The Patient Expectation in Dry Needling and Analgesia

NCT03673319 | Completed

• 1 other identifier: CEI18/087
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline at after intervention

Secondary Outcomes (3)

• Pain Pressure Threshold (PPT)

  Change up 1 hour

• Dry needling pain

  Change up 1 hour

• Dry needling anxiety

  Change up 1 hour

Study Arms (2)

Positive expectative

EXPERIMENTAL

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"

Procedure: Dry needling with positives expectation

Neutral expectatives

EXPERIMENTAL

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"

Procedure: Dry needling with neutral expectation

Interventions

Dry needling with positives expectation PROCEDURE

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"

Positive expectative

Dry needling with neutral expectation PROCEDURE

DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"

Neutral expectatives

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (2)

Institut Physiotherapy AND pain

Alcalá de Henares, Madrid, 28805, Spain

Location

Grupo Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28871, Spain

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Daniel Pecos-Martin, Phd

  Alcala University

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: October 4, 2018
• Primary Completion: April 30, 2019
• Study Completion: July 31, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)