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FatiguePhase 1/2NCT00731991

Art and Surface Electromyography (EMG)

A Phase 1/2 study testing ART, PNF and No Treatment in people with Fatigue, run by Logan College of Chiropractic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The general purpose of this research project is to use surface electromyography to compare the effect of Active Release Technique versus Proprioceptive Neuromuscular Facilitation on the electrical activity of the upper trapezius muscle at rest and during contraction. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Fatigue
What is being tested?
ART, PNF and No Treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
Aug 2008to Nov 2008
Phase
Phase 1/2
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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Not all of the below listed criteria must be present, but some combination of two or more should be present before the participant can be deemed to have hypertonic
  • hypertonic levator scapulae musculature.
  • Anterior head carriage
  • Internally rolled shoulders
  • Occupational risk of poor upper cross posture
  • Palpable muscular tightness
  • Tenderness to palpation of the area
  • Participant complaint of pain or tightness in the area

Who cannot join

  • Participants will be excluded from this study if they have a history of a trauma that lead to marked scar tissue in the upper trapezius muscle as this would alter the surface EMG readings due to injured and altered tissue.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Logan College of Chiropractic

    Chesterfield, Missouri, 63017

Other trials in United States

About this study

Official title: The Effects of Active Release Technique and Proprioceptive Neurological Facilitation on Surface EMGs of Hypertonic Upper Trapezius Musculature

The general purpose of this research project is to use surface electromyography to compare the effect of Active Release Technique versus Proprioceptive Neuromuscular Facilitation on the electrical activity of the upper trapezius muscle at rest and during contraction.

Read the detailed description

Both ART and PNF are soft tissue techniques used to decrease muscle hypertonicity, myospasm, and/or trigger points and increase the overall function of muscles.

Active-release technique, or ART®, is a form of myofascial therapy used in pain management that involves soft-tissue manipulation. ART has the expressed goal of restoring optimal texture, motion, and function of the soft tissue while releasing entrapped nerves or blood vessels. An injury to a soft-tissue structure commonly causes the muscle to shorten to guard or protect the area. A clinician who is performing ART makes a soft contact with one hand on the patient just distal to the injured area while the other hand develops tension on the soft tissue. While the contact tension is maintained, the structure is lengthened using an "active motion." During the motion, the lesion is palpated and the physical contact with the patient is changed or moved slightly in order to concentrate the tension in the appropriate tissue (Swann, et al).

Active Release Technique was developed by Dr. Michael Leahy and is widely used in rehabilitative and sports medicine for myofacial pain syndromes. The ART group will be treated by one investigator in concurrence with treatment methods outlined in Dr. Leahy's ART instructional manual. An ART treatment pass involves taking the tissue from a shortened position to a lengthened position while the administer maintains manual contact. We will perform three passes of ART with a 10 second rest period between passes. We will only perform ART on the symptomatic side (side that fits inclusion criteria); if both sides are involved, each side will be considered as a separate analysis.

The research backing ART is inadequate. Although there are numerous testimonials, limited published research studies could be found. Dr. George's study of the effect of ART, HVLA and no treatment on the temporomandibular joint and masticatory muscles showed no significant difference between the pre- and post-treatment mouth opening measurements. Another ART study of lateral epicondylitis concluded that the technique was successful in removing adhesions and promoting restoration of normal tissue but also stated that research was inadequate (Howitt, et al). A carpal tunnel study completed in 2006 used EMG to measure the effectiveness of ART. There were significant improvement in symptom severity and functional status after treatment, but no significant differences found in the EMG analyses (George, Tepe, and Busold 119-122).

Proprioceptive neuromuscular facilitation (PNF) stretching techniques are commonly used in the athletic and clinical environments to enhance both active and passive range of motion (ROM) with a view to optimizing motor performance and rehabilitation by elongating the muscle (Sharman, et al).

A second investigator will perform all the PNF using the published protocol from Warren Hammer, DC, MS, DABCO, in the text Functional Soft Tissue Examination and Treatment by Manual Methods, which is as follows:

The patient is supine with the examiner supporting the head so that the neck is in contralateral sidebending and ipsilateral rotation and flexion. The whole cervical spine and occiput is fixed and held in long-axis traction. With the other hand, the examiner contacts the shoulder with the forearm parallel to the table and pushes inferiorly to determine end feel. While maintaining the above position, the examiner asks the patient to resist by pushing the shoulder superiorly against the examiner's resistance for 7 seconds. The examiner then asks the patient to let go and, while stabilizing the head and neck, depresses the shoulder as far as possible for 12 seconds.

A previous study of PNF concluded that the technique caused short-term deficits in strength, power output, and muscle activation; it also increased ranges of motion (Marek, et al). A second previous study concluded that PNF caused an increase in electromyographic activity of the masticatory muscles (Olivo, et al).

Surface EMG is a reliable, non-invasive tool used for measuring muscular electrical activity. Electromyography (EMG) can provide unique information about the mechanical and motor control strategies during various types of muscle actions. EMG measures muscle activation, with surface EMG reflecting the algebraic sum of electric muscle action potentials that pass within the recording areas of the EMG electrodes. There, EMG amplitude quantifies muscle activation, which can be altered by the number of motor units recruited and the firing rates of the activated motor units. Thus, decreases in EMG amplitude due to decreases in muscle activation (Marek, et al). The surface EMG protocol will be performed completely by a third investigator.

Farina, et al published an article showing that the EMG can give reliable indications of muscle activity and fatigue. A previous study of muscle activity using surface EMG noted that based on visual inspections, all surface EMG variables showed consistent linear to moderately curvilinear behavior as a function of time (Muhammed, et al). Surface EMG has been widely used and accepted however care must be taken in pad placement as incorrect placement will give readings of improper musculature, as concluded in a study by Susan Mercer.

Conditions
Fatigue
Being tested
ART, PNF, No Treatment
Keywords
Muscle
Medical subject headings
Fatigue

What participants receive

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

  • ARTOther

    ART to the levator scapulae.

  • PNFOther

    PNF to the levator scapulae.

  • No TreatmentOther

    No treatment will be given. The participant will sit in the treatment room with the doctor for 4 minutes.

Study groups in NCT00731991
Study groupRoleWhat they receive
ARTActive comparatorART to the levator scapulae.
Receives: Other: ART
PNFActive comparatorPNF to the levator scapulae.
Receives: Other: PNF
ControlPlacebo comparatorNo treatment will be given. The participant will sit in the treatment room with the doctor for 4 minutes.
Receives: Other: No Treatment

What is being measured

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

  1. Surface EMG

    Measured: Participant receive Surface EMG then treatment with either ART or PNF followed by Surface EMG

Timeline

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

  1. First posted11 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731991
Sponsor's protocol ID
SR0408080128
Status last verified
Aug 2008
First submitted
7 Aug 2008
Last updated
3 Aug 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ART, PNF and No Treatment in people with Fatigue, run by Logan College of Chiropractic at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surface EMG (time frame: Participant receive Surface EMG then treatment with either ART or PNF followed by Surface EMG). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Aug 2009.

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