: 16558499 BACKGROUND

• Demchak TJ, Stone MB. Effectiveness of clinical ultrasound parameters on changing intramuscular temperature. J Sport Rehabil. 2008 Aug;17(3):220-9. doi: 10.1123/jsr.17.3.220.

  PMID: 18708676 BACKGROUND

• Draper DO, Castel JC, Castel D. Rate of temperature increase in human muscle during 1 MHz and 3 MHz continuous ultrasound. J Orthop Sports Phys Ther. 1995 Oct;22(4):142-50. doi: 10.2519/jospt.1995.22.4.142.

  PMID: 8535471 BACKGROUND

• Zhou Q, Lau S, Wu D, Shung KK. Piezoelectric films for high frequency ultrasonic transducers in biomedical applications. Prog Mater Sci. 2011 Feb;56(2):139-174. doi: 10.1016/j.pmatsci.2010.09.001.

  PMID: 21720451 BACKGROUND

• ter Haar G. Therapeutic applications of ultrasound. Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):111-29. doi: 10.1016/j.pbiomolbio.2006.07.005. Epub 2006 Aug 4.

  PMID: 16930682 BACKGROUND

• Hangiandreou NJ. AAPM/RSNA physics tutorial for residents. Topics in US: B-mode US: basic concepts and new technology. Radiographics. 2003 Jul-Aug;23(4):1019-33. doi: 10.1148/rg.234035034.

  PMID: 12853678 BACKGROUND

• Draper DO, Sunderland S. Examination of the law of grotthus-draper: does ultrasound penetrate subcutaneous fat in humans? J Athl Train. 1993 Fall;28(3):246-50.

  PMID: 16558239 BACKGROUND

• Leighton TG. What is ultrasound? Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):3-83. doi: 10.1016/j.pbiomolbio.2006.07.026. Epub 2006 Aug 15.

  PMID: 17045633 BACKGROUND

• Stewart HF, Abzug JL, Harris GR. Considerations in ultrasound therapy and equipment performance. Phys Ther. 1980 Apr;60(4):424-8. doi: 10.1093/ptj/60.4.424.

  PMID: 7360798 BACKGROUND

• Humphrey VF. Ultrasound and matter--physical interactions. Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):195-211. doi: 10.1016/j.pbiomolbio.2006.07.024. Epub 2006 Aug 15.

  PMID: 17079004 BACKGROUND

• O'Brien WD Jr. Ultrasound-biophysics mechanisms. Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):212-55. doi: 10.1016/j.pbiomolbio.2006.07.010. Epub 2006 Aug 8.

  PMID: 16934858 BACKGROUND

• Zeni J Jr, Pozzi F, Abujaber S, Miller L. Relationship between physical impairments and movement patterns during gait in patients with end-stage hip osteoarthritis. J Orthop Res. 2015 Mar;33(3):382-9. doi: 10.1002/jor.22772. Epub 2014 Dec 9.

  PMID: 25492583 BACKGROUND

• Eitzen I, Fernandes L, Nordsletten L, Risberg MA. Sagittal plane gait characteristics in hip osteoarthritis patients with mild to moderate symptoms compared to healthy controls: a cross-sectional study. BMC Musculoskelet Disord. 2012 Dec 20;13:258. doi: 10.1186/1471-2474-13-258.

  PMID: 23256709 BACKGROUND

• Steinhilber B, Haupt G, Miller R, Grau S, Janssen P, Krauss I. Stiffness, pain, and hip muscle strength are factors associated with self-reported physical disability in hip osteoarthritis. J Geriatr Phys Ther. 2014 Jul-Sep;37(3):99-105. doi: 10.1519/JPT.0b013e3182abe7b5.

  PMID: 24406707 BACKGROUND

• Baker KG, Robertson VJ, Duck FA. A review of therapeutic ultrasound: biophysical effects. Phys Ther. 2001 Jul;81(7):1351-8.

  PMID: 11444998 BACKGROUND

• Nelson AE, Renner JB, Schwartz TA, Kraus VB, Helmick CG, Jordan JM. Differences in multijoint radiographic osteoarthritis phenotypes among African Americans and Caucasians: the Johnston County Osteoarthritis project. Arthritis Rheum. 2011 Dec;63(12):3843-52. doi: 10.1002/art.30610.

