Patient Education and Basic Body Awareness Therapy in Hip Osteoarthritis: a Randomized Controlled Trial

NCT02884531 | Completed DMC

• 1 other identifier: Hip osteoarthritis RCT
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of hip osteoarthritis (OA) is rising in western countries due to an ageing population and the epidemic of obesity. Patients with hip OA tend to complain of hip pain and stiffness which affect alignment and mobility of the whole body and typically result in general musculoskeletal pain and disability. Clinical guidelines recommend a combination of exercise therapy, weight loss and education, adjusted to the individuals needs, to be tried out before arthroplasty eventually is offered. However, to obtain a satisfactory long-term outcome is a challenge as patients may not be motivated to comply with a training program including functional strength and mobility training, if not guided by a therapist. Basic Body Awareness Therapy (BBAT) may be an alternative training modality with a better potential for lasting effects. It is a low-impact movement therapy focusing on alignment of the body and quality of movements, implemented in daily life activities. In the BBAT learning process by doing, reflecting on and transferring body awareness into daily life movements, the investigators hypothesize that the patients will obtain self-efficacy and mastering, of importance for continued training on their own. This hypothesis will be examined in the present randomized controlled trial, comparing Patient Education combined with BBAT and Patient Education alone. The investigators will, accordingly, examine the supplementary effects of BBAT for patients with hip OA. They will also explore the importance of movement quality as observed by physiotherapist using Body Awareness Rating Scale, and how it relates to how patients perceive their movement performance. In the study the investigators will particularly address long-term effects of the intervention by comparing survival of the native hip in the two groups included in the study. Data from the study will be included in a national database of patients with non-surgical treatment of hip and knee OA (NOAR), giving rise to comparison of different movement therapies.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Numeric Rating Scale, change in pain

  Pain intensity during walking

  Baseline, 4 months and 1 year

• Hip disability and Osteoarthritis Outcome Score (HOOS), change in ADL

  Self-reported disability

  Baseline, 4 months and 1 year

Secondary Outcomes (9)

• Harris Hip Score (HHS)

  Baseline, 4 months and 1 year

• The EuroQol (EQ-5D-5L)

  Baseline, 4 months and 1 year

• Arthritis Self-efficacy Scale (ASES)

  Baseline, 4 months and 1 year

• The Patient Global Impression of Change (PGIC)

  4 months and 1 year

• 6-minutes walking - test

  Baseline, 4 months

Study Arms (2)

Patient Education and BBAT

EXPERIMENTAL

Patients will participate in Patient Education and Basic Body Awareness Therapy

Other: Patient Education and Basic Body Awareness Therapy; Behavioral: Patient Education

Patient Education

ACTIVE COMPARATOR

Patients will only participate in Patient Education

Behavioral: Patient Education

Interventions

Patient Education and Basic Body Awareness Therapy OTHER

Patient education (1/2 day) and a Physiotherapy movement modality (12 times, once a week)

Also known as: PE and BBAT

Patient Education and BBAT

Patient Education BEHAVIORAL

Patient education (1/2 day)

Also known as: PE

Patient Education; Patient Education and BBAT

Eligibility Criteria

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

You may qualify if:

• Women and men with primary OA according to the American College of Rheumatology Clinical Criteria, living in Bergen or within a reasonable travelling distance (judged by the patients).

You may not qualify if:

• Other known major physical or mental problems or disease that precludes movement training and participation in an educational program, known drug abuse, not speaking or understanding Norwegian language, pregnancy 5-9 months.

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator
• Bergen University College: collaborator

Study Sites (1)

University of Bergen

Bergen, 5018, Norway

Location

Related Publications (57)

• Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24.

  PMID: 21907813 BACKGROUND

• Grotle M, Hagen KB, Natvig B, Dahl FA, Kvien TK. Obesity and osteoarthritis in knee, hip and/or hand: an epidemiological study in the general population with 10 years follow-up. BMC Musculoskelet Disord. 2008 Oct 2;9:132. doi: 10.1186/1471-2474-9-132.

  PMID: 18831740 BACKGROUND

• Veje K, Hyllested JL, Ostergaard K. [Osteoarthritis. Pathogenesis, clinical features and treatment]. Ugeskr Laeger. 2002 Jun 10;164(24):3173-9. Danish.

