Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000214932
Ethics application status
Approved
Date submitted
7/02/2020
Date registered
21/02/2020
Date last updated
29/10/2021
Date data sharing statement initially provided
21/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Tasmanian Community HIp Pain (TasCHIP) Cohort Study
Scientific title
Tasmanian Community HIp Pain (TasCHIP) Cohort Study
Secondary ID [1] 298842 0
PG18-BH001
Universal Trial Number (UTN)
Trial acronym
TasCHIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip pain 313795 0
Groin pain 316274 0
Condition category
Condition code
Musculoskeletal 312208 312208 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 312299 312299 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Hip and/or groin pain is common in young and middle-aged people, and may represent arthritis in its early stages. These people have persistent pain, difficulty participating in work and functional activity and have worse quality of life compared to healthy people. This is at a time of peak work and family commitments. Improving the capacity of these individuals to participate fully in work and functional activity will have large positive personal and societal benefits.

100 people aged 18-55 years with hip and/or groin pain will be recruited. Participants will undergo baseline radiographs, clinical and demographic assessment and complete patient-reported outcome measures. Participants will be followed up at 6 and 12 (primary endpoint) months. Modifiable risk factors at baseline that predict increase in pain and worsening of quality of life (primary outcome) and changes in physical activity, sports participation, work participation and progression to hip surgery (secondary outcomes) at 6 and 12 months will be determined.
Intervention code [1] 315108 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320842 0
Change over 12 months in hip and/or groin pain using the Copenhagen Hip and Groin Outcome Score (HAGOS) pain subscale. The HAGOS-Pain subscale provides a single score from 0-100 points, where zero represents extreme hip and/or groin problems and 100 represents no hip and/or groin problems
Timepoint [1] 320842 0
12 months after completion of baseline assessment
Primary outcome [2] 320843 0
Change over 12 months in hip-related Quality of Life using the IHOT-33. This is a single score 0-100 points, where a score of zero represents worst quality of life and a score of 100 indicates best quality life .
Timepoint [2] 320843 0
12 months after completion of baseline assessment
Secondary outcome [1] 373017 0
Hip and/or groin pain using the Copenhagen Hip and Groin Outcome Score (HAGOS) pain subscale.
Timepoint [1] 373017 0
Baseline, 1 week and 6 months after completion of baseline assessment
Secondary outcome [2] 373018 0
Hip-related Quality of Life using the IHOT-33.
Timepoint [2] 373018 0
Baseline, 1 week and 6 months after completion of baseline assessment
Secondary outcome [3] 373021 0
Work participation using the Workplace Activity Limitations Scale (WALS).
Timepoint [3] 373021 0
Baseline, 6 and 12 months after completion of baseline assessment
Secondary outcome [4] 373394 0
Patient specific functional scale (PSFS)
Timepoint [4] 373394 0
Baseline, 6 and 12 months after completion of baseline assessment
Secondary outcome [5] 373395 0
Health-related quality of life using the EQ-5D
Timepoint [5] 373395 0
Baseline, 6 and 12 months after completion of baseline assessment
Secondary outcome [6] 373396 0
Progression to hip arthroscopy surgery, total hip arthroplasty (THA) or other hip surgeries.
Timepoint [6] 373396 0
Baseline, 6 and 12 months after completion of baseline assessment
Secondary outcome [7] 373397 0
Illness perception questionnaire
Timepoint [7] 373397 0
Baseline, 6 and 12 months after completion of baseline assessment
Secondary outcome [8] 373398 0
Keele STarT MSK Screening Tool
Timepoint [8] 373398 0
Baseline, 6 and 12 months after completion of baseline assessment
Secondary outcome [9] 373399 0
Hip and/or groin pain specific questionnaire. Hip and/or groin pain over previous week and month measured using a 11-point Numerical Pain Rating Scale; Hip and/or groin pain characteristics.
Timepoint [9] 373399 0
Baseline, 6 and 12 months after completion of baseline assessment
Secondary outcome [10] 373400 0
Hip Sport Activity Scale
Timepoint [10] 373400 0
Baseline, 6 and 12 months after completion of baseline assessment
Secondary outcome [11] 373401 0
International Physical Activity Questionnaire
Timepoint [11] 373401 0
Baseline, 6 and 12 months after completion of baseline assessment
Secondary outcome [12] 373402 0
Global Rating of Change
Timepoint [12] 373402 0
1 Week, 6 and 12 months after completion of baseline assessment
Secondary outcome [13] 373403 0
Short Form-36 (which will assess health-related quality of life)
Timepoint [13] 373403 0
Baseline
Secondary outcome [14] 373404 0
Hip flexion active and passive range of movement (range of movement will be measured with an inclinometer at the end of active and passive movement range)
Timepoint [14] 373404 0
Baseline
Secondary outcome [15] 373405 0
Hip internal and external passive range of movement in 90 degrees of hip flexion (range of movement will be measured with an goniometer at the end of passive movement range)
Timepoint [15] 373405 0
Baseline
Secondary outcome [16] 373406 0
Bent knee fall out (range of movement will be measured with a measurement ruler at the end of active movement range)
Timepoint [16] 373406 0
Baseline
Secondary outcome [17] 373407 0
Hip flexion muscle strength measured using a hand held dynamometer
Timepoint [17] 373407 0
Baseline
Secondary outcome [18] 379714 0
Hip extension muscle strength measured using a hand held dynamometer
Timepoint [18] 379714 0
baseline
Secondary outcome [19] 379715 0
Hip abduction muscle strength measured using a hand held dynamometer
Timepoint [19] 379715 0
Baseline
Secondary outcome [20] 379716 0
Hip adduction muscle strength measured using a hand held dynamometer
Timepoint [20] 379716 0
Baseline
Secondary outcome [21] 379718 0
Intra-articular hip pain (will be evaluated by using the Flexion-Adduction-Internal-Rotation (FADIR test)
Timepoint [21] 379718 0
Baseline
Secondary outcome [22] 379719 0
Greater trochanteric pain syndrome examination (will be evaluated by using the Single leg stance for 30
seconds, Flexion-Adduction-External Rotation-Resisted (FADDER-R) test, Adduction-Resisted (ADD-R) test and palpation)
Timepoint [22] 379719 0
Baseline
Secondary outcome [23] 379720 0
Groin pain clinical entity examination (will be performed to determine the presence of adductor-related, iliopsoas-related, pubic-related and inguinal-related groin pain)
Timepoint [23] 379720 0
Baseline
Secondary outcome [24] 379721 0
Single leg repeated rise test (measuring how many repetitions of a single leg sit to stand movement can
be repeated)
Timepoint [24] 379721 0
Baseline
Secondary outcome [25] 379722 0
Bony hip morphology (evaluated with anteroposterior pelvic and Dunn 45 degree view radiographs)
Timepoint [25] 379722 0
Baseline
Secondary outcome [26] 380104 0
Hip and/or groin symptoms using the HAGOS-symptoms subscale.
Timepoint [26] 380104 0
Baseline, 1 week, 6 and 12 months after completion of baseline assessment
Secondary outcome [27] 380105 0
Function in daily living (ADL) using the HAGOS-ADL subscale
Timepoint [27] 380105 0
Baseline, 1 week, 6 and 12 months after completion of baseline assessment
Secondary outcome [28] 380106 0
Function in sport and recreation (Sports/Rec) using the HAGOS-Sports/Rec subscale
Timepoint [28] 380106 0
Baseline, 1 week, 6 and 12 months after completion of baseline assessment
Secondary outcome [29] 380107 0
Participation in Physical Activities (PA) using the HAGOS-PA subscale
Timepoint [29] 380107 0
Baseline, 1 week, 6 and 12 months after completion of baseline assessment
Secondary outcome [30] 380108 0
hip and/or groin-related Quality of Life (QOL) using the HAGOS-QOL subscale
Timepoint [30] 380108 0
Baseline, 1 week, 6 and 12 months after completion of baseline assessment

