Neck Pain
Conditions
Keywords
Augmented Exercise, Cervicalgia, Manual Therapy, Manipulation, Quantitative Sensory
Brief summary
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
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.
Interventions
OTHERAugmented Exercise and Manual Therapy
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.
OTHERGeneral Exercise and Manual Therapy
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.
Sponsors
Walsh University
Youngstown State University
Des Moines University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neck Disability Index (NDI) | baseline; 36-48 hours; 96 hours | A functional questionnaire completed by the subject |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline; Immediate post intervention; 36-48 hours; 96 hours | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Range of Motion (ROM) | Baseline; Immediate post intervention; 36-48 hours; 96 hours | — |
| Change in Tampa Scale for Kinesiophobia | Baseline; 36-48 hours; 96 hours | — |
| Change in Strength | Baseline; immediate post intervention; 36-48 hours; 96 hours | — |
| Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) | Baseline; 36-48 hours; 96 hours | — |
| Clinical Equipoise | Baseline | Equipoise occurs when a given treatment has no evidence of being better than another and/or when the individual clinician has no preference of one treatment versus the other.Examiners will complete a form using an 11-point scale to quantify how much they believe the experimental group will have better outcomes or the control group will have better outcomes. |
| Change in Global Rating of Change (GROC) | Baseline; 36-48 hours; 96 hours | — |
| Compliance Measure | 96 hours | Each patient will complete a daily exercise diary. The examiner will assign a score for compliance based on the patient's knowledge and proficiency of performing their home program and the information in the daily exercise diary. |
Countries
United States
Outcome results
None listed