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临床试验/NCT03166358
NCT03166358Unknown不适用

Yoga for Pediatric Tension-Type Headache

Matthew Morris2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Headache diary - changes in headache frequency over follow-up

研究概览

简要总结

This study will determine the efficacy of an 8-week Hatha yoga intervention for adolescents with tension-type headache (TTH) and will assess theoretically-driven mediators of treatment response, including experimental pain sensitivity, chronic stress, and negative cognitions linked to chronic pain.

详细描述

Adolescents (ages 13 to 18) with TTH will be randomly assigned to either a Hatha yoga intervention (n = 20) or a wait-list control condition (n = 20). The yoga intervention will consist of 8 weekly classes lasting one hour each taught by an experienced yoga teacher. Each class will have a maximum of 10 participants. A baseline assessment including an experimental pain protocol, questionnaires, and hair samples (to determine cortisol concentrations in the past month) will be completed prior to the intervention. Biweekly questionnaires will be completed by both intervention and wait-list groups during the 8-week intervention period. The post-intervention assessment will include the experimental pain protocol, questionnaires, and hair samples (to determine cortisol concentrations in the past month). The wait-list control group will subsequently receive the yoga intervention and complete post-intervention and follow-up assessments (i.e., the wait-list group will complete one more experimental pain protocol and will provide one more hair sample than the intervention group); these data will then be merged with that of the yoga group to examine pre- and post-intervention effects. Both intervention and wait-list groups will complete questionnaires 3 months following completion of the yoga protocol.

Specific Aim 1: To determine the safety, feasibility, and acceptability of an 8-week Hatha Yoga Protocol (HYP) in adolescents (ages 13 to 18) with tension-type headache (CTTH). Hypothesis: At least 80% of adolescents will complete the HYP. Attrition rates will be compared between HYP and control groups to determine whether results may be biased given different durations of the study protocols between the two groups and interval between recruitment and intervention (i.e., control group will be in the protocol for two additional months and the intervention will be delayed by 8 weeks).

Specific Aim 2: To evaluate changes in primary outcomes (frequency and intensity of headaches, pain-related functional disability, health-related quality of life, medication use) from baseline to post-intervention in the HYP and usual care wait-list controls. Hypothesis: Participants in the HYP group will demonstrate greater reduction in headache frequency and intensity, decreases in pain-related functional disability, improvement in health-related quality of life, and reduction in medication use compared to wait-list controls from baseline to post-intervention. Secondary analyses will examine changes from pre- to post-intervention for the entire sample once the waitlist group has completed the HYP; in addition, sustained intervention effects will be determined by examining changes from post-intervention to 3-month follow-up for the entire sample.

Specific Aim 3: To assess changes in potential mediators of clinical outcomes following the HYP, including responses to experimental pain [conditioned pain modulation (CPM), temporal summation to second pain (TSSP)], alterations in stress response systems [hair cortisol concentrations, self-reported stress levels, stress hormone responses to experimental pain (cortisol, alpha-amylase, DHEA), heart rate variability responses to experimental pain] and pain-related cognitions (catastrophizing, self-efficacy, acceptance). Hypothesis: Participants in the HYP group will show increased CPM, decreased TSSP, reduced hair cortisol concentrations and self-reported stress levels, lower cortisol and alpha-amylase responses to experimental pain, higher DHEA responses to experimental pain, lower heart rate variability prior to experimental pain, reduced pain catastrophizing, increased pain self-efficacy, and increased pain acceptance compared to wait-list controls at post-intervention.

Although yoga has shown promise as a complementary health approach for chronic pain in adults, few studies have examined the potential efficacy of yoga for adolescents with chronic pain. Anticipated findings from the proposed study will help to determine whether - and how - an 8-week yoga intervention can improve pain-related outcomes in adolescents with TTH; these findings will be critical for refinement of the HYP for youth with TTH and for the design and implementation of a larger-scale, randomized controlled trial with an active control condition.

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 (Care Provider)

盲法说明

Yoga instructor is blind to yoga intervention or waitlist group status of participants.

入排标准

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

入选标准

  • Eligible participants will have a diagnosis of TTH with or without migraines according to the International Classification for Headache Disorders criteria, be between 13 and 18 years old (inclusive), English-speaking, and willing to be randomized and attend yoga sessions regularly.

排除标准

  • Participants will be excluded if they have any injury, disease, or metabolic dysfunction known to influence pain, have any physical limitations deemed by a medical practitioner to preclude yoga practice, had attended yoga classes in the previous 3 months, are currently pregnant, or have a history of drug or alcohol dependence within 6 months of screening.

结局指标

主要结局

Headache diary - changes in headache frequency over follow-up

时间窗: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

Headache frequency

Functional Disability Inventory - changes in pain-related functional disability over follow-up

时间窗: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

pain-related functional disability: perceived impact of general and physical health on psychosocial functioning in the last 2 weeks

Health-Related Quality of Life- Short Form-36: changes in physical functioning over follow-up

时间窗: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

health-related quality of life: physical functioning subscale

Headache diary - changes in headache intensity over follow-up

时间窗: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

Headache intensity

Headache Diary - changes in medication use over follow-up

时间窗: baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

frequency/type of medication used for preventive or abortive purposes

次要结局

  • changes in alpha-amylase reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks)(baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes))
  • changes in cortisol reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks)(baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes))
  • changes in conditioned pain modulation from pre-intervention to immediately following intervention (8 weeks)(baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes))
  • hair cortisol concentrations - changes in hair cortisol levels from pre-intervention to immediately following intervention (8 weeks)(baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes))
  • changes in DHEA reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks)(baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes))
  • changes in temporal summation from pre-intervention to immediately following intervention (8 weeks)(baseline, post-intervention (8 weeks) [waitlist group will complete an optional third assessment after they finish the yoga classes))

研究者

发起方
Matthew Morris
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthew Morris

Associate Professor

Meharry Medical College

研究点 (2)

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