Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001673437
Ethics application status
Approved
Date submitted
11/10/2016
Date registered
5/12/2016
Date last updated
13/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hypermobility and pain in competitive players.
Scientific title
The influence of Joint Hypermobility Syndrome on the incidence of pain in competitive players.
Secondary ID [1] 290298 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypermobility and pain 300543 0
Condition category
Condition code
Musculoskeletal 300402 300402 0 0
Other muscular and skeletal disorders
Injuries and Accidents 300403 300403 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
Material
The research will be performed among competitive players of Lesser Poland Volleyball and Swimmer League. The participants will e members of both male and female teams. Research material will include about 160 participants, out of which 80 will be males and 80 will be females between 15 and 35 years of age.

Method
In order to collect data we will use our own questionnaire and three different scales/questionnaire (Beighton, Carter and Wilkinson, Hakim and Graham) to estimate Joint Hypermobility of participants. In order to evaluate collected data we will implement methods of descriptive statistics and statistical analysis.

Questionnaire
Our anonymous questionnaire will be composed of 25 questions: closed questions, semi open and open questions. First part of questions will pertaine to physical attributes of participants i.e. sex, body height, body weight. Further part of the questionnaire will compose of questions pertaining to career length and number of practices during the season. Remaining ten questions dealt with injuries sustained within last year with particular emphasis on the joint. Last question included VAS scale, which will be used to estimate average intensity of pain of during and after the training..

Hypermobility evaluation
After filling up the questionnaire each participant will be evaluate with Beighton scale, Carter and Wilkinson Scale and Hakim and Graham Questionnaire in regards to increased range of motion of the joints.
Beighton Scale: All participants will performe five maneuvers including four (concerning lower and upper extremities) symmetrical exercises for which they could get maximum of nine points. In our study in order to diagnose Constitutional Joint Hypermobility the cutt off was > 4/9. To estimate increased range of motion of the joints five following maneuvers was performed. All five maneeuvers are parts of Beighton scale.
1. Hyperextension of the elbow joint >10 degrees.
The extension of the elbow joint was measured with goniometer with previous stabilization of the shoulder. The axis of the goniometer was set up on lateral epicondyle. The stable arm of the goniometer was aligned along the long axis of the participant's arm (directed towards greater tubercule of the humerus). The movable arm was aligned along radial bone (directed towards styloid proccess of radial bone) with forearm in supination.
2. Passive thumb – forearm touch.
This exercise was performed by participants themselves. Each team member passively flexed the thumb in CMC joint with simultaneous flexion in radio-metacarpal joint in order to touch the forearm with its thumb.
3. Hyperextension in MCP V joint >90.
The extension in MCP V joints was measured with goniometer. The goniometer was placed on the ulnar side of the hand. The stable arm of the goniometer was placed along the long axis of the fifth metacarpal bone, whereas the movable arm was placed along the long axis of the proximal phalanx. The axis of rotation of the goniometer was aligned with the axis of rotation of MCP V joint.
4. Hyperextension in the knee joint >10
This angle was also measured with goniometer. The axis of the goniometer was placed in the area of lateral condyle of the femur (superior to head of the fibula). The stable arm of the goniometer was placed along the femur aiming at the greater trochanter. The movable arm was placed along the fibula and was aiming at the lateral malleolus.
5. The ability of placing both hands flat on the floor with knees in extention was assessed.
Carter and Wilkinson Scale: All participants will performe five maneuvers including passive opposition of the thumb to the flexor aspect of forearm, passive hyperextension of the fingers so they lie parallel to the extensor aspect of the forearm, hyperextension of the elbow >10º, hyperextension of the knee >10º, increased dorsiflexion of the ankle and inversion of the foot..
Hakim and Graham Questionnaire: All participants will be asked five questions including Can you (or could you ever) place your hands flat on the floor without flexing your knees, Can you (or could you ever) bend your thumb to touch your forearm, As a child, did you amuse your friends by contorting your body into strange shapes or could you do the splits, As a child or teenager, did your kneecap or shoulder dislocate on more than one occasions Do you consider yourself “double jointed”.
Intervention code [1] 296104 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299844 0
level of hypermobility assessed by Beighton scale, Carte and Wilkinson Scale, Hakim and Graham Questionnaire
Timepoint [1] 299844 0
immediately after measurement
Primary outcome [2] 299845 0
pain level assessed by a subjective scale (VAS) of 1 to 10
Timepoint [2] 299845 0
immediately after measurement
Secondary outcome [1] 328294 0
injuries in the last five years assessed using a study-specific questionnaire
Timepoint [1] 328294 0
immediately after measurement

Eligibility
Key inclusion criteria
1.Competitive players of Lesser Poland Volleyball and Swimmer League.
2. Career length - minimum 2 years
3. The amount of practices per week - minimum 2 days
4. Hours of practice per week - minimum 2 hours
Minimum age
15 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Players of amator Lesser Poland Volleyball and Swimmer League.
2. Career length – less than 2 years
3. The amount of practices per week – less than 2 days
4. Hours of practice per week – less than 2 hours
5. Musculosceletal injuries and diseases than may affect the test results, degenerative changes in the joints.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To assess the correlation coefficient of chosen variables two statistical test will be used – Chi square (x2) and t-Student. For all compared variables the level of relevancywill set at alpha=0,05 (p<0,05). The correlation coefficient with probability of p<0,01 will be recognized as highly relevant, and correlation coefficient with probability of p<0,001 will be recognized as extremely relevant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/06/2016
Date of last participant enrolment
Anticipated
15/02/2017
Actual
Date of last data collection
Anticipated
15/02/2017
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 8301 0
Poland
State/province [1] 8301 0
Malopolska

Funding & Sponsors
Funding source category [1] 294675 0
Self funded/Unfunded
Name [1] 294675 0
Aneta Bac
Country [1] 294675 0
Poland
Primary sponsor type
Individual
Name
Aneta Bac
Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow Poland
Country
Poland
Secondary sponsor category [1] 293526 0
None
Name [1] 293526 0
Address [1] 293526 0
Country [1] 293526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296104 0
Bioethics Commission at the Regional Medical Chamber in Krakow
Ethics committee address [1] 296104 0
Ethics committee country [1] 296104 0
Poland
Date submitted for ethics approval [1] 296104 0
14/06/2016
Approval date [1] 296104 0
20/06/2016
Ethics approval number [1] 296104 0
93/KBL/OIL/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1159 1159 0 0
/AnzctrAttachments/371626-Aneta Bac. Ethics.pdf (Ethics approval)

Contacts
Principal investigator
Name 69562 0
A/Prof Aneta Bac
Address 69562 0
University of Physical Education
al. Jana Pawla II 78
31-571 Krakow
Country 69562 0
Poland
Phone 69562 0
+48126831065
Fax 69562 0
Email 69562 0
[email protected]
Contact person for public queries
Name 69563 0
Aneta Bac
Address 69563 0
University of Physical Education
al. Jana Pawla II 78
31-571 Krakow
Country 69563 0
Poland
Phone 69563 0
+48126831065
Fax 69563 0
Email 69563 0
[email protected]
Contact person for scientific queries
Name 69564 0
Aneta Bac
Address 69564 0
University of Physical Education
al. Jana Pawla II 78
31-571 Krakow
Country 69564 0
Poland
Phone 69564 0
+48126831065
Fax 69564 0
Email 69564 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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