Eligibility
Key inclusion criteria
Patients must:
(i) be aged 18-55 years;
(ii) Self-reported hip and/or groin pain for greater than 6 weeks;
(iii) Self-reported average hip and/or groin pain over previous month of >3/10 on a 11-point numerical pain rating scale
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they meet any of the following criteria:
(i) inability to understand English;
(ii) prior history of significant hip and/or groin condition such as congenital dislocation of the hip, Legg-Calve Perthes’ disease, slipped capital femoral epiphysis, avascular necrosis, acetabular fracture, hip dislocation or femoral neck fracture
(iv) prior history of hip and/or groin surgery (i.e. hip arthroscopy)
(v) physical inability to undertake testing procedures
(vi) expected increased likelihood of non-compliance such as a result of cognitive impairment, drug abuse or similar.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A sample size of 90 participants will provide 80% power to detect a partial correlation coefficient of at least 0.30 or greater between the specified predictor of interest and change in pain or QOL in a regression model adjusted for confounding covariates at a=0.05 (Stata/IC 13.1). 100 participants will allow for a drop-out rate of 10%. The use of multilevel models of the outcome repeated over time will allow nonbiased estimates of the one year change in the presence of missing data and allow increased precision of estimates of association.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Safety concerns
Date of first participant enrolment
Anticipated
28/02/2020
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 29250 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 303391 0
Charities/Societies/Foundations
Name [1] 303391 0
Physiotherapy Research Foundation
Country [1] 303391 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health, La Trobe University
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 303431 0
University
Name [1] 303431 0
Curtin University
Address [1] 303431 0
Department of Physiotherapy,
Curtin University
Kent St, Bentley WA 6102
Country [1] 303431 0
Australia
Other collaborator category [1] 281178 0
Commercial sector/Industry
Name [1] 281178 0
Bodysystem Physiotherapy
Address [1] 281178 0
38 Collins ST
Hobart, TAS 7000
Country [1] 281178 0
Australia
Other collaborator category [2] 281179 0
Commercial sector/Industry
Name [2] 281179 0
Radiology Tasmania
Address [2] 281179 0
314 Macquarie Street
Hobart, Tas 7004
Country [2] 281179 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303920 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 303920 0
Ethics committee country [1] 303920 0
Australia
Date submitted for ethics approval [1] 303920 0
24/05/2019
Approval date [1] 303920 0
02/09/2019
Ethics approval number [1] 303920 0
HEC19246

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95254 0
Dr Joanne Kemp
Address 95254 0
Latrobe Sport and Exercise Medicine Research Centre
School of Allied Health
La Trobe University
Bundoora VIC 3086
Country 95254 0
Australia
Phone 95254 0
+61 3 9479 1428
Fax 95254 0
Email 95254 0
[email protected]
Contact person for public queries
Name 95255 0
Joshua Heerey
Address 95255 0
Latrobe Sport and Exercise Medicine Research Centre
School of Allied Health
La Trobe University
Bundoora VIC 3086
Country 95255 0
Australia
Phone 95255 0
+61 419 508 647
Fax 95255 0
Email 95255 0
[email protected]
Contact person for scientific queries
Name 95256 0
Joanne Kemp
Address 95256 0
Latrobe Sport and Exercise Medicine Research Centre
School of Allied Health
La Trobe University
Bundoora VIC 3086
Country 95256 0
Australia
Phone 95256 0
+61 3 9479 1428
Fax 95256 0
Email 95256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.