Thrust Manipulation vs. Non-thrust Mobilizations for Mechanical Neck Pain

Not Applicable

• Conditions: Neck Pain
• Interventions: Other: Home Exercise Program; Other: Patient advice, encouragement, and education; Other: Thrust Manipulation; Other: Non-thrust Mobilizations

• Registration Number: NCT02619500
• Lead Sponsor: Youngstown State University

Brief Summary

The purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust mobilizations for mechanical neck pain when they are applied to both the cervical and thoracic spine. Both of these techniques have been compared in previous trials but a pragmatic approach will be employed as well as controlling for clinical equipoise.

Detailed Description

A total sample size of 136 subjects with mechanical neck pain will be recruited to participant in this trial from multiple clinic and university sites around the country. Each subject will be evaluated by a licensed physical therapist that specializes in orthopedic manual therapy (OMT). Each treating therapist will be blinded be the data collection and each data collection therapist will be blinded to the treatment allocation. Subjects data will be collected at the initial visit, second visit, and at discharge. The maximum number of weeks that a subject may be enrolled is 8 weeks (2 months). At that point, they are discharged from the study. The treating therapist will allocate the subject through the already completed randomization procedures. Once the subject is randomized, the treating therapist will perform the OMT based on their clinical reasoning and in a manner they feel would benefit the patient the most. In addition to the OMT, each subject will receive a home exercise program, advice, encouragement, and education. A number of outcome variables will be collected regarded pain and disability as well as one physical performance measure.

Study Timeline

• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-02
• Status Verified: 2016-02
• Study Start: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Chief complaint of neck pain. (Non-specific neck pain with a primary location between the superior nuchal line and the first thoracic spinous process)
• Age >18
• A minimum Neck Disability Index (NDI) score ≥ 20%

Exclusion Criteria

• Contraindications to OMT including; malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use.

• Nerve root compression diagnosed as having at least 2 of the following:

  • Upper extremity muscle weakness within a specific cervical/thoracic myotome
  • Diminished deep tendon reflexes of the biceps brachii, brachioradialis, or triceps muscle.
  • Diminished sensation to light touch or pinprick in a specific upper extremity dermatome.

• History of neck or thoracic spine surgery

• Neck pain of <2 on the NPRS

• Currently receiving other forms of conservative care and unwilling to stop for the duration of their participation in the study.

• Any pending litigation related to their neck pain

• Therapist is unable to elicit the chief complaint with passive accessory intervertebral movements (PAIVM).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thrust Manipulation	Patient advice, encouragement, and education	Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines.
Non-thrust Mobilizations	Home Exercise Program	Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines
Non-thrust Mobilizations	Patient advice, encouragement, and education	Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines
Thrust Manipulation	Home Exercise Program	Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines.
Thrust Manipulation	Thrust Manipulation	Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines.
Non-thrust Mobilizations	Non-thrust Mobilizations	Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines

Primary Outcome Measures

Name	Time	Method
Change from baseline on the Neck Disability Index (NDI)	3 days and 8 weeks	The NDI is a self-report measure of perceived disability and it is comprised of ten questions using an ordinal scale from 0 to 5 for a maximum of 50 points. The score is doubled to achieve a % score. The higher an individual scores on the NDI, the greater their perceived level of disability.

Secondary Outcome Measures

Name	Time	Method
Change from baseline on The Patient Specific Functional Scale (PSFS)	3 days and 8 weeks	The PSFS is a patient identified self-report questionnaire that measures general activity limitations. The scale ranges from 0 (unable to perform) to 10 (able to perform the activity at the level prior to injury). The patient reports three activities that are limited due to the current injury and an average rating for all three activities is calculated.
Change from baseline on The Numerical Pain Rating Scale (NPRS)	3 days and 8 weeks	The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Two separate pain ratings will be collected (current and average over a 24 hour period) experienced over 24 hours and then averaged for a composite score.
Change from baseline on The Global Rating Of Change Scale (GROC)	3 days and 8 weeks	The GROC is a 15-point scale used to quantify a patient's improvement with treatment or to record the clinical course of a condition over time. Patients are asked to describe their overall condition since the start of treatment until the present time with options ranging from -7 ("a very great deal worse") to +7 ("a very great deal better") and 0 being described as "about the same."
Change from baseline on the Deep Cervical Flexion Endurance (DCF)	3 days and 8 weeks	Patients are positioned in supine and will be instructed to maximally tuck his/her chin isometrically. Patients will then be instructed to lift their head 2.5 cm off the plinth and to maintain upper cervical flexion simultaneously for as long as they were able. A skin fold along the antero-lateral neck will be monitored and the investigator's hand will remain under the occiput of the patient for tactile cueing. The timing of the position began once the patient is in the correct position and stopped if; the patient's head drops into the fingers of the clinician, is elevated greater than one inch, the patient loses the skin fold on the antero-lateral neck, or the patient is unable to continue.

Trial Locations

Locations (1)

Youngstown state university; 🇺🇸 Youngstown, Ohio, United States