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

Primary Purpose

Neck Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Thoracic spinal manipulation

Trigger point dry needling

Cervical range of motion exercises

Posterior neck muscle activation exercise

Trigger point dry needling sham

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

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring trigger point dry needling, thoracic spine manipulation, deep cervical extensor muscle, deep cervical flexor muscle, shear wave elastography

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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
-

Sites / Locations

AMEDD Center & School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

SMT and TDN

SMT and Sham TDN

Arm Description

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.

Thoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.

Outcomes

Primary Outcome Measures

Change in Neck Disability Index (NDI)

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.

Change in Neck Disability Index (NDI)

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

Change in Numeric Pain Rating Scale (NPRS)

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".

Change in Numeric Pain Rating Scale (NPRS)

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".

Global Rate of Change (GRC)

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.

Global Rate of Change (GRC)

Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)

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.

Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)

Change in Deep Neck Flexor (DNF) Activation

Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL).

Change in Deep Neck Flexor (DNF) Activation

Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL).

Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.

PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.

Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.

PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.

Full Information

NCT ID

NCT02415660

First Posted

March 25, 2015

Last Updated

January 30, 2021

Sponsor

Brooke Army Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02415660

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

June 1, 2016 (Actual)

Primary Completion Date

March 3, 2020 (Actual)

Study Completion Date

August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brooke Army Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

Keywords

trigger point dry needling, thoracic spine manipulation, deep cervical extensor muscle, deep cervical flexor muscle, shear wave elastography

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SMT and TDN

Arm Type

Experimental

Arm Description

Arm Title

SMT and Sham TDN

Arm Type

Sham Comparator

Arm Description

Thoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.

Intervention Type

Procedure

Intervention Name(s)

Thoracic spinal manipulation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Trigger point dry needling

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cervical range of motion exercises

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Posterior neck muscle activation exercise

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Trigger point dry needling sham

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

Change in Neck Disability Index (NDI)

Description

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.

Time Frame

Change in NDI from baseline to 2-3 days

Title

Change in Neck Disability Index (NDI)

Description

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.

Time Frame

Change in NDI at 7-10 days

Secondary Outcome Measure Information:

Title

Change in Numeric Pain Rating Scale (NPRS)

Description

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".

Time Frame

Change in pain from baseline to 2-3 days

Title

Change in Numeric Pain Rating Scale (NPRS)

Description

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".

Time Frame

7-10 days

Title

Global Rate of Change (GRC)

Description

Time Frame

2-3 days

Title

Global Rate of Change (GRC)

Description

Time Frame

7-10 days

Title

Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)

Description

Time Frame

Day 1 pre and post intervention

Title

Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)

Description

Time Frame

7-10 days

Title

Change in Deep Neck Flexor (DNF) Activation

Description

Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL).

Time Frame

Day 1 pre and post intervention

Title

Change in Deep Neck Flexor (DNF) Activation

Description

Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL).

Time Frame

7-10 days

Title

Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.

Description

PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.

Time Frame

Day 1 pre and post intervention

Title

Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.

Description

PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.

Time Frame

7-10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M Boland, PT, DPT, PhD

Organizational Affiliation

Assistant Professor, Army-Baylor Doctoral Program in PT

Official's Role

Principal Investigator

Facility Information:

Facility Name

AMEDD Center & School

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18923311

Citation

Walker MJ, Boyles RE, Young BA, Strunce JB, Garber MB, Whitman JM, Deyle G, Wainner RS. The effectiveness of manual physical therapy and exercise for mechanical neck pain: a randomized clinical trial. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2371-8. doi: 10.1097/BRS.0b013e318183391e.

Results Reference

background

PubMed Identifier

21529779

Citation

O'Leary S, Cagnie B, Reeve A, Jull G, Elliott JM. Is there altered activity of the extensor muscles in chronic mechanical neck pain? A functional magnetic resonance imaging study. Arch Phys Med Rehabil. 2011 Jun;92(6):929-34. doi: 10.1016/j.apmr.2010.12.021. Epub 2011 May 6.

Results Reference

background

PubMed Identifier

23849933

Citation

Schomacher J, Falla D. Function and structure of the deep cervical extensor muscles in patients with neck pain. Man Ther. 2013 Oct;18(5):360-6. doi: 10.1016/j.math.2013.05.009. Epub 2013 Jul 12.

Results Reference

background

PubMed Identifier

20634268

Citation

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.

Results Reference

background

PubMed Identifier

23684553

Citation

Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.

Results Reference

background

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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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