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Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain

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ClinicalTrials.gov Identifier: NCT02415660
Recruitment Status : Recruiting
First Posted : April 14, 2015
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Brian Young, Brooke Army Medical Center

Brief Summary:
This study will assess the short term response of thoracic spinal manipulation with or without trigger point dry needling in 58 subjects with a primary complaint of mechanical neck pain.

Condition or disease Intervention/treatment Phase
Neck Pain Procedure: Thoracic spinal manipulation Procedure: Trigger point dry needling Behavioral: Cervical range of motion exercises Behavioral: Posterior neck muscle activation exercise Procedure: Trigger point dry needling sham Device: Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm Not Applicable

Detailed Description:

Neck pain is common, and return to duty rates after medical evacuation from theater for spinal pain is low. Muscles comprise the majority of the stability for the cervical spine, yet neck muscle function can be altered in the presence of pain. Research has consistently shown the benefit of including thoracic spine manipulation (SMT) in the treatment of patients with mechanical neck pain. Emerging evidence is now also showing promising benefit of including trigger point dry needling (TDN) for the treatment of mechanical neck pain. Treatment regimens commonly address anterior cervical stabilizing musculature, but little is known regarding the response to treatment of the deep posterior stabilizing musculature.

This study will assess the short term response of thoracic SMT with or without TDN in 58 subjects with a primary complaint of mechanical neck pain. Subjects will be randomized to receive 2 treatment visits approximately 2-3 days apart of either SMT+sham TDN or SMT+TDN. TDN will be directed to the upper trapezius and deep cervical extensor muscles of the neck. Outcomes of interest will be changes in function and pain. Assessments will be made at baseline, immediately after the first treatment, at the 2nd treatment, and approximately 5-7 days after the 2nd treatment visit. A subgroup of 20 subjects (10 per group) will also have the upper trapezius and deep cervical extensor muscle activation assessed via shear wave elastography, and deep cervical flexor activation assessed via the craniocervical flexion test.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain: A Randomized Clinical Trial
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SMT and TDN
Thoracic spinal manipulation and trigger point dry needling using Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Procedure: Thoracic spinal manipulation
All patients will receive 3 different thrust joint manipulations to the middle and upper thoracic spine region. Each technique will be applied up to 2 times, per the discretion of the treating therapist discretion

Procedure: Trigger point dry needling
The TDN treatment will consist of a trained investigator inserting a needle through the participant's skin, into the deep cervical extensor muscles and/or the upper trapezius muscles using FDA approved (FDA regulation # 880.5580) disposable 0.2-0.3 x 40-50 mm stainless steel Seirin J-type needles (Seirin, Japan). Those subjects randomized to TDN will undergo this treatment.

Behavioral: Cervical range of motion exercises
The patient will be instructed to place 5 fingers along the manubrium, and to flex the neck down until the chin touches the fingers. The patient will then be instructed to rotate the head as far as comfortably possible to one side, and then to the other side for 10 repetitions to each side, 3-4 times per day. The patient will progress from 5 fingers, to 4, 3, 2 and eventually 1 finger as neck mobility improves.

Behavioral: Posterior neck muscle activation exercise
The patient will be instructed to sit upright in a chair, and place 1-2 fingers over the C2 spinous process. Education to localize this landmark will be provided. The patient will then perform an isometric chin tuck exercise against the resistance they will apply at C2. This position will be held x 5 seconds and repeated 10 times, 3-4 times per day.

Device: Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm
A trained investigator will insert the needle through the participants skin into the deep cervical extensors and/or the upper trapezius muscles. Needles are FDA approved (#880.5580)

Sham Comparator: SMT and Sham TDN
Thoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Procedure: Thoracic spinal manipulation
All patients will receive 3 different thrust joint manipulations to the middle and upper thoracic spine region. Each technique will be applied up to 2 times, per the discretion of the treating therapist discretion

Behavioral: Cervical range of motion exercises
The patient will be instructed to place 5 fingers along the manubrium, and to flex the neck down until the chin touches the fingers. The patient will then be instructed to rotate the head as far as comfortably possible to one side, and then to the other side for 10 repetitions to each side, 3-4 times per day. The patient will progress from 5 fingers, to 4, 3, 2 and eventually 1 finger as neck mobility improves.

Behavioral: Posterior neck muscle activation exercise
The patient will be instructed to sit upright in a chair, and place 1-2 fingers over the C2 spinous process. Education to localize this landmark will be provided. The patient will then perform an isometric chin tuck exercise against the resistance they will apply at C2. This position will be held x 5 seconds and repeated 10 times, 3-4 times per day.

Procedure: Trigger point dry needling sham
The sham group will receive a simulated TDN. Using a toothpick in a needle guide-tube, the investigator will tap, rest, and twist the toothpick for approximately 30 seconds in the same 2 muscles, 2 sites in each muscle. The sham treatment will not penetrate the skin.




