TY - JOUR
T1 - First-line treatment for femoroacetabular impingement syndrome and hip-related quality of life
T2 - study protocol for a multicentre randomised controlled trial comparing a 6-month supervised strength exercise intervention to usual care (the Better Hip Trial)
AU - Foldager, Frederik Nicolai
AU - Kierkegaard-Brøchner, Signe
AU - Kemp, Joanne L
AU - van Tulder, Maurits W
AU - Lund, Bent
AU - Mygind-Klavsen, Bjarne
AU - Bibby, Bo Martin
AU - Dalgas, Ulrik
AU - Mechlenburg, Inger
PY - 2024/6/21
Y1 - 2024/6/21
N2 - Introduction Femoroacetabular impingement syndrome (FAIS) is a motion-related and position-related clinical condition of the hip associated with pain, reduced physical function and hip-related quality of life (QoL). Interestingly, higher maximal muscle strength is associated with less pain, better physical function and improved QoL in people with FAIS. Furthermore, preliminary evidence suggests that a proportion of patients with FAIS respond positively to strength exercise as first-line treatment. Nonetheless, there is little evidence supporting a specific exercise intervention offered as a first-line treatment. We will conduct a randomised controlled trial investigating the clinical effectiveness and cost-effectiveness of a 6-month strength exercise intervention compared with usual care as first-line treatment in patients with FAIS. Methods and analysis This is a multicentre randomised controlled trial that will be conducted at hospitals and physiotherapy clinics across Denmark and Australia. A total of 120 patients with FAIS will be randomised (1:1) to 6 months of supervised strength exercise or usual care. The primary outcome is the change in hip-related QoL measured using the International Hip and Outcome Tool 33 (iHOT-33) from baseline to the end of intervention. A health economic evaluation will be conducted from a societal and healthcare perspective based on the data collection over a 12-month period starting at baseline. The analysis will calculate incremental cost-effectiveness ratios using quality-adjusted life-years and iHOT-33 scores while estimating costs using microcosting and cost questionnaires. Secondary outcomes include objectively measured physical function at baseline and after 6 months and patient-reported outcomes measured at baseline, 3-month, 6-month and 12-month follow-up. Ethics and dissemination The trial has been approved by the Committee on Health Research Ethics in the Central Denmark Region (journal no 1-10-72-45-23) and La Trobe University Human Ethics Committee (HEC24042) and is registered at the Central Denmark Region List of Research Projects (journal no 1-16-02-115-23). Informed consent will be obtained from each participant before randomisation. Results will be published in international peer-reviewed scientific journals.
AB - Introduction Femoroacetabular impingement syndrome (FAIS) is a motion-related and position-related clinical condition of the hip associated with pain, reduced physical function and hip-related quality of life (QoL). Interestingly, higher maximal muscle strength is associated with less pain, better physical function and improved QoL in people with FAIS. Furthermore, preliminary evidence suggests that a proportion of patients with FAIS respond positively to strength exercise as first-line treatment. Nonetheless, there is little evidence supporting a specific exercise intervention offered as a first-line treatment. We will conduct a randomised controlled trial investigating the clinical effectiveness and cost-effectiveness of a 6-month strength exercise intervention compared with usual care as first-line treatment in patients with FAIS. Methods and analysis This is a multicentre randomised controlled trial that will be conducted at hospitals and physiotherapy clinics across Denmark and Australia. A total of 120 patients with FAIS will be randomised (1:1) to 6 months of supervised strength exercise or usual care. The primary outcome is the change in hip-related QoL measured using the International Hip and Outcome Tool 33 (iHOT-33) from baseline to the end of intervention. A health economic evaluation will be conducted from a societal and healthcare perspective based on the data collection over a 12-month period starting at baseline. The analysis will calculate incremental cost-effectiveness ratios using quality-adjusted life-years and iHOT-33 scores while estimating costs using microcosting and cost questionnaires. Secondary outcomes include objectively measured physical function at baseline and after 6 months and patient-reported outcomes measured at baseline, 3-month, 6-month and 12-month follow-up. Ethics and dissemination The trial has been approved by the Committee on Health Research Ethics in the Central Denmark Region (journal no 1-10-72-45-23) and La Trobe University Human Ethics Committee (HEC24042) and is registered at the Central Denmark Region List of Research Projects (journal no 1-16-02-115-23). Informed consent will be obtained from each participant before randomisation. Results will be published in international peer-reviewed scientific journals.
KW - Adult
KW - Australia
KW - Cost-Benefit Analysis
KW - Denmark
KW - Exercise Therapy/methods
KW - Female
KW - Femoracetabular Impingement/therapy
KW - Humans
KW - Multicenter Studies as Topic
KW - Muscle Strength
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Resistance Training/methods
KW - Treatment Outcome
KW - Musculoskeletal disorders
KW - Hip
KW - HEALTH ECONOMICS
KW - Rehabilitation medicine
UR - http://www.scopus.com/inward/record.url?scp=85196896929&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-078726
DO - 10.1136/bmjopen-2023-078726
M3 - Journal article
C2 - 38908842
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e078726
ER -