The Role of Mechanical Diagnosis and Therapy in the Management of Concussion

Mild Traumatic Brain Injury Clinical Trial

Official title:

The Role of Mechanical Diagnosis and Therapy in the Classification and Management of Concussion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859815
• Other study ID #: STUDY00006666
• Status: Recruiting
• Start date: July 20, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: State University of New York at Buffalo
• Contact: Michael R Brown, DPT, PhD
• Phone: 716-829-6801
• Email: mrbrown2[@]buffalo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine the role of a Mechanical Diagnosis and Therapy (MDT) examination in identifying participants diagnosed with concussion who display a directional preference compared to who don't display a directional preference.

Description:

Directional preference describes the clinical phenomenon where a specific direction of repeated movement and / or sustained position results in a clinically relevant improvement in symptoms. This improvement is usually accompanied by an improvement in function or mechanics or both. Its presence and relevance is determined over 2-3 visits. This study aims to identify the proportion of participants with concussion who present with a directional preference during the course of physical therapy. A secondary aim of this study is to investigate whether directional preference is associated with the eventual patient related outcomes following care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age = 13 - 65

• Complaints of neck pain, headache, or dizziness associated with a diagnosis of concussion or mild TBI

• Ability to read/write English

• Referral from physician

Exclusion Criteria:

• Age less than 13 or greater than 65

• Cause of symptoms is result of a work-related accident or motor vehicle accident

• Receiving concurrent treatment from a chiropractor or massage therapist

• Glasgow Coma Scale less than 12

• Lesion on head CT/MRI

• Focal neurological deficits associated with serious spinal pathology (fracture, infection, tumor, vertebrobasilar insufficiency)

• Inability to or unwilling to exercise as part of usual PT care

• Unable to read/write English

• History of osteopenia/osteoporosis or cancer

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Behavioral:
• Physical Therapy
As part of their normal care, participants will receive any combination of the following interventions to address their specific needs identified during the initial evaluation: cervical spine repeated movements (active range of motion), cervical spine stabilization exercise, aerobic exercise, motor control training, oculomotor/vestibular rehabilitation, stretching, soft-tissue mobilization, joint mobilization, and postural re-education activities.

Locations

Country	Name	City	State
United States	Summit Healthplex Physcial Therapy/Niagara Falls Memorial Medical Center	Niagara Falls	New York
United States	Goodlife Physical Therapy	Orland Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Return to sport/activity	This outcome represents the number of days it takes a patient to return to their prior level of participation in sport/activity	Up to 1 year
Other	Number of treatments	This outcome represents the number of physical therapy visits they completed before being discharged by the physician or physical therapist.	Up to 1 year
Primary	Directional preference classification	Outcome represents the patient's directional preference at the time of discharge from care. Patients will be classified as directional preference responders or non-responders.	Through study completion, up to 1 year.
Secondary	Post-Concussion Symptom Scale	The PCSS is a patient self-reported outcome measure that measures the amount of interference associated with a concussion across four domains: physical, cognitive, emotion, and sleep. The measure consists of 22 questions that relate to post-concussive symptoms. The measure uses a 7-point Likert scale, where 0 = no symptoms and 6 = severe symptoms. The greatest possible score is 132 and the lowest score is 0. Higher scores indicate higher severity of post-concussive symptoms.	Through study completion, up to 1 year.
Secondary	Neck Disability Index	The NDI is a patient self-reported outcome measure that measures the amounts of pain interference and self-reported disability related to neck pain. The measure consists of ten questions in the following domains: pain intensity, personal care, lifting, reading, sleeping, work, recreation, reading, concentration, and headaches. Each item is rated on a 0 to 5 scale, where 0 = no disability and 5 = complete disability. The highest possible raw score equals 50 points, the lowest possible score equals 0. The raw scores can also be converted to a percentage from 0 to 100%. Higher scores indicate higher levels of self-reported disability.	Through study completion, up to 1 year.
Secondary	Dizziness Handicap Inventory	The DHI is a patient self-reported outcome measure that measures the impact of dizziness on daily life. The DHI consists of 25 items measuring the impact of dizziness across three domains: functional (9 questions,= 36 points), emotional (9 questions = 36 points), and physical (7 questions = 28 points). Each item is rated on a 3 point scale (yes = 4, sometimes = 2, no = 0). Item scores are summed, with a possible total of 100 points. The best possible score is a 0. Higher scores indicate greater perceived handicap due to dizziness.	Through study completion, up to 1 year.