ClinicalTrials.gg
CompletedNCT06147869Updated Aug 23, 2024

Phonophoresis Versus Low-Level Laser on Dequervain

An interventional study of phonophoresis and Low level laser therapy in de Quervain Tenosynovitis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-08-23.

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

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
25 Years to 35 Years
Sex
Female
01

Study summary

De Quervain's tenosynovitis is a frequently encountered pain of the hand and wrist. It results from compression and irritation of the extensor pollicis brevis and abductor pollicis longs tendons as they pass through the first dorsal compartment of the wrist. Patients complain of tenderness and swelling proximal to the radial styloid process, as well as pain in the wrist and on the radial side of the hand. Owing to persistent pain and inflammation, the pinch and grasp strength of the hand is considerably compromised, coupled with tenderness over the anatomical snuff box. Although the condition occurs in both females and males, it is significantly more common in women, especially during pregnancy and postpartum. This condition can be caused by micro traumas that occur in the course of repetitive mechanical activities and systemic diseases of the connective tissue.The symptom of de Quervain syndrome is pain in the forearm at the height of the radial styloid process. The pain intensifies during the extension of the thumb. Other symptoms include redness and swelling in the region. Physiotherapeutic treatment is an important element of conservative treatment of de Quervain syndrome .

Read the detailed description

Phonophoresis is a method of driving topically applied substances across tissues using ultrasound (US) to enhance percutaneous absorption of selected drugs such as corticosteroids, local anaesthetics, and salicylates. Despite prevalent applications in various musculoskeletal conditions including de Quervain's disease, few modalities have been the target of as much controversy and speculation as phonophoresis. Standardised research is needed to accurately determine the efficacy of phonophoresis in pregnant females suffering from de Quervain's disease; more so because this vulnerable group is generally excluded from routine clinical trials and prevailing knowledge about the same is scant. Our study provides objective evidence regarding the applicability of phonophoresis in treating de Quervain's disease in pregnant women. It describes appropriate drug concentration, vehicle type, US frequency, and the mode for bringing about maximal improvements in the condition In physiotherapy LLLT is commonly used to relieve pain, reduce inflammation and accelerate tissue regeneration. So, it is usually recommended to treat De quervain's tenosynovitis, sprains, strains, low back pain, sciatica, postsurgical pain, shoulder pain, Sacro-iliac joint pain, Symphyseal pain, carpal tunnel syndrome, coccydynia, fibromyalgia, osteoarthritis, rheumatoid arthritis, disc herniation or degeneration, neuropathic pain, tendinitis, tennis elbow and plantar fasciitis. In the same time, according to The North American Association for Laser Therapy, LLLT is contraindicated in pregnancy, cancer, epileptic conditions and on eyes De Quervain's tenosynovitis is most common in women 30 to 50 years of age. Patients typically report several weeks of pain, often severe, on the radial aspect of the wrist at about the level of the radial styloid. Wrist pain and grip weakness are the hallmarks of de Quervain's tenosynovitis. Pinch grip, thumb extension or abduction. and wrist motion exacerbate and reproduce the pain.The pain of de Quervain's tenosynovitis can extend proximally up the forearm from the region of the anatomic "snuff box." Repetitive activities, especially activities that involve pinching with the thumb while moving the wrist in either the radial or ulnar direction, result in inflammation and pain within the shared tendon sheath of the abductor pollicis longus and extensor pollicis brevis

02

Conditions studied

  • de Quervain Tenosynovitis

Browse trials for

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 40 is below the median of 55 across 26 interventional studies indexed under De Quervain Disease.

Browse De Quervain Disease studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

    1. All participates are clinically diagnosed as they have De Quervain's tenosynovitis . 2. All patient will have positive Finkelstein test. 3. All patient will have severe pain, tenderness and swelling near the base of the thumb over the styloid process of the radius of their dominant hand and limitation of motion of the thumb and wrist joint. 4. Their ages will be ranged from 25-35 years old. 5. Their (BMI) will not exceed 30 kg/m2
  • The type of delivery is normal and caesarean section.
  • Their parity will be ranged from (2-4 children).
  • All patients will not receive any medical treatment to relieve pain or decrease inflammation.
  • All patients are not pregnant.

Exclusion criteria

Exclusion Criteria:

  • (1) Patients have diabetic mellitus, hypertension. (2) Patients have any cardiovascular diseases, heart diseases, renal diseases or any diseases (3) Patients have Rheumatoid Arthritis or Gout. (4) Patients have Cervical spondylosis with radiculopathy or any spinal diseases. (5) Patients have leukemia or tumor(benign or malignant)or even breast cancer. (6) Patients have double crush syndrome, carpal bone fracture or joint osteo-arthritis. (7) Patients have any deformities in their hands. (8) Patients have burns, ulcers, open wounds or any skin diseases in their dominant hands. (9) Patients have received medications or have injected with in their tender point.
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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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
40 participants (actual)

Study arms

  • Active comparator
    photopheresis

    Device: phonophoresis

  • Active comparator
    Low level laser

    Device: Low level laser therapy

Interventions

  • Devicephonophoresis

    Phonophoresis is a method of driving topically applied substances across tissues using ultrasound (US) to enhance percutaneous absorption of selected drugs such as corticosteroids, local anaesthetics, and salicylates

  • DeviceLow level laser therapy

    Low-level laser (light) therapy (LLLT) is a fast-growing technology used to treat a multitude of conditions that require stimulation of healing, relief of pain and inflammation, and restoration of function.

06

What researchers measure

Primary outcomes

  1. Visual analogue scale (VAS)

    This scale will be used by each patient before and after the treatment course to estimate the intensity of pain. The Visual Analogue Scale (VAS) is a graphic rating scale with numerical values ranging from 0 to 4, placed equidistantly on a line 10 cm long, drawn horizontally.

    Time frame: 4 weeks

07

Study locations

1 site
  • Sadat General Hospital
    Cairo, Egypt
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 Dec 2023 to primary completion in Jan 2024, 1 month.

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 1 month is below that.

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

Registered
Nov 9, 2023
First posted
Nov 28, 2023
StartActual
Dec 1, 2023
Primary completionActual
Jan 30, 2024
CompletionActual
Jun 30, 2024
Last update
Aug 23, 2024
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 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06147869
Lead sponsor
Cairo University
Responsible party
Reham Attia Mohamed Khotapy (student at master degree, Cairo University) — Principal investigator
First posted
Nov 28, 2023
Start date
Dec 1, 2023
Primary completion
Jan 30, 2024
Completion
Jun 30, 2024
Last update
Aug 23, 2024

Oversight

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 2024. 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