NCT06147869

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

November 9, 2023

Last Update Submit

August 22, 2024

Conditions

Outcome Measures

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.

    4 weeks

Study Arms (2)

photopheresis

ACTIVE COMPARATOR
Device: phonophoresis

Low level laser

ACTIVE COMPARATOR
Device: Low level laser therapy

Interventions

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

photopheresis

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.

Low level laser

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with dequervain tenosynovities pospartum
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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 body mass index (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.

You may not qualify if:

  • (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 steroid in their tender point.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadat General Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

De Quervain Disease

Interventions

PhonophoresisLow-Level Light Therapy

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsLaser TherapyPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will be carried out on forty lactating women suffering from De Quervain's tenosynovitis after 6 weeks from the delivery. They will be selected randomly from the out patient clinic of orthopedic in Kasr El Aini Hospital. Their ages will be ranged from 25-35 years old, their body mass index (BMI) will not exceed 30 Kg/m2 and their parity will be ranged from (2-4 children).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
student at master degree

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 28, 2023

Study Start

December 1, 2023

Primary Completion

January 30, 2024

Study Completion

June 30, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations