Craniosacral Therapy for Concussion Symptoms

NCT04820192 | Completed

• 1 other identifier: CST for PCS
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated the utilization of CranioSacral Therapy (CST) in patients with Post-Concussion Syndrome (PCS) and capture patient-reported perceptions of their lived experiences of treatment effect upon their symptoms. The first part part was a 10 year chart review of patients who sought out CST to capture data from the medical records. The second part was an anonymous post treatment survey.

Conditions

Post-Concussion Syndrome

Outcome Measures

Primary Outcomes (1)

• Patient-directed Utilization of CST

  Data extracted from medical chart to study how many sessions patients participated in (addressing their presenting symptoms). Number of sessions were recorded.

  Through study completion. 1 year - study is now completed

Secondary Outcomes (2)

• Demographic information

  3 months

• Post-treatment Patient-reported Outcome Survey

  Through study completion. 1 year - study is now completed

Study Arms (3)

Post-acute concussion (<6 months) or Post-Concussion Syndrome (PCS) (≥ 6 months)

Patients were divided into cohort groupings to compare outcomes of applying CranioSacral Therapy to their unique constellations of persistent symptoms attributed to their concussion injury. Symptoms less than 3-6 months duration may be part of the usually rate of injury resolution through rest along. Symptoms persisting after 6 months are considered PCS. Less than 6 months since injury were considered post-acute concussion stage of recovery.

Other: Craniosacral Therapy

Athletes (A) or Non-athletes (NA)

Reporting of symptoms that exist and/or persist may differ between patients who are/were athletes and concussions were sustained during their sporting events. Non-athletes may report differently. The types of injuries involved in the concussion were also captured.

Other: Craniosacral Therapy

Traditional gender.

Symptoms and response to rest has been reported to have differences between male and female patients. Age under 14 years was considered an exclusion due to immaturity in insight and reporting. Thus, young adult ages and older were included and observations between gender reporting was noted.

Other: Craniosacral Therapy

Interventions

Craniosacral Therapy OTHER

The Upledger method of applying both specific and non-specific manual therapy of gentle, sustained, non-invasive stretch to soft tissues of fascia, meninges and osseous attachments. Fluid exchange is also believed to be a resulting result of CST. Treatment is applied to myofascial and osseous sites over the entire body, tending to specific and unique constellation of tissue restrictions and osseous compressions of soft tissue.

Athletes (A) or Non-athletes (NA); Post-acute concussion (<6 months) or Post-Concussion Syndrome (PCS) (≥ 6 months); Traditional gender.

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ten year retrospective chart review of patients who received craniosacral therapy addressing symptoms post concussion

You may qualify if:

• Charts were extracted from a group of 212 of patients with a history of concussion to a final chart review size of 67. These patients had specifically sought of CST to address symptoms of Post Concussion Syndrome.

You may not qualify if:

• Was determined for the 2nd part of study: Post Treatment Outcome Survey. Final group size of 47 excluded those under age 14 and those with confounding medical or personal issues or involved in litigation.

Sponsors & Collaborators

• Special Therapies, Inc.: lead

Study Sites (1)

Special Therapies, Inc.

Waukesha, Wisconsin, 53186, United States

Location

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Susan Kratz, OTR

  Special Therapies, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: January 15, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

US (1)