  PMID: 12082761 BACKGROUND

• Truszczynska A, Drzal-Grabiec J, Rapala K, Tarnowski A, Gorniak K, Bialecki J. Characteristics of selected parameters of body posture in patients with hip osteoarthritis. Ortop Traumatol Rehabil. 2014 May-Jun;16(3):351-60. doi: 10.5604/15093492.1112959.

  PMID: 25058110 BACKGROUND

• Dosanjh S, Matta JM, Bhandari M; Anterior THA Research Collaborative. The final straw: a qualitative study to explore patient decisions to undergo total hip arthroplasty. Arch Orthop Trauma Surg. 2009 Jun;129(6):719-27. doi: 10.1007/s00402-008-0671-1. Epub 2008 Jun 17.

  PMID: 18560849 BACKGROUND

• Espehaug B, Furnes O, Engesaeter LB, Havelin LI. Hip arthroplasty in Norway 1989-2008. Tidsskr Nor Laegeforen. 2011 Aug 23;131(16):1543-8. doi: 10.4045/tidsskr.09.1091. English, Norwegian.

  PMID: 21866193 BACKGROUND

• Fevang BT, Lie SA, Havelin LI, Engesaeter LB, Furnes O. Improved results of primary total hip replacement. Acta Orthop. 2010 Dec;81(6):649-59. doi: 10.3109/17453674.2010.537807.

  PMID: 21110699 BACKGROUND

• Dale H, Fenstad AM, Hallan G, Havelin LI, Furnes O, Overgaard S, Pedersen AB, Karrholm J, Garellick G, Pulkkinen P, Eskelinen A, Makela K, Engesaeter LB. Increasing risk of prosthetic joint infection after total hip arthroplasty. Acta Orthop. 2012 Oct;83(5):449-58. doi: 10.3109/17453674.2012.733918.

  PMID: 23083433 BACKGROUND

• Jiang L, Rong J, Wang Y, Hu F, Bao C, Li X, Zhao Y. The relationship between body mass index and hip osteoarthritis: a systematic review and meta-analysis. Joint Bone Spine. 2011 Mar;78(2):150-5. doi: 10.1016/j.jbspin.2010.04.011. Epub 2010 Jun 30.

  PMID: 20580591 BACKGROUND

• Viester L, Verhagen EA, Oude Hengel KM, Koppes LL, van der Beek AJ, Bongers PM. The relation between body mass index and musculoskeletal symptoms in the working population. BMC Musculoskelet Disord. 2013 Aug 12;14:238. doi: 10.1186/1471-2474-14-238.

  PMID: 23937768 BACKGROUND

• Apold H, Meyer HE, Espehaug B, Nordsletten L, Havelin LI, Flugsrud GB. Weight gain and the risk of total hip replacement a population-based prospective cohort study of 265,725 individuals. Osteoarthritis Cartilage. 2011 Jul;19(7):809-15. doi: 10.1016/j.joca.2011.03.013. Epub 2011 Apr 12.

  PMID: 21524707 BACKGROUND

• Mork PJ, Holtermann A, Nilsen TI. Effect of body mass index and physical exercise on risk of knee and hip osteoarthritis: longitudinal data from the Norwegian HUNT Study. J Epidemiol Community Health. 2012 Aug;66(8):678-83. doi: 10.1136/jech-2011-200834. Epub 2012 Apr 17.

  PMID: 22511797 BACKGROUND

• Vincent HK, Heywood K, Connelly J, Hurley RW. Obesity and weight loss in the treatment and prevention of osteoarthritis. PM R. 2012 May;4(5 Suppl):S59-67. doi: 10.1016/j.pmrj.2012.01.005.

  PMID: 22632704 BACKGROUND

• Paans N, van den Akker-Scheek I, Dilling RG, Bos M, van der Meer K, Bulstra SK, Stevens M. Effect of exercise and weight loss in people who have hip osteoarthritis and are overweight or obese: a prospective cohort study. Phys Ther. 2013 Feb;93(2):137-46. doi: 10.2522/ptj.20110418. Epub 2012 Sep 27.

