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Completed

NCT Number: NCT04695548

Physiotherapy in the Reduction of Post-needling Soreness

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.

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Key information

Conditions

Dry Needling Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Myofascial Pain Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Soreness, Muscle Trigger Point Pain, Myofascial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical University Physiotherapy and pain

Alcalá de Henares, Madrid, 2805, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Concentric contraction exercise

Other

The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds

Other names: Muscle concentric contraction

Isometric contraction exercise

Other

The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds

Other names: Muscle isometric contraction

Eccentric contraction exercise

Other

The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of asking the participant to lower their shoulder, against the resistance of the elastic band, in a slow and controlled manner for 5 seconds.

Other names: Muscle eccentric contraction

Analytic passive stretching

Other

The patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds.

Other names: Muscle passive stretching

Primary outcomes

  1. Post-needling soreness intensity

    Time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.

    The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.

Secondary outcomes

  1. Pain Catastrophizing

    Time frame: Change from Baseline Pain Catastrophizing at 72 hours.

    This scale is a Likert-type questionnaire with 5 levels (0-4) that includes 13 items that measure 3 dimensions of catastrophism: magnification, rumination and despair. The Spanish version of this scale has shown to have an appropriate internal consistency, test-retest reliability and sensitivity to changes.

  2. Fear of Pain.

    Time frame: Change from Baseline Fear of Pain at 72 hours.

    Fear of Pain Questionnaire. This scale is a Likert-type questionnaire with 5 levels (1-5) with 3 lists of 10 sub-items that contemplate 3 different aspects of fear of pain: fear of mild pain, fear of severe pain, fear of pain related to the area doctor. The Spanish version of this scale has shown to have an acceptable validity and reliability.

  3. Pain Anxiety Symptoms

    Time frame: Change from Baseline Pain Anxiety at 72 hours.

    The Pain Anxiety Symptoms Scale. This Likert-type questionnaire with 6 levels (0-5) includes 20 items that measure 4 dimensions of pain anxiety: cognitive anxiety, escape / avoidance, fear and physiological anxiety. The Spanish version of this scale has been shown to have appropriate validity and reliability

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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