ClinicalTrials.gg
CompletedNCT05141799Updated Aug 5, 2022

Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis

An interventional study of high intensity laser therapy in De Quervain Disease, sponsored by Kocaeli University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-05.

Sponsored by Kocaeli University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • De Quervain Disease

Browse trials for

Keywords

  • Hand grip strength
  • high-intensity laser therapy
  • De Quervain Disease
03

In context

De Quervain Disease

30 studies on the registry are indexed under De Quervain Disease; 7 are open to participants now.

This study's enrollment of 64 is above the median of 55 across 26 interventional studies indexed under De Quervain Disease.

Browse De Quervain Disease studies →

Lead sponsor

Kocaeli University is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients diagnosed with unilateral De Quervain tenosynovitis 18-65 years old

Exclusion criteria

Exclusion Criteria:

  • pain history of less than four weeks,
  • upper extremity entrapment neuropathy,
  • major psychiatric disease,
  • upper extremity surgical treatment history,
  • history,
  • chronic rheumatic disease,
  • cervical radiculopathy,
  • cervical myelopathy,
  • local injection prior to De Quervain tenosynovitis and receiving physical therapy.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    high-intensity laser therapy (HILT)

    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.

    Device: high intensity laser therapy

  • Sham comparator
    sham HILT

    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.

    Device: high intensity laser therapy

Interventions

  • Devicehigh intensity laser therapy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 Minutes

  2. 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.

    Time frame: 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.

    Time frame: 10 Seconds

07

Study locations

1 site
  • Private Medar Hospital
    Kocaeli, Golcuk 41650, Turkey
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Jun 2022, 3 months.

Of 16 interventional studies with no phase under De Quervain Disease, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 28. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2021
First posted
Dec 2, 2021
StartActual
Mar 11, 2022
Primary completionActual
Jun 30, 2022
CompletionActual
Jun 30, 2022
Last update
Aug 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05141799
Lead sponsor
Kocaeli University
Responsible party
Emine Dundar Ahi, MD (Assistant Professor, Kocaeli University) — Principal investigator
First posted
Dec 2, 2021
Start date
Mar 11, 2022
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Last update
Aug 5, 2022

Study contacts

Emine Dundar Ahi, assist prof
principal investigator · Kocaeli University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion