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Hypermobility, JointNCT00526266

Evaluating Physiological Markers of Emotional Trauma: A Randomized Controlled Comparison of Mind-Body Therapies

A study testing Emotional Freedom Techniques (EFT) and Diaphragmatic Breathing (DB) in people with Hypermobility, Joint and Depression, run by Soul Medicine Institute 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 purpose of the study is to determine if a physiological marker, joint rotation of the upper body, can be affected by the release of emotional trauma during a brief psychotherapeutic encounter, and whether acupressure is an active ingredient in EFT. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Hypermobility, Joint, Depression, Anxiety
What is being tested?
Emotional Freedom Techniques (EFT) and Diaphragmatic Breathing (DB)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteUnited States
Study dates
Sep 2007to Jan 2018
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 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Limited Range of Motion (ROM) of a joint in the upper body

Who cannot join

  • Post-operative recovery
  • Receiving rehabilitation treatment
  • Under psychiatric care
  • Currently using prescription psychotropic medication

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Integrative Medical Clinic of Santa Rosa (IMCSR)

    Santa Rosa, California, 95403

Other trials in United States

About this study

The purpose of the study is to determine if a physiological marker, joint rotation of the upper body, can be affected by the release of emotional trauma during a brief psychotherapeutic encounter, and whether acupressure is an active ingredient in EFT.

Read the detailed description

The effect of emotional trauma on physiological functioning has been documented in a number of studies. The largest of these is the ACE study, (ACE=Adverse Childhood Experiences), which examined the health outcomes of over 17,000 patients at Kaiser Permanente Hospitals. It was performed by Kaiser in collaboration with the Centers for Disease Control, on a population with a median age of 56. The ACE study found that those patients with a high incidence of Adverse Childhood Experiences or ACEs had higher rates of bone fractures, cancer, heart disease, hypertension, depression, smoking, suicide, diabetes, and other physical and psychological ailments. The authors of the study compared the health care system's focus on treating disease in adults to a fire brigade directing their water at the smoke, rather than at the originating fire. They recommended that health care providers focus on the emotional trauma which they believe contributes to many illnesses.

The current study seeks to determine if the treatment of emotional trauma has an effect on physiological function. As a marker of physiological function, the authors of this study have chosen the range of motion of the joints of the upper body. Shoulder joint stiffness and syndromes such as frozen shoulder typically take months or even years to heal, and rapid resolution is unusual, though most such injuries do indeed heal over time. Range of motion is a convenient marker of physiological change because it can be measured accurately in degrees using a goniometer, a protractor-like device routinely used in occupational therapy and physical therapy. Changes after treatment can be immediately noted.

The emotional trauma treatment modalities being investigated are Emotional Freedom Techniques or EFT, and Diaphragmatic Breathing or DB, with the DB group receiving an identical protocol but with DB substituted for the acupressure component of EFT. They are being compared with a no treatment control group. Studies of EFT have shown this therapy to be effective in removing or reducing emotional traumas, such as phobias, in a single brief treatment session, as well as in reducing anxiety. The effects hold over time. Most prior studies using EFT as a treatment modality study the effects of only one session, and have found that EFT can be effective even with a very brief course of treatment. For the current study, one 30 minute EFT treatment is undertaken. The range of motion of the shoulder joint is recorded before and after treatment by a licensed occupational therapist using a goniometer. The Diaphragmatic Breathing protocol used by the second group has a verbal content identical to the EFT group, but substitutes DB for acupressure. A follow up assessment of subjects is done after 30 days. Range of motion usually does not relapse, but instead becomes greater, following conventional treatments, and this measure has the advantage of requiring a relatively short follow up period, rather than the longer period required for other physiological markers.

The purpose of the study is to discover if a significant change in the range of motion occurs after treatment, and to dismantle the acupressure from the verbal component of EFT by substituting DB for this portion of the protocol.

Being tested
Emotional Freedom Techniques (EFT), Diaphragmatic Breathing (DB)
Medical subject headings
Joint Instability, Depression, Anxiety Disorders

What participants receive

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

  • Emotional Freedom Techniques (EFT)Behavioural

    A half hour treatment with EFT following a standardized protocol. Both Range of Motion (ROM) physical issues are treated with EFT, as well as any possible emotional issues underlying limited ROM.

  • Diaphragmatic Breathing (DB)Behavioural

    Diaphragmatic Breathing (DB) instead of EFT tapping, but with all the "Setup Statements" and components of the Experimental Group, with the exception of tapping. DB is substituted for tapping.

Study groups in NCT00526266
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Behavioral: Emotional Freedom Techniques (EFT)
2Placebo comparatorNot described
Receives: Behavioral: Diaphragmatic Breathing (DB)
3No interventionNo Treatment

What is being measured

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

  1. Mental Health Symptoms

    Measured: One Treatment Session

Secondary outcomes (1)
  1. Range of Motion (ROM) of joints of the upper body

    Measured: Before and immediately after treatment

Timeline

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

  1. First posted10 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionJan 2018
  4. Study completionJan 2018

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00526266
Sponsor's protocol ID
ROM-ACEP-SMI-IMCSR-1
Status last verified
Apr 2018
First submitted
6 Sep 2007
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Church, D., & Nelms, J. (2016). Pain, range of motion, and psychological symptoms in a population with frozen shoulder: A randomized controlled dismantling study of Clinical EFT (emotional freedom techniques). Archives of Scientific Psychology, 15(1), 38-48. doi:10.1037/arc0000028

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Freedom Techniques (EFT) and Diaphragmatic Breathing (DB) in people with Hypermobility, Joint and Depression, run by Soul Medicine Institute 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 1 inclusion and 4 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 25 Apr 2018. 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.

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?

Mental Health Symptoms (time frame: One Treatment Session). 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 NCT00526266, which also lists 1 linked publication.

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 25 Apr 2018.

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