  PMID: 22020742 BACKGROUND

• Cibulka MT, White DM, Woehrle J, Harris-Hayes M, Enseki K, Fagerson TL, Slover J, Godges JJ. Hip pain and mobility deficits--hip osteoarthritis: clinical practice guidelines linked to the international classification of functioning, disability, and health from the orthopaedic section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2009 Apr;39(4):A1-25. doi: 10.2519/jospt.2009.0301. No abstract available.

  PMID: 19352008 BACKGROUND

• Nicolella DP, O'Connor MI, Enoka RM, Boyan BD, Hart DA, Resnick E, Berkley KJ, Sluka KA, Kwoh CK, Tosi LL, Coutts RD, Havill LM, Kohrt WM. Mechanical contributors to sex differences in idiopathic knee osteoarthritis. Biol Sex Differ. 2012 Dec 23;3(1):28. doi: 10.1186/2042-6410-3-28.

  PMID: 23259740 BACKGROUND

• Iversen MD. Managing Hip and Knee Osteoarthritis with Exercise: What is the Best Prescription? Ther Adv Musculoskelet Dis. 2010 Oct;2(5):279-90. doi: 10.1177/1759720X10378374.

  PMID: 22870454 BACKGROUND

• Pulsatelli L, Addimanda O, Brusi V, Pavloska B, Meliconi R. New findings in osteoarthritis pathogenesis: therapeutic implications. Ther Adv Chronic Dis. 2013 Jan;4(1):23-43. doi: 10.1177/2040622312462734.

  PMID: 23342245 BACKGROUND

• Loeser RF. Age-related changes in the musculoskeletal system and the development of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):371-86. doi: 10.1016/j.cger.2010.03.002.

  PMID: 20699160 BACKGROUND

• Bennell KL, Hinman RS. A review of the clinical evidence for exercise in osteoarthritis of the hip and knee. J Sci Med Sport. 2011 Jan;14(1):4-9. doi: 10.1016/j.jsams.2010.08.002. Epub 2010 Sep 17.

  PMID: 20851051 BACKGROUND

• Loyola-Sanchez A, Richardson J, MacIntyre NJ. Efficacy of ultrasound therapy for the management of knee osteoarthritis: a systematic review with meta-analysis. Osteoarthritis Cartilage. 2010 Sep;18(9):1117-26. doi: 10.1016/j.joca.2010.06.010. Epub 2010 Jul 14.

  PMID: 20637297 BACKGROUND

• Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.

  PMID: 22563589 BACKGROUND

• Murphy LB, Helmick CG, Cisternas MG, Yelin EH. Estimating medical costs attributable to osteoarthritis in the US population: comment on the article by Kotlarz et al. Arthritis Rheum. 2010 Aug;62(8):2566-7; author reply 2567-8. doi: 10.1002/art.27514. No abstract available.

  PMID: 20506219 BACKGROUND

• Arokoski J. Pain in hip and knee osteoarthritis. Pain Manag. 2014 May;4(3):177-80. doi: 10.2217/pmt.14.12. No abstract available.

  PMID: 24953071 BACKGROUND

• Murphy LB, Helmick CG, Schwartz TA, Renner JB, Tudor G, Koch GG, Dragomir AD, Kalsbeek WD, Luta G, Jordan JM. One in four people may develop symptomatic hip osteoarthritis in his or her lifetime. Osteoarthritis Cartilage. 2010 Nov;18(11):1372-9. doi: 10.1016/j.joca.2010.08.005. Epub 2010 Aug 14.

  PMID: 20713163 BACKGROUND

• Sartor CD, Watari R, Passaro AC, Picon AP, Hasue RH, Sacco IC. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Mar 19;13:36. doi: 10.1186/1471-2474-13-36.

  PMID: 22429765 BACKGROUND

• Fernandes L, Storheim K, Nordsletten L, Risberg MA. Development of a therapeutic exercise program for patients with osteoarthritis of the hip. Phys Ther. 2010 Apr;90(4):592-601. doi: 10.2522/ptj.20090083. Epub 2010 Feb 25.

  PMID: 20185613 BACKGROUND

• Brosseau L, Wells GA, Pugh AG, Smith CA, Rahman P, Alvarez Gallardo IC, Toupin-April K, Loew L, De Angelis G, Cavallo S, Taki J, Marcotte R, Fransen M, Hernandez-Molina G, Kenny GP, Regnaux JP, Lefevre-Colau MM, Brooks S, Laferriere L, McLean L, Longchamp G. Ottawa Panel evidence-based clinical practice guidelines for therapeutic exercise in the management of hip osteoarthritis. Clin Rehabil. 2016 Oct;30(10):935-946. doi: 10.1177/0269215515606198. Epub 2015 Sep 23.

  PMID: 26400851 BACKGROUND

• Monaghan B, Grant T, Hing W, Cusack T. Functional exercise after total hip replacement (FEATHER): a randomised control trial. BMC Musculoskelet Disord. 2012 Nov 28;13:237. doi: 10.1186/1471-2474-13-237.

  PMID: 23190932 BACKGROUND

• Eitzen I, Fernandes L, Nordsletten L, Risberg MA. No effects of a 12-week supervised exercise therapy program on gait in patients with mild to moderate osteoarthritis: a secondary analysis of a randomized trial. J Negat Results Biomed. 2015 Mar 5;14:5. doi: 10.1186/s12952-015-0023-y.

  PMID: 25886499 BACKGROUND

• Monticone M, Ambrosini E, Rocca B, Lorenzon C, Ferrante S, Zatti G. Task-oriented exercises and early full weight-bearing contribute to improving disability after total hip replacement: a randomized controlled trial. Clin Rehabil. 2014 Jul;28(7):658-68. doi: 10.1177/0269215513519342. Epub 2014 Jan 23.

  PMID: 24459172 BACKGROUND

• Outermans JC, van Peppen RP, Wittink H, Takken T, Kwakkel G. Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. Clin Rehabil. 2010 Nov;24(11):979-87. doi: 10.1177/0269215509360647. Epub 2010 Aug 18.

  PMID: 20719820 BACKGROUND

• Straudi S, Martinuzzi C, Pavarelli C, Sabbagh Charabati A, Benedetti MG, Foti C, Bonato M, Zancato E, Basaglia N. A task-oriented circuit training in multiple sclerosis: a feasibility study. BMC Neurol. 2014 Jun 7;14:124. doi: 10.1186/1471-2377-14-124.

  PMID: 24906545 BACKGROUND

• de Vreede PL, Samson MM, van Meeteren NL, Duursma SA, Verhaar HJ. Functional-task exercise versus resistance strength exercise to improve daily function in older women: a randomized, controlled trial. J Am Geriatr Soc. 2005 Jan;53(1):2-10. doi: 10.1111/j.1532-5415.2005.53003.x.

  PMID: 15667369 BACKGROUND

• Hoeksma HL, Dekker J, Ronday HK, Heering A, van der Lubbe N, Vel C, Breedveld FC, van den Ende CH. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial. Arthritis Rheum. 2004 Oct 15;51(5):722-9. doi: 10.1002/art.20685.

  PMID: 15478147 BACKGROUND

• Krauss I, Steinhilber B, Haupt G, Miller R, Martus P, Janssen P. Exercise therapy in hip osteoarthritis--a randomized controlled trial. Dtsch Arztebl Int. 2014 Sep 1;111(35-36):592-9. doi: 10.3238/arztebl.2014.0592.

  PMID: 25249361 BACKGROUND

• Koybasi M, Borman P, Kocaoglu S, Ceceli E. The effect of additional therapeutic ultrasound in patients with primary hip osteoarthritis: a randomized placebo-controlled study. Clin Rheumatol. 2010 Dec;29(12):1387-94. doi: 10.1007/s10067-010-1468-5. Epub 2010 May 26.

  PMID: 20499122 BACKGROUND

• McQuade KJ, de Oliveira AS. Effects of progressive resistance strength training on knee biomechanics during single leg step-up in persons with mild knee osteoarthritis. Clin Biomech (Bristol). 2011 Aug;26(7):741-8. doi: 10.1016/j.clinbiomech.2011.03.006. Epub 2011 Apr 21.

  PMID: 21514018 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• Songning Zhang, PhD

  Director, Biomechanics/Sports Medicine Lab, Department of Kinesiology, Recreation, & Sport Studies College of Education, Health and Human Sciences. The University of Tennessee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 14, 2016
• Study Start: January 10, 2017
• Primary Completion: January 8, 2018
• Study Completion: January 9, 2018
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

CO (1)