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The Influence of Expectations on Post-needling Soreness and Pain Processing After Dry Needling Treatment

Primary Purpose

Placebo Effect, Pain Intensity, Disability

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry Needling
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placebo Effect focused on measuring placebo effect, Dry Needling, diffuse noxious inhibitory control, Myalgia

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Be between 18 and X years of age.
  • Presence of at least one latent myofascial trigger point in the upper trapezius muscle.
  • Patients who speak and understand Spanish correctly.
  • Subjects without previous experience in dry puncture treatment.

Exclusion Criteria:

  • If patients had neurological signs and symptoms.
  • Subjects with a history of trauma, fracture or previous spinal surgery.
  • Subjects with a history of musculoskeletal and/or rheumatological diseases.
  • Unsurpassed fear of needles
  • Coagulation disorders
  • Infiltration of corticosteroids or local anesthetics for one year prior to the study.
  • Taking analgesic or anti-inflammatory medication the week before the study.

Sites / Locations

  • Eleuterio A Sánchez

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Placebo Effect

Nocebo Effect

Neutral Effect

Arm Description

Group with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature" Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced.

Group with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ". Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced.

Group with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects" Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
To evaluate the pain that the patient has, we use the VAS (Appendix 1). This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies. This scale will be used accompanying each CROM measurement as well as in pre-treatment measurements.

Secondary Outcome Measures

Neck Disability Index
It will be used to measure the level of disability perceived by the patient as a result of their neck pain, after performing the technique and to check whether it appears during the control measurements. It is a questionnaire composed of 10 sections on different activities of daily living (ADLs); self-care, reading, lifting weights, driving, sleeping, recreational activities, work, concentration, pain intensity and headache. Each section scores from 0 to 5, with zero being no pain and five being the worst pain imaginable. (Maximum 50 points). Therefore, in order of appearance, of the 6 options, the first option of each item represents 0 and the last one 5. The higher the score obtained, the greater the patient's disability.
STAI (State-Trait Anxiety)
Questionnaire composed of 20 items with 4 points each that evaluate "state anxiety" (transitory emotional condition influenced by environmental factors that decrease or increase anxiety) and another 20 that evaluate "trait anxiety" (personality factor that predisposes to suffer or not suffer anxiety). The 2-part score ranks patients at a percentile to the general population. The higher the score, the greater the anxiety. It is one of the most widely used tools in research to measure levels of general anxiety.
Beck II (Depression)
A 21-item scale used to assess the severity of depression. The patient has to select for each item the response alternative that best reflects his/her state during the last week. The total score is obtained by adding up the values of the selected items, which range from 0 to 3. The commonly accepted cut-off points for grading intensity/severity are as follows: 0 to 9, no depression; 10 to 18, mild depression; 19 to 29, moderate depression, and ≥ 30 points, severe depression.
PCS (Pain Catastrophizing Scale)
It consists of 14 items valued on a 5-point scale. It evaluates the degree to which they have thoughts and feelings when they experience pain.
TSK (Tampa Scale for Kinesiophobia)
17 items, 4 points each where higher scores indicate higher levels of fear of movement.
PASS-20 (Pain Anxiety Symptoms Scale)
It has four 5-item subscales that measure avoidance, fearful thoughts, cognitive and physiological anxiety, and pain responses. Participants rate each item on a 6-point scale ranging from never (0) to always (5).
FPQ-III (Fear of Pain Questionnaire)
It consists of 30 items, each with 5 points that measure fear over specific situations that normally produce pain

Full Information

First Posted
August 30, 2020
Last Updated
April 10, 2022
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04571827
Brief Title
The Influence of Expectations on Post-needling Soreness and Pain Processing After Dry Needling Treatment
Official Title
The Influence of Expectations on Post-needling Soreness and Pain Processing After Dry Needling Treatment: an Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
November 9, 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea 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
The general objective of the study is to determine the effectiveness on local mechanical hypoalgesia, pain intensity, disability and psychological variables of the deep dry needling technique on a latent trigger point of the upper trapezius muscle. The specific objective of the study is to observe the interaction between patient expectations and hypoalgesic effects in patients who will receive the same technique but with different explanations about it before punction and which could influence on the modulation of post-punction pain.
Detailed Description
Study design: A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical trial was conducted, where both the study subject and the researcher performing the measurements do not know which treatment group they belong to. Participants The sample was composed of 42 healthy patients residing in the Community of Madrid, all of whom were recruited personally for the study. All of them will have 15 incisions by dry needling in latent trigger point of the upper trapezium localized by palpation. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand. Patients were randomly assigned using GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 3 study groups. Each group will be given a different sentence: one group will be attempted to influence with positive expectation, another with neutral expectation, and yet another will be attempted to influence with negative expectation. Measurement instruments Measurement of the range of movement by means of an inclinometer. To measure the range of movement the patient will be seated in a chair; feet supported on the floor, triple flexion of lower limbs of 90º (hip, knee and foot), back well supported and straight, head straight and look at the horizon. The inclinometer will be positioned to measure flexion, extension, right and left tilt and right and left rotation. The inclinometer for CROM (cervical range of motion) is approved and validated in different studies. Measurement of pain threshold to pressure A digital algometer was used to measure mechanical hyperalgesia. The model used was the X® brand, consisting of a 1 cm2 cylindrical rubber attached to a pressure gauge. It is calibrated in kilograms (kg) and pounds. The scale expressed in kg/cm2 was used. All patients were familiarized with this test through a trial session. They were instructed to say STOP when the pressure sensation changed to painful. Three perpendicular measurements were made on an active or latent myofascial trigger point situated in upper trapezium muscle, the mean was calculated and the data were recorded for analysis. A rest period of 30 seconds was established between the measurements. A dermographic pencil was used to mark these points prior to measurement. The intra-assay reliability is high in the upper trapezius muscle (ICC = 0.94-0.97). The minimum detectable change (CMD) for considering the results as clinically relevant in the upper trapezius fibres has been shown to be between 0.45 kgf and 1.13 kgf. Procedural protocol Prior to the technique, the patient will be explained that the study seeks to observe if pain appears after the dry needling procedure. During the explanation, the desired expectation will be introduced: Group with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature" Group with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects" Group with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placebo Effect, Pain Intensity, Disability, Dry Needling
Keywords
placebo effect, Dry Needling, diffuse noxious inhibitory control, Myalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Studio design: A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical trial will be carried out in which both the study subject and the researcher who made the measurements do not know which treatment group they belong to. Participants The sample was composed of 42 healthy patients residing in the Community of Madrid, all of whom were personally recruited for the study. All of them will have 15 incisions with dry needles in the latent trigger point of the upper trapezium. All patients will read the information sheet that explains what the study will consist of, as well as the informed consent form, which they will voluntarily sign before the intervention. Each group will be given a different sentence: one group will attempt to influence with a positive expectation, another with a neutral expectation, and yet another will attempt to influence with a negative expectation.
Masking
ParticipantOutcomes Assessor
Masking Description
Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced: Group with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature" Group with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects" Group with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ". Neither the subjects assigned to the groups nor the researchers who measured the variables knew which group they belonged to. Patients will be randomly assigned through GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 3 study groups.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Effect
Arm Type
Experimental
Arm Description
Group with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature" Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced.
Arm Title
Nocebo Effect
Arm Type
Experimental
Arm Description
Group with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ". Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced.
