Craniosacral Therapy for Concussion Symptoms

Post-Concussion Syndrome Clinical Trial

Official title:

Effects of CranioSacral Therapy Upon Symptoms of Post-Acute Concussion and Post-Concussion Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04820192
• Other study ID #: CST for PCS
• Status: Completed
• Start date: January 15, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: March 2021
• Source: Special Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Post-Concussion Syndrome
• Syndrome

Intervention

Other:
• Craniosacral Therapy
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.

Locations

Country	Name	City	State
United States	Special Therapies, Inc.	Waukesha	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Special Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographic information	Additional data extracted from chart review to study trends of population sample included: gender differences in reporting, athletes/non-athletes reporting, time since injury, etiology of concussion (sports vs. non-sports).	3 months
Secondary	Post-treatment Patient-reported Outcome Survey	Anonymous 10 question survey for participants meeting inclusion criteria from the original 67 (from chart review) recruited to complete an anonymous electronic survey. This survey highlighted symptoms they experienced from their concussions and if CST had any effect on any of the symptoms. Symptom list was extracted from the standard Post Concussion Symptom Checklist.	Through study completion. 1 year - study is now completed