De Quervain DiseaseNCT05141799
Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis
A study testing high intensity laser therapy in people with De Quervain Disease, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
68 De Quervain tenosynovitis(MPS) diagnosed patients will be randomly divided into 2 groups. To groups; splinting+exercise+high-intensity laser therapy (HILT) and splinting+exercise+sham HILT will be applied. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- De Quervain Disease
- What is being tested?
- high intensity laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2022to 30 Jun 2022
- 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
- patients diagnosed with unilateral De Quervain tenosynovitis 18-65 years old
Who cannot join
- pain history of less than four weeks,
- upper extremity entrapment neuropathy,
- major psychiatric disease,
- upper extremity surgical treatment history,
- malignancy history,
- chronic rheumatic disease,
Show all 9Show fewer
- cervical radiculopathy,
- cervical myelopathy,
- local corticosteroid injection prior to De Quervain tenosynovitis and receiving physical therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis; a Prospective, Randomized, Controlled Study
68 De Quervain tenosynovitis(MPS) diagnosed patients will be randomly divided into 2 groups. To groups; splinting+exercise+high-intensity laser therapy (HILT) and splinting+exercise+sham HILT will be applied. Visual anolog scale (VAS) scores, quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire and Hand grip strength measurements of the patients before-after treatment will be recorded and will be evaluated statistically.
- Conditions
- De Quervain Disease
- Being tested
- high intensity laser therapy
- Keywords
- Hand grip strength, high-intensity laser therapy, De Quervain Disease
- Medical subject headings
- De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity laser therapyDevice
Laser treatment is noninvasive and painless and can be easily administered in therapy units for a wide range of conditions. High-intensity laser therapy (HILT) has gained importance for the treatment of different kinds of sports injuries such as tendon injuries, contusions, and muscle spasms.
| Study group | Role | What they receive |
|---|---|---|
| high-intensity laser therapy (HILT) | Active comparator | we will apply the HILT device to the most painful area of the wrist in two phases. In both phase I and phase II, the laser will be applied using continuous circular movements.
The first three sessions (phase I) will be used to provide analgesic effects at an intermittent phase, applying a 75 sec, 8 W, 6 J/cm2 treatment for a total of 150 J of energy. The subsequent six sessions (phase II) will provide a biostimulatory effect at a continuous phase, applying a 30 sec, 6 W, 120 to 150 J/cm2 treatment. The HILT will be applied for a total of nine treatment sessions over a period of three consecutive weeks. Receives: Device: high intensity laser therapy |
| sham HILT | Sham comparator | We will apply the HILT device to the most painful area of the wrist by using continuous circular movements, but the laser instrument will switched off during applications. The sham HILT will be applied for a total of nine treatment sessions over a period of three consecutive weeks. Receives: Device: high intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire
The QDASH is a self-reported questionnaire that measures the physical functions and symptoms of patients with upper limb problems. It includes 11 items from the DASH survey, and to calculate the QDASH score, atleast 10 of the 11 items should be answered. Each item contains five answer options, and the total score of the scale is calculated from the individual item scores (0=no disability and 100=the most serious disability). The first eight items of the QDASH questionnaire measure the patient's daily life function and social activity limitations. The ninth question assesses the pain intensity, and the 10th question evaluates the feeling of "pins and needles" in the upper extremity. The last question is designed to evaluate the sleep problem due to pain.
Measured: 5 Minutes
JAMAR hydraulic hand dynamometer
Hand grip strength measurements will take with a JAMAR hydraulic hand dynamometer (Lafayette Instrument, Lafayette, IN, USA) are known to provide reliable results and these measurements will be obtain while the patient will stand with a full extension of the elbow and wrist. Each patient will be asked to squeeze the dynamometer with full force for a maximum of three seconds. First on the healthy side and then on the effected side, three measurements will be taken, and the averages will be obtain.
Measured: 2 minutes
Secondary outcomes (1)
visual analog scale (VAS)
Visual anolog scale (VAS) A Visual Analogue Scale (VAS) is a horizontal line, 100 mm in length measurement instrument that tries to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Measured: 10 Seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start11 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Quervain DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Dundar Ahi, MD, Kocaeli University
- Investigators
- Emine Dundar Ahi, assist prof, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141799
- Sponsor's protocol ID
- 2/2020.K-061
- Status last verified
- Aug 2022
- First submitted
- 19 Nov 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis; a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05141799
- Acronym / sponsor ID
- 2/2020.K-061
- Conditions
- De Quervain Disease
- Keywords
- Hand grip strength, high-intensity laser therapy, De Quervain Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Dec 2021 (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.
68 De Quervain tenosynovitis(MPS) diagnosed patients will be randomly divided into 2 groups. To groups; splinting+exercise+high-intensity laser therapy (HILT) and splinting+exercise+sham HILT will be applied. Visual anolog scale (VAS) scores, quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire and Hand grip strength measurements of the patients before-after treatment will be recorded and will be evaluated statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensity laser therapy (HILT) | Active comparator | Device: high intensity laser therapywe will apply the HILT device to the most painful area of the wrist in two phases. In both phase I and phase II, the laser will be applied using continuous circular movements. The first three sessions (phase I) will be used to provide analgesic effects at an intermittent phase, applying a 75 sec, 8 W, 6 J/cm2 treatment for a total of 150 J of energy. The subsequent six sessions (phase II) will provide a biostimulatory effect at a continuous phase, applying a 30 sec, 6 W, 120 to 150 J/cm2 treatment. The HILT will be applied for a total of nine treatment sessions over a period of three consecutive weeks. |
| sham HILT | Sham comparator | Device: high intensity laser therapyWe will apply the HILT device to the most painful area of the wrist by using continuous circular movements, but the laser instrument will switched off during applications. The sham HILT will be applied for a total of nine treatment sessions over a period of three consecutive weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with unilateral De Quervain tenosynovitis 18-65 years old
Key exclusion criteria (9 listed)
- pain history of less than four weeks,
- upper extremity entrapment neuropathy,
- major psychiatric disease,
- upper extremity surgical treatment history,
- malignancy history,
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 intensity laser therapyLaser treatment is noninvasive and painless and can be easily administered in therapy units for a wide range of conditions. High-intensity laser therapy (HILT) has gained importance for the treatment of different kinds of sports injuries such as tendon injuries, contusions, and muscle spasms. | Device | high-intensity laser therapy (HILT), sham HILT |
Primary outcome
quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire
Time frame: 5 Minutes
The QDASH is a self-reported questionnaire that measures the physical functions and symptoms of patients with upper limb problems. It includes 11 items from the DASH survey, and to calculate the QDASH score, atleast 10 of the 11 items should be answered. Each item contains five answer options, and the total score of the scale is calculated from the individual item scores (0=no disability and 100=the most serious disability). The first eight items of the QDASH questionnaire measure the patient's daily life function and social activity limitations. The ninth question assesses the pain intensity, and the 10th question evaluates the feeling of "pins and needles" in the upper extremity. The last question is designed to evaluate the sleep problem due to pain.
JAMAR hydraulic hand dynamometer
Time frame: 2 minutes
Hand grip strength measurements will take with a JAMAR hydraulic hand dynamometer (Lafayette Instrument, Lafayette, IN, USA) are known to provide reliable results and these measurements will be obtain while the patient will stand with a full extension of the elbow and wrist. Each patient will be asked to squeeze the dynamometer with full force for a maximum of three seconds. First on the healthy side and then on the effected side, three measurements will be taken, and the averages will be obtain.
1 secondary outcome
visual analog scale (VAS)
Time frame: 10 Seconds
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 5 Aug 2022.
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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.
Emine Dundar Ahi, assist prof principal investigator
Kocaeli 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 high intensity laser therapy in people with De Quervain Disease, run by Kocaeli 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 1 inclusion and 9 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 5 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire (time frame: 5 Minutes). The study lists 2 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 5 Aug 2022.