Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization

NCT00504686 | Completed Phase 1

• 1 other identifier: HIC 06-14
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study. The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index

  4 weeks, 6 months

Secondary Outcomes (1)

• Pain

  4 week, 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

manual therapy - thoracic spine thrust manipulation

Other: manual therapy; Other: exercise

2

ACTIVE COMPARATOR

therapeutic exercise

Other: exercise

Interventions

manual therapy OTHER

manual therapy - thoracic spine thrust manipulation

1

exercise OTHER

therapeutic exercise

1; 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary complaint of neck pain with or without unilateral upper extremity symptoms
• Age between 18-60 years old
• NDI score greater than 10 points

You may not qualify if:

• Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
• History of whiplash injury within the past six weeks
• Diagnosis of cervical spinal stenosis or 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, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
• Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
• Muscle weakness involving a major muscle group of the upper extremity
• Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps reflex)
• Diminished or absent sensation to pinprick in any upper extremity dermatome

Sponsors & Collaborators

• Franklin Pierce University: lead
• Newton-Wellesley Hospital: collaborator

Study Sites (1)

Concord Hospital

Concord, New Hampshire, 03301, United States

Location

Related Publications (1)

• Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.

  PMID: 20634268 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal Manipulations; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joshua A Cleland, PT, PhD

  Franklin Pierce University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2007
• First Posted: July 20, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 3, 2009

Record last verified: 2009-02

Locations

US (1)