OMTrigger Inject- Treating Trigger Points: Comparing Muscle Energy Technique vs. Lidocaine Needling Technique

NCT05009264 | Terminated DMC

• 1 other identifier: IRB 2021-1045
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to determine if osteopathic manipulative treatment is as effective to traditional lidocaine injection technique in treating myofascial trigger points in regard to post intervention pain intensity and quality of life.

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (6)

• Pain Intensity

  0-10, measured using a point system; where 0 = no pain and 10 = maximum pain.

  Prior to intervention

• Measurement on quality of life, evaluate neck and upper extremity function.

  Utilizing the neck disability index score which is used to evaluate neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicating more disability.

  Prior to intervention

• Pain Intensity

  0-10, measured using a point system; where 0 = no pain and 10 = maximum pain.

  Immediately after intervention

• Measurement on quality of life, evaluate neck and upper extremity function.

  Utilizing the neck disability index score which is used to evaluate neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicating more disability.

  immediately after intervention

• Pain Intensity

  0-10, measured using a point system; where 0 = no pain and 10 = maximum pain.

  1 week after intervention

• Measurement on quality of life, evaluate neck and upper extremity function.

  Utilizing the neck disability index score which is used to evaluate neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicating more disability.

  1 week after intervention

Study Arms (2)

OMT Group

This group will receive OMT muscle energy as treatment for myofascial pain syndrome

Procedure: OMT

Injection Group

This group will receive lidocaine injections for myofascial pain syndrome

Procedure: OMT

Interventions

OMT PROCEDURE

OMT will be performed on identified areas of trapezius trigger points

Also known as: muscle energy

Injection Group; OMT Group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is a prospective cohort study comprised of participants between ages 25-75 that presented to Atlanticare Regional Medical Center interventional pain department and Philadelphia College of Osteopathic Medicine Osteopathic Clinic between 2021 August and 2021 october with trigger point in the upper trapezius muscle. It is expected that approximately 60 patients will be enrolled to produce approximately 50 evaluable subjects.

You may qualify if:

• The subjects will only be recruited into the study if participants have met all the following criteria:
• Ages between 25 and 75 years.
• Previous or current diagnosis of MTrP in the upper trapezius region according to the criteria in reference
• active/latent MTrP in the upper trapezius region
• The diagnostic criteria to establish myofascial trigger point is adopted from prior investiogators and include:
• Presence of palpable taut band in the skeletal muscle
• Presence of hypersensitive tender spot in the taut band
• Presence of local twitch response upon stimulation of the taut band
• Reproduction of referred pain upon palpation
• Presence of spontaneous referred pain pattern

You may not qualify if:

• Pregnancy or immunocompromise
• Fever/infection
• Previous history of whiplash injury
• Previous history of cervical surgery, cervical radiculopathy, or myelopathy
• Severe disc or cervical lesion
• Evidence of cognitive deficit
• Degenerative or inflammatory disease of the cervical spine or shoulder, fibromyalgia, or neuromuscular diseases
• Use of medications (anticoagulants, anti-inflammatory etc.) or illicit drug use (1 week prior to treatment or follow up)
• Received treatment for MPS a month before the study recruitment

Sponsors & Collaborators

• AtlantiCare Regional Medical Center: lead
• Philadelphia College of Osteopathic Medicine: collaborator

Study Sites (1)

AtlantiCare Regional Medical Center

Atlantic City, New Jersey, 08401, United States

Location

Related Publications (1)

• Hong CZ, Hsueh TC. Difference in pain relief after trigger point injections in myofascial pain patients with and without fibromyalgia. Arch Phys Med Rehabil. 1996 Nov;77(11):1161-6. doi: 10.1016/s0003-9993(96)90141-0.

  PMID: 8931529 RESULT

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Tocopherols

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Brendan S Kelly, DO

  AtlantiCare Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 17, 2021
• Study Start: January 12, 2022
• Primary Completion: March 1, 2022
• Study Completion: May 31, 2022
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

US (1)