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

De Quervain Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423223
• Other study ID #: van yüzüncü yil tip
• Status: Completed
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: October 19, 2022

Study information

• Verified date: November 2022
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 19, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• De Quervain Disease
• Tenosynovitis

Intervention

Device:
• Paraffin Bath Therapy
Device named 'Fizyowax 1300' (Fizyomed, Turkey).
• Extracorporeal Shock Wave Therapy
Device named 'Elettronica Pagani,Italy' and will be used with radial probe.

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	at baseline (before the treatment)
Primary	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"	2 weeks after baseline (at the end of treatment)
Primary	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"	6 weeks after baseline (one month after the end of treatment)
Primary	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.	at baseline (before the treatment)
Primary	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.	2 weeks after baseline (at the end of treatment)
Primary	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.	6 weeks after baseline (one month after the end of treatment)