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

NCT ID: NCT04571827

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2020-12-02

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 ".

Conditions

Placebo Effect; Pain Intensity; Disability; Dry Needling

Study Design

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

Study Groups

Placebo Effect

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 Type: EXPERIMENTAL

Dry Needling

Intervention Type: 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.

Nocebo Effect

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 Type: EXPERIMENTAL

Dry Needling

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: 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.

Interventions

Dry Needling

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Eleuterio Atanasio Sánchez Romero

Professor Orofacial Pain AND Craniomandibular Disorders / Invasive Techniques in Physical Therapy / Orthopedic Manual Physical Therapist ( PT, MSc, PhD) International Doctorate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josué Fernández Carnero, PhD

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

Eleuterio A Sánchez Romero, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

Eleuterio A Sánchez

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 33921101 (View on PubMed)

Other Identifiers

Expectative Influence

Identifier Type: -

Identifier Source: org_study_id