Lateral EpicondylitisNCT06568796
Comparison of the Effects of Trigger Point Ischemic Compression Massage and Focused Extracorporeal Shoch Wave Therapy of the Patients With Lateral Epicondylitis: a Randomized Controlled Trial
A study of Lateral Epicondylitis, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
To compare the effects of Trigger Point Ischaemic Compression Massage (TPICM) and Focused Extracarporeal Shock Wave Therapy (focused ESWT) on pain level, muscle strength, Joint range of motion, functionality and quality of life in patients with lateral epicondylitis (LE) in a randomised controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lateral Epicondylitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female individuals between the ages of 18-60
- being diagnosed with lateral epicondylitis
- volunteering to participate in the study
Who cannot join
- non-cooperation
- presence of systemic and metabolic diseases
- malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
- pregnancy
- utilization of another treatment for lateral epicondylitis during the study period
- previous invasive treatment with steroids for lateral epicondylitis
- any treatment for lateral epicondylitis in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gülhane Eğitim ve Araştırma Hastanesi
Ankara, 06010
About this study
Official title: Comparison of the Effects of Trigger Point Ischemic Compression Massage and Focused Extracarporeal Shock Wave Therapy on Pain Level, Muscle Strength, Joint Range of Motion, Functionality and Quality of Life in Patients With Lateral Epicondylitis: a Randomized Controlled Trial
To compare the effects of Trigger Point Ischaemic Compression Massage (TPICM) and Focused Extracarporeal Shock Wave Therapy (focused ESWT) on pain level, muscle strength, Joint range of motion, functionality and quality of life in patients with lateral epicondylitis (LE) in a randomised controlled trial.
Read the detailed description
The study was planned to include at least 66 patients who presented to the sports medicine clinic of Gülhane Training and Research Hospital with lateral epicondyle pain for at least 2 months, were diagnosed with lateral epicondylitis and verbally and in writing declared that they were willing to participate in the study.
Patients participating in the study;
- assessment of pain intensity with visual analog scale (VAS)
- Evaluation of hand grip strength with jamar hand dynamometer
- Isokinetic muscle strength assessment of wrist muscles with biodex isokinetic system 3
- assessment of wrist range of motion with a manual goniometer
- Function assessment with PRTEE-T
- DASH questionnaire
- SF-36 quality of life assessment will be performed before and after treatment. inclusion criteria
- Male and female individuals aged 18-60 years
- being diagnosed with lateral epicondilitis
- volunteering to participate in the study exclusion criteria from eswt treatment
- non-cooperation
- presence of systemic and metabolic diseases
- malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
- pregnancy
- utilization of another treatment for lateral epicondylitis during the study period
- previous invasive treatment with steroids for lateral epicondylitis
- any treatment for lateral epicondylitis in the last 6 months
- Conditions
- Lateral Epicondylitis
- Being tested
- randomize controlled study
- Keywords
- lateral epicondylitis, trigger points ıschemıc compressıon massage, focus eswt
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
randomize controlled studyOther
eswt treatment
| Study group | Role | What they receive |
|---|---|---|
| Focused Ekstracorporeal Shoch Wave Theraphy and Exercise | Experimental | Individuals will be administered focused ekstracorporeal shoch wave theraphy 1 day a week for 4 weeks. Individuals will exercise every day Receives: Other: randomize controlled study |
| Trigger Point Ischemic Compression Massage and Exercise | Experimental | Individuals will receive trigger point ischemic compression massage 2 days a week for 4 weeks. Individuals will exercise every day Receives: Other: randomize controlled study |
| Exercise | No intervention | Individuals will only exercise every day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
grip strenght asessment with jamar hand dynamometer
It will be grip strength assessment with jamar hand dynamometer
Measured: baseline-up to 4 weeks
muscle strenght asessment with isocinetic system
It will be elbow flexor and extansor muscle strength asessment with isocinetic system
Measured: baseline-up to 4 weeks
range of motion asessment with universal goniometer
It will be elbow range of motion asessment with universal goniometer
Measured: baseline-up to 4 weeks
assessment of quality of life with quality of life questionnaire
It will be asessment of quality of life with life questionnaire
Measured: baseline-up to 4 weeks
pain level asessment with visual analog scale
It will be asessment of pain level with visual analog scale
Measured: baseline-up to 4 weeks
assessment of functionality with functionality questionnaire
It will be asessment of functionality with functionality questionnaire
Measured: baseline-up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Jun 2023
- Primary completion1 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bihter Aslanyurek, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568796
- Sponsor's protocol ID
- 2023-117
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 26 Aug 2024
- 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 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Trigger Point Ischemic Compression Massage and Focused Extracarporeal Shock Wave Therapy on Pain Level, Muscle Strength, Joint Range of Motion, Functionality and Quality of Life in Patients With Lateral Epicondylitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06568796
- Acronym / sponsor ID
- 2023-117
- Conditions
- Lateral Epicondylitis
- Keywords
- lateral epicondylitis, trigger points ıschemıc compressıon massage, focus eswt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 23 Aug 2024 (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.
