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

NCT05423223 | Completed

• 1 other identifier: van yüzüncü yıl tıp
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

De Quervain Disease

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Paraffin Bath Therapy

ACTIVE COMPARATOR

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

Extracorporeal Shock Wave Therapy

ACTIVE COMPARATOR

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

Interventions

Paraffin Bath Therapy DEVICE

Device named 'Fizyowax 1300' (Fizyomed, Turkey).

Paraffin Bath Therapy

Extracorporeal Shock Wave Therapy DEVICE

Device named 'Elettronica Pagani,Italy' and will be used with radial probe.

Extracorporeal Shock Wave Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yuzuncu Yil University

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

De Quervain Disease

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Volkan Şah

  Yüzüncü Yıl Üniversitesi Tıp Fakültesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: July 25, 2022
• Primary Completion: September 5, 2022
• Study Completion: October 19, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)