A Multiple Component Mobile-aid Pain Reduction Intervention to Decrease Myofascial Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myofascial Pain Syndrome

Intervention / Treatment
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* Behavioral: Multiple Component Mobile-Aid Pain Reduction Intervention
* Other: Osteopathic Manipulation Treatment
* Other: Sham Osteopathic Manipulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No treatment condition<br>Group 1 (no treatment condition) will only receive educational materials through email and a weekly phone call from Coordinator to reduce dropouts for 12 weeks. | |
| Active Comparator: Multiple component mobile-aid pain reduction intervention + sham osteopathic manipulation treatment<br>Group 2 will receive the new intervention and sham osteopathic manipulative treatment for 12 weeks. | Behavioral: Multiple Component Mobile-Aid Pain Reduction Intervention<br>* 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.<br>Other: Sham Osteopathic Manipulation<br>* 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.<br>|
| Active Comparator: Multiple component mobile-aid pain reduction intervention + osteopathic manipulation treatment<br>Group 3 will receive both the multiple component mobile-aid pain reduction intervention and actual osteopathic manipulation treatment for 12 weeks. | Behavioral: Multiple Component Mobile-Aid Pain Reduction Intervention<br>* 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.<br>Other: Osteopathic Manipulation Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Continuously for 12 weeks | 
| Sensor Parameter - Daily Step Count | Participants' daily step count will be collected from their Garmin device . | Continuously for 12 weeks | 
| Sensor Parameter - Sleep Hours | Participants' sleep hours will be collected from their Garmin device. | 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. | Continuously for 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial Pain Syndrome, Low Back Pain, Myofascial Trigger Points