Clinical trial NCT05860205: A Multiple Component Mobile-aid Pain Reduction Intervention to Decrease Myofascial Pain
Official title: A Feasibility and Pilot Study of a Multiple Component Mobile-aid Pain Reduction Intervention to Decrease Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial Pain Syndrome
Low Back Pain
Myofascial Trigger Points
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Edward Via Virginia College of Osteopathic Medicine
First posted: 2023-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 (no treatment condition) will only receive educational materials through email and a weekly phone call from the Coordinator to reduce dropouts for 12 weeks. Group 2 will receive the new multiple component mobile-aid pain reduction intervention (MCMAPRI) and sham osteopathic manipulative treatment \[OMT\] for 12 weeks. Group 3 will receive both MCMAPRI and actual OMT for 12 weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: (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.

Exclusion Criteria: (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.

Primary outcomes:
measure: Self-report pain Level
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Pain pressure threshold (PPT)
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Elasticity of the Myofascial Trigger Point
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Depth of the Myofascial Trigger Point
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Size of the Myofascial Trigger Point
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Secondary outcomes:
measure: Pain intensity and interference
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Physical functioning/quality of life
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Sleep Disturbance
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Sleep duration
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Pain catastrophizing
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Depression
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Anxiety
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Global satisfaction with treatment
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Substance use
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Sit to Stand test (STS)
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Get Up and Go (GUG)
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Six-minute walk
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Sensor Parameter - Posture
timeFrame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
measure: Sensor Parameter - Uptime
timeFrame: Continuously for 12 weeks
measure: Sensor Parameter - Daily Step Count
timeFrame: Continuously for 12 weeks
measure: Sensor Parameter - Sleep Hours
timeFrame: Continuously for 12 weeks
measure: Sensor Parameter - Stress Scores
timeFrame: Continuously for 12 weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
city: Auburn
country: United States
facility: Edward Via College of Osteopathic Medicine (VCOM)
state: Alabama
Study officials:
affiliation: Auburn University
name: Pao-Feng Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edward Via College of Osteopathic Medicine
name: Joseph Edison, DO
role: PRINCIPAL_INVESTIGATOR
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