Manual Therapy and Augmented Exercise for Neck Pain

NCT01750736 | Completed

• 1 other identifier: DMUPT-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Neck Pain

Keywords

Augmented Exercise; Cervicalgia; Manual Therapy; Manipulation; Quantitative Sensory

Outcome Measures

Primary Outcomes (1)

• Change in Neck Disability Index (NDI)

  A functional questionnaire completed by the subject

  baseline; 36-48 hours; 96 hours

Secondary Outcomes (4)

• 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

Other Outcomes (7)

• 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

  Baseline

Study Arms (2)

Augmented Exercise and Manual Therapy

EXPERIMENTAL

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

General Exercise and Manual Therapy

ACTIVE COMPARATOR

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

Interventions

Augmented Exercise and Manual Therapy 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.

Also known as: Manipulation, Mobilization, Self-Mobilization

Augmented Exercise and Manual Therapy

General Exercise and Manual Therapy 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.

Also known as: Manipulation, Mobilization, Self-Mobilization

General Exercise and Manual Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Des Moines University: lead
• Walsh University: collaborator
• Youngstown State University: collaborator

Study Sites (3)

Des Moines University

Des Moines, Iowa, 50325, United States

Location

Walsh University

North Canton, Ohio, 44720, United States

Location

Youngstown State University

Youngstown, Ohio, 44555, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Shannon Petersen, DScPT

  Des Moines University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 17, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

US (3)