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Completed

NCT Number: NCT01750736

Manual Therapy and Augmented Exercise for Neck Pain

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Des Moines University, Des Moines, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Manipulation, Mobilization, Self-Mobilization

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.

Other names: Manipulation, Mobilization, Self-Mobilization

Primary outcomes

  1. Change in Neck Disability Index (NDI)

    Time frame: baseline; 36-48 hours; 96 hours

    A functional questionnaire completed by the subject

Secondary outcomes

  1. Change in Numeric Pain Rating Scale (NPRS)

    Time frame: baseline; 36-48 hours; 96 hours

  2. Change in Self Reported Activity Scale (SAA)

    Time frame: Baseline; 36-48 hours; 96 hours

  3. Change in Pressure Pain Threshold (PPT)

    Time frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours

  4. Change in Vibratory Measure

    Time frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours

    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.

Other outcomes

  1. Change in Tampa Scale for Kinesiophobia

    Time frame: Baseline; 36-48 hours; 96 hours

  2. Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)

    Time frame: Baseline; 36-48 hours; 96 hours

  3. Clinical Equipoise

    Time frame: Baseline

    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.

  4. Change in Global Rating of Change (GROC)

    Time frame: Baseline; 36-48 hours; 96 hours

  5. Compliance Measure

    Time frame: 96 hours

    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.

  6. Change in Range of Motion (ROM)

    Time frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours

  7. Change in Strength

    Time frame: Baseline; immediate post intervention; 36-48 hours; 96 hours

Sponsors and collaborators

Lead sponsor

Des Moines University

Other

Collaborators

  • Walsh University
  • Youngstown State University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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