Myofascial Pain SyndromeNCT05860205

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

A study testing Multiple Component Mobile-Aid Pain Reduction Intervention and Osteopathic Manipulation Treatment in people with Myofascial Pain Syndrome, run by Kailea Manning at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Myofascial Pain Syndrome
What is being tested?: Multiple Component Mobile-Aid Pain Reduction Intervention and Osteopathic Manipulation Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 2 sitesUnited States
Study dates: May 2023to Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

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.

Trial locations and contacts

2 sites in 1 country.

Pao-Feng Tsai, PhD contact

334-844-6807

pzt0022@auburn.edu

United States2 sites

Auburn University
Auburn, Alabama, 36849
Pao-Feng Tsai, PhD, 334-844-6807, pzt0022@auburn.edu
Chih-Hsuan Wang, PhD, wangchi@auburn.edu
Edward Via College of Osteopathic Medicine (VCOM)
Auburn, Alabama, 36849

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Myofascial Pain Syndrome
Being tested: Multiple Component Mobile-Aid Pain Reduction Intervention, Osteopathic Manipulation Treatment, Sham Osteopathic Manipulation
Keywords: Myofascial Pain Syndrome, Low Back Pain, Myofascial Trigger Points
Medical subject headings: Myofascial Pain Syndromes, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multiple Component Mobile-Aid Pain Reduction InterventionBehavioural
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 TreatmentOther
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 ManipulationOther
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.

Study groups in NCT05860205
Study group	Role	What they receive
No treatment condition	No intervention	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.
Multiple component mobile-aid pain reduction intervention + sham osteopathic manipulation treatment	Active comparator	Group 2 will receive the new intervention and sham osteopathic manipulative treatment for 12 weeks. Receives: Behavioral: Multiple Component Mobile-Aid Pain Reduction Intervention; Other: Sham Osteopathic Manipulation
Multiple component mobile-aid pain reduction intervention + osteopathic manipulation treatment	Active comparator	Group 3 will receive both the multiple component mobile-aid pain reduction intervention and actual osteopathic manipulation treatment for 12 weeks. Receives: Behavioral: Multiple Component Mobile-Aid Pain Reduction Intervention; Other: Osteopathic Manipulation Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (17)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Continuously for 12 weeks
Sensor Parameter - Daily Step Count
Participants' daily step count will be collected from their Garmin device .
Measured: Continuously for 12 weeks
Sensor Parameter - Sleep Hours
Participants' sleep hours will be collected from their Garmin device.
Measured: 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.
Measured: Continuously for 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2023Dec 2023

