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

Recruiting

• Conditions: Mild Traumatic Brain Injury; Brain Concussion
• Interventions: Behavioral: Physical Therapy

• Registration Number: NCT05859815
• Lead Sponsor: State University of New York at Buffalo

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Study Start: 2023-07-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Directional preference non-responder	Physical Therapy	This group is comprised of participants who did not respond to repeated movements in any specific direction that significantly improved their symptoms and/or their ability to move their head/neck.
Directional preference responder	Physical Therapy	This group is comprised of participants who responded to repeated movements in a direction (e.g., neck flexion) that significantly improved their symptoms and/or their ability to move their head/neck.

Primary Outcome Measures

Name	Time	Method
Directional preference classification	Through study completion, up to 1 year.	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.

Secondary Outcome Measures

Name	Time	Method
Post-Concussion Symptom Scale	Through study completion, up to 1 year.	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.
Neck Disability Index	Through study completion, up to 1 year.	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.
Dizziness Handicap Inventory	Through study completion, up to 1 year.	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.

Trial Locations

Locations (2)

Summit Healthplex Physcial Therapy/Niagara Falls Memorial Medical Center; 🇺🇸 Niagara Falls, New York, United States

Goodlife Physical Therapy; 🇺🇸 Orland Park, Illinois, United States