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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
1.Posture training through the wearable device, UPRIGHT GO. The participant wears the device on their neck. The device 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 palloff press. 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. 4. Strategies to improve daily level of activity including wearing a Garmin device that tracks their daily physical activity and reminds them to walk and the use of the communication principle to assist participants in overcoming barriers to physical activity.
Osteopathic Manipulation Treatment (OMT) will be conducted by putting pressure on certain muscles in the back and performing OMT exercises on the patient. The physician will treat participants with OMT twice during month 1 and once during month 2 and 3.
The sham osteopathic manipulation treatment (OMT) will be performed by the medical team. Hands will be placed on the patient as if the OMT is being performed. The physician will treat participants with sham OMT twice during month 1 and once during month 2 and 3.
Auburn University
Auburn, Alabama, United States
Edward Via College of Osteopathic Medicine (VCOM)
Auburn, Alabama, United States
Self-report pain Level
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.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Pain pressure threshold (PPT)
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.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Elasticity of the Myofascial Trigger Point
The elasticity of myofascial trigger points will be measured through the analysis of ultrasound images taken.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Depth of the Myofascial Trigger Point
The depth of the myofascial trigger points in the muscle will be measured through the analysis of ultrasound images taken.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Size of the Myofascial Trigger Point
The size of the myofascial trigger points will be measured through the analysis of ultrasound images taken.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Pain intensity and interference
Pain intensity and interference will be measured using the Pain Enjoyment and General Activity (PEG) Scale. The minimum score is 0 and the maximum score is 10. A higher score suggests more intense pain and pain interference, however, this measure is used to track participants' pain over the study to determine if the intervention(s) has been effective for decreasing pain.
Time frame: 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
Physical functioning/quality of life will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form 6b. The minimum score is 6 and the maximum score is 30. A higher score suggests worse physical functioning and quality of life.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Sleep Disturbance
Sleep disturbance will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 6a. For the Sleep Disturbance Short Form 6a, the minimum score is 6 and the maximum score is 30. A higher score suggests more sleep disturbance.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Sleep duration
Sleep disturbance will be measured by the National Institutes of Health (NIH) Common Data Elements (CDE) Sleep duration question. When interpreting the single NIH CDE Sleep duration question, a lower duration of sleep suggests more sleep disturbance.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Pain catastrophizing
Pain catastrophizing will be measured by the Pain Catastrophizing Scale. The minimum score is 0 and the maximum score is 52. A higher score suggests more pain catastrophizing.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Depression
Depression will be measured using the Patient Health Questionnaire-2 (PHQ-2) to measure depression. The minimum score is 0 and the maximum score is 6 where a higher score indicates higher levels of depression.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Anxiety
Anxiety will be measured using the Generalized Anxiety Disorder-2 (GAD-2). The minimum score is 0 and the maximum score is 6. A higher score suggests higher levels of anxiety.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Global satisfaction with treatment
Global satisfaction with treatment will be measured using the Patient Global Impression of Change (PGIC) Scale. This includes one item with a minimum score of 0 and a maximum score of 6. A higher score represents pain worsening from the time of the study.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Substance use
The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Screener will be used to measure substance use. Each item is measured on a 4 point scale where 0 represents Daily or Almost Daily and 4 represents Never. Any score other than 0 suggests a positive screen for substance use.
Time frame: 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)
The Sit to Stand test (STS) will be used to measure physical function. This test asks participants to stand up and sit down as fast as they can 5 times while the assessor records the time.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Get Up and Go (GUG)
The Get Up and Go (GUG) test will be used to measure physical function. This test asks the participant to begin from a seated position, walk to a marked point that is 3meters away, turn around and walk back, ending in a seated position while the assessor records the time it takes to complete.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Six-minute walk
The six-minute walk test will also be used to measure physical function. This tests asks participants to walk as far as they can in 6 minutes. Participants will walk back and forth along a pre-measured 30 meter stretch. The assessor will record the total length the participant walked when time is up.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Sensor Parameter - Posture
Two hour recording session of the participant sitting at a desk, wearing movement sensors, to determine the percentage of poor posture during that recording session.
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
Sensor Parameter - Uptime
Poor posture will be measured by "Uptime" using the UPRIGHT GO sensor daily.
Time frame: Continuously for 12 weeks
Sensor Parameter - Daily Step Count
Participants' daily step count will be collected from their Garmin device .
Time frame: Continuously for 12 weeks
Sensor Parameter - Sleep Hours
Participants' sleep hours will be collected from their Garmin device.
Time frame: Continuously for 12 weeks
Sensor Parameter - Stress Scores
Participants' stress scores will be collected from their Garmin device. Devices will provide a stress level between 0 and 100, which correspond to the following scale:0-25: Resting state, 26-50: Low stress, 51-75: Medium stress, 76-100: High stress.
Time frame: Continuously for 12 weeks
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