First posted16 May 2023
Study startMay 2023 (estimated)
Primary completionSep 2023 (estimated)
Study completionDec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05860205
Sponsor's protocol ID: MPS2022
Status last verified: May 2023
First submitted: 18 Apr 2023
Last updated: 16 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Dua A, Chang KV. Myofascial Pain Syndrome. 2025 Apr 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499882/
PubMed 29763057
Skootsky SA, Jaeger B, Oye RK. Prevalence of myofascial pain in general internal medicine practice. West J Med. 1989 Aug;151(2):157-60.
PubMed 2788962
Botwin KP, Patel BC. Electromyographically guided trigger point injections in the cervicothoracic musculature of obese patients: a new and unreported technique. Pain Physician. 2007 Nov;10(6):753-6.
PubMed 17987097
Iglesias-Gonzalez JJ, Munoz-Garcia MT, Rodrigues-de-Souza DP, Alburquerque-Sendin F, Fernandez-de-Las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in patients with chronic nonspecific low back pain. Pain Med. 2013 Dec;14(12):1964-70. doi: 10.1111/pme.12224. Epub 2013 Aug 15.
PubMed 23947760
Lundberg U, Kadefors R, Melin B, Palmerud G, Hassmen P, Engstrom M, Dohns IE. Psychophysiological stress and EMG activity of the trapezius muscle. Int J Behav Med. 1994;1(4):354-70. doi: 10.1207/s15327558ijbm0104_5.
PubMed 16250795
Tsai PF, Wang CH, Zhou Y, Ren J, Jones A, Watts SO, Chou C, Ku WS. A classification algorithm to predict chronic pain using both regression and machine learning - A stepwise approach. Appl Nurs Res. 2021 Dec;62:151504. doi: 10.1016/j.apnr.2021.151504. Epub 2021 Sep 28.
PubMed 34815000
Boissoneault J, Sevel L, Letzen J, Robinson M, Staud R. Biomarkers for Musculoskeletal Pain Conditions: Use of Brain Imaging and Machine Learning. Curr Rheumatol Rep. 2017 Jan;19(1):5. doi: 10.1007/s11926-017-0629-9.
PubMed 28144827
Chu Y, Zhao X, Han J, Su Y. Physiological Signal-Based Method for Measurement of Pain Intensity. Front Neurosci. 2017 May 26;11:279. doi: 10.3389/fnins.2017.00279. eCollection 2017.
PubMed 28603478
Jiang, M. et al. Ultra-short-term analysis of heart rate variability for real-time acute pain monitoring with wearable electronics. IEEE International Conference on Bioinformatics and Biomedicine (BIBM), 1025-1032 (2017).
Tavakolian M, Hadid A. Deep binary representation of facial expressions: A novel framework for automatic pain intensity recognition. In2018 25th IEEE International Conference on Image Processing (ICIP) 2018 Oct 7 (pp. 1952-1956). IEEE.
Gupta G, Alok M. Effectiveness of plank exercise in low back pain. Int. J. Sci. Res. 2018;9(5).
Withall J, Jago R, Fox KR. Why some do but most don't. Barriers and enablers to engaging low-income groups in physical activity programmes: a mixed methods study. BMC Public Health. 2011 Jun 28;11:507. doi: 10.1186/1471-2458-11-507.
PubMed 21711514
Carroll JK, Fiscella K, Epstein RM, Sanders MR, Williams GC. A 5A's communication intervention to promote physical activity in underserved populations. BMC Health Serv Res. 2012 Oct 30;12:374. doi: 10.1186/1472-6963-12-374.
PubMed 23110376
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.
PubMed 31547140
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.
PubMed 30245619

Want to know more?

Pao-Feng Tsai, PhD

334-844-6807

pzt0022@auburn.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility and Pilot Study of a Multiple Component Mobile-aid Pain Reduction Intervention to Decrease Myofascial Pain Syndrome
ClinicalTrials.gov ID: NCT05860205
Acronym / sponsor ID: MPS2022
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial Pain Syndrome, Low Back Pain, Myofascial Trigger Points
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Kailea ManningUniversity, hospital or other
Collaborators: Edward Via Virginia College of Osteopathic Medicine
Study start: May 2023 (estimated)
Primary completion: Sep 2023 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 16 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
No treatment condition	No intervention	–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.
Multiple component mobile-aid pain reduction intervention + sham osteopathic manipulation treatment	Active comparator	Behavioral: Multiple Component Mobile-Aid Pain Reduction Intervention, Other: Sham Osteopathic ManipulationGroup 2 will receive the new intervention and sham osteopathic manipulative treatment for 12 weeks.
Multiple component mobile-aid pain reduction intervention + osteopathic manipulation treatment	Active comparator	Behavioral: Multiple Component Mobile-Aid Pain Reduction Intervention, Other: Osteopathic Manipulation TreatmentGroup 3 will receive both the multiple component mobile-aid pain reduction intervention and actual osteopathic manipulation treatment for 12 weeks.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multiple Component Mobile-Aid Pain Reduction Intervention1.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.	Behavioural	Multiple component mobile-aid pain reduction intervention + osteopathic manipulation treatment, Multiple component mobile-aid pain reduction intervention + sham osteopathic manipulation treatment
Osteopathic Manipulation TreatmentOsteopathic 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.	Other	Multiple component mobile-aid pain reduction intervention + osteopathic manipulation treatment
Sham Osteopathic ManipulationThe 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.	Other	Multiple component mobile-aid pain reduction intervention + sham osteopathic manipulation treatment

