Comparative Effects of Paraffin Bath Therapy and ESWT in Patients With De Quervain Tenosynovitis

Comparative Effects of Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy on Pain and Hand Functions in Patients With De Quervain Tenosynovitis

There is no study in the literature comparing both paraffin bath therapy and Extracorporeal Shock Wave Therapy (ESWT) in the treatment of patients with De Quervain Tenosynovitis. The aim of this study is performing this comparison.

Study Overview

• Status: Completed
• Conditions: De Quervain Disease
• Intervention / Treatment: Device: Paraffin Bath Therapy; Device: Extracorporeal Shock Wave Therapy

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey
    • Yuzuncu Yil University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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
Visual Analogue Scale (VAS)	patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse	at baseline (before the treatment)
Visual Analogue Scale (VAS)	patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse	2 weeks after baseline (at the end of treatment)
Visual Analogue Scale (VAS)	patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse	6 weeks after baseline (one month after the end of treatment)
Duruöz Hand Index (DHI)	Duruöz Hand Index (DHI) is a functional disability scale that can be used successfully to assess the functional disability with different hand arthropathies. It consists of 18 items that evaluate hand and wrist activities. The answers are evaluated on a 6-level (0-5) Likert scale and the total score ranges from 0 to 90.	at baseline (before the treatment)
Duruöz Hand Index (DHI)	Duruöz Hand Index (DHI) is a functional disability scale that can be used successfully to assess the functional disability with different hand arthropathies. It consists of 18 items that evaluate hand and wrist activities. The answers are evaluated on a 6-level (0-5) Likert scale and the total score ranges from 0 to 90.	2 weeks after baseline (at the end of treatment)
Duruöz Hand Index (DHI)	Duruöz Hand Index (DHI) is a functional disability scale that can be used successfully to assess the functional disability with different hand arthropathies. It consists of 18 items that evaluate hand and wrist activities. The answers are evaluated on a 6-level (0-5) Likert scale and the total score ranges from 0 to 90.	6 weeks after baseline (one month after the end of treatment)

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

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: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Tenosynovitis; De Quervain Disease
• Other Study ID Numbers: Van YYÜ School of Medicine

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