OMT as an Adjunctive Treatment in MDD

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Procedure: Osteopathic Manipulative Treatment

• Registration Number: NCT05065580
• Lead Sponsor: Spectrum Health - Lakeland

Brief 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.

Detailed 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")

Study Timeline

• Study Start: 2021-03-12
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-04
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Status Verified: 2023-06
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Somatic Symptom Score	Osteopathic Manipulative Treatment	Patients meeting PHQ-9 (Patient health Questionnaire)-9 with score greater than 10 with Somatic Symptom Score less than 7. These patients will receive the OMT treatment protocol and PHQ-9 and SSS scales will be recorded at 0, 4, and 8 weeks.
High Somatic Symptom Score	Osteopathic Manipulative Treatment	Patients meeting PHQ-9 (Patient health Questionnaire)-9 with score greater than 10 with Somatic Symptom Score 8 or greater These patients will receive the OMT treatment protocol and PHQ-9 and SSS scales will be recorded at 0, 4, and 8 weeks.

Primary Outcome Measures

Name	Time	Method
PHQ-9 (Patient Health Questionnaire) results post treatment	8 weeks	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.

Trial Locations

Locations (1)

Lakeland Regional Healthcare; 🇺🇸 Saint Joseph, Michigan, United States