Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001243202
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
23/07/2018
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The association between hip joint and hip muscle control in asymptomatic individuals and individuals with osteoarthritis
Scientific title
The effect of sustained hip stretch on neuromuscular control of hip muscles in asymptomatic individuals and individuals with osteoarthritis: a repeated-measures, cross-sectional study
Secondary ID [1] 295527 0
None
Universal Trial Number (UTN)
U1111-1217-3728
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 308793 0
Condition category
Condition code
Musculoskeletal 307728 307728 0 0
Osteoarthritis
Musculoskeletal 307729 307729 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a passive, sustained stretch at the hip joint. This will be done in one session. The stretch will be performed three times by a clinical researcher. Each stretch will be maintained for 3 minutes.

This intervention will be delivered to asymptomatic participants during Phase I, and individuals with osteoarthritis during the Phase II.

Participants will receive both interventions (i.e. stretch and active control). Participants will be randomly allocated to a sequence of intervention (i.e. stretch followed by active control or active control followed by stretch).

During the stretch, participants will be positioned prone, with their knee at 90° of flexion. The hip will be internally rotated to its maximum range. This position will impose mechanical loading into the hip joint, and it is hypothesized that it will stimulate mechanoreceptors at the hip joint.

There will be a 10 minute interval between the two conditions.

The following directions will be used for placing electrodes:
Rectus Femoris: midpoint 50% on the line from the ASIA to the superior part of the patella.
Adductor Longus: four fingerbreadths from the pubic tubercule into the muscle belly – palpate the tendon.
Gluteus Maximus: 50% on the line between the sacral vertebrae (midpoint of the base of the sacrum) and the greater trochanter.
Biceps Femoris: 50% on the line between the ischial tuberosity and the lateral epicondyle of the tibia.
Gluteus Medius: 50% on the line from the iliac crest to the trochanter.
Tensor Fascia Lata: On the line from the anterior ASIS to the lateral femoral condyle in the proximal 1/6.
Intervention code [1] 301835 0
Rehabilitation
Comparator / control treatment
Participants will be positioned in prone, with knee at 90° of flexion and hip at neutral position. No hip movement will be performed. This position will be kept for 3 sets of 3 min. This position will not impose any mechanical loading into the hip joint, as the hip will be maintained in neutral position.

During the control condition, participants will be positioned in prone, with knee at 90° of flexion and hip at neutral position. No hip movement will be performed. This will be done in one session. The hip will be kept in neutral by a clinical researcher. Each repetition will be maintained for 3 minutes.

This control condition will be delivered to asymptomatic participants during Phase I, and individuals with osteoarthritis during the Phase II.

Participants will receive both interventions (i.e. stretch and active control). Participants will be randomly allocated to a sequence of intervention (i.e. stretch followed by active control or active control followed by stretch).

There will be a 10 minute interval between the two conditions.

The following directions will be used for placing electrodes:
Rectus Femoris: midpoint 50% on the line from the ASIA to the superior part of the patella.
Adductor Longus: four fingerbreadths from the pubic tubercule into the muscle belly – palpate the tendon.
Gluteus Maximus: 50% on the line between the sacral vertebrae (midpoint of the base of the sacrum) and the greater trochanter.
Biceps Femoris: 50% on the line between the ischial tuberosity and the lateral epicondyle of the tibia.
Gluteus Medius: 50% on the line from the iliac crest to the trochanter.
Tensor Fascia Lata: On the line from the anterior ASIS to the lateral femoral condyle in the proximal 1/6.
Control group
Active

Outcomes
Primary outcome [1] 306717 0
Gluteus maximus muscle onset will be assessed using surface EMG, and expressed in milliseconds.
Timepoint [1] 306717 0
This will be assessed at baseline (before) and follow-up (after) each experimental condition. Each experimental condition consists of. 3 sets of 3 minutes of sustained stretch or control, with 1 min interval between each set. So, each experimental condition will last approximately 11 minutes. Baseline and Follow-up measurements will occur before and after the 11 minutes experimental condition.
Primary outcome [2] 306718 0
Gluteus medius muscle onset will be assessed using surface EMG, and expressed in milliseconds.
Timepoint [2] 306718 0
This will be assessed at baseline (before) and follow-up (after) each experimental condition. Each experimental condition consists of. 3 sets of 3 minutes of sustained stretch or control, with 1 min interval between each set. So, each experimental condition will last approximately 11 minutes. Baseline and Follow-up measurements will occur before and after the 11 minutes experimental condition.
Primary outcome [3] 306719 0
Biceps femoris muscle onset will be assessed using surface EMG, and expressed in milliseconds.
Timepoint [3] 306719 0
This will be assessed at baseline (before) and follow-up (after) each experimental condition. Each experimental condition consists of. 3 sets of 3 minutes of sustained stretch or control, with 1 min interval between each set. So, each experimental condition will last approximately 11 minutes. Baseline and Follow-up measurements will occur before and after the 11 minutes experimental condition.
Secondary outcome [1] 349326 0
Rectus femoris muscle onset will be assessed using surface EMG, and expressed in milliseconds.
Timepoint [1] 349326 0
This will be assessed at baseline (before) and follow-up (after) each experimental condition. Each experimental condition consists of. 3 sets of 3 minutes of sustained stretch or control, with 1 min interval between each set. So, each experimental condition will last approximately 11 minutes. Baseline and Follow-up measurements will occur before and after the 11 minutes experimental condition.
Secondary outcome [2] 349327 0
Tensor fascia lata muscle onset will be assessed using surface EMG, and expressed in milliseconds.
Timepoint [2] 349327 0
This will be assessed at baseline (before) and follow-up (after) each experimental condition. Each experimental condition consists of. 3 sets of 3 minutes of sustained stretch or control, with 1 min interval between each set. So, each experimental condition will last approximately 11 minutes. Baseline and Follow-up measurements will occur before and after the 11 minutes experimental condition.
Secondary outcome [3] 349328 0
Adductor longus muscle onset will be assessed using surface EMG, and expressed in milliseconds.
Timepoint [3] 349328 0
This will be assessed at baseline (before) and follow-up (after) each experimental condition. Each experimental condition consists of. 3 sets of 3 minutes of sustained stretch or control, with 1 min interval between each set. So, each experimental condition will last approximately 11 minutes. Baseline and Follow-up measurements will occur before and after the 11 minutes experimental condition.

