The Effect of Dry Needling at the Thoracolumbar Junction on Measures of Sympathetic Outflow and Local and Remote Muscular Flexibility in Subjects With Low Back Pain and Decreased Hamstring Length
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nova Southeastern University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Pressure pain threshold
Study Overview
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.
Detailed Description
Although DN is being used more often in treatment of musculoskeletal disorders, there continues to be little agreement about the pathways on which it works. Research on the neurophysiological effects of DN has increased in the past 10 years, however much about the treatment is still poorly understood. A better understanding of the neurophysiological mechanisms on which DN acts, and how it influences structures distant from the site of treatment, can lead to improved choices of therapeutic activities, and potentially superior outcomes.
Many studies have investigated the effects of joint mobilization or manipulation on the sympathetic nervous system (SNS), but fewer studies have investigated the effects of DN. Of the studies on joint mobilization, a large percentage examined treatment to the cervical spine, specifically C5, and tested SNS-related outcomes in the cervical spine, upper thoracic spine, and upper extremities (UEs). The sympathetic nerve fibers that supply the lower extremities (LEs) originate from T10-L2, and future research should investigate the effects on the LE when its direct sympathetic connection is treated.
At this time, there is minimal research on manual therapy treatment to the thoracolumbar (TL) spine and its effect on the LEs. The thoracic spine is the origin of nearly all SNS outflow to the extremities, and should therefore not be overlooked as a potentially "silent" contributor to musculoskeletal dysfunction in the extremities.
The goals of this study are:
- To quantify the magnitude of the SNS response to DN at the TL junction in subjects with low back pain and decreased hamstring length, using valid measures of SNS activity.
- To describe the effect of DN at the TL junction on muscle length both local and remote to the site of treatment.
- To determine if DN to the TL junction has a significantly greater segmental sympatho-excitatory effect than extrasegmental effect, as measured by pressure-pain threshold (PPT) in the LE and UE.
- To determine if immediate changes in SNS activity after DN are related to clinically meaningful outcomes at 24-hour follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
- •BMI greater than 30 kg/m2
Arms & Interventions
Dry Needling Group
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.
Intervention: Dry needling (Procedure)
Sham Needling Group
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.
Intervention: Dry needling (Procedure)
Outcomes
Primary Outcomes
Pressure pain threshold
Time Frame: 24 hours after dry needling or sham condition
measured via Wagner algometer in kg/cm\^2 in upper and lower extremity
Pressure pain threshold
Time Frame: immediately before dry needling or sham condition
measured via Wagner algometer in kg/cm\^2 in upper and lower extremity
Pressure pain threshold
Time Frame: immediately following dry needling or sham condition
measured via Wagner algometer in kg/cm\^2 in upper and lower extremity
Secondary Outcomes
- Fingertip to Floor(24 hours after dry needling or sham condition)
- Oswestry Disability Index(24 hours after dry needling or sham condition)
- Straight Leg Raise(24 hours after dry needling or sham condition)
- Heart Rate Variability(24 hours after dry needling or sham condition)
- Electrodermal Activity(24 hours after dry needling or sham condition)
- Skin Temperature(24 hours after dry needling or sham condition)
- Numeric Pain Rating Scale(24 hours after dry needling or sham condition)
- Knee Extension(24 hours after dry needling or sham condition)
- Global Rating of Change(24 hours after dry needling or sham condition)
- Fingertip to Floor(immediately before dry needling or sham condition)
- Knee Extension(immediately after dry needling or sham condition)
- Oswestry Disability Index(immediately before 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)
- Straight Leg Raise(immediately before dry needling or sham condition)
- Straight Leg Raise(immediately after dry needling or sham condition)
- Knee Extension(immediately before dry needling or sham condition)
- Fingertip to Floor(immediately after dry needling or sham condition)
- Electrodermal Activity(immediately before dry needling or sham condition)
- Electrodermal Activity(immediately after dry needling or sham condition)
- Skin Temperature(immediately before dry needling or sham condition)
- Skin Temperature(immediately after dry needling or sham condition)
- Heart Rate Variability(immediately before dry needling or sham condition)
- Heart Rate Variability(immediately after dry needling or sham condition)