WomanNCT03896204
Effect of Telephone-supported Joint Protection Technique Training
A study testing telephone-suppoted joint protection technique and joint protection technique training in people with Woman and Epicondylitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
There is limited evidence of the efficacy of joint protection principles in individuals diagnosed with lateral epicondylitis in the literature. The aim of this study was to investigate the effect of training of the telephone supported joint protection technique education on pain and upper extremity function in… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Woman, Epicondylitis
- What is being tested?
- telephone-suppoted joint protection technique and joint protection technique training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2019to 29 May 2019
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- -individuals with a history of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Telephone-supported Joint Protection Technique Training on Pain and Functionality in Lateral Epicondylitis
There is limited evidence of the efficacy of joint protection principles in individuals diagnosed with lateral epicondylitis in the literature. The aim of this study was to investigate the effect of training of the telephone supported joint protection technique education on pain and upper extremity function in individuals with lateral epicondylitis. New information will be obtained according to the results.
Read the detailed description
There is limited evidence of the efficacy of joint protection principles in individuals diagnosed with lateral epicondylitis in the literature. The aim of this study was to investigate the effect of training of the telephone supported joint protection technique education on pain and upper extremity function in individuals with lateral epicondylitis. New information will be obtained according to the results.
- Conditions
- Woman, Epicondylitis
- Being tested
- telephone-suppoted joint protection technique, joint protection technique training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-suppoted joint protection techniqueBehavioural
After joint protection technics training, patients will be followed up with telephone support for 1 month.
joint protection technique trainingBehavioural
Training will be given to individuals about joint protection technique
| Study group | Role | What they receive |
|---|---|---|
| telephone-supported group | Experimental | Not described Receives: Behavioral: telephone-suppoted joint protection technique |
| Other group | Experimental | Not described Receives: Behavioral: joint protection technique training |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand grip strength
Jamar hand dynamometer; which has high validity and reliability across several studies and is therefore accepted as the gold standard for the measurement of hand grip strength.
Measured: first month
pain and function
The Lateral Epicondylitis Function Scale; This scale is specially designed to evaluate patients with LE
Measured: first month
function
The Upper Extremity Functional Index; Lower scores indicate increased difficulty with the relevant activity resulting from the subject's condition involving the upper limb
Measured: first month
beahviour
Joint Protection Behavior Assessment-Short Form; evaluate the behavior of individuals during daily activities that require using the hands
Measured: first month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start29 Mar 2019
- Primary completion29 Apr 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomanStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgü İnal, Trakya University
- Investigators
- Özgü İnal, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896204
- Sponsor's protocol ID
- 2019/32
- Status last verified
- Apr 2020
- First submitted
- 28 Mar 2019
- Last updated
- 13 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telephone-supported Joint Protection Technique Training on Pain and Functionality in Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT03896204
- Acronym / sponsor ID
- 2019/32
- Conditions
- Woman, Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 29 Mar 2019 (actual)
- 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.
There is limited evidence of the efficacy of joint protection principles in individuals diagnosed with lateral epicondylitis in the literature. The aim of this study was to investigate the effect of training of the telephone supported joint protection technique education on pain and upper extremity function in individuals with lateral epicondylitis. New information will be obtained according to the results.
Detailed description
There is limited evidence of the efficacy of joint protection principles in individuals diagnosed with lateral epicondylitis in the literature. The aim of this study was to investigate the effect of training of the telephone supported joint protection technique education on pain and upper extremity function in individuals with lateral epicondylitis. New information will be obtained according to the results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telephone-supported group | Experimental | Behavioral: telephone-suppoted joint protection technique |
| Other group | Experimental | Behavioral: joint protection technique training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -individuals with a history of surgery
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 |
|---|---|---|
| telephone-suppoted joint protection techniqueAfter joint protection technics training, patients will be followed up with telephone support for 1 month. | Behavioural | telephone-supported group |
| joint protection technique trainingTraining will be given to individuals about joint protection technique | Behavioural | Other group |
Primary outcome
hand grip strength
Time frame: first month
Jamar hand dynamometer; which has high validity and reliability across several studies and is therefore accepted as the gold standard for the measurement of hand grip strength.
pain and function
Time frame: first month
The Lateral Epicondylitis Function Scale; This scale is specially designed to evaluate patients with LE
function
Time frame: first month
The Upper Extremity Functional Index; Lower scores indicate increased difficulty with the relevant activity resulting from the subject's condition involving the upper limb
beahviour
Time frame: first month
Joint Protection Behavior Assessment-Short Form; evaluate the behavior of individuals during daily activities that require using the hands
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 13 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Özgü İnal principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone-suppoted joint protection technique and joint protection technique training in people with Woman and Epicondylitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 0 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 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
hand grip strength (time frame: first month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2020.