Physiotherapy in the Reduction of Post-needling Soreness
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2021
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedStudy Start
First participant enrolled
February 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJuly 19, 2021
July 1, 2021
2 months
January 2, 2021
July 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Post-needling soreness intensity
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.
Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.
Secondary Outcomes (3)
Pain Catastrophizing
Change from Baseline Pain Catastrophizing at 72 hours.
Fear of Pain.
Change from Baseline Fear of Pain at 72 hours.
Pain Anxiety Symptoms
Change from Baseline Pain Anxiety at 72 hours.
Study Arms (4)
Concentric contraction exercise
EXPERIMENTALAfter applying the dry needling technique to the upper trapezius muscle, 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
Isometric contraction exercise
EXPERIMENTALAfter applying the dry needling technique to the upper trapezius muscle, 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
Eccentric contraction exercise
EXPERIMENTALAfter applying the dry needling technique to the upper trapezius muscle, 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
Analytic passive stretching.
EXPERIMENTALAfter applying the dry needling technique to the upper trapezius muscle, 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.
Interventions
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
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
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.
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.
Eligibility Criteria
You may qualify if:
- Age between 18 and 65 years;
- Cervical pain.
- Presence of an active PGM in the upper trapezius muscle.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical University Physiotherapy and pain
Alcalá de Henares, Madrid, 2805, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Pecos-Martin, PhD
Alcala University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 2, 2021
First Posted
January 5, 2021
Study Start
February 23, 2021
Primary Completion
April 25, 2021
Study Completion
June 30, 2021
Last Updated
July 19, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share