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临床试验/NCT02420197
NCT02420197已完成不适用

Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Neck Pain

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2015年1月最近更新:
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
74
试验地点
1
主要终点
Neck-related disability as assessed by the neck disability index

研究概览

简要总结

The purpose of this study is to investigate if high-intensity resistance training can induce additional beneficial effects, for patients with moderate to severe long term pain in the neck, when added to a multidisciplinary treatment program.

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)

入排标准

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

入选标准

  • Referred to the multidisciplinary clinic for treatment of pain in the neck
  • Long term (≥ 3months) or recurrent (≥ 2 periods of ≥ 4 weeks the past year) non-specific neck pain,
  • Pain intensity ≥ 4 on numerical rating scale (0-10)

排除标准

  • Severe somatic condition (unstable injury, malignity, infectious disease, active rheumatic disease, severe osteoporosis)
  • Psychiatric condition/disease that severely impairs group functioning
  • Insufficient comprehension of Norwegian language to participate in group sessions and fill out questionnaires
  • Awaiting surgery of neck
  • Alcohol or drug abuse
  • Ongoing compensation case or applying for disability benefits due to pain in the neck
  • Engaged in high-intensity resistance training on a regular basis the last 6 months
  • Contra-indications for high-intensity resistance training (i.e. shoulder complications)

研究组 & 干预措施

High-intensity resistance training

Experimental

Full body, progressive strength training with Theraband® Elastic bands. Three times per week for 12 weeks - 3 weeks with supervised sessions at the clinic, and 9 weeks of home training.Three guided sessions will be offered during the home training period.

干预措施: High-intensity resistance training (Behavioral)

High-intensity resistance training

Experimental

Full body, progressive strength training with Theraband® Elastic bands. Three times per week for 12 weeks - 3 weeks with supervised sessions at the clinic, and 9 weeks of home training.Three guided sessions will be offered during the home training period.

干预措施: Multidisciplinary rehabilitation program (Behavioral)

General physical activity

Active Comparator

12 weeks of general physical activity - 3 weeks with supervised sessions at the clinic, and 9 weeks of individually adjusted home training. This include circle-training, low-intensity resistance exercises, endurance exercises, ball playing, body awareness, stretching, and relaxation techniques, and similar activities. Neither moderate nor high-intensity resistance exercise is included for participants in this group.Three guided sessions will be offered during the home training period.

干预措施: General physical activity (Behavioral)

General physical activity

Active Comparator

12 weeks of general physical activity - 3 weeks with supervised sessions at the clinic, and 9 weeks of individually adjusted home training. This include circle-training, low-intensity resistance exercises, endurance exercises, ball playing, body awareness, stretching, and relaxation techniques, and similar activities. Neither moderate nor high-intensity resistance exercise is included for participants in this group.Three guided sessions will be offered during the home training period.

干预措施: Multidisciplinary rehabilitation program (Behavioral)

结局指标

主要结局

Neck-related disability as assessed by the neck disability index

时间窗: 12 weeks

Neck disability index

次要结局

  • Patient's' perceived effect of the treatment assessed by the Patient specific functioning scale(3 and 12 weeks + 6 and 12 months)
  • Work ability assessed by Work ability index(3 and 12 weeks + 6 and 12 months)
  • Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire(3 and 12 weeks + 6 and 12 months)
  • Anxiety and depression assessed by Hopkins symptom checklist(3 and 12 weeks + 6 and 12 months)
  • Quality of life assessed by EQ-5D-5L(3 and 12 weeks + 6 and 12 months)
  • Pain assessed by the Numerical Pain Rating Scale(3 and 12 weeks + 6 and 12 months)
  • Physical activity level assessed by a questionnaire from the HUNT study(3 and 12 weeks + 6 and 12 months)
  • Use of analgesics assessed by a questionnaire from the HUNT study(3 and 12 weeks + 6 and 12 months)
  • Pressure pain threshold of the tibialis anterior muscle measured using an algometer(3 and 12 weeks + 6 and 12 months)
  • Strength in the neck measured using a handheld dynamometer(3 and 12 weeks + 6 and 12 months)
  • Grip strength measured using a handheld dynamometer(3 and 12 weeks + 6 and 12 months)
  • Patient's' perceived effect of the treatment assessed by the Global rating of change scale(3 and 12 weeks + 6 and 12 months)
  • Neck-related disability as assessed by the neck disability index(3 weeks + 6 and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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