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临床试验/NCT04696341
NCT04696341已完成不适用

The Effectiveness of a Novel Massage Method Matrix Rhythm Therapy in Chronic Neck Pain

Pamukkale University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2011年3月25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
30
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

Thirty individuals with chronic neck pain randomised into two groups. Group I (15 subjects) received a total of 10 sessions as 5 sessions a week.Hot pack to cervical and upper thoracic regions (20 minutes), conventional Transcutaneous Electrical Nerve Stimulation (TENS) (100 Hz for 40 μsec), therapeutic ultrasound (1 Megahertz (MHz) for 5 minutes) and conventional massage were applied. Five sessions of Matrix Rhythm Therapy (2., 5., 6., 8., 10. sessions of combined physiotherapy programme) was added at combined physiotherapy Group II. Matrix Rhythm Therapy was applied to cervical and thoracic regions using 10 Hz frequency for 30 minutes.

Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm. Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm. Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain. Turkish version of Beck Depression Inventory was used to assess emotional status of participants.

详细描述

The study included patients aged between 25-65 years who had neck pain for at least 3 months. Patients with radiculopathy who had motor findings, who underwent any operations due to neck problems, who had systemic, neurologic and psychiatric diseases, inflammatory or infectious diseases, history of malignity, congenital anomalies, who benefited from another therapy modality and the ones in whom physical therapy modalities could not be used due to contraindications (individuals with sensory disorders, who use cardiac pace maker) were excluded from the study.

A total of 36 individuals were randomly assigned into 2 groups. Randomization was allocated by numbered envelopes method. A total of 30 subjects (15 in Matrix Rhythm Therapy (MRT) group and 15 in CG) with neck pain due to mechanic causes like cervical discopathy, cervical arthrosis or myofascial pain syndrome were participated in this study.

All assessments were done by the same physiotherapist (FU) before therapy and at the end of treatment sessions. The physiotherapist who did the assessments did not know to which group the subjects were belonged. Another physiotherapist who was not informed about the results of the evaluation treated the patients.

Home-based exercise programs and recommendations were also given to patients. Matrix Rhythm Therapy is developed by Dr. Ulrich G. Randall at the university of Erlangen/Nuremberg. Longitudinal stroking, compression and spooning techniques are specific methods of MRT. Therapies of the patients were done by the physiotherapist who had certificate of MRT application.

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 (Investigator)

盲法说明

All assessments were done by the same physiotherapist (FU) before therapy and at the end of treatment sessions. The physiotherapist who did the assessments did not know to which group the subjects were belonged. Another physiotherapist who was not informed about the results of the evaluation treated the patients.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having neck pain for at least 3 months

排除标准

  • radiculopathy with motor findings
  • undergoing surgical operation for neck pathologies
  • having a systemic , neurologic, psychiatric diseases
  • inflammatory or infectious diseases targeting this region
  • physical therapy modalities could not be used due to contraindications (individuals with sensory disorders, who use cardiac pace maker)
  • pregnancy
  • malignancy

结局指标

主要结局

Pain intensity

时间窗: Baseline

Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm (0: I have no pain, 10: I have an intolerable pain). Higher scores mean a worse outcome.

Disability

时间窗: Baseline

Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain. NDI is composed of a total of 10 questions of which 4 about subjective symptoms Each section is scored between 0 and 5. For total scores 0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability

Muscle spasm

时间窗: Baseline

Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm (0: no spasm, 10: the most severe spasm). Higher scores mean a worse outcome.

Emotional status

时间窗: Baseline

Turkish version of Beck Depression Inventory was used to assess emotional status of participants. Each question of the questionnaire which is composed of 21 questions is scored between 0 and 3. Higher scores than 17 mean risc for depression.

次要结局

  • Emotional status(2 weeks)
  • Muscle spasm(2 weeks)
  • Disability(2 weeks)
  • Pain intensity(2 weeks)

研究者

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

Ayşe Nur OYMAK SOYSAL

Lecturar

Pamukkale University

研究点 (2)

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