de Quervain TenosynovitisNCT06147869
Phonophoresis Versus Low-Level Laser on Dequervain
A study testing phonophoresis and Low level laser therapy in people with de Quervain Tenosynovitis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- de Quervain Tenosynovitis
- What is being tested?
- phonophoresis and Low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 30 Jun 2024
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phonophoresis Versus Low-Level Laser Therapy on Dequervain Tenosynovitis After Delivery
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
- Conditions
- de Quervain Tenosynovitis
- Being tested
- phonophoresis, Low level laser therapy
- 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.
phonophoresisDevice
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
Low level laser therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| photopheresis | Active comparator | Not described Receives: Device: phonophoresis |
| Low level laser | Active comparator | Not described Receives: Device: Low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Dec 2023
- Primary completion30 Jan 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for de Quervain TenosynovitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Attia Mohamed Khotapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147869
- Sponsor's protocol ID
- Phonophoresis versus laser
- Status last verified
- Aug 2024
- First submitted
- 9 Nov 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phonophoresis Versus Low-Level Laser Therapy on Dequervain Tenosynovitis After Delivery
- ClinicalTrials.gov ID
- NCT06147869
- Acronym / sponsor ID
- Phonophoresis versus laser
- Conditions
- de Quervain Tenosynovitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Nov 2023 (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.
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 .
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| photopheresis | Active comparator | Device: phonophoresis |
| Low level laser | Active comparator | Device: Low level laser therapy |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- (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.
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 |
|---|---|---|
| phonophoresisPhonophoresis 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 | Device | photopheresis |
| Low level laser therapyLow-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. | Device | Low level laser |
Primary outcome
Visual analogue scale (VAS)
Time frame: 4 weeks
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.
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 23 Aug 2024.
Related trials for de Quervain Tenosynovitis
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
RecruitingPhase 4
Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
De Quervain Tenosynovitis
Recruiting
De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy.
De Quervain Disease, Hand Tenosynovitis
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 phonophoresis and Low level laser therapy in people with de Quervain Tenosynovitis, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 1 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 23 Aug 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 Egypt. 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 analogue scale (VAS) (time frame: 4 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 23 Aug 2024.