Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000595213
Ethics application status
Approved
Date submitted
11/02/2018
Date registered
17/04/2018
Date last updated
17/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of hydrotherapy and manual therapy in osteoarthritis of the hip.
Scientific title
Comparison the impact of hydrotherapy (Watsu) and manual therapy on pain level, hip range of motion, functional status, low back pain and muscle activity in patients with osteoarthritis of the hip.
Secondary ID [1] 294018 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip osteoarthritis 306541 0
low back pain 306542 0
Condition category
Condition code
Musculoskeletal 305642 305642 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 306012 306012 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will participate in 5-week hydrotherapy (group A) or manual therapy (group B) programme 2 times a week. Each session will last for approximately 45 minutes.
Hydrotherapy (Watsu) will take place in a pool with a warm water (32-34 degrees Celsius). Before the first session the therapist will explain how the Watsu therapy session starts and ends. The therapist and patient dressed in swimwear together will enter the pool. The patient, supported by the therapist lies on his/her back in the water and closes his/her eyes. Supported mainly by the forearms placed under the head and initially under the pelvis the therapist moves the patient through the water in flowing, rhythmical motions which includes intermittent gentle massage and stretching. During each session the therapist will perform the same techniques in a sequence recommended by Worldwide Aquatic Bodywork Association (WABA): breath dance, slow offering, freeing the spine, one leg slow offering, two legs slow offering, accordion, accordion in rotation, near leg rotation, far leg rotation, arm leg rock, thigh press, arm play and lift, chest opening, leg press, arm back around, lengthening spine, spine pull, undulating spine, hip push, seaweed, figure 4 (it is the name of movement sequence), breath dance, wall return. There should be no conversation between the patient and therapist during therapy, however patient should inform about any pain during therapy. The distance between the patient and the therapist ranges from full arms length to close cradling. After a session of approximately 45 min, the therapist assists the patient to a seated position in the pool. Next, the patient shower, dress, rest for 5–15 min and then leave.
Manual therapy in group B will take place indoor. It will consists of hip joint traction, post isometric muscle relaxation of identified shortened muscles surrounding the hip joint, trigger point therapy. In both groups all manipulations will be repeated until the therapist stated optimal results of the session.
In both groups a physical therapist will administrate the intervention. It will be one-on-one face-to-face exercise session. There will be an attendance list to monitor patients adherence to intervention.
Intervention code [1] 300290 0
Rehabilitation
Intervention code [2] 300291 0
Treatment: Other
Comparator / control treatment
The comparator group will be manual therapy group (group B).

Manual therapy intervention (group B) will be performed 2 times per week for 5 weeks. Each session will last for approximately 45 minutes. Manual therapy will take place indoor. It will consists of hip joint traction, post isometric muscle relaxation of identified shortened muscles surrounding the hip joint, trigger point therapy. All manipulations will be repeated until the therapist stated optimal results of the session.
Physical therapist will administrate the intervention. It will be one-on-one face-to-face intervention. There will be an attendance list to monitor patients adherence to intervention.
Control group
Active

Outcomes
Primary outcome [1] 304753 0
Pain (VAS scale 0-10)
Timepoint [1] 304753 0
baseline,
after 5 weeks post-commencement of intervention,
after 1 and 3 months of intervention completion
Primary outcome [2] 304754 0
Functional status (Hip range of motion, assessed using a goniometer)
Timepoint [2] 304754 0
baseline,
after 5 weeks post-commencement of intervention,
after 1 and 3 months of intervention completion
Primary outcome [3] 304755 0
Gluteus medius, tensor fasciae latae activity (sEMG).