  PMID: 23023813 BACKGROUND

• Scotece M, Conde J, Gomez R, Lopez V, Lago F, Gomez-Reino JJ, Gualillo O. Beyond fat mass: exploring the role of adipokines in rheumatic diseases. ScientificWorldJournal. 2011;11:1932-47. doi: 10.1100/2011/290142. Epub 2011 Oct 25.

  PMID: 22194660 BACKGROUND

• Moe RH, Haavardsholm EA, Christie A, Jamtvedt G, Dahm KT, Hagen KB. Effectiveness of nonpharmacological and nonsurgical interventions for hip osteoarthritis: an umbrella review of high-quality systematic reviews. Phys Ther. 2007 Dec;87(12):1716-27. doi: 10.2522/ptj.20070042. Epub 2007 Sep 25.

  PMID: 17906289 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

• Roos EM, Juhl CB. Osteoarthritis 2012 year in review: rehabilitation and outcomes. Osteoarthritis Cartilage. 2012 Dec;20(12):1477-83. doi: 10.1016/j.joca.2012.08.028. Epub 2012 Sep 7.

  PMID: 22960093 BACKGROUND

• Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.

  PMID: 23595142 BACKGROUND

• Walsh NE, Brooks P, Hazes JM, Walsh RM, Dreinhofer K, Woolf AD, Akesson K, Lidgren L; Bone and Joint Decade Task Force for Standards of Care for Acute and Chronic Musculoskeletal Pain. Standards of care for acute and chronic musculoskeletal pain: the Bone and Joint Decade (2000-2010). Arch Phys Med Rehabil. 2008 Sep;89(9):1830-45. doi: 10.1016/j.apmr.2008.04.009.

  PMID: 18760171 BACKGROUND

• Klassbo M, Larsson G, Harms-Ringdahl K. Promising outcome of a hip school for patients with hip dysfunction. Arthritis Rheum. 2003 Jun 15;49(3):321-7. doi: 10.1002/art.11110.

  PMID: 12794786 BACKGROUND

• Skou ST, Odgaard A, Rasmussen JO, Roos EM. Group education and exercise is feasible in knee and hip osteoarthritis. Dan Med J. 2012 Dec;59(12):A4554.

  PMID: 23290290 BACKGROUND

• Jensen C, Roos EM, Kjaersgaard-Andersen P, Overgaard S. The effect of education and supervised exercise vs. education alone on the time to total hip replacement in patients with severe hip osteoarthritis. A randomized clinical trial protocol. BMC Musculoskelet Disord. 2013 Jan 14;14:21. doi: 10.1186/1471-2474-14-21.

  PMID: 23311889 BACKGROUND

• Svege I, Nordsletten L, Fernandes L, Risberg MA. Exercise therapy may postpone total hip replacement surgery in patients with hip osteoarthritis: a long-term follow-up of a randomised trial. Ann Rheum Dis. 2015 Jan;74(1):164-9. doi: 10.1136/annrheumdis-2013-203628. Epub 2013 Nov 19.

  PMID: 24255546 BACKGROUND

• Pedersen BK, Saltin B. Evidence for prescribing exercise as therapy in chronic disease. Scand J Med Sci Sports. 2006 Feb;16 Suppl 1:3-63. doi: 10.1111/j.1600-0838.2006.00520.x.

  PMID: 16451303 BACKGROUND

• Beckwee D, Vaes P, Cnudde M, Swinnen E, Bautmans I. Osteoarthritis of the knee: why does exercise work? A qualitative study of the literature. Ageing Res Rev. 2013 Jan;12(1):226-36. doi: 10.1016/j.arr.2012.09.005. Epub 2012 Sep 28.

  PMID: 23026409 BACKGROUND

• Fransen M, McConnell S, Bell M. Exercise for osteoarthritis of the hip or knee. Cochrane Database Syst Rev. 2003;(3):CD004286. doi: 10.1002/14651858.CD004286.

  PMID: 12918008 BACKGROUND

• McNair PJ, Simmonds MA, Boocock MG, Larmer PJ. Exercise therapy for the management of osteoarthritis of the hip joint: a systematic review. Arthritis Res Ther. 2009;11(3):R98. doi: 10.1186/ar2743. Epub 2009 Jun 25.

