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Completed

NCT Number: NCT04820192

Craniosacral Therapy for Concussion Symptoms

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.

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Key information

Conditions

Post-Concussion Syndrome Brain Concussion Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Special Therapies, Inc.

Waukesha, Wisconsin, 53186, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Patient-directed Utilization of CST

    Time frame: 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 outcomes

  1. Demographic information

    Time frame: 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).

  2. Post-treatment Patient-reported Outcome Survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Special Therapies, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2021
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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