Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Real Dry Needling
Sham Dry Needling
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Neck Ache, Cervicalgia, Cervicodynia, Neckache, Cervical Pain, Dry Needling
Eligibility Criteria
Inclusion Criteria:
- Pain in the neck area, including the upper trapezius muscle;
- At least one active TrP (i.e., TrP which referred pain is able to reproduce the patient symptoms in the upper trapezius)
- Ability to read and understand Spanish
- Self-reported Intensity of pain rating on the 0-10 NPRS for the neck-shoulder region is 3 or greater
- Ability to understand, write, and speak Spanish fluently
Exclusion Criteria:
- Neurological symptoms or signs compatible with cervical radiculopathy or myelopathy
- Cervical trauma
- Systemic diseases
- Pregnancy
- Psychiatric problems
- Fear of needles.
Sites / Locations
- Universidad Complutense de Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Dry Needling
Sham Dry Needling
Arm Description
One single session of DN
One single session of Sham DN
Outcomes
Primary Outcome Measures
Skin Conductance
Measured in the hand of the needled upper trapezius. Measured in microsiemens.
Secondary Outcome Measures
Pressure Pain Sensitivity
Measurement of pressure pain threshold in C5-C6 zygapophyseal joints, dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of index finger and and the tibialis anterior muscle.
Pressure Pain Stimuli for Temporal Summation
Measurement of pressure pain stimuli until reach a 6 points in the numeric pain rating scale in the interphalangeal joint of index finger.
Temporal Summation
Pain response using a numeric pain rating scale will be assessed to pressure stimuli. Series of brief contacts (10 stimuli) of pressure pain threshold will be applied dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of the index finger.
Conditioned Pain Modulation (CPM)
CPM will be tested using the lower extremity submaximal effort tourniquet test. Pressure pain threshold (PPT) was assessed using algometry at the dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint at the index finger. After determining the pressure pain threshold (PPT) baseline, the conditioning stimulus was induced using a modified submaximal effort tourniquet procedure.Subjects verbally rated their leg pain until 6 was reached. Although the tourniquet remained inflated, PPT algometry assessment was performed in the same location as previously described (kg/cm2)
Temporal Summation during conditioned stimuli.
Pain response using a numeric pain rating scale with a 10 scores (0-No pain - 10 The worst pain) will be assessed to pressure stimuli. Series of brief contacts (10 stimuli) of pressure pain threshold will be applied dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of the index finger using a lower extremity submaximal effort tourniquet test
Pain Intensity (Numeric Pain Rating Scale)
Pain intensity measured with a 10 scores (0 - No pain - 10 The worst pain) numeric scale
Neck Pain-related Disability
The Northwick Park Neck Pain (NPQ) assess pain related disability by measuring pain and limitations in the daily activities
Global Rating of Change Scale (GRoC)
The patients answered about their perception of improvement during the treatment period on a scale ranging from -7 (a very great deal worse) to zero (about the same) to 7 (a very great deal better).
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK-11) was used to evaluate fear of movement and avoidance. Range from 11 to 44 points.
Pain Catastrophizing
Pain catastrophizing scale (PCS) is a 12-item questionnaire with three components of catastrophizing: magnification, rumination, and helplessness (ranging from 0-52)
Pain Intensity during Intervention (Numeric Pain Rating Scale)
Pain intensity of the intervention was measured on a 10 points numeric pain rating scale (NPRS), 0 (no pain) to 10 (worst pain),
Full Information
NCT ID
NCT05391568
First Posted
May 17, 2022
Last Updated
June 21, 2022
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05391568
Brief Title
Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain
Official Title
Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain. A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain in the neck is a musculoskeletal disorder that affects many individuals. Dry needling has shown an effective technique for the treatment of shoulder and neck disorders. The mechanisms of action of the dry needling are not well-known. This study aims to evaluate the effects of dry needling in the upper trapezius on the autonomic nervous system and nociceptive pain processing in patients with non-specific neck pain.
Hypothesis: Dry needling applied in the upper trapezius in patients with non-specific neck pain produced greater activation of the autonomic nervous system and nociceptive pain processing than sham dry needling.
Detailed Description
A randomized, double-blind, placebo-controlled clinical trial, using Dry Needling (DN). DN is a technique to treat musculoskeletal pain and physical impairment that consists of introducing needling filaments in the muscle trigger points.
Study Aims:
Aim #1: The primary aim of the study is to compare the effect (during the technique and five minutes after intervention) of a single session of DN on autonomic nervous system as measured by skin conductance in patients with non-specific neck pain with random assignment to two treatments: DN or Sham DN
Aim #2: The secondary aim of the study is to compare the immediate effect on pain sensitivity as measured by pressure pain threshold, activation of descending inhibition pain pathways as measured by temporal summation and conditioned pain modulation in patients with non-specific neck pain with random assignment to two treatments: DN and Sham DN.