Arm Title
Neutral Effect
Arm Type
Experimental
Arm Description
Group with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects" Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced.
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
Deep dry needling procedure All subjects received a deep dry neddling technique on a latent myofascial trigger point of the upper trapezius muscle by isolating it by a pincer grasp with the thumb and index finger. This myofascial trigger point was previously found following the diagnostic criteria described by Travell & Simons and Fernández-de-las-Peñas et al., and the deep dry needling intervention applied was based on the technique described by Hong. The patients were placed in a prone position. Prior to the technique, the area was disinfected with an antiseptic solution. Fifteen incisions were made with a 0.26x40mm monofilament needle. The number of local twitch response made were noted. After removing the needle, at the end a soft compression was made with a cotton to reduce the possible appearance of bleeding.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
To evaluate the pain that the patient has, we use the VAS (Appendix 1). This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies. This scale will be used accompanying each CROM measurement as well as in pre-treatment measurements.
Time Frame
Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
It will be used to measure the level of disability perceived by the patient as a result of their neck pain, after performing the technique and to check whether it appears during the control measurements. It is a questionnaire composed of 10 sections on different activities of daily living (ADLs); self-care, reading, lifting weights, driving, sleeping, recreational activities, work, concentration, pain intensity and headache. Each section scores from 0 to 5, with zero being no pain and five being the worst pain imaginable. (Maximum 50 points). Therefore, in order of appearance, of the 6 options, the first option of each item represents 0 and the last one 5. The higher the score obtained, the greater the patient's disability.
Time Frame
Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Title
STAI (State-Trait Anxiety)
Description
Questionnaire composed of 20 items with 4 points each that evaluate "state anxiety" (transitory emotional condition influenced by environmental factors that decrease or increase anxiety) and another 20 that evaluate "trait anxiety" (personality factor that predisposes to suffer or not suffer anxiety). The 2-part score ranks patients at a percentile to the general population. The higher the score, the greater the anxiety. It is one of the most widely used tools in research to measure levels of general anxiety.
Time Frame
Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Title
Beck II (Depression)
Description
A 21-item scale used to assess the severity of depression. The patient has to select for each item the response alternative that best reflects his/her state during the last week. The total score is obtained by adding up the values of the selected items, which range from 0 to 3. The commonly accepted cut-off points for grading intensity/severity are as follows: 0 to 9, no depression; 10 to 18, mild depression; 19 to 29, moderate depression, and ≥ 30 points, severe depression.
Time Frame
Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Title
PCS (Pain Catastrophizing Scale)
Description
It consists of 14 items valued on a 5-point scale. It evaluates the degree to which they have thoughts and feelings when they experience pain.
Time Frame
Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Title
TSK (Tampa Scale for Kinesiophobia)
Description
17 items, 4 points each where higher scores indicate higher levels of fear of movement.
Time Frame
Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Title
PASS-20 (Pain Anxiety Symptoms Scale)
Description
It has four 5-item subscales that measure avoidance, fearful thoughts, cognitive and physiological anxiety, and pain responses. Participants rate each item on a 6-point scale ranging from never (0) to always (5).
Time Frame
Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Title
FPQ-III (Fear of Pain Questionnaire)
Description
It consists of 30 items, each with 5 points that measure fear over specific situations that normally produce pain
Time Frame
Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be between 18 and X years of age. Presence of at least one latent myofascial trigger point in the upper trapezius muscle. Patients who speak and understand Spanish correctly. Subjects without previous experience in dry puncture treatment. Exclusion Criteria: If patients had neurological signs and symptoms. Subjects with a history of trauma, fracture or previous spinal surgery. Subjects with a history of musculoskeletal and/or rheumatological diseases. Unsurpassed fear of needles Coagulation disorders Infiltration of corticosteroids or local anesthetics for one year prior to the study. Taking analgesic or anti-inflammatory medication the week before the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josué Fernández Carnero, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eleuterio A Sánchez Romero, PhD
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eleuterio A Sánchez
City
Madrid
ZIP/Postal Code
28670
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33921101
Citation
Sanchez Romero EA, Lim T, Villafane JH, Boutin G, Riquelme Aguado V, Martin Pintado-Zugasti A, Alonso Perez JL, Fernandez Carnero J. The Influence of Verbal Suggestion on Post-Needling Soreness and Pain Processing after Dry Needling Treatment: An Experimental Study. Int J Environ Res Public Health. 2021 Apr 15;18(8):4206. doi: 10.3390/ijerph18084206.
Results Reference
derived

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The Influence of Expectations on Post-needling Soreness and Pain Processing After Dry Needling Treatment

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