It is a composite primary outcome.
Timepoint [3] 304755 0
baseline,
after 5 weeks post-commencement of intervention,
after 1 and 3 months of intervention completion
Secondary outcome [1] 343006 0
Functional status (questionnaire - WOMAC)
Timepoint [1] 343006 0
baseline,
after 5 weeks post-commencement of intervention,
after 1 and 3 months of intervention completion
Secondary outcome [2] 343007 0
Functional status (questionnaire - HARRIS HIP SCORE)
Timepoint [2] 343007 0
baseline,
after 5 weeks post-commencement of intervention,
after 1 and 3 months of intervention completion
Secondary outcome [3] 343008 0
Functional status (questionnaire - OSWESTRY)
Timepoint [3] 343008 0
baseline,
after 5 weeks post-commencement of intervention,
after 1 and 3 months of intervention completion
Secondary outcome [4] 343994 0
lumbar erector spinae muscles activity (sEMG)
Timepoint [4] 343994 0
baseline,
after 5 weeks post-commencement of intervention,
after 1 and 3 months of intervention completion
Secondary outcome [5] 345114 0
Functional status (questionnaire - ROLAND -MORRIS)
Timepoint [5] 345114 0
baseline,
after 5 weeks post-commencement of intervention,
after 1 and 3 months of intervention completion

Eligibility
Key inclusion criteria
- Primary osteoarthritis of the hip (stage II according to the American College of Rheumatology classification)
- No systemic contraindications to undertake the proposed forms of exercise
- Written consent to participate in a clinical trial
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to walk independently,
arthroplasty of any joint,
pharmacological treatment with impact on pain intensity, muscle tension,
pregnancy,
recently completed physiotherapy treatments (less than 3 months),
active cancer.

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
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 9577 0
Poland
State/province [1] 9577 0

Funding & Sponsors
Funding source category [1] 298640 0
University
Name [1] 298640 0
Poznan University School of Physical Education, Gorzow Wielkopolski
Country [1] 298640 0
Poland
Primary sponsor type
University
Name
Poznan University School of Physical Education, Gorzow Wielkopolski
Address
Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski
Country
Poland
Secondary sponsor category [1] 297813 0
None
Name [1] 297813 0
Address [1] 297813 0
Country [1] 297813 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299600 0
Bioethics committee - Poznan University of Medical Sciences
Ethics committee address [1] 299600 0
Komisja Bioetyczna przy Uniwersytecie Medycznym im. Karola Marcinkowskiego w Poznaniu, ul. Bukowska 70, pok A204, 60-812 Poznan
Ethics committee country [1] 299600 0
Poland
Date submitted for ethics approval [1] 299600 0
Approval date [1] 299600 0
02/02/2017
Ethics approval number [1] 299600 0
165/17

Summary
Brief summary
The goal of the study is to assess and compare changes in functional status in patients with hip osteoarthritis. Study participants will be patients with hip osteoarthritsis, stage II before arthroplasty recruited from the Department of Ortopedic Surgery, Specialistic Hospital in Szczecin Zdunowo and the Department of Ortopedic Surgery Specialistic Hospital in Gorzow Wielkopolski. 60 patients will be randomised into 2 groups - the hydrotherapy group - patients will undergo the 5-week hydrotherapy (Watsu) 2 times a week, the manual therapy group will undergo the 5-week manual therapy 2 times a week. Hydrotherapy (Watsu) will take place in a warm (34 degrees od Celsius) pool. During each session the therapist will perform the same techniques in a sequence recommended by Worldwide Aquatic Bodywork Association (WABA). Manual therapy will consists of hip joint traction, post isometric muscle relaxation of identified shortened muscles surrounding the hip joint, trigger point therapy. In both groups all manipulations will be repeated until the therapist stated optimal results of the session.
Before and after 5 weeks, 1 and 3 month after intervention completion patients will undergo the following examinations: functional status, pain level, hip range of motion, gluteus medius, tensor fasciae latae, lumbar erector spinae muscles activity (sEMG). Statistical analysis will be performed with the use of Statistica 10 software. Study has been approved by the research Bioethics Comittee.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80982 0
Dr Anita Kulik
Address 80982 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6 66-400 Gorzow Wielkopolski
Country 80982 0
Poland
Phone 80982 0
+48957279222
Fax 80982 0
Email 80982 0
[email protected]
Contact person for public queries
Name 80983 0
Dr Anita Kulik
Address 80983 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6 66-400 Gorzow Wielkopolski
Country 80983 0
Poland
Phone 80983 0
+48957279222
Fax 80983 0
Email 80983 0
[email protected]
Contact person for scientific queries
Name 80984 0
Dr Anita Kulik
Address 80984 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6 66-400 Gorzow Wielkopolski
Country 80984 0
Poland
Phone 80984 0
+48957279222
Fax 80984 0
Email 80984 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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