Shoulder PainNCT02631395
The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball
A study testing Exercise in people with Shoulder Pain, run by Norwegian University of Science and Technology.
Trial summary
Very little is known about the potential for preventing the prevalence of shoulder complaints in handball players, particularly younger players. The aim of this study is to evaluate the effect of a shoulder training program on shoulder pain during a season of team handball. Read more about this study
- Who is it for?
- Ages 15 to 17 years, women only
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- team handball players in the top division in the J16 class in the Trøndelag region in Norway
Who cannot join
- previous shoulder operations og fractures in the shoulder region
About this study
Very little is known about the potential for preventing the prevalence of shoulder complaints in handball players, particularly younger players. The aim of this study is to evaluate the effect of a shoulder training program on shoulder pain during a season of team handball.
Read the detailed description
Six teams, consisting of 13 to 25 players each, were randomized into two groups throughout their competition seasons. Three teams participated in a seven--month, three--times--a--week shoulder--muscle strength--training program while three teams participated in a comparable handball training program but did not conduct any specific upper--body strength training. Effects of this strength--training program were evaluated by comparing pre-- and post--training data from a survey on shoulder complaints based on a self--report questionnaire (quick DASH) and Visual Analogue Scale (VAS). The players completed the VAS on pain once a month. In addition to that the players were tested in a maximum push up test, dynamometer test for internal and external rotation strength in the shoulder and throwing distance in the pre- and posttest.
- Conditions
- Shoulder Pain
- Being tested
- Exercise, Control group
- Keywords
- Exercise movement techniques
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Three teams participated in a seven--month, three--times--a--week shoulder--muscle strength--training program while three teams participated in a comparable handball training program but did not conduct any specific upper--body strength training.
Control groupOther
The three teams in the Control Group trained as normal throughout the season and participated in a comparable handball training program, but did not conduct any specific upper--body strength training
| Study group | Role | What they receive |
|---|---|---|
| Training group | Other | Six teams, consisting of 13 to 25 players each, were randomized into two groups throughout their competition season; the training Group (intervention Group) and the Control Group.The intervention group completed strength training exercises Three times a week the Whole competition season. Receives: Other: Exercise |
| Control group | Other | The three teams in the Control Group trained as normal throughout the season and participated in a comparable handball training program, but did not conduct any specific upper--body strength training Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain (Visual Analogue Scale)
Effects of this strength--training program were evaluated by comparing pre-- and post--training data from a survey on shoulder complaints based on a self--report questionnaire (quick DASH) and Visual Analogue Scale (VAS). The players completed the VAS form on shoulder pain in the beginning of the season, then once a month throughout the season, and then in the end of the season.
Measured: 7 months
Secondary outcomes (4)
Shoulder strength
External and internal rotation strength in the shoulder was measured with a handheld dynamometer in the beginning and in the end of the season.
Measured: 7 months
Push ups
The Maximum number of push ups the players were able to perform was recorded in the beginning and in the end of the season.
Measured: 7 months
Throwing distance
The Maximum throwing distance With a handball was recorded in the beginning and in the end of the season.
Measured: 7 months
Shoulder function (Quick DASH)
The quick DASH questionaire was completed in the beginning and in the end of the season.
In addition to the VAS and Quick DASH, the players were tested in a maximum push up test, dynamometer test for internal and external rotation strength in the shoulder and throwing distance in the pre- and posttest (see secondary outcome measures).
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Harry Størksen, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631395
- Sponsor's protocol ID
- SorTrondelagUC
- Status last verified
- Jan 2017
- First submitted
- 5 May 2015
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Osteras H, Sommervold M, Skjolberg A. Effects of a strength-training program for shoulder complaint prevention in female team handball athletes. A pilot study. J Sports Med Phys Fitness. 2015 Jul-Aug;55(7-8):761-7. Epub 2014 Dec 17.
PubMed 25514821
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball
- ClinicalTrials.gov ID
- NCT02631395
- Acronym / sponsor ID
- SorTrondelagUC
- Conditions
- Shoulder Pain
- Keywords
- Exercise movement techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very little is known about the potential for preventing the prevalence of shoulder complaints in handball players, particularly younger players. The aim of this study is to evaluate the effect of a shoulder training program on shoulder pain during a season of team handball.
Detailed description
Six teams, consisting of 13 to 25 players each, were randomized into two groups throughout their competition seasons. Three teams participated in a seven--month, three--times--a--week shoulder--muscle strength--training program while three teams participated in a comparable handball training program but did not conduct any specific upper--body strength training. Effects of this strength--training program were evaluated by comparing pre-- and post--training data from a survey on shoulder complaints based on a self--report questionnaire (quick DASH) and Visual Analogue Scale (VAS). The players completed the VAS on pain once a month. In addition to that the players were tested in a maximum push up test, dynamometer test for internal and external rotation strength in the shoulder and throwing distance in the pre- and posttest.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Other | Other: ExerciseSix teams, consisting of 13 to 25 players each, were randomized into two groups throughout their competition season; the training Group (intervention Group) and the Control Group.The intervention group completed strength training exercises Three times a week the Whole competition season. |
| Control group | Other | Other: Control groupThe three teams in the Control Group trained as normal throughout the season and participated in a comparable handball training program, but did not conduct any specific upper--body strength training |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- team handball players in the top division in the J16 class in the Trøndelag region in Norway
Key exclusion criteria (1 listed)
- previous shoulder operations og fractures in the shoulder region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThree teams participated in a seven--month, three--times--a--week shoulder--muscle strength--training program while three teams participated in a comparable handball training program but did not conduct any specific upper--body strength training. | Other | Training group |
| Control groupThe three teams in the Control Group trained as normal throughout the season and participated in a comparable handball training program, but did not conduct any specific upper--body strength training | Other | Control group |
Primary outcome
Shoulder pain (Visual Analogue Scale)
Time frame: 7 months
Effects of this strength--training program were evaluated by comparing pre-- and post--training data from a survey on shoulder complaints based on a self--report questionnaire (quick DASH) and Visual Analogue Scale (VAS). The players completed the VAS form on shoulder pain in the beginning of the season, then once a month throughout the season, and then in the end of the season.
4 secondary outcomes
Shoulder strength
Time frame: 7 months
Push ups
Time frame: 7 months
Throwing distance
Time frame: 7 months
Shoulder function (Quick DASH)
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Results publication: PubMed 25514821Osteras H, Sommervold M, Skjolberg A. Effects of a strength-training program for shoulder complaint prevention in female team handball athletes. A pilot study. J Sports Med Phys Fitness. 2015 Jul-Aug;55(7-8):761-7. Epub 2014 Dec 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Harry Størksen study director
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Shoulder Pain, run by Norwegian University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain (Visual Analogue Scale) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.