Clinical trial NCT03673319: The Patient Expectation in Dry Needling and Analgesia
Official title: The Influence of Patient Expectation in Dry Needling Induced Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Intensity: Visual Analog Scale (VAS)
timeFrame: Change from Baseline at after intervention
Secondary outcomes:
measure: Pain Pressure Threshold (PPT)
timeFrame: Change up 1 hour
measure: Dry needling pain
timeFrame: Change up 1 hour
measure: Dry needling anxiety
timeFrame: Change up 1 hour
Other outcomes:
Locations:
city: Alcala de Henares
country: Spain
facility: Grupo Fisioterapia y Dolor
state: Madrid
city: Alcalá De Henares
country: Spain
facility: Institut Physiotherapy AND pain
state: Madrid
Study officials:
affiliation: Alcala University
name: Daniel Pecos-Martin, Phd
role: PRINCIPAL_INVESTIGATOR
References: