Lateral EpicondylitisNCT06301152
Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy
A study testing high intensive laser and extracorporeal shock wave therapy in people with Lateral Epicondylitis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- high intensive laser and extracorporeal shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 30 May 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Lateral epicondylitis
- Age >18
Who cannot join
- Operation history about elbow
- Received physical therapy, or had a steroid injection to the elbow in the three months
- Cervical radiculopathy,
- Elbow deformities,
- Fibromyalgia syndrome,
- Carpal tunnel syndrome,
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- Neurological impairments in the upper extremity,
- Chronic inflammatory conditions,
- Hemophilia,
- Pregnant,
- History of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy in Treatment of Lateral Epicondylitis: A Randomized Controlled Study
Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE).
Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment.
- Conditions
- Lateral Epicondylitis
- Being tested
- high intensive laser, extracorporeal shock wave therapy
- Keywords
- Lateral Epicondylitis, High Intensive Laser Therapy, Extracorporeal Shock Wave Therapy, Musculoskeletal ultrasound
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensive laserDevice
high-intensity laser ,three times in a week, for three weeks, 9 session
extracorporeal shock wave therapyDevice
extracorporeal shock wave therapy, once a week, for three weeks ,3 times,
| Study group | Role | What they receive |
|---|---|---|
| high intensive laser | Experimental | high-intensity laser was applied 3 times in a week, for three weeks, total of 9 sessions Receives: Device: high intensive laser |
| extracorporeal shock wave therapy | Experimental | extracorporeal shock wave therapy was applied once a week, for three weeks total of 3 sessions Receives: Device: extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
score 0-10, 0 minimum value, mean is no pain, score 10 is maximum value, pain is very severe
Measured: Baseline, 1 week and 6 weeks
Secondary outcomes (3)
Quick Disability Arm, Shoulder and Hand questionary,
Quick Disability Arm, Shoulder and Hand questionary, minimum score 0 maximum score 100, high score value is associated with poor functional status
Measured: Baseline, 1 week and 6 weeks
hand grip strength
evaluates the maximum isometric contraction strength of hand and forearm muscles, 20-69 age male 47-40kg, female 30-24kg is normal value. ow value is associated with poor function
Measured: Baseline, 1 week and 6 weeks
musculoskeletal ultrasonography
common extensor tendon thickness;>0.40-0.41cm measurement result is associated with thickening of the tendon
Measured: Baseline, 1 week and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Sep 2022
- Primary completion1 Oct 2022
- Study completion30 May 2023
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 City Hospital BilkentThe 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
- Model description
- two different treatment modalities were applied in two groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301152
- Sponsor's protocol ID
- E2-22-1905
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy in Treatment of Lateral Epicondylitis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06301152
- Acronym / sponsor ID
- E2-22-1905
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, High Intensive Laser Therapy, Extracorporeal Shock Wave Therapy, Musculoskeletal ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 8 Mar 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.
Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE).
Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two different treatment modalities were applied in two groups
| Arm | Type | Receives |
|---|---|---|
| high intensive laser | Experimental | Device: high intensive laserhigh-intensity laser was applied 3 times in a week, for three weeks, total of 9 sessions |
| extracorporeal shock wave therapy | Experimental | Device: extracorporeal shock wave therapyextracorporeal shock wave therapy was applied once a week, for three weeks total of 3 sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Lateral epicondylitis
- Age >18
Key exclusion criteria (11 listed)
- Operation history about elbow
- Received physical therapy, or had a steroid injection to the elbow in the three months
- Cervical radiculopathy,
- Elbow deformities,
- Fibromyalgia syndrome,
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 |
|---|---|---|
| high intensive laserhigh-intensity laser ,three times in a week, for three weeks, 9 session | Device | high intensive laser |
| extracorporeal shock wave therapyextracorporeal shock wave therapy, once a week, for three weeks ,3 times, | Device | extracorporeal shock wave therapy |
Primary outcome
Visual analog scale
Time frame: Baseline, 1 week and 6 weeks
score 0-10, 0 minimum value, mean is no pain, score 10 is maximum value, pain is very severe
3 secondary outcomes
Quick Disability Arm, Shoulder and Hand questionary,
Time frame: Baseline, 1 week and 6 weeks
hand grip strength
Time frame: Baseline, 1 week and 6 weeks
musculoskeletal ultrasonography
Time frame: Baseline, 1 week and 6 weeks
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 8 Mar 2024.
- 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.
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 testing high intensive laser and extracorporeal shock wave therapy in people with Lateral Epicondylitis, run by Ankara City Hospital Bilkent 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 2 inclusion and 11 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 8 Mar 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?
Visual analog scale (time frame: Baseline, 1 week and 6 weeks). 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 8 Mar 2024.