De Quervain DiseaseNCT05423223
Comparative Effects of Paraffin Bath Therapy and ESWT on Quality of Life and Sleep in De Quervain Tenosynovitis
A study testing Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy in people with De Quervain Disease, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
There is no study in the literature comparing effects of both paraffin bath therapy and Extracorporeal Shock Wave Therapy (ESWT) on life and sleep quality of patients with De Quervain Tenosynovitis . The aim of this study is performing this comparison. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- De Quervain Disease
- What is being tested?
- Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2022to 19 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Meeting De Quervain diagnostic criteria
- Not having applied any physical therapy modality to the hand-wrist in the last 1 month
- Not using pain medication in the last 1 month,
- Not using local anesthetics or steroid injections on the hand-wrist in the last 3 months
- Have received written consent to participate in the study, and have come to the last control at the 6th week.
Who cannot join
- Neurological diseases (especially neuropathies),
- Malignancy
- Rheumatological diseases
- Pregnancy
- History of hand/wrist fracture or surgery
- Hand/wrist trauma in the last 1 month
- Coagulation disorder diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy on Quality of Life and Sleep in Patients With De Quervain Tenosynovitis
There is no study in the literature comparing effects of both paraffin bath therapy and Extracorporeal Shock Wave Therapy (ESWT) on life and sleep quality of patients with De Quervain Tenosynovitis . The aim of this study is performing this comparison.
- Conditions
- De Quervain Disease
- Being tested
- Paraffin Bath Therapy, Extracorporeal Shock Wave 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.
Paraffin Bath TherapyDevice
Device named 'Fizyowax 1300' (Fizyomed, Turkey).
Extracorporeal Shock Wave TherapyDevice
Device named 'Elettronica Pagani,Italy' and will be used with radial probe.
| Study group | Role | What they receive |
|---|---|---|
| Paraffin Bath Therapy | Active comparator | Paraffin bath therapy is a physical therapy method that can create a temperature increase of 7.5 °C in the joint capsule and 4.5 °C in the muscle. Receives: Device: Paraffin Bath Therapy |
| Extracorporeal Shock Wave Therapy | Active comparator | Extracorporeal shock wave therapy (ESWT) is a noninvasive treatment that involves delivery of shock waves to injured soft tissue to reduce pain and promote healing. Receives: Device: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSQI (Pittsburgh Sleep Quality Index)
PUKI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"
Measured: at baseline (before the treatment)
PSQI (Pittsburgh Sleep Quality Index)
PUKI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"
Measured: 2 weeks after baseline (at the end of treatment)
PSQI (Pittsburgh Sleep Quality Index)
PUKI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"
Measured: 6 weeks after baseline (one month after the end of treatment)
NEADL (Nottingham extended activities of daily living ) scale
It consists of 4 sub-sections: mobility (6 items), kitchen (5 items), indoor (5 items) and leisure time activities (6 items). The answer to each question has a rank between 0 and 3 points. The sum of the rank values of 22 items varies between 0 and 66 points, with 0-worst and 66-best values in daily activities.
Measured: at baseline (before the treatment)
NEADL (Nottingham extended activities of daily living ) scale
It consists of 4 sub-sections: mobility (6 items), kitchen (5 items), indoor (5 items) and leisure time activities (6 items). The answer to each question has a rank between 0 and 3 points. The sum of the rank values of 22 items varies between 0 and 66 points, with 0-worst and 66-best values in daily activities.
Measured: 2 weeks after baseline (at the end of treatment)
NEADL (Nottingham extended activities of daily living ) scale
It consists of 4 sub-sections: mobility (6 items), kitchen (5 items), indoor (5 items) and leisure time activities (6 items). The answer to each question has a rank between 0 and 3 points. The sum of the rank values of 22 items varies between 0 and 66 points, with 0-worst and 66-best values in daily activities.
