Manual Therapy and Augmented Exercise for Neck Pain

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750736
• Other study ID #: DMUPT-001
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: February 10, 2015
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2015
• Source: Des Moines University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Augmented 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.
• General 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.

Locations

Country	Name	City	State
United States	Des Moines University	Des Moines	Iowa
United States	Walsh University	North Canton	Ohio
United States	Youngstown State University	Youngstown	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Des Moines University	Walsh University, Youngstown State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Tampa Scale for Kinesiophobia		Baseline; 36-48 hours; 96 hours	No
Other	Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)		Baseline; 36-48 hours; 96 hours	No
Other	Clinical Equipoise	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.	Baseline	No
Other	Change in Global Rating of Change (GROC)		Baseline; 36-48 hours; 96 hours	No
Other	Compliance Measure	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.	96 hours	No
Other	Change in Range of Motion (ROM)		Baseline; Immediate post intervention; 36-48 hours; 96 hours	No
Other	Change in Strength		Baseline; immediate post intervention; 36-48 hours; 96 hours	No
Primary	Change in Neck Disability Index (NDI)	A functional questionnaire completed by the subject	baseline; 36-48 hours; 96 hours	No
Secondary	Change in Numeric Pain Rating Scale (NPRS)		baseline; 36-48 hours; 96 hours	No
Secondary	Change in Self Reported Activity Scale (SAA)		Baseline; 36-48 hours; 96 hours	No
Secondary	Change in Pressure Pain Threshold (PPT)		Baseline; Immediate post intervention; 36-48 hours; 96 hours	No
Secondary	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	No