Back to resultsComparative Effects of Paraffin Bath Therapy and ESWT on Quality of Life and Sleep in De Quervain Tenosynovitis
Primary Purpose
De Quervain Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Paraffin Bath Therapy
Extracorporeal Shock Wave Therapy
Sponsored by
About this trial
This is an interventional treatment trial for De Quervain Disease
Eligibility Criteria
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
Sites / Locations
- Yuzuncu Yil University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Paraffin Bath Therapy
Extracorporeal Shock Wave Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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"
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"
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"
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05423223
First Posted
June 14, 2022
Last Updated
November 28, 2022
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT05423223
Brief Title
Comparative Effects of Paraffin Bath Therapy and ESWT on Quality of Life and Sleep in De Quervain Tenosynovitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
De Quervain Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paraffin Bath Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Extracorporeal Shock Wave Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Paraffin Bath Therapy
Intervention Description
Device named 'Fizyowax 1300' (Fizyomed, Turkey).
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy
Intervention Description
Device named 'Elettronica Pagani,Italy' and will be used with radial probe.
Primary Outcome Measure Information:
Title
PSQI (Pittsburgh Sleep Quality Index)
Description
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)
Title
PSQI (Pittsburgh Sleep Quality Index)
Description
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)
Title
PSQI (Pittsburgh Sleep Quality Index)
Description
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)
Title
NEADL (Nottingham extended activities of daily living ) scale
Description
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)
Title
NEADL (Nottingham extended activities of daily living ) scale
Description
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)
Title
NEADL (Nottingham extended activities of daily living ) scale
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volkan Şah
Organizational Affiliation
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuzuncu Yil University
City
Van
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effects of Paraffin Bath Therapy and ESWT on Quality of Life and Sleep in De Quervain Tenosynovitis
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