Manual Therapy and Augmented Exercise for Neck Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Augmented Exercise and Manual Therapy; Other: General Exercise and Manual Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Des Moines, Iowa, United States, 50325
      • Des Moines University
  • Ohio
    • North Canton, Ohio, United States, 44720
      • Walsh University
    • Youngstown, Ohio, United States, 44555
      • Youngstown State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented Exercise and Manual Therapy; 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; 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.; Other Names: Manipulation; Mobilization; Self-Mobilization
Active Comparator: General Exercise and Manual Therapy; 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; 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.; Other Names: Manipulation; Mobilization; Self-Mobilization

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tampa Scale for Kinesiophobia		Baseline; 36-48 hours; 96 hours
Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)		Baseline; 36-48 hours; 96 hours
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
Change in Global Rating of Change (GROC)		Baseline; 36-48 hours; 96 hours
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
Change in Range of Motion (ROM)		Baseline; Immediate post intervention; 36-48 hours; 96 hours
Change in Strength		Baseline; immediate post intervention; 36-48 hours; 96 hours

Collaborators and Investigators

• Sponsor: Des Moines University
• Collaborators: Walsh University; Youngstown State University
• Investigators: Principal Investigator: Shannon Petersen, DScPT, Des Moines University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 11, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): February 12, 2015
• Last Update Submitted That Met QC Criteria: February 10, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Manual Therapy; Manipulation; Cervicalgia; Augmented Exercise; Quantitative Sensory
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: DMUPT-001