Clinical trial NCT04695548: Physiotherapy in the Reduction of Post-needling Soreness
Official title: Comparison of Isometric, Concentric, Eccentric Exercise and Passive Stretching in the Reduction of Post-needling Soreness in Patients With Cranial and/or Cervical Pain Related to Myofascial Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Needling
Soreness, Muscle
Trigger Point Pain, Myofascial
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2021-01-05
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: Dry needling is a minimally invasive technique which generates good results and neuromuscular benefits. Its application involves a highly prevalent effect called post-needling soreness. It is defined as a residual pain, located in the incision area, with a self-limiting period of 24-72 hours, as a result of a physiological process generated by the technique.

So far, different clinical trials have been carried out to measure the effectiveness of several techniques for reducing post-needling soreness, reaching positive results. However, no studies have been found with the aim of distinguish which method is more effective for this goal; therefore, it is clear the need to continue investigating on the subject and comparing these techniques among them.

Detailed description: Main objective. To figure out if one of the four techniques (isometric, concentric, eccentric contraction exercise and analytic passive stretching) is more effective for reducing post- needling soreness immediately, at 12, 24, 48 and 72 hours.

Objectives. To verify if there is a correlation between independent variables and post-needling soreness.

Study type. Non-blinded randomized clinical trial. Intervention. Dry needling on an active myofascial trigger point in superior trapezius, followed by one of the following treatments according to the specific group: 1) concentric contraction exercise, 2) isometric contraction exercise, 3) eccentric contraction exercise or 4) analytic passive stretching.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years;
* Cervical pain.
* Presence of an active PGM in the upper trapezius muscle.

Exclusion Criteria:

* Traumatic history in the cervical region;
* Inability to understand or perform the required exercises;
* Pregnancy in the first trimester;
* Altered state of coagulation;
* Immunosuppression status;
* State of alteration of sensitivity (e.g. central sensitization processes, fibromyalgia, etc.);
* Unavoidable fear of needles;
* Lack of knowledge about the use of the WhatsApp or Telegram messaging platform

Primary outcomes:
measure: Post-needling soreness intensity
timeFrame: Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.
Secondary outcomes:
measure: Pain Catastrophizing
timeFrame: Change from Baseline Pain Catastrophizing at 72 hours.
measure: Fear of Pain.
timeFrame: Change from Baseline Fear of Pain at 72 hours.
measure: Pain Anxiety Symptoms
timeFrame: Change from Baseline Pain Anxiety at 72 hours.
Other outcomes:
Locations:
city: Alcala de Henares
country: Spain
facility: Clinical University Physiotherapy and pain
state: Madrid
Study officials:
affiliation: Alcala University
name: Daniel Pecos-Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References: