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

NCT05860205 | Unknown

• 1 other identifier: MPS2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Myofascial Pain Syndrome

Keywords

Myofascial Pain Syndrome; Low Back Pain; Myofascial Trigger Points

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (17)

• Pain intensity and interference

  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

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

• Sleep Disturbance

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

• Sleep duration

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

• Pain catastrophizing

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

Study Arms (3)

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.

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.

Behavioral: Multiple Component Mobile-Aid Pain Reduction Intervention; Other: Osteopathic Manipulation Treatment

Interventions

Multiple Component Mobile-Aid Pain Reduction Intervention BEHAVIORAL

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.

Multiple component mobile-aid pain reduction intervention + osteopathic manipulation treatment; Multiple component mobile-aid pain reduction intervention + sham osteopathic manipulation treatment

Osteopathic Manipulation Treatment OTHER

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.

Multiple component mobile-aid pain reduction intervention + osteopathic manipulation treatment

Sham Osteopathic Manipulation OTHER

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 + sham osteopathic manipulation treatment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Kailea Manning: lead
• Edward Via Virginia College of Osteopathic Medicine: collaborator

Study Sites (2)

Auburn University

Auburn, Alabama, 36849, United States

Location

Edward Via College of Osteopathic Medicine (VCOM)

Auburn, Alabama, 36849, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Myofascial Pain Syndromes; Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Pao-Feng Tsai, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

• Joseph Edison, DO

  Edward Via College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pao-Feng Tsai, PhD

CONTACT

334-844-6807; pzt0022@auburn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will not know if they are assigned to the multiple component mobile-aid pain reduction intervention and sham osteopathic manipulation treatment group or the multiple component mobile-aid pain reduction intervention and actual osteopathic manipulation treatment group. Additionally, the outcomes assessors will not know which groups the participants have been assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Coordinator

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 16, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

US (2)