A Multiple Component Mobile-aid Pain Reduction Intervention to Decrease Myofascial Pain
NCT ID: NCT05860205
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-05-31
2023-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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No treatment condition
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.
No interventions assigned to this group
Multiple component mobile-aid pain reduction intervention + sham osteopathic manipulation treatment
Group 2 will receive the new intervention and sham osteopathic manipulative treatment for 12 weeks.
Multiple Component Mobile-Aid Pain Reduction Intervention
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.
Sham Osteopathic Manipulation
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.
Multiple component mobile-aid pain reduction intervention + osteopathic manipulation treatment
Group 3 will receive both the multiple component mobile-aid pain reduction intervention and actual osteopathic manipulation treatment for 12 weeks.
Multiple Component Mobile-Aid Pain Reduction Intervention
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
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.
Interventions
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Multiple Component Mobile-Aid Pain Reduction Intervention
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
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.
Sham Osteopathic Manipulation
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.
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
64 Years
ALL
Yes
Sponsors
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Edward Via Virginia College of Osteopathic Medicine
OTHER
Kailea Manning
OTHER
Responsible Party
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Kailea Manning
Research Coordinator
Principal Investigators
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Pao-Feng Tsai, PhD
Role: PRINCIPAL_INVESTIGATOR
Auburn University
Joseph Edison, DO
Role: PRINCIPAL_INVESTIGATOR
Edward Via College of Osteopathic Medicine
Locations
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Auburn University
Auburn, Alabama, United States
Edward Via College of Osteopathic Medicine (VCOM)
Auburn, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Dua A, Chang KV. Myofascial Pain Syndrome. 2025 Apr 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499882/
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Calatayud J, Escriche-Escuder A, Cruz-Montecinos C, Andersen LL, Perez-Alenda S, Aiguade R, Casana J. Tolerability and Muscle Activity of Core Muscle Exercises in Chronic Low-back Pain. Int J Environ Res Public Health. 2019 Sep 20;16(19):3509. doi: 10.3390/ijerph16193509.
Zaccaro A, Piarulli A, Laurino M, Garbella E, Menicucci D, Neri B, Gemignani A. How Breath-Control Can Change Your Life: A Systematic Review on Psycho-Physiological Correlates of Slow Breathing. Front Hum Neurosci. 2018 Sep 7;12:353. doi: 10.3389/fnhum.2018.00353. eCollection 2018.
Wandner LD, Domenichiello AF, Beierlein J, Pogorzala L, Aquino G, Siddons A, Porter L, Atkinson J; NIH Pain Consortium Institute and Center Representatives. NIH's Helping to End Addiction Long-termSM Initiative (NIH HEAL Initiative) Clinical Pain Management Common Data Element Program. J Pain. 2022 Mar;23(3):370-378. doi: 10.1016/j.jpain.2021.08.005. Epub 2021 Sep 9.
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Other Identifiers
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MPS2022
Identifier Type: -
Identifier Source: org_study_id
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