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临床试验/NCT06527014
NCT06527014已完成不适用

Comparison of the Effectiveness of Pulsed Radiofrequency (pRF) to the Suprascapular Nerve Versus Conventional Physical Therapy Program in Chronic Shoulder Pain

Ankara City Hospital Bilkent2 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Numarical Rating Scale

研究概览

简要总结

Regardless of the etiology, chronic shoulder pain is a distressing condition that affects daily life and is among the first common reasons for musculoskeletal system problems when admitting to clinics. Pulsed radiofrequency (pRF) treatment to the suprascapular nerve (SSN) is a promising interventional procedure, that is thought to be effective in case of chronic shoulder pain. However, conventional physical therapy program is preferred more often and found more applicable. The aim of current study is to compare the effectiveness of two treatment procedures.

详细描述

This study carried out in 27 chronic shoulder pain patients aged between 18-75 years in Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital. Total of 25 patients, who had > 3 months shoulder pain and pain more than > 4 according to the numerical rating scale (NRS), completed the study. Twenty-seven patients randomized into two groups, 21 patients underwent pRF of Suprascapular nerve (SSN) in Group 1; 16 patients received 10 sessions conventional physical therapy (CPT) program. One patient did not come to follow-ups after SSN pRF procedure, other patient did not complete the 10 session CPT program.

Approval for the study was granted by the 2nd Ethics Committee of Ankara Bilkent City Hospital (Protocol number: E2-23-3799). The study was conducted in line with the Helsinki Declaration. All patients signed informed consent prior to participation.

Inclusion criteria were 1) shoulder pain lasts more than 3 months 2) Shoulder pain more than 4 according to NRS 3) no passive range of motion limitation 4) unilateral chronic shoulder pain 5) INR> 1.2 in blood samples.

Exclusion criteria were 1) Adhesive capsulitis that cause passive range of motion in shoulder joint 2) History of intra-articular joint injection or physical therapy at the last 6 months 3) History of fracture, trauma or surgery 4) Accompanying rheumatologic disease or other inflammatory arthritis involved shoulder joint 5) Local infection, sepsis, malignancy or pregnancy 6) Uncontrolled diabetes or other co-morbidities that worsens general condition 7) History of allergy to the materials used in treatment 8) Mental disorders that lead incooperation.

After the informed consent patients divided into 2 groups with closed envelope method by the staff who is not participated in the study. Group 1 underwent SSN pRF and Group 2 received 10 sessions of CPT program including hotpack, therapeatic ultrasound as a deep heater and transcutaneous electrical nerve stimulation (TENS). All patients were thought shoulder exercises such as pendulum exercises and isometric exercises around shoulder muscles to be performed individually until the 1st month follow-up.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Shoulder pain lasts more than 3 months
  • Shoulder pain more than 4 according to NRS
  • No passive range of motion limitation
  • Unilateral chronic shoulder pain
  • INR> 1.2 in blood samples.
  • Exclusion Criteria
  • Adhesive capsulitis that cause passive range of motion in shoulder joint
  • History of intra-articular joint injection or physical therapy at the last 6 months
  • History of fracture, trauma or surgery
  • Accompanying rheumatologic disease or other inflammatory arthritis involved shoulder joint
  • Local infection, sepsis, malignancy or pregnancy
  • Uncontrolled diabetes or other co-morbidities that worsens general condition
  • History of allergy to the materials used in treatment
  • Mental disorders that lead incooperation.

排除标准

  • 未提供

结局指标

主要结局

Numarical Rating Scale

时间窗: partcipants were evaluated at baseline and 1st month follow-up

Numerical rating scale (NRS): It is a rating scale for self reported pain. 0 , means there is no pain and 10, represents the most pain experienced in life time.

QuickDASH

时间窗: partcipants were evaluated at baseline and 1st month follow-up

It is self-reported questionnaire related to pain and disfunction. Abilities and symptoms are asked about last week. All questions are rated 0-5. Higher scores are related more disability for upper extremity.

次要结局

未报告次要终点

研究者

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

Hüma Bölük Şenlikci

Associate Professor

Ankara City Hospital Bilkent

研究点 (2)

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