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NCT Number: NCT00128869

Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain

This study aims to compare whether or not there is a difference in the effectiveness of upper back (thoracic spine) mobilizations versus manipulations used in a population of patients with mechanical neck pain. The investigators hypothesize that patients receiving a manipulative technique will experience better outcomes than patients receiving the mobilization techniques and these results will be evident at a 48-hour follow-up.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sharp Rees-Stealy Medical Group, San Diego, California, United States

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About this study

Patients with mechanical neck pain who meet the study's inclusion criteria, who do not meet the study's exclusion criteria will be offered an opportunity to participate in this study. They will be issued an informed consent detailing the study and will have time to decide whether or not to participate. Once they have enlisted in the study they will complete forms to assess their current functional level. The investigator will then perform a standard clinical exam on the upper quarter to include a comprehensive subjective examination, upper extremity strength, reflexes, sensory assessment, cervical range of motion, thoracic range of motion and pain assessment. Once the above data have been collected and the patient has met the criteria for the study, a second investigator will then choose a randomized and sealed envelope which will indicate the treatment to be performed. The patient will either receive mobilization or manipulation to the thoracic spine. Mobilizations will be performed in prone over the spinous processes of T1-T6. Each one will be performed for 30 seconds each with force directed posterioanterior. The manipulation will be performed in supine with the patient's arms crossed over his/her chest. The therapist will pull the patient's arms downward to create spinal flexion down to the level where the manipulation will occur. The therapist's manipulative hand will stabilize the lower vertebrae of the motion segment and his/her body will be used to push down through the patient's arms to perform a high velocity, low amplitude thrust of the superior vertebrae. The manipulation will first be attempted in the upper thoracic spine; if a cavitation is heard on the first attempt he/she will move onto the middle thoracic area. If a cavitation is not heard he/she will attempt a second time before moving on to the next area. Both areas will receive a maximum of two attempts. Once the manipulation or mobilization is performed the patient will be assigned one home exercise which includes rotation of the cervical spine in both directions for 10 reps, 3-4 times per day. The patient will return within 48 hours for final data collection which will include a global rating of change scale completed both by the therapist and the patient, pain diagram and scale, neck disability index, cervical and thoracic range of motion measurements, and a side effects questionnaire. The patient will then be discharged from the study and will continue with physical therapy as deemed appropriate at the time of examination.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary complaint of neck pain with duration of symptoms greater than 4 weeks
  • Age between 18-60 years old

Exclusion criteria

  • Red flags from the medical neck screening questionnaire to include tumor, fracture, metabolic disease, rheumatoid arthritis (RA), osteoporosis, prolonged history of steroid use.
  • History of whiplash injury
  • Diagnosis of cervical spinal stenosis
  • Bilateral upper extremity symptoms
  • Evidence of central nervous system involvement to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes
  • Two or more positive neurological signs consistent with nerve root compression to include muscle weakness involving a major muscle group of the upper extremity; diminished upper extremity muscle stretch reflex; diminished or absent sensation to pinprick in any upper extremity dermatome.
  • Prior surgery to the neck or thoracic spine
  • Pending legal action regarding neck pain

Treatment and study plan

spine mobilizations

Procedure

spine manipulations

Procedure

Primary outcomes

  1. Pain Diagram and Scale

  2. Neck Disability Scale

  3. Global Rating of Change Scale

Secondary outcomes

  1. Side Effects Questionnaire

Sponsors and collaborators

Lead sponsor

Newton-Wellesley Hospital

Other

Registry information

Official study title

Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain: A Randomized Clinical Trial

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 10, 2005
Registry last updated
May 13, 2008

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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