Primary outcome

Self-report pain Level
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

17 secondary outcomes

Pain intensity and interference
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
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
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
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
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
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
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
Time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)
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)
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)
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
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
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
Time frame: Continuously for 12 weeks
Sensor Parameter - Daily Step Count
Time frame: Continuously for 12 weeks
Sensor Parameter - Sleep Hours
Time frame: Continuously for 12 weeks
Sensor Parameter - Stress Scores
Time frame: Continuously for 12 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
Background: PubMed 29763057Dua A, Chang KV. Myofascial Pain Syndrome. 2025 Apr 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499882/
Background: PubMed 2788962Skootsky SA, Jaeger B, Oye RK. Prevalence of myofascial pain in general internal medicine practice. West J Med. 1989 Aug;151(2):157-60.
Background: PubMed 17987097Botwin KP, Patel BC. Electromyographically guided trigger point injections in the cervicothoracic musculature of obese patients: a new and unreported technique. Pain Physician. 2007 Nov;10(6):753-6.
Background: PubMed 23947760Iglesias-Gonzalez JJ, Munoz-Garcia MT, Rodrigues-de-Souza DP, Alburquerque-Sendin F, Fernandez-de-Las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in patients with chronic nonspecific low back pain. Pain Med. 2013 Dec;14(12):1964-70. doi: 10.1111/pme.12224. Epub 2013 Aug 15.
Background: PubMed 16250795Lundberg U, Kadefors R, Melin B, Palmerud G, Hassmen P, Engstrom M, Dohns IE. Psychophysiological stress and EMG activity of the trapezius muscle. Int J Behav Med. 1994;1(4):354-70. doi: 10.1207/s15327558ijbm0104_5.
Background: PubMed 34815000Tsai PF, Wang CH, Zhou Y, Ren J, Jones A, Watts SO, Chou C, Ku WS. A classification algorithm to predict chronic pain using both regression and machine learning - A stepwise approach. Appl Nurs Res. 2021 Dec;62:151504. doi: 10.1016/j.apnr.2021.151504. Epub 2021 Sep 28.
Background: PubMed 28144827Boissoneault J, Sevel L, Letzen J, Robinson M, Staud R. Biomarkers for Musculoskeletal Pain Conditions: Use of Brain Imaging and Machine Learning. Curr Rheumatol Rep. 2017 Jan;19(1):5. doi: 10.1007/s11926-017-0629-9.
Background: PubMed 28603478Chu Y, Zhao X, Han J, Su Y. Physiological Signal-Based Method for Measurement of Pain Intensity. Front Neurosci. 2017 May 26;11:279. doi: 10.3389/fnins.2017.00279. eCollection 2017.
BackgroundJiang, M. et al. Ultra-short-term analysis of heart rate variability for real-time acute pain monitoring with wearable electronics. IEEE International Conference on Bioinformatics and Biomedicine (BIBM), 1025-1032 (2017).
BackgroundTavakolian M, Hadid A. Deep binary representation of facial expressions: A novel framework for automatic pain intensity recognition. In2018 25th IEEE International Conference on Image Processing (ICIP) 2018 Oct 7 (pp. 1952-1956). IEEE.
BackgroundGupta G, Alok M. Effectiveness of plank exercise in low back pain. Int. J. Sci. Res. 2018;9(5).
Background: PubMed 21711514Withall J, Jago R, Fox KR. Why some do but most don't. Barriers and enablers to engaging low-income groups in physical activity programmes: a mixed methods study. BMC Public Health. 2011 Jun 28;11:507. doi: 10.1186/1471-2458-11-507.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pao-Feng Tsai, PhD contact

334-844-6807

pzt0022@auburn.edu

Pao-Feng Tsai, PhD principal investigator

Auburn University

Joseph Edison, DO principal investigator

Edward Via College of Osteopathic Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pao-Feng Tsai, PhD (334-844-6807, pzt0022@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-report pain Level (time frame: Baseline (Time 1), Change from Baseline at 6 weeks (Time 2), and Change from Baseline at 12 weeks (Time 3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05860205, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.