To compare the effects of Trigger Point Ischaemic Compression Massage (TPICM) and Focused Extracarporeal Shock Wave Therapy (focused ESWT) on pain level, muscle strength, Joint range of motion, functionality and quality of life in patients with lateral epicondylitis (LE) in a randomised controlled trial.
Detailed description
The study was planned to include at least 66 patients who presented to the sports medicine clinic of Gülhane Training and Research Hospital with lateral epicondyle pain for at least 2 months, were diagnosed with lateral epicondylitis and verbally and in writing declared that they were willing to participate in the study.
Patients participating in the study;
- assessment of pain intensity with visual analog scale (VAS)
- Evaluation of hand grip strength with jamar hand dynamometer
- Isokinetic muscle strength assessment of wrist muscles with biodex isokinetic system 3
- assessment of wrist range of motion with a manual goniometer
- Function assessment with PRTEE-T
- DASH questionnaire
- SF-36 quality of life assessment will be performed before and after treatment. inclusion criteria
- Male and female individuals aged 18-60 years
- being diagnosed with lateral epicondilitis
- volunteering to participate in the study exclusion criteria from eswt treatment
- non-cooperation
- presence of systemic and metabolic diseases
- malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
- pregnancy
- utilization of another treatment for lateral epicondylitis during the study period
- previous invasive treatment with steroids for lateral epicondylitis
- any treatment for lateral epicondylitis in the last 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focused Ekstracorporeal Shoch Wave Theraphy and Exercise | Experimental | Other: randomize controlled studyIndividuals will be administered focused ekstracorporeal shoch wave theraphy 1 day a week for 4 weeks. Individuals will exercise every day |
| Trigger Point Ischemic Compression Massage and Exercise | Experimental | Other: randomize controlled studyIndividuals will receive trigger point ischemic compression massage 2 days a week for 4 weeks. Individuals will exercise every day |
| Exercise | No intervention | –Individuals will only exercise every day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female individuals between the ages of 18-60
- being diagnosed with lateral epicondylitis
- volunteering to participate in the study
Key exclusion criteria (7 listed)
- non-cooperation
- presence of systemic and metabolic diseases
- malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
- pregnancy
- utilization of another treatment for lateral epicondylitis during the study period
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 |
|---|---|---|
| randomize controlled studyeswt treatment | Other | Focused Ekstracorporeal Shoch Wave Theraphy and Exercise, Trigger Point Ischemic Compression Massage and Exercise |
Primary outcome
grip strenght asessment with jamar hand dynamometer
Time frame: baseline-up to 4 weeks
It will be grip strength assessment with jamar hand dynamometer
muscle strenght asessment with isocinetic system
Time frame: baseline-up to 4 weeks
It will be elbow flexor and extansor muscle strength asessment with isocinetic system
range of motion asessment with universal goniometer
Time frame: baseline-up to 4 weeks
It will be elbow range of motion asessment with universal goniometer
assessment of quality of life with quality of life questionnaire
Time frame: baseline-up to 4 weeks
It will be asessment of quality of life with life questionnaire
pain level asessment with visual analog scale
Time frame: baseline-up to 4 weeks
It will be asessment of pain level with visual analog scale
assessment of functionality with functionality questionnaire
Time frame: baseline-up to 4 weeks
It will be asessment of functionality with functionality questionnaire
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 26 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Lateral Epicondylitis, run by Ankara Yildirim Beyazıt 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 3 inclusion and 7 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 26 Aug 2024. 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?
grip strenght asessment with jamar hand dynamometer (time frame: baseline-up to 4 weeks). The study lists 6 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 26 Aug 2024.