Immediate Effect of Dry Needling of the Lumbar Multifidus on Pain Sensitivity In A Healthy Population

NCT05845697 | Completed

• 1 other identifier: IRB202202632
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to test the effects of trigger point dry needling to the low back in a healthy population. The main aims are to answer:

• Is there a change in sensitivity to experimental pain after trigger point dry needling
• To determine if there is an association between demographic and psychological factors and immediate changes in pain sensitivity after receiving trigger point dry needling. Participants will be randomly assigned to one of two groups a dry needling group or a sham dry needling group. The dry needling group will receive trigger point dry needling to the lumbar spine. The sham dry needling group will receive needling to the lumbar spine with a sham needle which does not penetrate the skin. In other words, researchers will compare an intervention group and a sham group to see if dry needling has an immediate change in pain sensitivity in response to experimentally induced pain.

Conditions

Low Back Pain

Keywords

trigger point dry needling; quantitative sensory testing; low back pain

Outcome Measures

Primary Outcomes (6)

• Change in Heat Thermal Pain Threshold degrees Celsius baseline and Heat Thermal Pain Threshold degrees Celsius immediately following intervention

  Participants will indicate when an thermode of ascending temperatures first changes from a sensation of warmth to painful by saying "pain" and indicating the amount of pain with a visual analog scale. This change will be calculated by taking the difference between the two scores.

  Baseline and immediately following the intervention

• Change in Cold Thermal Pain Threshold degrees Celsius baseline and Cold Thermal Pain Threshold degrees Celsius immediately following intervention

  Participants will indicate when an thermode of descending temperatures first changes from a sensation of cold to painful by saying "pain" and indicating the amount of pain with a visual analog scale. This change will be calculated by taking the difference between the two scores.

  Baseline and immediately following the intervention

• Change in Pressure Pain Threshold Kilopascals baseline and Pressure Pain Threshold Kilopascals immediately after following intervention

  Participants will indicate when ascending pressure from an algometer first changes from a sensation of pressure to painful by saying "pain" and indicating the amount of pain with a visual analog scale. This change will be calculated by taking the difference between the two scores.

  Baseline and immediately following the intervention

• Change in baseline Thermal Temporal Summation

  Participants will rate the pain associated with a series of 10 heat pulses applied to the skin on a 0 to 100 numerical rating scale with 0= no pain to 100= worst pain imaginable.

  Baseline and immediately following the intervention

• Change in baseline After sensation

  After sensation is the term used to describe the measurement of pain that remains after a painful stimulus. Participants will rate the pain remaining every 15 seconds for a total of one minute following the final thermal pulse in the Thermal Temporal Summation protocol (as described in outcomes 4). The numeric rating scale is (0 - 100) with "0" being no pain at all and "100" being worst pain imaginable

  Baseline and immediately following the intervention

• Change in baseline Conditioned pain modulation

  Pressure pain threshold will be assessed immediately prior to and following a pain inducing cold water bath immersion. Condition pain modulation will be defined by the changes in pressure pain threshold prior to and immediately following the cold water bath immersion

  Baseline and immediately following the intervention

Secondary Outcomes (3)

• Expectations

  Baseline, immediately following intervention

• Degree to which expectations met

  Immediately following follow pain testing

• Blinding

  Immediately following the assigned intervention

Study Arms (2)

Actual dry needling group

EXPERIMENTAL

Will receive actual dry needling of the lumbar multifidus with a 50-60mm filiform needle

Other: Trigger point dry needling

Sham dry needling group

SHAM COMPARATOR

Will receive needling from a sham needle that is blunted so it does not pierce the skin but has been shown to be valid for being indistinguishable from receiving an actual needle.

Other: Sham dry needling

Interventions

Trigger point dry needling OTHER

Filiform needle that pierces the skin and is inserted into an identified trigger point in the muscle

Actual dry needling group

Sham dry needling OTHER

A validated sham dry needle that is blunted on the end and does not pierce the skin

Sham dry needling group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 - 65
• Be pain-free

You may not qualify if:

• a) Non-English speaker
• b) presence of a medical condition known to affect sensation
• c) history of surgery to the low back
• d) history of blood clotting disorders or medical conditions associated with bleeding disorders
• e) Current use of the medication causing difficulty with clotting (such as blood thinners)
• f) Contraindication to the application of needles including, but not limited to, fear of needles or metal allergy --g) women who are pregnant or planning on becoming pregnant any contraindication to application of ice or cold pack, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Joel Bialosky, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomized control

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 6, 2023
• Study Start: June 3, 2023
• Primary Completion: April 13, 2024
• Study Completion: April 13, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)