A phase II trial for the efficacy of physiotherapy intervention for early-onset hip osteoarthritis: Study protocol for a randomised controlled trial
- Kemp, Joanne, Moore, Kate, Fransen, Marlene, Russell, Trevor, Crossley, Kay
- Authors: Kemp, Joanne , Moore, Kate , Fransen, Marlene , Russell, Trevor , Crossley, Kay
- Date: 2015
- Type: Text , Journal article
- Relation: Trials Vol. 16, no. 1 (2015), p. 1-8
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- Description: Background: Early-onset hip osteoarthritis is commonly seen in people undergoing hip arthroscopy and is associated with increased pain, reduced ability to participate in physical activity, reduced quality of life and reduced range of motion and muscle strength. Despite this, the efficacy of non-surgical interventions such as exercise therapies remains unknown. The primary aim is to establish the feasibility of a phase III randomised controlled trial investigating a targeted physiotherapy intervention for people with early-onset hip osteoarthritis. The secondary aims are to determine the size of treatment effects of a physiotherapy intervention, targeted to improve hip joint range and hip-related symptoms in early-onset hip osteoarthritis following hip arthroscopy, compared to a health-education control. Methods: This protocol describes a randomised, assessor- and participant-blind, controlled clinical trial. We will include 20 participants who are (i) aged between 18 and 50 years; (ii) have undergone hip arthroscopy during the past six to 12 months; (iii) have early-onset hip osteoarthritis (defined as chondrolabral pathology) at the time of hip arthroscopy; and (iv) experience hip-related pain during activities. Primary outcome will be the feasibility of a phase III clinical trial. Secondary outcomes will be (i) perceived global change score; (ii) hip-related symptoms (measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale, activity subscale, and sport and recreation subscale); (iii) hip quality of life (measured using the HOOS quality of life subscale and International Hip Outcome tool; (iv) hip muscle strength and (v) hip range of motion. The physiotherapy intervention is semi-standardised, including joint and soft tissue mobilisation and stretching, hip and trunk muscle retraining and functional and activity-specific retraining and education. The control intervention encompasses individualised health education, with the same frequency and duration as the intervention. The trial primary end-point is the conclusion of the 12-week intervention, and follow-up measures will be collected at the 12-week post-baseline assessment. Discussion: The findings of this study will provide guidance regarding the feasibility of a full-scale phase III randomised controlled trial, prior to its undertaking. Trial registration: The trial protocol was registered with the Australian Clinical Trials Registry (number: 12614000426684) on 17 April 2014. © Kemp et al.
- Authors: Kemp, Joanne , Moore, Kate , Fransen, Marlene , Russell, Trevor , Crossley, Kay
- Date: 2015
- Type: Text , Journal article
- Relation: Trials Vol. 16, no. 1 (2015), p. 1-8
- Full Text:
- Reviewed:
- Description: Background: Early-onset hip osteoarthritis is commonly seen in people undergoing hip arthroscopy and is associated with increased pain, reduced ability to participate in physical activity, reduced quality of life and reduced range of motion and muscle strength. Despite this, the efficacy of non-surgical interventions such as exercise therapies remains unknown. The primary aim is to establish the feasibility of a phase III randomised controlled trial investigating a targeted physiotherapy intervention for people with early-onset hip osteoarthritis. The secondary aims are to determine the size of treatment effects of a physiotherapy intervention, targeted to improve hip joint range and hip-related symptoms in early-onset hip osteoarthritis following hip arthroscopy, compared to a health-education control. Methods: This protocol describes a randomised, assessor- and participant-blind, controlled clinical trial. We will include 20 participants who are (i) aged between 18 and 50 years; (ii) have undergone hip arthroscopy during the past six to 12 months; (iii) have early-onset hip osteoarthritis (defined as chondrolabral pathology) at the time of hip arthroscopy; and (iv) experience hip-related pain during activities. Primary outcome will be the feasibility of a phase III clinical trial. Secondary outcomes will be (i) perceived global change score; (ii) hip-related symptoms (measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale, activity subscale, and sport and recreation subscale); (iii) hip quality of life (measured using the HOOS quality of life subscale and International Hip Outcome tool; (iv) hip muscle strength and (v) hip range of motion. The physiotherapy intervention is semi-standardised, including joint and soft tissue mobilisation and stretching, hip and trunk muscle retraining and functional and activity-specific retraining and education. The control intervention encompasses individualised health education, with the same frequency and duration as the intervention. The trial primary end-point is the conclusion of the 12-week intervention, and follow-up measures will be collected at the 12-week post-baseline assessment. Discussion: The findings of this study will provide guidance regarding the feasibility of a full-scale phase III randomised controlled trial, prior to its undertaking. Trial registration: The trial protocol was registered with the Australian Clinical Trials Registry (number: 12614000426684) on 17 April 2014. © Kemp et al.
Psychometric properties of patient-reported outcome measures for hip arthroscopic surgery
- Kemp, Joanne, Collins, Natalie, Roos, Ewa, Crossley, Kay
- Authors: Kemp, Joanne , Collins, Natalie , Roos, Ewa , Crossley, Kay
- Date: 2013
- Type: Text , Journal article
- Relation: American Journal of Sports Medicine Vol. 41, no. 9 (2013), p. 2065-2073
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- Description: Background: Patient-reported outcomes (PROs) are considered the gold standard when evaluating outcomes in a surgical population. While the psychometric properties of some PROs have been tested, the properties of newer PROs in patients undergoing hip arthroscopic surgery remain somewhat unknown. Purpose: To evaluate the reliability, validity, responsiveness, and interpretability of 5 PROs (Copenhagen Hip and Groin Outcome Score [HAGOS], Hip Disability and Osteoarthritis Outcome Score [HOOS], Hip Outcome Score [HOS], International Hip Outcome Tool [iHOT-33], and Modified Harris Hip Score [MHHS]) in a population undergoing hip arthroscopic surgery and also to provide a recommendation of the best PROs in patients undergoing hip arthroscopic surgery. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Study participants were adults (mean age, 37 ± 11 years) who had undergone hip arthroscopic surgery 12 to 24 months previously and pain-free, healthy age-matched controls (mean age, 35 ± 11 years). Baseline characteristics including age, height, weight, waist girth, physical activity, and occupation were collected for both groups. The hip arthroscopic surgery group completed the 5 PRO questionnaires on 3 occasions, while the healthy control group completed the PRO questionnaires on 1 occasion. The reliability (test-retest reliability [intraclass correlation coefficient, or ICC] and minimal detectable change [MDC]), validity (construct validity, ability to detect a difference between groups, acceptability including floor and ceiling effects), responsiveness, and interpretability (minimal important change [MIC]) of each measure were calculated. Results: The test-retest reliability of PROs was excellent (ICC, 0.91-0.97), with an MDC of<20%. The HOOS, HAGOS, and iHOT- 33 had acceptable content validity. All PROs demonstrated construct validity and were able to detect a difference between the hip arthroscopic surgery and control groups. No measures demonstrated a floor effect; however, the MHHS and subscales relating to activities of daily living of the HOOS, HOS, and HAGOS demonstrated a ceiling effect. The HOOS, iHOT-33, and MHHS demonstrated adequate responsiveness, and the MIC for all measures was<11 points of a possible 100 points. Conclusion: The PROs of the HOOS and iHOT-33 demonstrate psychometric properties that may enable researchers and clinicians to use them with confidence in a population undergoing hip arthroscopic surgery. The psychometric properties of the MHHS, HOS, and some subscales of the HAGOS are reduced, and these PROs may be less valuable in this group. © 2013 The Author(s). National Health and Medical Research Council (Australia) Health Professional Research Training (Postdoctoral) Fellowship (No. 628918).
- Kemp, Joanne, Schache, Anthony, Makdissi, Michael, Sims, Kevin, Crossley, Kay
- Authors: Kemp, Joanne , Schache, Anthony , Makdissi, Michael , Sims, Kevin , Crossley, Kay
- Date: 2013
- Type: Text , Journal article
- Relation: Journal of Science and Medicine in Sport Vol. 16, no. 4 (2013), p. 292-296
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- Description: Objectives: This study investigated tests of hip muscle strength and functional performance. The specific objectives were to: (i) establish intra- and inter-rater reliability; (ii) compare differences between dominant and non-dominant limbs; (iii) compare agonist and antagonist muscle strength ratios; (iv) compare differences between genders; and (v) examine relationships between hip muscle strength, baseline measures and functional performance. Design: Reliability study and cross-sectional analysis of hip strength and functional performance. Methods: In healthy adults aged 18-50. years, normalised hip muscle peak torque and functional performance were evaluated to: (i) establish intra-rater and inter-rater reliability; (ii) analyse differences between limbs, between antagonistic muscle groups and genders; and (iii) associations between strength and functional performance. Results: Excellent reliability (intra-rater ICC = 0.77-0.96; inter-rater ICC = 0.82-0.95) was observed. No difference existed between dominant and non-dominant limbs. Differences in strength existed between antagonistic pairs of muscles: hip abduction was greater than adduction (p < 0.001) and hip ER was greater than IR (p < 0.001). Men had greater ER strength (p = 0.006) and hop for distance (p < 0.001) than women. Strong associations were observed between measures of hip muscle strength (except hip flexion) and age, height, and functional performance. Conclusions: Deficits in hip muscle strength or functional performance may influence hip pain. In order to provide targeted rehabilitation programmes to address patient-specific impairments, and determine when individuals are ready to return to physical activity, clinicians are increasingly utilising tests of hip strength and functional performance. This study provides a battery of reliable, clinically applicable tests which can be used for these purposes. © 2012 Sports Medicine Australia.
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