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

November 28, 2022 updated by: Volkan Şah, Yuzuncu Yıl University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey
        • Yuzuncu Yil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device named 'Fizyowax 1300' (Fizyomed, Turkey).
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
Device named 'Elettronica Pagani,Italy' and will be used with radial probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
at baseline (before the treatment)
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"
2 weeks after baseline (at the end of treatment)
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"
6 weeks after baseline (one month after the end of treatment)
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.
at baseline (before the treatment)
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.
2 weeks after baseline (at the end of treatment)
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.
6 weeks after baseline (one month after the end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 25, 2022

Primary Completion (ACTUAL)

September 5, 2022

Study Completion (ACTUAL)

October 19, 2022

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (ACTUAL)

June 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • van yüzüncü yıl tıp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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