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CompletedNCT05423223Updated Nov 29, 2022

Comparative Effects of Paraffin Bath Therapy and ESWT on Quality of Life and Sleep in De Quervain Tenosynovitis

An interventional study of Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy in De Quervain Disease, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • De Quervain Disease

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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 70 is above the median of 55 across 26 interventional studies indexed under De Quervain Disease.

Browse De Quervain Disease studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

  • 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 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.

Exclusion criteria

Exclusion Criteria:

  • Neurological diseases (especially neuropathies),
  • Rheumatological diseases
  • Pregnancy
  • History of hand/wrist fracture or surgery
  • Hand/wrist trauma in the last 1 month
  • Coagulation disorder diseases
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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Paraffin Bath Therapy

    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.

    Device: Paraffin Bath Therapy

  • Active comparator
    Extracorporeal Shock Wave Therapy

    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.

    Device: Extracorporeal Shock Wave Therapy

Interventions

  • DeviceParaffin Bath Therapy

    Device named 'Fizyowax 1300' (Fizyomed, Turkey).

  • DeviceExtracorporeal Shock Wave Therapy

    Device named 'Elettronica Pagani,Italy' and will be used with radial probe.

06

What researchers measure

Primary outcomes

  1. 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"

    Time frame: at baseline (before the treatment)

  2. 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"

    Time frame: 2 weeks after baseline (at the end of treatment)

  3. 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"

    Time frame: 6 weeks after baseline (one month after the end of treatment)

  4. 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.

    Time frame: at baseline (before the treatment)

  5. 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.

    Time frame: 2 weeks after baseline (at the end of treatment)

  6. 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.

    Time frame: 6 weeks after baseline (one month after the end of treatment)

07

Study locations

1 site
  • Yuzuncu Yil University
    Van, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 Jul 2022 to primary completion in Sep 2022, 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
Jun 14, 2022
First posted
Jun 21, 2022
StartActual
Jul 25, 2022
Primary completionActual
Sep 5, 2022
CompletionActual
Oct 19, 2022
Last update
Nov 29, 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 Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05423223
Responsible party
Volkan Şah (Principal Investigator, Yuzuncu Yıl University) — Principal investigator
First posted
Jun 21, 2022
Start date
Jul 25, 2022
Primary completion
Sep 5, 2022
Completion
Oct 19, 2022
Last update
Nov 29, 2022

Study contacts

Volkan Şah
principal investigator · Yüzüncü Yıl Üniversitesi Tıp Fakültesi

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 Nov 2022. You cannot join it, but the record below documents what was studied.

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