Manual Therapy and Augmented Exercise for Neck Pain

Study Overview
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Brief Summary
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Manual therapy and exercise have shown to be beneficial for people with neck pain, however it is not clear how outcomes following a general exercise program compare to specific exercises intended to augment a specific manual/hands-on intervention. This study will compare outcomes following manual therapy and a specific exercise program with manual therapy and a general exercise program.

Detailed Description
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The purpose of this study is to determine if specific neck exercises intended to augment specific manual therapy treatments result in better outcomes than standard neck exercises in people with neck pain. Clinical tests and measurements as well as patient questionnaires will be completed and compared between groups. A secondary purpose is to determine if self report of activity is correlated with functional improvements. We hypothesize that a specifically applied home exercise that augments the effects of the manual therapy intervention will lead to improvements in outcomes in patients with neck pain. We hypothesize that higher reports of self activity will be correlated with improvements in outcomes.

Official Title
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The Use of a Home Exercise Program to Augment a Manual Therapy Intervention: a Randomized Controlled Trial

Conditions
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Neck Pain

Intervention / Treatment
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* Other: Augmented Exercise and Manual Therapy
* Other: General Exercise and Manual Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with complaint of neck pain, neck motion limitations, pain at end-range neck ROM, limited cervical/cervical and thoracic joint mobility, neck pain with manual segmental examination Exclusion Criteria: The presence of any red flags (i.e. tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, signs and symptoms of vertebrobasilar insufficiency, etc.), use of blood thinners, whiplash injury in the past 6 weeks, evidence of central nervous system involvement (such as hyperreflexia, sensory disturbances in the hands, unsteadiness during walking, etc.), history of spinal surgery, workers compensation or pending legal action regarding their neck pain, insufficient English language skills to complete questionnaires, unable to comply with schedule

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented Exercise and Manual Therapy<br>Subjects will receive manual therapy according to clinical guidelines followed by instruction in a specific exercise to augment the specific manual treatment provided. | Other: Augmented Exercise and Manual Therapy<br>* Session 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform the augmented exercise at home and at each data collection session.<br>* Other names: Self-Mobilization;|
| Active Comparator: General Exercise and Manual Therapy<br>Subjects will receive manual therapy according to clinical guidelines followed by instruction in a general neck range of motion exercise. | Other: General Exercise and Manual Therapy<br>* Session 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform general range of motion exercises for the neck at home and at each data collection session.<br>* Other names: Self-Mobilization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neck Disability Index (NDI) | A functional questionnaire completed by the subject | baseline; 36-48 hours; 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numeric Pain Rating Scale (NPRS) |  | baseline; 36-48 hours; 96 hours | 
| Change in Self Reported Activity Scale (SAA) |  | Baseline; 36-48 hours; 96 hours | 
| Change in Pressure Pain Threshold (PPT) |  | Baseline; Immediate post intervention; 36-48 hours; 96 hours | 
| Change in Vibratory Measure | A specialized tool is used to measure sensory threshold; it is a hand-held sensor with a small vibrating tip held against the skin. This device measures how the nerves react to vibration. The procedure is non-invasive. Little or no discomfort should be felt during the test. | Baseline; Immediate post intervention; 36-48 hours; 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmented Exercise, Cervicalgia, Manual Therapy, Manipulation, Quantitative Sensory