Measured: 6 weeks after baseline (one month after the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start25 Jul 2022
- Primary completion5 Sep 2022
- Study completion19 Oct 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Şah, Yuzuncu Yil University
- Investigators
- Volkan Şah, Principal investigator, Yüzüncü Yıl Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423223
- Sponsor's protocol ID
- van yüzüncü yıl tıp
- Status last verified
- Nov 2022
- First submitted
- 14 Jun 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy on Quality of Life and Sleep in Patients With De Quervain Tenosynovitis
- ClinicalTrials.gov ID
- NCT05423223
- Acronym / sponsor ID
- van yüzüncü yıl tıp
- Conditions
- De Quervain Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 21 Jun 2022 (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.
There is no study in the literature comparing effects of both paraffin bath therapy and Extracorporeal Shock Wave Therapy (ESWT) on life and sleep quality of patients with De Quervain Tenosynovitis . The aim of this study is performing this comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paraffin Bath Therapy | Active comparator | Device: Paraffin Bath TherapyParaffin bath therapy is a physical therapy method that can create a temperature increase of 7.5 °C in the joint capsule and 4.5 °C in the muscle. |
| Extracorporeal Shock Wave Therapy | Active comparator | Device: Extracorporeal Shock Wave TherapyExtracorporeal shock wave therapy (ESWT) is a noninvasive treatment that involves delivery of shock waves to injured soft tissue to reduce pain and promote healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being 18 years or older
- Meeting De Quervain diagnostic criteria
- Not having applied any physical therapy modality to the hand-wrist in the last 1 month
- Not using pain medication in the last 1 month,
- Not using local anesthetics or steroid injections on the hand-wrist in the last 3 months
Key exclusion criteria (7 listed)
- Neurological diseases (especially neuropathies),
- Malignancy
- Rheumatological diseases
- Pregnancy
- History of hand/wrist fracture or surgery
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 |
|---|---|---|
| Paraffin Bath TherapyDevice named 'Fizyowax 1300' (Fizyomed, Turkey). | Device | Paraffin Bath Therapy |
| Extracorporeal Shock Wave TherapyDevice named 'Elettronica Pagani,Italy' and will be used with radial probe. | Device | Extracorporeal Shock Wave Therapy |
Primary outcome
PSQI (Pittsburgh Sleep Quality Index)
Time frame: at baseline (before the treatment)
PUKI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"
PSQI (Pittsburgh Sleep Quality Index)
Time frame: 2 weeks after baseline (at the end of treatment)
PUKI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"
PSQI (Pittsburgh Sleep Quality Index)
Time frame: 6 weeks after baseline (one month after the end of treatment)
PUKI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"
NEADL (Nottingham extended activities of daily living ) scale
Time frame: at baseline (before the treatment)
It consists of 4 sub-sections: mobility (6 items), kitchen (5 items), indoor (5 items) and leisure time activities (6 items). The answer to each question has a rank between 0 and 3 points. The sum of the rank values of 22 items varies between 0 and 66 points, with 0-worst and 66-best values in daily activities.
NEADL (Nottingham extended activities of daily living ) scale
Time frame: 2 weeks after baseline (at the end of treatment)
It consists of 4 sub-sections: mobility (6 items), kitchen (5 items), indoor (5 items) and leisure time activities (6 items). The answer to each question has a rank between 0 and 3 points. The sum of the rank values of 22 items varies between 0 and 66 points, with 0-worst and 66-best values in daily activities.
NEADL (Nottingham extended activities of daily living ) scale
Time frame: 6 weeks after baseline (one month after the end of treatment)
It consists of 4 sub-sections: mobility (6 items), kitchen (5 items), indoor (5 items) and leisure time activities (6 items). The answer to each question has a rank between 0 and 3 points. The sum of the rank values of 22 items varies between 0 and 66 points, with 0-worst and 66-best values in daily activities.
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 29 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for De Quervain Disease
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NAC-REPAIR for Post-surgical Pain
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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.
Volkan Şah principal investigator
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy in people with De Quervain Disease, run by Yuzuncu Yil 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 6 inclusion and 7 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 29 Nov 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. 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?
PSQI (Pittsburgh Sleep Quality Index) (time frame: at baseline (before the treatment)). The study lists 6 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 29 Nov 2022.