  PMID: 19555502 BACKGROUND

• Fransen M, McConnell S, Hernandez-Molina G, Reichenbach S. Exercise for osteoarthritis of the hip. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD007912. doi: 10.1002/14651858.CD007912.pub2.

  PMID: 24756895 BACKGROUND

• Fransen M, McConnell S, Hernandez-Molina G, Reichenbach S. Does land-based exercise reduce pain and disability associated with hip osteoarthritis? A meta-analysis of randomized controlled trials. Osteoarthritis Cartilage. 2010 May;18(5):613-20. doi: 10.1016/j.joca.2010.01.003. Epub 2010 Feb 10.

  PMID: 20188228 BACKGROUND

• Escalante Y, Saavedra JM, Garcia-Hermoso A, Silva AJ, Barbosa TM. Physical exercise and reduction of pain in adults with lower limb osteoarthritis: a systematic review. J Back Musculoskelet Rehabil. 2010;23(4):175-86. doi: 10.3233/BMR-2010-0267.

  PMID: 21079296 BACKGROUND

• Golightly YM, Allen KD, Caine DJ. A comprehensive review of the effectiveness of different exercise programs for patients with osteoarthritis. Phys Sportsmed. 2012 Nov;40(4):52-65. doi: 10.3810/psm.2012.11.1988.

  PMID: 23306415 BACKGROUND

• Tak E, Staats P, Van Hespen A, Hopman-Rock M. The effects of an exercise program for older adults with osteoarthritis of the hip. J Rheumatol. 2005 Jun;32(6):1106-13.

  PMID: 15940775 BACKGROUND

• Fernandes L, Storheim K, Sandvik L, Nordsletten L, Risberg MA. Efficacy of patient education and supervised exercise vs patient education alone in patients with hip osteoarthritis: a single blind randomized clinical trial. Osteoarthritis Cartilage. 2010 Oct;18(10):1237-43. doi: 10.1016/j.joca.2010.05.015. Epub 2010 Jul 13.

  PMID: 20633669 BACKGROUND

• Poulsen E, Hartvigsen J, Christensen HW, Roos EM, Vach W, Overgaard S. Patient education with or without manual therapy compared to a control group in patients with osteoarthritis of the hip. A proof-of-principle three-arm parallel group randomized clinical trial. Osteoarthritis Cartilage. 2013 Oct;21(10):1494-503. doi: 10.1016/j.joca.2013.06.009. Epub 2013 Jun 21.

  PMID: 23792189 BACKGROUND

• Bennell KL, Egerton T, Martin J, Abbott JH, Metcalf B, McManus F, Sims K, Pua YH, Wrigley TV, Forbes A, Smith C, Harris A, Buchbinder R. Effect of physical therapy on pain and function in patients with hip osteoarthritis: a randomized clinical trial. JAMA. 2014 May 21;311(19):1987-97. doi: 10.1001/jama.2014.4591.

  PMID: 24846036 BACKGROUND

• Wallis JA, Taylor NF. Pre-operative interventions (non-surgical and non-pharmacological) for patients with hip or knee osteoarthritis awaiting joint replacement surgery--a systematic review and meta-analysis. Osteoarthritis Cartilage. 2011 Dec;19(12):1381-95. doi: 10.1016/j.joca.2011.09.001. Epub 2011 Sep 10.

  PMID: 21959097 BACKGROUND

• Gill SD, McBurney H. Does exercise reduce pain and improve physical function before hip or knee replacement surgery? A systematic review and meta-analysis of randomized controlled trials. Arch Phys Med Rehabil. 2013 Jan;94(1):164-76. doi: 10.1016/j.apmr.2012.08.211. Epub 2012 Sep 4.

  PMID: 22960276 BACKGROUND

• Greenfield BH, Jensen GM. Understanding the lived experiences of patients: application of a phenomenological approach to ethics. Phys Ther. 2010 Aug;90(8):1185-97. doi: 10.2522/ptj.20090348. Epub 2010 Jun 10.

