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Trial record 21 of 976 for:    scale | Norway

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

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ClinicalTrials.gov Identifier: NCT02884531
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
Haukeland University Hospital
Bergen University College
Information provided by (Responsible Party):
Liv Inger Strand, University of Bergen

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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Other: Patient Education and Basic Body Awareness Therapy Behavioral: Patient Education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment and Treatment Responses to Patient Education and Basic Body Awareness Therapy in Hip Osteoarthritis: a Randomized Controlled Trial
Actual Study Start Date : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Patient Education and BBAT
Patients will participate in Patient Education and Basic Body Awareness Therapy
Other: Patient Education and Basic Body Awareness Therapy
Patient education (1/2 day) and a Physiotherapy movement modality (12 times, once a week)
Other Name: PE and BBAT

Behavioral: Patient Education
Patient education (1/2 day)
Other Name: PE

Active Comparator: Patient Education
Patients will only participate in Patient Education
Behavioral: Patient Education
Patient education (1/2 day)
Other Name: PE




Primary Outcome Measures :
  1. Numeric Rating Scale, change in pain [ Time Frame: Baseline, 4 months and 1 year ]
    Pain intensity during walking

  2. Hip disability and Osteoarthritis Outcome Score (HOOS), change in ADL [ Time Frame: Baseline, 4 months and 1 year ]
    Self-reported disability


Secondary Outcome Measures :
  1. Harris Hip Score (HHS) [ Time Frame: Baseline, 4 months and 1 year ]
    Assesses hip disabilities and effect of treatment on four domains

  2. The EuroQol (EQ-5D-5L) [ Time Frame: Baseline, 4 months and 1 year ]
    A generic health index comprising a five-part questionnaire and a visual analogue self-rating scale

  3. Arthritis Self-efficacy Scale (ASES) [ Time Frame: Baseline, 4 months and 1 year ]
    A questionnaire about self-efficacy regarding pain and symptoms

  4. The Patient Global Impression of Change (PGIC) [ Time Frame: 4 months and 1 year ]
    Assesses the patients' own impression of change over time

  5. 6-minutes walking - test [ Time Frame: Baseline, 4 months ]
    Walking distance (inside) during the time limit of 6 minutes

  6. Chair test. [ Time Frame: Baseline, 4 months ]
    The patient repeats rising up from a chair and sitting down during 30 seconds and the number is counted

  7. Stairs test. [ Time Frame: Baseline, 4 months ]
    The number of seconds used to walk up and down 18 steps x 3 is measured

  8. Body Awareness Rating Scale (BARS) [ Time Frame: Baseline, 4 months ]
    Consists of two assessment parts: 1) observation and assessment of movement quality based on 12 movements and 2) interview with the patient about movement awareness immediately after exploring each movement.

  9. UCLA Activity Score [ Time Frame: Baseline, 4 months and 1 year ]
    Assesses degree of Activity on ordinal scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884531


Contacts
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Contact: Liv I Strand, Dr.philos. +47 92462447 liv.strand@uib.no
Contact: Aarid Liland Olsen, MSc +47 94136128 Aarid.Olsen@uib.no

Locations
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Norway
University of Bergen Recruiting
Bergen, Norway, 5018
Contact: Guri Rørtveit, PhD    +47 55586141    Guri.Rortveit@uib.no   
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Bergen University College
Investigators
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Principal Investigator: Liv I Strand, Dr.philos. University of Bergen

Publications:
Dropsy J. Den harmoniska kroppen - en osynlig övning. Stocholm, Bokforlaget Natur och Kultur Sverige, 1983.
Yalom I. The Theory and Practise of Group Psychotherapy. 3 ed. New York NY: Basic Books; 1995.
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.
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.

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Responsible Party: Liv Inger Strand, Professor, dr. philos., University of Bergen
ClinicalTrials.gov Identifier: NCT02884531     History of Changes
Other Study ID Numbers: Hip osteoarthritis RCT
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the RCT has been completed, the plan is to enter data in a national register for patients with osteoarthritis, NOAR. The patients give their consent to this.

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases