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

NCT02415660 | Completed

• 1 other identifier: 404153-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 NDI from baseline to 2-3 days

• 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 NDI at 7-10 days

Secondary Outcomes (10)

• Change in Numeric Pain Rating Scale (NPRS)

  Change in pain from baseline to 2-3 days

• Change in Numeric Pain Rating Scale (NPRS)

  7-10 days

• Global Rate of Change (GRC)

  2-3 days

• Global Rate of Change (GRC)

  7-10 days

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

  Day 1 pre and post intervention

Study Arms (2)

SMT and TDN

EXPERIMENTAL

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; Procedure: Trigger point dry needling; Behavioral: Cervical range of motion exercises; Behavioral: Posterior neck muscle activation exercise; Device: Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm

SMT and Sham TDN

SHAM COMPARATOR

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; Behavioral: Cervical range of motion exercises; Behavioral: Posterior neck muscle activation exercise; Procedure: Trigger point dry needling sham

Interventions

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

SMT and Sham TDN; SMT and TDN

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.

SMT and TDN

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.

SMT and Sham TDN; SMT and TDN

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.

SMT and Sham TDN; SMT and TDN

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.

SMT and Sham TDN

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)

SMT and TDN

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

AMEDD Center & School

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (5)

• 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.

  PMID: 18923311 BACKGROUND

• 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.

  PMID: 21529779 BACKGROUND

• 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.

  PMID: 23849933 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 23684553 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• David M Boland, PT, DPT, PhD

  Assistant Professor, Army-Baylor Doctoral Program in PT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Army-Baylor Doctoral Program in PT

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 14, 2015
• Study Start: June 1, 2016
• Primary Completion: March 3, 2020
• Study Completion: August 1, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)