  PMID: 20539020 BACKGROUND

• Jensen GM. Learning: what matters most. Phys Ther. 2011 Nov;91(11):1674-89. doi: 10.2522/ptj.2011.mcmillan.lecture. Epub 2011 Sep 8. No abstract available.

  PMID: 21903733 BACKGROUND

• Dropsy J. Den harmoniska kroppen - en osynlig övning. Stocholm, Bokforlaget Natur och Kultur Sverige, 1983.

  BACKGROUND

• Skjaerven LH, Kristoffersen K, Gard G. An eye for movement quality: a phenomenological study of movement quality reflecting a group of physiotherapists' understanding of the phenomenon. Physiother Theory Pract. 2008 Jan-Feb;24(1):13-27. doi: 10.1080/01460860701378042.

  PMID: 18300105 BACKGROUND

• Skjaerven LH, Kristoffersen K, Gard G. How can movement quality be promoted in clinical practice? A phenomenological study of physical therapist experts. Phys Ther. 2010 Oct;90(10):1479-92. doi: 10.2522/ptj.20090059. Epub 2010 Aug 5.

  PMID: 20688872 BACKGROUND

• Skatteboe UB, Friis S, Hope MK, Vaglum P. Body awareness group therapy for patients with personality disorders. 1. Description of the therapeutic method. Psychother Psychosom. 1989;51(1):11-7. doi: 10.1159/000288128.

  PMID: 2602527 BACKGROUND

• Yalom I. The Theory and Practise of Group Psychotherapy. 3 ed. New York NY: Basic Books; 1995.

  BACKGROUND

• Giorgi A. The theory, practice and evaluation of the phenomenological method as a qualitative research procedure. Journal of Phenomenological Psychology; 28 (2), 235-260, 1997.

  BACKGROUND

• Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505-14. doi: 10.1002/art.1780340502.

  PMID: 2025304 BACKGROUND

• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

  PMID: 3785962 BACKGROUND

• Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

  PMID: 11690728 BACKGROUND

• Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.

  PMID: 15208174 BACKGROUND

• Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Immediate efficacy of neuromuscular exercise in patients with severe osteoarthritis of the hip or knee: a secondary analysis from a randomized controlled trial. J Rheumatol. 2014 Jul;41(7):1385-94. doi: 10.3899/jrheum.130642. Epub 2014 Jun 15.

  PMID: 24931956 BACKGROUND

• Nilsdotter AK, Lohmander LS, Klassbo M, Roos EM. Hip disability and osteoarthritis outcome score (HOOS)--validity and responsiveness in total hip replacement. BMC Musculoskelet Disord. 2003 May 30;4:10. doi: 10.1186/1471-2474-4-10. Epub 2003 May 30.

  PMID: 12777182 BACKGROUND

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 BACKGROUND

• Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.

  PMID: 2912463 BACKGROUND

• Lauridsen HH, Hartvigsen J, Korsholm L, Grunnet-Nilsson N, Manniche C. Choice of external criteria in back pain research: Does it matter? Recommendations based on analysis of responsiveness. Pain. 2007 Sep;131(1-2):112-20. doi: 10.1016/j.pain.2006.12.023. Epub 2007 Feb 2.

  PMID: 17276006 BACKGROUND

• Tveter AT, Dagfinrud H, Moseng T, Holm I. Health-related physical fitness measures: reference values and reference equations for use in clinical practice. Arch Phys Med Rehabil. 2014 Jul;95(7):1366-73. doi: 10.1016/j.apmr.2014.02.016. Epub 2014 Mar 5.

  PMID: 24607837 BACKGROUND

• Skjaerven LH, Gard G, Sundal MA, Strand LI. Reliability and Validity of the Body Awareness Rating Scale (BARS), an Observational Assessment tool of Movement Quality. European Journal of Physiotherapy, 17(1), 19-21, 2015.

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Liv I Strand, Dr.philos.

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment at inclusion was done before randomization, and was also blinded at follow-ups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, dr. philos.

Model Details: A blinded RCT

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 31, 2016
• Study Start: October 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available from January 2021 to January 2023
• Access Criteria: All data that has relevance to NOAR will be shared

Locations

NO (1)