NCT01092715

Brief Summary

Neck pain is a common problem in our society, accounting for 20% of all chiropractic visits. Physical therapy interventions for chronic neck pain have been chosen based on the patient's symptoms and examination findings. These interventions include superficial and deep heat, massage, traction, manual therapy, and exercise programs. There is little controlled research addressing the efficacy of these therapies. Although many of these interventions provide some patients with pain relief and increased function, studies often utilize multiple interventions on the same subject such as heat, ultrasound, cervical traction, range of motion exercises, making interpretation of the results difficult. Much of the literature to date has focused on studies of subjects suffering from acute neck pain. Many of these studies suggest that subjects report decreased pain, decreased disability and increased cervical spine active range of motion. There are no controlled studies comparing the effects of spinal mobilization and standard physical therapy on subjects with chronic neck pain. The object of this study is two fold: 1) to determine the score variability of two neck disability questionnaires )both baseline and change scores) to be used in sample size calculations, and 2) to establish the ability to recruit, treat and follow sufficient numbers of subjects needed for a full clinical trial. The ability to predict outcomes of neck pain treatment will lead to more appropriate therapies and an avoidance of unnecessary treatments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
Last Updated

March 25, 2010

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

March 23, 2010

Last Update Submit

March 24, 2010

Conditions

Neck Pain

Keywords

Neck painSpinal manipulationMassage

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index

    Neck Disability Index score (patient generated score from questionnaire)

    6 weeks

Study Arms (2)

Mobilization

EXPERIMENTAL

Spinal mobilization and exercises

Procedure: Spinal mobilizationProcedure: Neck exercises

Massage

ACTIVE COMPARATOR

Neck massage and exercises

Procedure: MassageProcedure: Neck exercises

Interventions

Spinal mobilizationPROCEDURE

Non thrust mobilization to the cervical spine

Mobilization
MassagePROCEDURE

Sedative massage to cervical paraspinal muscles

Massage
Neck exercisesPROCEDURE

Range of motion exercises to include foraminal opening

MassageMobilization

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neck pain of at least 12 weeks duration

You may not qualify if:

  • Signs and/or symptoms of cervical radiculopathy or myelopathy
  • Symptomatic shoulder pathology
  • History of cervical spine surgery
  • History of motor vehicle collision within the past three years
  • Recent neck or shoulder trauma
  • Fibromyalgia or generalized pain syndrome
  • History of cancer affecting the head or neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Dept of Physical Medicine & Rehabilitation

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Timothy J Madson, PT

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Timothy J Madson, PT

    Mayo Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 25, 2010

Study Start

June 1, 2003

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

March 25, 2010

Record last verified: 2010-03

Locations

US(1)