Clinical trial NCT01750736: Manual Therapy and Augmented Exercise for Neck Pain
Official title: The Use of a Home Exercise Program to Augment a Manual Therapy Intervention: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Augmented Exercise
Cervicalgia
Manual Therapy
Manipulation
Quantitative Sensory
Lead sponsor: Des Moines University
Sponsor class: OTHER
Collaborators: name: Walsh University
name: Youngstown State University
First posted: 2012-12-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Neck Disability Index (NDI)
timeFrame: baseline; 36-48 hours; 96 hours
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: baseline; 36-48 hours; 96 hours
measure: Change in Self Reported Activity Scale (SAA)
timeFrame: Baseline; 36-48 hours; 96 hours
measure: Change in Pressure Pain Threshold (PPT)
timeFrame: Baseline; Immediate post intervention; 36-48 hours; 96 hours
measure: Change in Vibratory Measure
timeFrame: Baseline; Immediate post intervention; 36-48 hours; 96 hours
Other outcomes:
measure: Change in Tampa Scale for Kinesiophobia
timeFrame: Baseline; 36-48 hours; 96 hours
measure: Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
timeFrame: Baseline; 36-48 hours; 96 hours
measure: Clinical Equipoise
timeFrame: Baseline
measure: Change in Global Rating of Change (GROC)
timeFrame: Baseline; 36-48 hours; 96 hours
measure: Compliance Measure
timeFrame: 96 hours
measure: Change in Range of Motion (ROM)
timeFrame: Baseline; Immediate post intervention; 36-48 hours; 96 hours
measure: Change in Strength
timeFrame: Baseline; immediate post intervention; 36-48 hours; 96 hours
Locations:
city: Des Moines
country: United States
facility: Des Moines University
state: Iowa
city: North Canton
country: United States
facility: Walsh University
state: Ohio
city: Youngstown
country: United States
facility: Youngstown State University
state: Ohio
Study officials:
affiliation: Des Moines University
name: Shannon Petersen, DScPT
role: PRINCIPAL_INVESTIGATOR
References: