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

• Sponsor: Yuzuncu Yıl University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05423223
• Collaborator: (none)
• Enrollment: 70
• Arms: 2
• Anticipated Duration (Months): 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
De Quervain Disease	Device: Paraffin Bath Therapy; Device: Extracorporeal Shock Wave Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 25, 2022
• Anticipated Primary Completion Date: Sep 5, 2022
• Anticipated Study Completion Date: Sep 19, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. PSQI (Pittsburgh Sleep Quality Index) [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"

2. PSQI (Pittsburgh Sleep Quality Index) [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"

3. PSQI (Pittsburgh Sleep Quality Index) [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"

4. NEADL (Nottingham extended activities of daily living ) scale [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.

5. NEADL (Nottingham extended activities of daily living ) scale [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.

6. NEADL (Nottingham extended activities of daily living ) scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yuzuncu Yıl University

Investigators

• Principal Investigator: Volkan Şah, Yüzüncü Yıl Üniversitesi Tıp Fakültesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Volkan Şah, Principal Investigator, Yuzuncu Yıl University
• ClinicalTrials.gov Identifier: NCT05423223
• Other Study ID Numbers: van yüzüncü yıl tıp
• First Posted: Jun 21, 2022
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tenosynovitis; De Quervain Disease

Study Results

No Results Posted as of Jun 23, 2022