Post-Concussion SyndromeNCT04820192
Craniosacral Therapy for Concussion Symptoms
An observational study of Post-Concussion Syndrome, run by Special Therapies, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- Craniosacral Therapy
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2018to 30 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Ten year retrospective chart review of patients who received craniosacral therapy addressing symptoms post concussion
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of CranioSacral Therapy Upon Symptoms of Post-Acute Concussion and Post-Concussion Syndrome
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
- Being tested
- Craniosacral Therapy
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniosacral TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Craniosacral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion. 1 year - study is now completed
Secondary outcomes (2)
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).
Measured: 3 months
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.
Measured: Through study completion. 1 year - study is now completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start15 Jan 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Special Therapies, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Vaughan Kratz, Special Therapies, Inc.
- Investigators
- Susan Kratz, OTR, Principal investigator, Special Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820192
- Sponsor's protocol ID
- CST for PCS
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CranioSacral Therapy Upon Symptoms of Post-Acute Concussion and Post-Concussion Syndrome
- ClinicalTrials.gov ID
- NCT04820192
- Acronym / sponsor ID
- CST for PCS
- Conditions
- Post-Concussion Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Special Therapies, Inc.University, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-acute concussion (<6 months) or Post-Concussion Syndrome (PCS) (≥ 6 months) | – | Other: Craniosacral TherapyPatients 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) | – | Other: Craniosacral TherapyReporting 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. | – | Other: Craniosacral TherapySymptoms 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. |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ten year retrospective chart review of patients who received craniosacral therapy addressing symptoms post concussion
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Craniosacral TherapyThe 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. | Other | Athletes (A) or Non-athletes (NA), Post-acute concussion (<6 months) or Post-Concussion Syndrome (PCS) (≥ 6 months), Traditional gender. |
Primary outcome
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.
2 secondary outcomes
Demographic information
Time frame: 3 months
Post-treatment Patient-reported Outcome Survey
Time frame: Through study completion. 1 year - study is now completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Post-Concussion Syndrome
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Kratz, OTR principal investigator
Special Therapies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Concussion Syndrome, run by Special Therapies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-directed Utilization of CST (time frame: Through study completion. 1 year - study is now completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.