OMT as an Adjunctive Treatment in MDD

Major Depressive Disorder Clinical Trial

Official title:

Osteopathic Manipulative Treatment as an Adjunctive Treatment in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05065580
• Other study ID #: EGME#05-2021
• Status: Completed
• Phase: N/A
• Start date: March 12, 2021
• Est. completion date: March 23, 2023

Study information

• Verified date: June 2023
• Source: Spectrum Health - Lakeland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

participants will be receiving OMT 1x/week for 8 weeks. Each appointment with be a duration of 30 minutes. Patients will be required to fill out PHQ-9 and SSS-8 questionnaires before beginning the study and following the conclusion of the study.

Description:

Individuals will receive weekly OMT for a duration of 8 weeks. Primary assessment will be performed on initial visit, making note of the most severe somatic restrictions, but highest priority will be given to cervical and shoulder regions (most tension is noted here in patients with MDD). Focusing on only the cranial, cervical, and shoulder regions will allow for a more standardized approach to treatment.

Osteopathic manipulative treatment (OMT) is the manipulation of tissues (muscles, joints, fascia, etc.) that is used to help restore movement and function throughout the body by a combination of stretching, gentle pressure, and resistance. The techniques we have chosen to use will focus primarily on muscle and fascia in the cranial, cervical, and shoulder regions.

Cranial techniques used include:

Suboccipital release - this helps to relieve muscle and fascial tension surrounding the head and neck, patient is supine, physician places finger pads below occipital protuberance at the base of the occiput as patient's relaxes head and lets it rest on physician's finger pads, position is held until softening of musculature is felt

Vault hold - helps to restore cranial motion, patient is supine, physician places index finger on greater wing of sphenoid, middle finger on squamous portion of temporal bone, ring finger on mastoid process of temporal bone, and pinky finger on squamous portion of occipital bone, hands remain in this position to monitor cranial motion and determine if there is a dysfunction

They will NOT be performing any high velocity low amplitude (HVLA) techniques, which requires a rapid, therapeutic force within the motion of the joint (this is the technique that is often responsible for the "cracking" or "popping")

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients 18-65, patients with diagnosis of MDD, PHQ-9 score > 10 at screening and baseline

Exclusion Criteria:

• history of mania, hypomania, or psychosis as defined in DSM V

• current substance abuse, including abuse within the previous 6 months

• patients with a cognitive disorder or dementia

• patients with other axis I diagnosis (anxiety disorders, dissociative disorders, etc.) that was primary in the past 6 months

• receiving other forms of manual therapy during study

• authors belief that there was significant suicidal risk

• changes in medication or psychotherapy within 6 weeks of starting study or during study period

• history of migraines

• presence of any other significant organic disease (infectious, cardiac, pulmonary, gastrointestinal, renal, etc.)

• other absolute contraindications to OMT (malignancy, infection, myelopathy, severe osteoporosis, increased ICP, intracranial bleeding, fractures, etc.)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Procedure:
• Osteopathic Manipulative Treatment
Individuals will receive the following techniques during weekly OMT (osteopathic manipulative techniques) for a duration of 8 weeks: 1. Suboccipital release 2. Vault hold. 3. Soft tissue techniques at the cervical and shoulder region 4.There will be NO high velocity low amplitude (HVLA) techniques

Locations

Country	Name	City	State
United States	Lakeland Regional Healthcare	Saint Joseph	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health - Lakeland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PHQ-9 (Patient Health Questionnaire) results post treatment	compare PHQ-9 results in the two groups based on SSS-8 (Somatic Symptom Score) score before and after treatment. PHQ-9 is a depression score ranging from 0 through 27. No depression 0-4, mild 5-9, moderate 10-14, moderately severe 15-19, severe 20-27. The SSS-8 ranges from 0 through 32. No to minimal symptoms range from 0 through 3, low from 4-7, medium 8-11\, high 12-15, very high 16-32.	8 weeks