Craniosacral Therapy for Concussion Symptoms

Completed

• Conditions: Post-Concussion Syndrome
• Interventions: Other: Craniosacral Therapy

• Registration Number: NCT04820192
• Lead Sponsor: Special Therapies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2021-03
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-acute concussion (<6 months) or Post-Concussion Syndrome (PCS) (≥ 6 months)	Craniosacral Therapy	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.
Athletes (A) or Non-athletes (NA)	Craniosacral Therapy	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.
Traditional gender.	Craniosacral Therapy	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.

Primary Outcome Measures

Name	Time	Method
Patient-directed Utilization of CST	Through study completion. 1 year - study is now completed	Data extracted from medical chart to study how many sessions patients participated in (addressing their presenting symptoms). Number of sessions were recorded.

Secondary Outcome Measures

Name	Time	Method
Post-treatment Patient-reported Outcome Survey	Through study completion. 1 year - study is now completed	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.
Demographic information	3 months	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).

Trial Locations

Locations (1)

Special Therapies, Inc.; 🇺🇸 Waukesha, Wisconsin, United States