The Patient Expectation in Dry Needling and Analgesia

NCT ID: NCT03673319

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2019-07-31

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Positive expectative

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"

Group Type: EXPERIMENTAL

Dry needling with positives expectation

Intervention Type: 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"

Neutral expectatives

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"

Group Type: EXPERIMENTAL

Dry needling with neutral expectation

Intervention Type: PROCEDURE

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

Interventions

Dry needling with positives expectation

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

Dry needling with neutral expectation

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Daniel Pecos Martín

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Pecos-Martin, Phd

Role: PRINCIPAL_INVESTIGATOR

Alcala University

Locations

Institut Physiotherapy AND pain

Alcalá de Henares, Madrid, Spain

Grupo Fisioterapia y Dolor

Alcalá de Henares, Madrid, Spain

Countries

Spain

Other Identifiers

CEI18/087

Identifier Type: -

Identifier Source: org_study_id