Blinding and Previous Experiences of Dry Needling
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Placebo needle
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Dry needling, Placebo, Myofascial pain syndrome, Blinding
Eligibility Criteria
Inclusion Criteria:
- Non-specific mechanical neck pain of at least 3 months of duration
- Between 18-60 years old
- At least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms
Exclusion Criteria:
- whiplash injury;
- previous cervical or thoracic surgery;
- cervical radiculopathy or myelopathy;
- diagnosis of fibromyalgia syndrome;
- having undergone physical therapy in the previous 6 months;
- fear to needles
Sites / Locations
- Gracia Gallego-Sendarrubias
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DN group
Placebo needle
Arm Description
The intervention group will receive real dry needling (DN) (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle.
The placebo group will receive sham needling in an active MTrP within the upper trapezius muscle. A sham needle will be used as placebo. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin.
Outcomes
Primary Outcome Measures
Changes in Neck Pain Intensity between baseline and follow-up periods
The intensity of neck pain at rest and during active movement of the cervical spine in rotation will be assessed with a visual analogue scale (VAS).
Identification (blinding) of the needling intervention
Participants will be asked directly after the intervention whether they thought they had received a real intervention or a sham. Answering categories were: 'yes' (real DN) or 'no' (sham DN).
Secondary Outcome Measures
Changes in Pressure pain sensitivity between baseline and follow-up periods
Pressure pain thresholds (PPT) will be assessed at the upper trapezius muscle, spinous process of C7 and distant pain-free area of the lower extremity (heel)
Changes in patients self-perceived improvement between baseline and follow-up periods
Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better).
Descriptors of worsening or improving are assigned with values ranging from -1 to -7 and +1 to +7, respectively
Full Information
NCT ID
NCT03592095
First Posted
June 2, 2018
Last Updated
December 10, 2020
Sponsor
European University of Madrid
1. Study Identification
Unique Protocol Identification Number
NCT03592095
Brief Title
Blinding and Previous Experiences of Dry Needling
Official Title
Blinding of Dry Needling Technique Based on Previous Experiences: A Double-blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European University of Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Dry needling (DN) is a treatment technique widely used in patients with various musculoskeletal health problems due to myofascial trigger points (MTrP). DN has shown to have positive effect on pain and function in patients with mechanical neck pain. These positive results are thought to be the consequence of specific neurophysiological and mechanical processes. Research has shown that DN induces 1) end plate inhibition, 2) reduction of inflammatory substances, 3) increase of blood flow and oxygen and 4) a reduction of nociceptive afferent activity. However, the exact working mechanisms underlying DN effects is still a topic of debate. This trial addresses one of the major methodological issues in needle testing,the effects of proper blinding. DN is a specific technique that is not easily be replaced by another comparable intervention. A sham needle with a blunt tip was created that simulates penetration into the skin without actually doing so. Research about a valid method for the control in needling studies is for this reason of particular relevance. A proper blinding technique is of importance to further the field of DN.
Detailed Description
The objectives of this study are to analysize short-term effects on pain intensity and pressure pain sensitivity according to previous experience (blinding) in subjects with mechanical neck pain receiving real or sham-DN and to determine the success in masking DN versus sham DN in patients with mechanical neck pain based on prior experience with this technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Dry needling, Placebo, Myofascial pain syndrome, Blinding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DN group
Arm Type
Experimental
Arm Description
The intervention group will receive real dry needling (DN) (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle.
Arm Title
Placebo needle
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive sham needling in an active MTrP within the upper trapezius muscle. A sham needle will be used as placebo. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin.
Intervention Type
Device
Intervention Name(s)
Dry needling
Intervention Description
Real dry needling will be conducted according to Hong description, fast-in and fast-out interventions. The intervention will be applied until a total of four local twitch responses will be elicited
Intervention Type
Device
Intervention Name(s)
Placebo needle
Intervention Description
Sham dry needling with be conducted with a sham needle (Steitberger's Park sham device (PSD). This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient.
Primary Outcome Measure Information:
Title
Changes in Neck Pain Intensity between baseline and follow-up periods
Description
The intensity of neck pain at rest and during active movement of the cervical spine in rotation will be assessed with a visual analogue scale (VAS).
Time Frame
Baseline, inmediately after and 1 week after intervention
Title
Identification (blinding) of the needling intervention
Description
Participants will be asked directly after the intervention whether they thought they had received a real intervention or a sham. Answering categories were: 'yes' (real DN) or 'no' (sham DN).
Time Frame
Inmediately after intervention
Secondary Outcome Measure Information:
Title
Changes in Pressure pain sensitivity between baseline and follow-up periods
Description
Pressure pain thresholds (PPT) will be assessed at the upper trapezius muscle, spinous process of C7 and distant pain-free area of the lower extremity (heel)
Time Frame
Baseline, inmediately after and 1 week after intervention
Title
Changes in patients self-perceived improvement between baseline and follow-up periods
Description
Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better).
Descriptors of worsening or improving are assigned with values ranging from -1 to -7 and +1 to +7, respectively
Time Frame
Baseline and 1 week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-specific mechanical neck pain of at least 3 months of duration
Between 18-60 years old
At least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms
Exclusion Criteria:
whiplash injury;
previous cervical or thoracic surgery;
cervical radiculopathy or myelopathy;
diagnosis of fibromyalgia syndrome;
having undergone physical therapy in the previous 6 months;
fear to needles
Facility Information:
Facility Name
Gracia Gallego-Sendarrubias
City
Madrid
State/Province
Rest Of The World
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Blinding and Previous Experiences of Dry Needling
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