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临床试验/NCT07417722
NCT07417722已完成不适用

Investigation of the Effects of Peloidotherapy on Pain Severity, Functional Status, and Ultrasonographic Findings in Patients With Carpal Tunnel Syndrome: A Randomized, Prospective, Single-Blind Study

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Boston Carpal Tunnel Questionnaire (BCTQ)

研究概览

简要总结

Carpal tunnel syndrome is a common condition caused by pressure on a nerve at the wrist. It can lead to pain, numbness, weakness, and difficulty using the hand during daily activities.

In this clinical trial, researchers will study a non-drug treatment approach for people with carpal tunnel syndrome. Participants will be randomly assigned to one of two groups. One group will receive a wrist splint and a home exercise program. The other group will receive peloidotherapy in addition to the same splint and exercise program.

Pain, hand function, daily activities, quality of life, hand strength, and ultrasound findings of the median nerve will be evaluated before treatment, at the end of treatment, and during follow-up periods.

The goal of this study is to determine whether adding peloidotherapy to wrist splint and a home exercise program provides additional benefits in reducing pain and improving hand function in people with carpal tunnel syndrome.

详细描述

Carpal tunnel syndrome is a common compressive neuropathy caused by entrapment of the median nerve at the wrist. It is characterized by pain, numbness, paresthesia, weakness, and functional limitations of the hand, which may negatively affect daily activities and quality of life. Conservative treatment approaches are frequently preferred, particularly in mild to moderate cases, and include wrist splinting, exercise programs, and physical therapy modalities.

This randomized, prospective, single-blind clinical trial was conducted to investigate the effects of peloidotherapy as an adjunct to wrist splint and a home exercise program in individuals with carpal tunnel syndrome. Eligible participants diagnosed with carpal tunnel syndrome were randomly assigned to one of two treatment groups.

The control group received a wrist splint and a structured home exercise program. The intervention group received peloidotherapy in addition to the same wrist splint and home exercise program. Peloidotherapy was applied in standardized 15 sessions under controlled conditions throughout the treatment period.

Clinical and functional assessments were performed at four time points: at baseline before treatment (week 0), at the end of the treatment period (week 3), and during follow-up at one month (week 7) and three months (week 15) after completion of treatment. This assessment schedule was designed to evaluate both short-term and sustained effects of the interventions.

Outcome measures included pain intensity, functional status of the hand, functional disability, quality of life, hand grip strength, neuropathic pain characteristics, and ultrasonographic evaluation of the median nerve, including measurements of the nerve cross-sectional area.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor was blinded to group allocation. No other participants or study personnel were masked.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with mild or mild-to-moderate carpal tunnel syndrome confirmed by electromyography (EMG)
  • Presence of clinical symptoms for at least 3 months
  • Age 18 years and older
  • No limitation in wrist joint range of motion

排除标准

  • Cervical radiculopathy
  • Polyneuropathy
  • Pregnancy
  • Presence of underlying metabolic diseases (diabetes mellitus, inflammatory rheumatic diseases, thyroid disorders)
  • Presence of hand osteoarthritis
  • Previous wrist or hand surgery
  • Severe carpal tunnel syndrome confirmed by electromyography (EMG)
  • Thenar muscle atrophy
  • Corticosteroid injection for carpal tunnel syndrome or use of a wrist splint within the last 6 months
  • History of malignancy
  • Receipt of peloid therapy or any physical therapy modality for carpal tunnel syndrome within the last 6 months
  • Contraindications to peloid therapy (impaired skin integrity or active infection at the application site)

研究组 & 干预措施

Non-Peloid Therapy Group

Active Comparator

Participants receive treatment consisting of wrist splinting and a structured home exercise program. No peloid therapy is administered.

干预措施: Wrist Splint (Device)

Non-Peloid Therapy Group

Active Comparator

Participants receive treatment consisting of wrist splinting and a structured home exercise program. No peloid therapy is administered.

干预措施: Home Exercise Program (Other)

Peloid Therapy Group

Experimental

Participants receive wrist splinting and a structured home exercise program in addition to peloid therapy. Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions.

干预措施: Peloid Therapy (Other)

Peloid Therapy Group

Experimental

Participants receive wrist splinting and a structured home exercise program in addition to peloid therapy. Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions.

干预措施: Wrist Splint (Device)

Peloid Therapy Group

Experimental

Participants receive wrist splinting and a structured home exercise program in addition to peloid therapy. Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions.

干预措施: Home Exercise Program (Other)

结局指标

主要结局

Boston Carpal Tunnel Questionnaire (BCTQ)

时间窗: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)

Symptom severity and functional status measured using the Boston Carpal Tunnel Questionnaire (BCTQ), which includes Symptom Severity and Functional Status subscales. Each item is scored from 1 to 5 and subscale scores are calculated as the mean of item scores. Higher scores indicate worse symptoms and functional limitation.

次要结局

  • Median Nerve Cross-Sectional Area(Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).)
  • QuickDASH Score(Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15))
  • Visual Analog Scale for Pain at Rest(Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15))
  • Visual Analog Scale for Pain During Activity(Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15))
  • Visual Analog Scale for Night Pain(Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15))

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

İrem Çiftler Gayret.

Resident Physician in Physical Medicine and Rehabilitation

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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