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临床试验/NCT02735668
NCT02735668已完成不适用

Is Multimodal Physiotherapy More Effective Than Exercise Alone in Women With Peripheral Persistent Pain Following Breast Cancer Treatment? A Single-blinded Randomized Clinical Trial

University of Alcala1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Pain Intensity

研究概览

简要总结

The aim of this study is to determine the effectiveness of a multimodal physiotherapy intervention including scapula exercises in addition to deep dry needling and neurodynamic techniques versus scapula exercises only versus conventional shoulder exercises on pain intensity, perceived disability, scapula muscle activity and health-related quality of life.

详细描述

Introduction: chronic shoulder pain is a frequent consequence after breast cancer treatment with a reported prevalence of 25% to 60% and is commonly termed "Persistent Pain after Breast Cancer Treatment" (PPBCT). Frequently, PPBCT includes neuropathic pain due to damage of neural tissue during surgery. However, recent studies, consider that myofascial pain syndrome and heightened mechanosensitivity of neural tissue can be also present in this women. Although PPBCT is typically managed with pharmacological treatment,currently, physiotherapy is presented as an alternative method. Physiotherapy in relation to the shoulder, commonly, focuses its treatment with therapeutic exercise. In this sense, there is great controversy about which are the most appropriate exercises. Recent authors, bet for more precise and analytical exercises in relation with scapula and reject conventional exercises for the shoulder. Taking into account each of the sources of pain presented by these women and the benefits of therapeutic exercise, it would be interesting to study which approach of physiotherapy treatment would be more appropriate in these women.

Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups:

An experimental group, where the participants will be treated with Multimodal Physiotherapy;

Another experimental group where will be realized Scapular Exercises only;

And a third group where will be done Shoulder Conventional Exercises.

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)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with peripheral persistent pain following breast cancer treatment (surgery and/or radiotherapy and/or chemotherapy) with pain for at least 6 months.
  • Women who do not present contraindications for physiotherapy (infection, metastasis, locoregional recurrence).
  • Women who have read, understood and signed informed consent freely

排除标准

  • Women treated with bilateral breast cancer.
  • Women with shoulder pain episodes prior to breast cancer treatment.
  • Women with predominant central sensitization pain identified by the Central Sensitization Inventory (> 40 points)
  • Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.

研究组 & 干预措施

Shoulder Conventional Exercises

Active Comparator

The protocol consists in:

  • Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment.
  • Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

干预措施: Shoulder Conventional Exercises (Other)

Shoulder Conventional Exercises

Active Comparator

The protocol consists in:

  • Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment.
  • Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

干预措施: Therapeutic Education (Behavioral)

Multimodal Physiotherapy

Experimental

The protocol consists in:

  • Dry Needling in active myofascial trigger points.
  • Neurodynamic techniques.
  • Scapular exercises.
  • Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

干预措施: Multimodal Physiotherapy (Other)

Multimodal Physiotherapy

Experimental

The protocol consists in:

  • Dry Needling in active myofascial trigger points.
  • Neurodynamic techniques.
  • Scapular exercises.
  • Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

干预措施: Scapular exercises (Other)

Multimodal Physiotherapy

Experimental

The protocol consists in:

  • Dry Needling in active myofascial trigger points.
  • Neurodynamic techniques.
  • Scapular exercises.
  • Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

干预措施: Therapeutic Education (Behavioral)

Scapular exercises

Experimental

The protocol consists in:

  • Scapular exercises
  • Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

干预措施: Scapular exercises (Other)

Scapular exercises

Experimental

The protocol consists in:

  • Scapular exercises
  • Therapeutic Education about chronic shoulder pain.

The treatment duration is 1 day per week during 6 weeks.

干预措施: Therapeutic Education (Behavioral)

结局指标

主要结局

Pain Intensity

时间窗: Change from baseline VAS at after 9 physical therapy sessions, 3 and 6 months after baseline assessments will be require

Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".

次要结局

  • Health-related quality of life(At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.)
  • Pain and Disability(At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.)
  • Root-Mean-Square (RMS) EMG Amplitude(At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.)
  • Onset EMG(At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.)
  • Myofascial Pain Syndrome. Active myofascial trigger points of the muscles involved in shoulder. Travell and Simon's Criteria were used.(At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.)

研究者

发起方
University of Alcala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Virginia Prieto Gómez

Research Expert of Healthcare (Msc)

University of Alcala

研究点 (1)

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