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The Patient Expectation in Dry Needling and Analgesia

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling with positives expectation
Dry needling with neutral expectation
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • neck pain (≥3 months of duration)
  • VAS of 4-5 of pain.
  • Presence of at least one active MTrP located at the upper trapezius.

Exclusion Criteria:

  • Patients with previous cervical spine or shoulder surgery.
  • Cervical spine radiculopathy or myelopathy.
  • Systemic disease.
  • Fibromyalgia.
  • Pregnancy.
  • Using sedative drugs.
  • Needle phobia.
  • Bleeding disorder.
  • anticoagulant medication.
  • Previous experience with DN for myofascial pain.
  • Skin lesion and infection or inflammatory oedema at the MTrPs site

Sites / Locations

  • Grupo Fisioterapia y Dolor
  • Institut Physiotherapy AND pain

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Positive expectative

Neutral expectatives

Arm Description

Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"

Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"

Outcomes

Primary Outcome Measures

Pain Intensity: Visual Analog Scale (VAS)
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's current pain before, during DN and immediately after DN. We will follow the paradigm of Conditioned pain modulation (CPM) paradigm. CPM will be induced by inflating an occlusion cuff (conditioning stimulus) at the arm, at the opposite side from the affected upper trapezius.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain"(the best value) and the other end representing "worst pain" (the worse value). Subjects will be asked to rate their current pain with a mark on the scale.

Secondary Outcome Measures

Pain Pressure Threshold (PPT)
The PPT serves to determine the sensitivity of hiperalgesic focus. The investigators will done it with one algometer. Lower values are a worse result. Higher values are a better result.
Dry needling pain
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's pain during DN intervention.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" (the best value) and the other end representing "worst pain" (the worse value). Subjects will be asked to rate their current dry needling pain with a mark on the scale.
Dry needling anxiety
The investigators use a Visual Analog Scale (VAS) to determine the anxiety of the patient during DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no anxiety"(the best value) and the other end representing "worst anxiety"(the worse value). Subjects were asked to rate their current dry needling anxiety with a mark on the scale

Full Information

First Posted
September 13, 2018
Last Updated
August 14, 2019
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT03673319
Brief Title
The Patient Expectation in Dry Needling and Analgesia
Official Title
The Influence of Patient Expectation in Dry Needling Induced Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

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
This study will evaluate placebo mechanisms related to dry needling(DN) trying to determinate whether an additive effect occurs when DN is provided with an instructional set known to enhance placebo analgesia. External manipulation of patient expectation for receiving DN will be performed, in a similar way as has been already done in studies investigating the influence of expectation on spinal manipulative therapy interventions. The main purpose of this study will be therefore to determine, for the first time, how subjects' expectation about the effect of DN influences the resultant hypoalgesia. Analgesic effects of DN will be assessed using the conditioned pain modulation (CPM) paradigm, which has not been previously evaluated in relation to DN.
Detailed Description
Just before DN intervention, participants will receive a positive or a neutral expectation instructional set regarding effects of a DN technique on pain perception. This instructional set will be randomly allocated to each patient. Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain". Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain". DN intervention An experienced and trained physical therapist will provide DN to all the subjects. This researcher will be blinded to the specific expectation instructional set the participant receives. Participants will receive one session of DN treatment for the active Myofascial Trigger Points(MTrP) located at the upper trapezius muscle. They will be placed in a prone position on the examination table. Solid filament needles of 0.30 mm diameter and 40 mm length will be used. The needle will be inserted into the skin over the palpated MTrP using pincer palpation, and slowly advanced perpendicularly until it reaches the MTrP and a twitch response is elicited.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive expectative
Arm Type
Experimental
Arm Description
Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"
Arm Title
Neutral expectatives
Arm Type
Experimental
Arm Description
Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"
Intervention Type
Procedure
Intervention Name(s)
Dry needling with positives expectation
Intervention Description
DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"
Intervention Type
Procedure
Intervention Name(s)
Dry needling with neutral expectation
Intervention Description
DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"
Primary Outcome Measure Information:
Title
Pain Intensity: Visual Analog Scale (VAS)
Description
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's current pain before, during DN and immediately after DN. We will follow the paradigm of Conditioned pain modulation (CPM) paradigm. CPM will be induced by inflating an occlusion cuff (conditioning stimulus) at the arm, at the opposite side from the affected upper trapezius.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain"(the best value) and the other end representing "worst pain" (the worse value). Subjects will be asked to rate their current pain with a mark on the scale.
Time Frame
Change from Baseline at after intervention
Secondary Outcome Measure Information:
Title
Pain Pressure Threshold (PPT)
Description
The PPT serves to determine the sensitivity of hiperalgesic focus. The investigators will done it with one algometer. Lower values are a worse result. Higher values are a better result.
Time Frame
Change up 1 hour
Title
Dry needling pain
Description
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's pain during DN intervention.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" (the best value) and the other end representing "worst pain" (the worse value). Subjects will be asked to rate their current dry needling pain with a mark on the scale.
Time Frame
Change up 1 hour
Title
Dry needling anxiety
Description
The investigators use a Visual Analog Scale (VAS) to determine the anxiety of the patient during DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no anxiety"(the best value) and the other end representing "worst anxiety"(the worse value). Subjects were asked to rate their current dry needling anxiety with a mark on the scale
Time Frame
Change up 1 hour

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: neck pain (≥3 months of duration) VAS of 4-5 of pain. Presence of at least one active MTrP located at the upper trapezius. Exclusion Criteria: Patients with previous cervical spine or shoulder surgery. Cervical spine radiculopathy or myelopathy. Systemic disease. Fibromyalgia. Pregnancy. Using sedative drugs. Needle phobia. Bleeding disorder. anticoagulant medication. Previous experience with DN for myofascial pain. Skin lesion and infection or inflammatory oedema at the MTrPs site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martin, Phd
Organizational Affiliation
Alcala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grupo Fisioterapia y Dolor
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain
Facility Name
Institut Physiotherapy AND pain
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IDP does not exist

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The Patient Expectation in Dry Needling and Analgesia

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