Testing the Effects of High-dose Vitamin B6 Supplements on Pain Thresholds and Tolerance in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Cold immersion pain tolerance
研究概览
简要总结
This clinical trial aims to explore the effect of Vitamin B6 supplementation on pain thresholds and tolerance in healthy adults using thermal and electrical stimulation. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 increases pain thresholds and tolerance.
详细描述
The main questions it aims to answer are:
- How does vitamin B6 affect pain thresholds and tolerance following a single 100mg dose?
- How does vitamin B6 affect pain thresholds following daily supplementation for up to a month?
- Does vitamin B6 supplementation affect measures related to the experience of pain, such as state anxiety, sleep, diet, and mood at different time points
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over the age of 18 years
- •Fluent speaker of English language
排除标准
- •Under 18 years
- •Presence or history of chronic pain
- •Presence of neuropathic/nerve pain
- •Raynaud's syndrome
- •Using any vitamin supplementations that contain Vitamin B6 at more than the RDA, or combinations of B vitamins.
- •On any medication that is GABA agonistic
- •Any use of analgesic/anti-inflammatory medication up to 48 hours prior to any of the testing sessions.
- •Any heart conditions
- •Newly acquired tattoos on the pain stimulation site
研究组 & 干预措施
Vitamin-B6
Participants will consume one high-dose Vitamin B6 100 mg tablet orally once daily for one month. Vitamin B6 will be provided as Pyridoxal-5'-Phosphate (PLP).
干预措施: Vitamin B6 100 MG (Drug)
Placebo
Participants will consume a Placebo tablet matching the appearance of the Vitamin B6 tablets in the Experimental arm orally once daily for one month.
干预措施: Placebo (Other)
结局指标
主要结局
Cold immersion pain tolerance
时间窗: This will be done at baseline, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Pain tolerance will be measured by recording the number of seconds the participant is willing to keep their hand immersed in a 5 degree celsius cold bath, up to a maximum of 120 sec.
Electrical pain sensitivity
时间窗: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Pain sensitivity will be measured using electrical stimulation. Starting at an initial intensity of 0.3 mA, the intensity of each subsequently applied electrical stimulus will be increased in steps of 0.3 mA each, with a maximum intensity of 10 mA. The procedure will be continued until the participant perceives the applied shock as moderately painful (equivalent to a pain rating of 5 out of 10 or higher). The procedure will be repeated three times. The average intensity (in mA) needed for participants to perceive a moderate pain sensation will be used as outcome measure. Low values will therefore indicate a high sensitivity to electrical stimulation, whereas high values will indicate a low pain sensitivity in response to electrical stimulation.
Thermal sensory threshold
时间窗: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Sensory threshold will be measured using thermal stimulation (heat stimulation). The starting temperature of the applied probe will be adjusted to the individual's skin temperature and then slowly increased (0.5 deg C/s) until the participant feels a slight warm sensation. For safety, the temperature will never exceed 50 deg C. The procedure will be repeated three times. The average change in temperature (in degree Celsius) needed for participants to perceive a warm sensation will be used as outcome measure. Low values will therefore indicate a high sensitivity to warmth, whereas high values will indicate a low warmth sensitivity.
Thermal pain tolerance
时间窗: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Pain tolerance will be measured using thermal stimulation (heat stimulation). The starting temperature of the applied probe will be adjusted to the individual's skin temperature and then slowly increased (1 deg C/s) until the participant feels that they can't tolerate the heat anymore. For safety, the temperature will never exceed 50 deg C. The procedure will be repeated three times. The average change in temperature (in degree Celsius) needed for participants to reach their pain tolerance will be used as outcome measure. Low values will therefore indicate low pain tolerance, whereas high values will indicate high pain tolerance.
Pain wind-up
时间窗: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Pain sensitisation will be measured using a wind-up paradigm (temporal summation) with thermal stimulation (heat simulation). The thermal probe will start at 32 deg C and increase in temperature (100 deg C/s) to 49 deg C. After a duration of 800 ms, the temperature will return to baseline. Participants will be asked for a pain rating on a scale form 0 (not painful) to 10 (extremely painful). Subsequently, a series of 10 heat stimuli (identical to the once above, ISI 400 ms) will be applied. Participants will be asked to rate the most intense pain that they felt across the series, using the same 0-10 rating scale. The difference in pain ratings in response to the series and to the single stimulus will be used as the outcome measure. Higher (positive) ratings will indicate a stronger sensitisation to repeated painful stimuli. In contrast, negative values will indicate habituation to repeated painful stimuli.
Thermal pain threshold
时间窗: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Pain threshold will be measured using thermal stimulation (heat stimulation). The starting temperature of the applied probe will be adjusted to the individual's skin temperature and then slowly increased (1 deg C/s) until the participant feels a slight pain/burning sensation. For safety, the temperature will never exceed 50 deg C. The procedure will be repeated three times. The average change in temperature (in degree Celsius) needed for participants to perceive a slight pain/burning sensation will be used as outcome measure. Low values will therefore indicate high pain sensitivity, whereas high values will indicate low pain sensitivity.
次要结局
- State anxiety(This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention)
- Dietary intake(This will be measured at baseline during their first visit only)
- Positive and negative affect(This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention)
- Sleep quality(This will be done at baseline, 3-5 days, 11-13, and 28-35 days after the start of the intervention)
研究者
David Field
Associate professor
University of Reading