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NCT Number: NCT05423223

Comparative Effects of Paraffin Bath Therapy and ESWT on Quality of Life and Sleep in 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.

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Key information

Conditions

De Quervain Disease Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yuzuncu Yil University

Van, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paraffin Bath Therapy

Device

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

Extracorporeal Shock Wave Therapy

Device

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

Primary outcomes

  1. 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"

  2. 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"

  3. 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"

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Comparative Effects of Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy on Quality of Life and Sleep in Patients With De Quervain Tenosynovitis

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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