Dry Needling at the Thoracolumbar Junction on Measures of Sympathetic Outflow and Flexibility

NCT03630172 | Completed

• 1 other identifier: 2018-289-Non-NSU Health
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Dry needling (DN) is becoming more frequently performed by physical therapists around the world to treat musculoskeletal pain. Dry needling is a form of trigger point therapy that evolved from using injections of local anesthetics. Although dry needling is becoming more commonly used, there is little agreement on how it works. Researchers have focused their efforts investigating other forms of manual therapy until very recently. To date, no studies have looked at how dry needling effects muscles distant from the area being treated. Most of the body's sympathetic nervous system (fight or flight response) is located in the thoracic spine, it may be a "silent" contributor to musculoskeletal problems in the arms and legs. The purpose of this study is to determine how dry needling the thoracolumbar junction affects pain, flexibility, and other non-invasive measures of nervous system output in people who have low back pain and tightness of their hamstring muscles. Standard dry needling treatment will be compared with a placebo. The investigators hypothesize that dry needling will have a greater sympathetic nervous system response, as measured by changes in heart rate, skin temperature and skin conductance, when compared with the placebo. The investigators also hypothesize that dry needling will have a greater positive effect on flexibility of the low back and hamstring muscles when compared to the placebo.

Conditions

Low Back Pain

Keywords

low back pain; dry needling; flexibility; sympathetic nervous system

Outcome Measures

Primary Outcomes (3)

• Pressure pain threshold

  measured via Wagner algometer in kg/cm\^2 in upper and lower extremity

  immediately before dry needling or sham condition

• Pressure pain threshold

  measured via Wagner algometer in kg/cm\^2 in upper and lower extremity

  immediately following dry needling or sham condition

• Pressure pain threshold

  measured via Wagner algometer in kg/cm\^2 in upper and lower extremity

  24 hours after dry needling or sham condition

Secondary Outcomes (24)

• Oswestry Disability Index

  immediately before dry needling or sham condition

• Oswestry Disability Index

  24 hours after dry needling or sham condition

• Numeric Pain Rating Scale

  immediately before dry needling or sham condition

• Numeric Pain Rating Scale

  immediately after dry needling or sham condition

• Numeric Pain Rating Scale

  24 hours after dry needling or sham condition

Study Arms (2)

Dry Needling Group

EXPERIMENTAL

Dry needles will be sterile, and 0.30 x 60mm in gauge and length. Needles will be placed using an inferomedial approach with the subject positioned in prone. The needle is inserted perpendicular to the skin and then is guided inferiorly and medially until it reaches the lamina. Needles will be manipulated in a "pistoning" fashion for 15 seconds.

Procedure: Dry needling

Sham Needling Group

SHAM COMPARATOR

Non-penetrating needles were constructed by cutting 100mm needles where the handle meets the shaft, and sanding down any rough edges. Guide tubes from 40mm needles will be used. These needles will be place in the same location and manipulated in the same fashion as in the dry needling group, except the needles will not have penetrated the skin.

Procedure: Dry needling

Interventions

Dry needling PROCEDURE

Using a thin, filiform needle to penetrate a muscle and its trigger point to produce a local twitch response

Dry Needling Group; Sham Needling Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low Back Pain
• decreased flexibility greater than or equal to 15 degrees of at least one hamstring, as measured by KE
• Age 18-70 years

You may not qualify if:

• Local skin lesion, local or systemic infection
• Previous treatment of DN to any body part
• History of abnormal bleeding
• Presence of radicular symptoms
• Prescription anticoagulant therapy
• Autoimmune disease, central nervous system disorder, or diabetes
• Previous surgery to lumbar spine
• Inability to read and understand English, or cognitive impairment that would limit the ability to give consent.
• Pregnancy
• BMI greater than 30 kg/m2

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Sports and Orthopaedic Therapy Services, LLC

Kensington, Maryland, 20895, United States

Location

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MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Nicole G Clark, MSPT

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Random assignment will occur using opaque envelopes. The primary investigator (who is also the care provider) will select an envelope when a subject arrives. The research assistant, who will be blinded to group allocation, will take the pre and post intervention measurements. The primary investigator will be blinded to the pre and post intervention measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomly assigned to one of two dry needling conditions: dry needling or placebo.

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 14, 2018
• Study Start: September 15, 2018
• Primary Completion: August 10, 2019
• Study Completion: August 10, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)