Eligibility
Key inclusion criteria
Phase I: 24 asymptomatic individuals will be recruited.

Phase II: a sample of 10 participants with hip OA will be recruited. Confirmation of hip OA diagnosis will be achieved by a combination of physical tests and radiological findings as per the American College of Rheumatology.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Phase I:
Participants will be excluded if they present any signs of disorders that potentially impact the structure and function of the hip joint. This will be confirmed by questionnaire and by clinical examination.
(i) Hip, knee or ankle limited disorders, as assessed by functional test and passive range of motion with overpressure.
(ii) Musculoskeletal lower limb or back disorders that required assessment or treatment in the last 6 months;
(iii) Neurological impairment or condition affecting lower limb function
(iv) Systemic inflammatory disease (e.g. rheumatoid arthritis)

Phase II:
(i) Musculoskeletal lower limb or back disorders that required assessment or treatment in the last 6 months;
(ii) Primary complaint of gluteal tendinopathy (clinical diagnosis), low back pain or referred back pain;
(iii) History of hip trauma or surgery (leading to secondary hip osteoarthritis)
(iv) Knee joint replacement/known knee joint pathology/limited knee range of motion (<90° flexion) that may impact ability to perform the intervention
(v) Corticosteroid use (oral or intra-articular) in the past 3 months
(vi) Neurological impairment or condition affecting lower limb function
(vii) Systemic inflammatory disease (e.g. rheumatoid arthritis)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment outside Australia
Country [1] 10640 0
New Zealand
State/province [1] 10640 0
Otago, Dunedin

Funding & Sponsors
Funding source category [1] 300108 0
Charities/Societies/Foundations
Name [1] 300108 0
Jack Thomson Grant - Otago Medical Research Foundation
Country [1] 300108 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
325 Great King Street, 9054
Postcode: PO Box 56
Dunedin
Country
New Zealand
Secondary sponsor category [1] 299508 0
None
Name [1] 299508 0
Address [1] 299508 0
Country [1] 299508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300950 0
University of Otago Ethics Committee
Ethics committee address [1] 300950 0
University of Otago Council PO Box 56 Dunedin 9054 New Zealand
Ethics committee country [1] 300950 0
New Zealand
Date submitted for ethics approval [1] 300950 0
05/04/2018
Approval date [1] 300950 0
11/07/2018
Ethics approval number [1] 300950 0
H18/034

Summary
Brief summary
Hip joint osteoarthritis (OA) is a debilitating disease that impacts quality of life, resulting in around 8000 joint replacements in New Zealand per annum. Nerve receptors in the hip capsule may be involved in fine-tuning the muscles surrounding the joint, and failure of this mechanism might be related to hip OA, but its role is unclear. This study aims to provide unique insight by using nerve-muscle control techniques to elucidate the potential role of the capsule in hip OA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85386 0
Dr Daniel Cury Ribeiro
Address 85386 0
325 Great King Street, School of Physiotherapy, University of Otago, North Dunedin, 9016
Country 85386 0
New Zealand
Phone 85386 0
+64 3 479 7455
Fax 85386 0
Email 85386 0
[email protected]
Contact person for public queries
Name 85387 0
Daniel Cury Ribeiro
Address 85387 0
325 Great King Street, School of Physiotherapy, University of Otago, North Dunedin, 9016
Country 85387 0
New Zealand
Phone 85387 0
+64 3 479 7455
Fax 85387 0
Email 85387 0
[email protected]
Contact person for scientific queries
Name 85388 0
Daniel Cury Ribeiro
Address 85388 0
325 Great King Street, School of Physiotherapy, University of Otago, North Dunedin, 9016
Country 85388 0
New Zealand
Phone 85388 0
+64 3 479 7455
Fax 85388 0
Email 85388 0
[email protected]

No information has been provided regarding IPD availability


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.