Primary Outcome Measures :
  1. Change in Neck Disability Index (NDI) [ Time Frame: Change in NDI from baseline to 2-3 days ]
    The NDI is a revised form of the Oswestry Low Back Pain Index. It is designed to measure the activities of daily living in persons with neck pain.

  2. Change in Neck Disability Index (NDI) [ Time Frame: Change in NDI at 7-10 days ]
    The NDI is a revised form of the Oswestry Low Back Pain Index. It is designed to measure the activities of daily living in persons with neck pain.


Secondary Outcome Measures :
  1. Change in Numeric Pain Rating Scale (NPRS) [ Time Frame: Change in pain from baseline to 2-3 days ]
    An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain".

  2. Change in Numeric Pain Rating Scale (NPRS) [ Time Frame: 7-10 days ]
    An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain".

  3. Global Rate of Change (GRC) [ Time Frame: 2-3 days ]
    The GRC assesses subjective perception of overall change over time and the importance of that change. A 15-point Likert type scale ranging from -7 (very great deal worse) to +7 (a very great deal better) will be used.

  4. Global Rate of Change (GRC) [ Time Frame: 7-10 days ]
    The GRC assesses subjective perception of overall change over time and the importance of that change. A 15-point Likert type scale ranging from -7 (very great deal worse) to +7 (a very great deal better) will be used.

  5. Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE) [ Time Frame: Day 1 pre and post intervention ]
    Shear-Wave Elastography (SWE) is an evolving technology that uses advanced ultrasound imaging to quantify tissue stiffness (i.e., elasticity). This technology will be utilized to assess change in passive muscle activation response to treatment.

  6. Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE) [ Time Frame: 7-10 days ]
    Shear-Wave Elastography (SWE) is an evolving technology that uses advanced ultrasound imaging to quantify tissue stiffness (i.e., elasticity). This technology will be utilized to assess change in passive muscle activation response to treatment.

  7. Change in Deep Neck Flexor (DNF) Activation [ Time Frame: Day 1 pre and post intervention ]
    Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL).

  8. Change in Deep Neck Flexor (DNF) Activation [ Time Frame: 7-10 days ]
    Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL).

  9. Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer. [ Time Frame: Day 1 pre and post intervention ]
    PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.

  10. Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer. [ Time Frame: 7-10 days ]
    PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-64 years and eligible for military health care
  2. Primary complaint of mechanical neck pain provoked by posture, movement or palpation of neck musculature, with or without unilateral upper extremity symptoms.
  3. Presence of active trigger points in either the upper trapezius or deep cervical extensor muscles.
  4. Able to make one initial appointment at the Army Medical Department Center and School at Fort Sam Houston, one treatment visit approximately 2-3 days after the initial visit, and then a final outcome visit approximately 5-7 days after 2nd visit.
  5. No less than 10 points (0-50 range) on the Neck Disability Index.

Exclusion Criteria:

  1. Prior history of whiplash injury resulting in neck pain which required medical treatment.
  2. Any prior physical therapy, chiropractic, acupuncture treatment or injections for neck pain within the past 3 months.
  3. History of cervical spine surgery.
  4. History of any systemic disorder in which thoracic spine manipulation and TDN would be contraindicated (i.e. osteoporosis, bleeding disorders or anticoagulant medication use)
  5. Signs and symptoms consistent with nerve root compression (i.e. diminished upper extremity strength, sensation or reflexes), cervical artery insufficiency (i.e. nystagmus, gait disturbances, Horner Syndrome) or upper cervical ligament instability (i.e. Sharp-Purser, alar ligament, transverse ligament tests).
  6. Current primary complaint of headaches
  7. Pending legal action regarding their neck pain
  8. Inability to read and understand English
  9. Females known or thought to be pregnant


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415660


Contacts
Contact: David M Boland, PT, DPT, PhD 931-206-9527 david.m.boland2.mil@mail.mil
Contact: Brian Young, PT, DSc 210-386-2133 byoungpt@gmail.com

Locations
United States, Texas
AMEDD Center & School Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: David M Boland, PT, DPT, PhD    931-206-9527    david.m.boland2.mil@mail.mil   
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
Principal Investigator: David M Boland, PT, DPT, PhD Assistant Professor, Army-Baylor Doctoral Program in PT

Publications:
Responsible Party: Brian Young, Assistant Professor, Army-Baylor Doctoral Program in PT, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT02415660     History of Changes
Other Study ID Numbers: 404153-1
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Brian Young, Brooke Army Medical Center:
trigger point dry needling
thoracic spine manipulation
deep cervical extensor muscle
deep cervical flexor muscle
shear wave elastography

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms