Craniosacral Therapy for Concussion Symptoms

NCT ID: NCT04820192

Last Updated: 2021-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Concussion Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Craniosacral Therapy

Intervention Type 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)

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.

Craniosacral Therapy

Intervention Type 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.

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.

Craniosacral Therapy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Special Therapies, Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susan Vaughan Kratz

Clinical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan Kratz, OTR

Role: PRINCIPAL_INVESTIGATOR

Special Therapies, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Special Therapies, Inc.

Waukesha, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CST for PCS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.