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临床试验/NCT02724826
NCT02724826已完成不适用

Effects of Qigong and Exercise Therapy Among Patients With Chronic Neck Pain

Lund University0 个研究点目标入组 122 人开始时间: 2000年8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
入组人数
122
主要终点
Pain Intensity

研究概览

简要总结

A randomized controlled, multicenter trial comparing qigong and exercise therapy concerning pain intensity, treatment expectations, disability, neck movements and quality of life in subjects with non-specific, long-term NP after three and twelve months.

详细描述

A randomized controlled, multicenter trial comparing qigong and exercise therapy concerning pain intensity, treatment expectations, disability, neck movements and quality of life in subjects with non-specific, long-term NP. A comparison will be performed between the two randomized treatment groups in these variables before and after three and 12 months.

Participants were recruited via an advertisement in a local newspaper. Inclusion: Men and women between 18-65 years of age with nonspecific, long term neck pain (<3 months).Exclusion criteria were chronic tension-type headache, migrain, traumatic neck injuries, neurologic signs or symptoms. rheumatic diseases, fibromyalgia or other severe physiologic or physical diserases and difficulties in understand the Swedish language.

The enrollment of participants, the randomization procedure and the performance of measurements were conducted by four independent physiotherapists. Randomization was done in blocks of 30 according to a sealed envelope technique. Assessments were made before treatment (baseline), immediately after treatment and at six and 12-month follow-ups. All participants answered questionnaires about demographic data, pain (duration and intensity) and disability. Pain intensity was rated as current NP and average NP during the week before the assessment, measured with a visual analogue scale (VAS - measured in millimeters with the end points 0 = no pain and 100 = unbearable pain) (Carlsson, 1983). Neck Movements was measured with cervico Thorac Ratio (CTR) (Norlander 2995), Disability was measured with the Neck Disability Index (NDI) (Vernon, 1991), which consists of a ten-item, scaled questionnaire where the total scores are recalculated into percent (0%, no disability; 100%, maximum disability). The items assess NP according to intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and recreation. Quality of Life was measured with the SF-36 questionnaire (Sullivan1995).

Study participants One hundred and twenty-two subjects with long-term, non-specific NP were randomized to the interventions of qigong (n=60) and exercise therapy (n=62). Eighty-six (70%) were women and 36 (30%) men, with a mean age of 44 years

The participants were allocated randomly to receive qigong or exercise therapy. In each group, the participants received ten to 12 treatments over a period of three months, and each treatment session lasted one hour. A treatment-specific guideline was developed for each treatment. Treatments were provided by experienced physiotherapists; the physiotherapist responsible for qigong had nothing to do with exercise therapy and vice versa. An attendance list was kept during the intervention period, and all participants were informed that they had to attend at least eight of the 12 sessions to be included for analysis in the study.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Men and women between 18-65 years of age
  • •nonspecific, long term neck pain (<3 months).

排除标准

  • •chronic tension-type headache,
  • •migraine,
  • •traumatic neck injuries,
  • •neurologic signs or symptoms,
  • •rheumatic diseases,
  • •fibromyalgia or other severe physiologic or physical diseases
  • •difficulty in understand the Swedish language

研究组 & 干预措施

Qigong therapy

Experimental

The qigong treatment was done according to medical qigong, and is a way of affecting and directing qi (energy) for medical benefit. Each qigong practice included body posture adjustment, gentle movement, meditation, relaxation, breathing regulation practices and massage. The qigong was practiced in groups of ten to 15 participants. Each qigong session started with information about the philosophy and a general warm-up with soft movements and 14 selected qigong exercises according to the Biyun method.

干预措施: Exercise therapy (Behavioral)

Exercise therapy

Active Comparator

Exercise therapy was carried out individually, adjusted for each participant. A physiotherapist instructed the participant with focused on the cervical and shoulder/thoracic regions. Each training session included stationary bicycle for ten minutes, 40 minutes of dynamic exercises. These exercises consisted of active movements in all neck directions and muscle exercises aimed to maintain/increase circulation, endurance and strength. The load at the muscle exercises was to achieve between 30 and 70% of maximum muscle capacity and was gradually increased as endurance and strength were gained.

干预措施: Qigong therapy (Behavioral)

结局指标

主要结局

Pain Intensity

时间窗: 3 months and after 1 year

measured with a visual analogue scale (VAS - measured in millimeters with the end points 0 = no pain and 100 = unbearable pain)

次要结局

  • Disability, measured with the Neck Disability Index (NDI)(3 months and after 1 year)
  • Segmental flexion and mobility in the cervico-thoracic spine(3 months and after 1 year)
  • Expectation(3 months)
  • Quality of Life (SF36)(3 months and after 1 year)

研究者

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

Liselott Persson

RPT. PhD

Lund University

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