Manual Therapy and Augmented Exercise for Neck Pain

NCT ID: NCT01750736

Last Updated: 2015-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-06-30

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.

Conditions

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Augmented Exercise and Manual Therapy

Intervention Type OTHER

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

Subjects will receive manual therapy according to clinical guidelines followed by instruction in a general neck range of motion exercise.

Group Type ACTIVE_COMPARATOR

General Exercise and Manual Therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Manipulation Mobilization Self-Mobilization Manipulation Mobilization Self-Mobilization

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Walsh University

OTHER

Sponsor Role collaborator

Youngstown State University

OTHER

Sponsor Role collaborator

Des Moines University

OTHER

Sponsor Role lead

Responsible Party

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Shannon Petersen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shannon Petersen, DScPT

Role: PRINCIPAL_INVESTIGATOR

Des Moines University

Locations

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Des Moines University

Des Moines, Iowa, United States

Site Status

Walsh University

North Canton, Ohio, United States

Site Status

Youngstown State University

Youngstown, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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DMUPT-001

Identifier Type: -

Identifier Source: org_study_id

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