Skip to main content
OpenTrials
Completed

NCT Number: NCT02415660

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMEDD Center & School

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-64 years and eligible for military health care
  • Primary complaint of mechanical neck pain provoked by posture, movement or palpation of neck musculature, with or without unilateral upper extremity symptoms.
  • Presence of active trigger points in either the upper trapezius or deep cervical extensor muscles.
  • 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.
  • No less than 10 points (0-50 range) on the Neck Disability Index.

Exclusion criteria

  • Prior history of whiplash injury resulting in neck pain which required medical treatment.
  • Any prior physical therapy, chiropractic, acupuncture treatment or injections for neck pain within the past 3 months.
  • History of cervical spine surgery.
  • History of any systemic disorder in which thoracic spine manipulation and TDN would be contraindicated (i.e. osteoporosis, bleeding disorders or anticoagulant medication use)
  • 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).
  • Current primary complaint of headaches
  • Pending legal action regarding their neck pain
  • Inability to read and understand English
  • Females known or thought to be pregnant

-

Treatment and study plan

Thoracic spinal manipulation

Procedure

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

trigger point dry needling

Procedure

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.

Cervical range of motion exercises

Behavioral

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.

Posterior neck muscle activation exercise

Behavioral

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.

Trigger point dry needling sham

Procedure

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.

Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm

Device

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2015
Registry last updated
Feb 2, 2021

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.

Published trials that share one or more normalized conditions with this study.