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

NCT04571827 | Completed

• 1 other identifier: Expectative Influence
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Placebo Effect; Pain Intensity; Disability; Dry Needling

Keywords

placebo effect; Dry Needling; diffuse noxious inhibitory control; Myalgia

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (7)

• Neck Disability Index

  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

• STAI (State-Trait Anxiety)

  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

• Beck II (Depression)

  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

• PCS (Pain Catastrophizing Scale)

  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

• TSK (Tampa Scale for Kinesiophobia)

  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

Study Arms (3)

Placebo Effect

EXPERIMENTAL

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.

Other: Dry Needling

Nocebo Effect

EXPERIMENTAL

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.

Other: Dry Needling

Neutral Effect

EXPERIMENTAL

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.

Other: Dry Needling

Interventions

Dry Needling OTHER

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.

Neutral Effect; Nocebo Effect; Placebo Effect

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Eleuterio A Sánchez

Madrid, 28670, Spain

Location

Related Publications (1)

• 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.

  PMID: 33921101 DERIVED

MeSH Terms

Conditions

Pain; Myalgia

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Josué Fernández Carnero, PhD

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

• Eleuterio A Sánchez Romero, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Orofacial Pain AND Craniomandibular Disorders / Invasive Techniques in Physical Therapy / Orthopedic Manual Physical Therapist ( PT, MSc, PhD) International Doctorate

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: October 1, 2020
• Study Start: October 1, 2020
• Primary Completion: November 9, 2020
• Study Completion: December 2, 2020
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

ES (1)