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临床试验/NCT05860205
NCT05860205尚未招募不适用

A Feasibility and Pilot Study of a Multiple Component Mobile-aid Pain Reduction Intervention to Decrease Myofascial Pain Syndrome

Kailea Manning4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
4
主要终点
Self-report pain Level

研究概览

简要总结

The goal of this clinical trial is to pilot test a newly developed multiple component mobile-aid pain reduction intervention (MCMAPRI) and the feasibility of implementing this intervention in adult patients with myofascial pain syndrome of the low back. The main questions it aims to answer are:

  • What are the effects of the MCMAPRI intervention on reducing levels of myofascial pain in adult patients with myofascial pain syndrome of the low back?
  • What is the feasibility for implementing the MCMAPRI intervention in adult patients with myofascial pain syndrome of the low back?

Participants will be randomly assigned to one of three groups: no treatment group, MCMAPRI intervention + sham osteopathic manipulation treatment, or MCMAPRI intervention +osteopathic manipulation treatment.

  • Participants assigned to the no treatment group will only receive educational materials through email and a weekly phone call from the coordinator to reduce dropouts.
  • Participants assigned to the multiple component mobile-aid pain reduction intervention+sham osteopathic manipulation treatment group will be asked to engage in posture training through a wearable device (i.e., UPRIGHT GO), a core muscle training and stretching exercise program, stress reduction through breath focus, and in strategies to improve their level of daily activity (i.e., wearing a Garmin device). This group will receive a sham osteopathic manipulation treatment by placing hands on the patient as if osteopathic manipulation treatment is being performed.
  • Participants assigned to the MCMAPRI intervention+sham osteopathic manipulation treatment group will be asked to engage in posture training through a wearable device (i.e., UPRIGHT GO), a core muscle training and stretching exercise program, stress reduction through breath focus, and in strategies to improve their level of daily activity (i.e., wearing a Garmin device). This group will receive actual osteopathic manipulation treatment by putting pressure on certain muscles in the back and performing osteopathic manipulation treatment exercises on the patient.

Researchers will compare the no treatment group, multiple component mobile-aid pain reduction intervention+sham osteopathic manipulation treatment group, and multiple component mobile-aid pain reduction intervention+osteopathic manipulation treatment group to see if there are decreased levels of pain, increased physical activity, better posture, and reduced levels of stress.

详细描述

Design: A three group randomized control trial will be used to pilot test the effect of our newly created multiple component mobile-aid pain reduction intervention (MCMAPRI) on lowering myofascial pain in the low back and for examining the possibility of implementing this intervention in the desired population. The study will consist of a convenience sample of 30 adult patients who currently have myofascial pain of the low back (i.e., tender knots in the low back). This will be a 12-week study with outcomes measured at Week 1 (T1), Week 8 (T2), and Week 14 (T3). Participants will be randomly placed in one of the following three groups after screening and meeting the study criteria. Group 1 (no treatment condition) will only receive educational materials through email and a weekly phone call from Coordinator to reduce dropouts. Group 2 will receive the new intervention and sham osteopathic manipulative treatment [OMT] for 12 weeks. The multiple component mobile-aid pain reduction intervention will include four components: (1) Posture training through the wearable device, UPRIGHT GO which provides biofeedback to poor posture with vibrations and tracks posture; (2) A daily core muscle training and stretching exercise program including trunk rotation, lumbar rotation, hip flexor stretch, side plank, glute bridge, suitcase carry, and the palloff press exercises; (3) Participants will practice stress reduction through breath focus which will help them to concentrate on deep breathing to help them ignore distracting thoughts and sensations; and (4) Strategies to improve daily level of activity including asking the participants to wear a Garmin device that tracks their daily physical activity and the use of the communication principle to assist participants in overcoming barriers to physical activity. For those who receive multiple component mobile-aid pain reduction intervention, initial training will occur right after the pretest and follow-up training will occur at the midpoint of the program. The sham osteopathic manipulation treatment will be performed by our medical team. Hands will be placed on the patient as if the osteopathic manipulation treatment is being performed. The physician will treat participants with sham osteopathic manipulation treatment twice during month 1 and once during month 2 and 3. Group 3 will receive both multiple component mobile-aid pain reduction intervention and actual osteopathic manipulation treatment. osteopathic manipulation treatment will be conducted by putting pressure on certain muscles in the back and performing osteopathic manipulation treatment exercises on the patient. The physician will treat participants with osteopathic manipulation treatment twice during month 1 and once during month 2 and 3.

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, Outcomes Assessor)

盲法说明

The participants will not know if they are assigned to the multiple component mobile-aid pain reduction intervention and sham osteopathic manipulation treatment group or the multiple component mobile-aid pain reduction intervention and actual osteopathic manipulation treatment group. Additionally, the outcomes assessors will not know which groups the participants have been assigned to.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Myofascial pain syndrome (MPS) of the low back with myofascial trigger points (MTrPs) as specified by Travell and Simons (2) normal neurological examination including manual muscle testing, sensory exam, and deep tendon reflexes, (3) English-speaking, (4) age 18 - 64 and reside in the community, (5) exhibiting low level of physical activity as defined by 150 minutes of moderate-intense physical activity weekly, and (6) exhibiting poor posture.

排除标准

  • (1) malignancy, (2) major psychiatric disorder, such as bipolar disorder and depression, (3) cognitive impairment, (4) systematic pain condition, such as Fibromyalgia, (5) previous surgical procedures in the spine and/or back within six months, (6) pregnancy, (7) body mass index (BMI) of 40 or higher, (8) any health conditions that would prevent performing the testing and intervention procedures, (9) MPS due to pelvic obliquity, scoliosis, anatomical leg length discrepancies, (10) MPS treatment within the last three months or daily use of opioids, or (11) other contraindications that would prevent receiving proposed interventions as identified by study physicians.

结局指标

主要结局

Self-report pain Level

时间窗: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)

Patients will be asked to report their pain level verbally using a scale from 0-10 where 0 represents no pain and 10 represents the worst pain they have ever felt.

Pain pressure threshold (PPT)

时间窗: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)

PPT will be measured by applying pressure to the trigger points on the patients back using an algometer device. The patient will be instructed to tell as as soon as they feel pain at which point the device is removed and the total pounds of force that were applied will be recorded.

Elasticity of the Myofascial Trigger Point

时间窗: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)

The elasticity of myofascial trigger points will be measured through the analysis of ultrasound images taken.

Depth of the Myofascial Trigger Point

时间窗: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)

The depth of the myofascial trigger points in the muscle will be measured through the analysis of ultrasound images taken.

Size of the Myofascial Trigger Point

时间窗: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)

The size of the myofascial trigger points will be measured through the analysis of ultrasound images taken.

次要结局

  • Pain intensity and interference(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Physical functioning/quality of life(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Anxiety(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Sit to Stand test (STS)(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Sensor Parameter - Posture(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Sensor Parameter - Uptime(Continuously for 12 weeks)
  • Sleep Disturbance(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Depression(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Global satisfaction with treatment(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Sensor Parameter - Stress Scores(Continuously for 12 weeks)
  • Get Up and Go (GUG)(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Sleep duration(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Pain catastrophizing(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Sensor Parameter - Daily Step Count(Continuously for 12 weeks)
  • Substance use(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Six-minute walk(Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3))
  • Sensor Parameter - Sleep Hours(Continuously for 12 weeks)

研究者

发起方
Kailea Manning
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kailea Manning

Research Coordinator

Auburn University

研究点 (4)

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