Aim #3: The secondary aim of the study is to compare the immediate effect on intensity of pain as numeric pain rating scale (NPRS), relating pain disability (Northwick Park Neck Pain Questionnaire), fear-avoidance of movement (Tampa Scale for Kinesiophobia) and Catastrophizing (Pain Catastrophizing Scale)
Aim #4: The secondary aim of the study is to correlate effects between clinical and other variables.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Ache, Cervicalgia, Cervicodynia, Neckache, Cervical Pain, Dry Needling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
One single session of DN
Arm Title
Sham Dry Needling
Arm Type
Sham Comparator
Arm Description
One single session of Sham DN
Intervention Type
Other
Intervention Name(s)
Real Dry Needling
Intervention Description
Needle will be placed at trapezius muscle. "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle.
Intervention Type
Other
Intervention Name(s)
Sham Dry Needling
Intervention Description
Sham needle will be placed at trapezius muscle. Simulated "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle.
Primary Outcome Measure Information:
Title
Skin Conductance
Description
Measured in the hand of the needled upper trapezius. Measured in microsiemens.
Time Frame
Through study completion, an average of 20 minutes
Secondary Outcome Measure Information:
Title
Pressure Pain Sensitivity
Description
Measurement of pressure pain threshold in C5-C6 zygapophyseal joints, dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of index finger and and the tibialis anterior muscle.
Time Frame
Baseline; Immediate (10 minutes after intervention)
Title
Pressure Pain Stimuli for Temporal Summation
Description
Measurement of pressure pain stimuli until reach a 6 points in the numeric pain rating scale in the interphalangeal joint of index finger.
Time Frame
Baseline; Immediate (10 minutes after intervention)
Title
Temporal Summation
Description
Pain response using a numeric pain rating scale will be assessed to pressure stimuli. Series of brief contacts (10 stimuli) of pressure pain threshold will be applied dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of the index finger.
Time Frame
Baseline; Immediate (10 minutes after intervention)
Title
Conditioned Pain Modulation (CPM)
Description
CPM will be tested using the lower extremity submaximal effort tourniquet test. Pressure pain threshold (PPT) was assessed using algometry at the dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint at the index finger. After determining the pressure pain threshold (PPT) baseline, the conditioning stimulus was induced using a modified submaximal effort tourniquet procedure.Subjects verbally rated their leg pain until 6 was reached. Although the tourniquet remained inflated, PPT algometry assessment was performed in the same location as previously described (kg/cm2)
Time Frame
Baseline; Immediate (10 minutes after intervention)
Title
Temporal Summation during conditioned stimuli.
Description
Pain response using a numeric pain rating scale with a 10 scores (0-No pain - 10 The worst pain) will be assessed to pressure stimuli. Series of brief contacts (10 stimuli) of pressure pain threshold will be applied dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of the index finger using a lower extremity submaximal effort tourniquet test
Time Frame
Baseline; Immediate (10 minutes after intervention)
Title
Pain Intensity (Numeric Pain Rating Scale)
Description
Pain intensity measured with a 10 scores (0 - No pain - 10 The worst pain) numeric scale
Time Frame
Baseline; one week after intervention
Title
Neck Pain-related Disability
Description
The Northwick Park Neck Pain (NPQ) assess pain related disability by measuring pain and limitations in the daily activities
Time Frame
Baseline; one week after intervention
Title
Global Rating of Change Scale (GRoC)
Description
The patients answered about their perception of improvement during the treatment period on a scale ranging from -7 (a very great deal worse) to zero (about the same) to 7 (a very great deal better).
Time Frame
One week after intervention
Title
Kinesiophobia
Description
The Tampa Scale for Kinesiophobia (TSK-11) was used to evaluate fear of movement and avoidance. Range from 11 to 44 points.
Time Frame
Baseline; one week after intervention
Title
Pain Catastrophizing
Description
Pain catastrophizing scale (PCS) is a 12-item questionnaire with three components of catastrophizing: magnification, rumination, and helplessness (ranging from 0-52)
Time Frame
Baseline; one week after intervention
Title
Pain Intensity during Intervention (Numeric Pain Rating Scale)
Description
Pain intensity of the intervention was measured on a 10 points numeric pain rating scale (NPRS), 0 (no pain) to 10 (worst pain),
Time Frame
Baseline; immediate (ten minutes after intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pain in the neck area, including the upper trapezius muscle;
At least one active TrP (i.e., TrP which referred pain is able to reproduce the patient symptoms in the upper trapezius)
Ability to read and understand Spanish
Self-reported Intensity of pain rating on the 0-10 NPRS for the neck-shoulder region is 3 or greater
Ability to understand, write, and speak Spanish fluently
Exclusion Criteria:
Neurological symptoms or signs compatible with cervical radiculopathy or myelopathy
Cervical trauma
Systemic diseases
Pregnancy
Psychiatric problems
Fear of needles.
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain
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