NCT Number: NCT07629141
Currently, no previous studies have investigated how the position of a muscle before dry needling may influence the outcome and effectiveness of the treatment.
This study aims to demonstrate whether the position of the upper trapezius muscle during dry needling treatment influences the outcome of that treatment in subjects with neck pain.
A total of 46 participants with chronic neck pain will be recruited and randomly assigned to two groups: a dry needling group with the muscle in a stretched position and a dry needling group with the muscle in a shortened position. A total of two treatment sessions will be performed, separated by a 7-day interval. The primary outcome measure will be the intensity of neck and head pain, measured using the visual analog scale (VAS). Other variables to be measured include the cervical disability index, kinesiophobia, and catastrophizing (using a self-completion questionnaire), as well as participants' expectations and post-needling pain.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Clinical University Physiotherapy and pain, Alcalá de Henares, Madrid, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ten incisions will be made in a posteroanterior direction while the patient lies prone and the muscle is grasped with a pincer grip between the first three fingers. The technique will be applied to the area that is mechanically most hyperalgesic and related to the reproduction of the patient's pain.
Ten incisions will be made in a posteroanterior direction while the patient lies prone and the muscle is grasped with a pincer grip between the first three fingers. The technique will be applied to the area that is mechanically most hyperalgesic and related to the reproduction of the patient's pain.
Time frame: Change from baseline at 3 months
Intensity of neck and head pain: This was measured using the visual analog scale (VAS). It consists of a 10 cm horizontal line, where 0 cm on the left side represents "no pain" and 10 cm on the right side represents "maximum pain." The subject marks a perpendicular line at the point they consider to represent their pain intensity. The examiner then places a millimeter ruler on the scale, assigning a numerical value to the line drawn by the patient. The VAS has proven to be a valid and reliable tool (intraclass correlation coefficient [ICC] 0.71-0.99).
Time frame: Change from baseline at 3 months
The degree of disability associated with neck pain will be measured using the Neck Disability Index (NDI) questionnaire in its Spanish version. The NDI is a 10-item questionnaire, and each item is scored on a scale of 0 to 5 points, with a range of 0 to 50 points. The higher the score, the greater the degree of disability. The NDI has proven to be a reliable tool (ICC 0.98).
Time frame: Change from baseline at 3 months
The Tampa Kinesiophobia Scale (TSK-11) short version will be used to assess fear of movement. It is an 11-item scale rated on a four-point scale ranging from "strongly agree" to "strongly disagree." Scores range from 11 to 44, with higher scores indicating greater fear of movement and/or (re)injury. This questionnaire has demonstrated similar properties to the original TSK scale, proving to be a valid and reliable instrument.
Time frame: Change from baseline at 3 months
Catastrophizing Scale (PCS). The PCS has 13 items scored from 0 to 4 and is composed of three subscales: rumination, magnification, and helplessness. The overall score ranges from 0 to 52. Higher scores indicate a greater degree of pain catastrophizing. A total score >30 represents a clinically significant level of pain catastrophizing. This questionnaire has been shown to be reliable (ICC 0.94).
Time frame: Change from baseline at 3 months
Local twitch response (LTRs). The LTRs produced by needle insertion during dry needling will be counted. LTRs are generally associated with better treatment outcomes. A higher number of LTRs indicates better results, and a lower number of LTRs indicates worse results.
Time frame: Change from baseline mobility at one week after intervention
Flexion, inclination, extension and rotational movement ranges will be measured with a cervical goniometer
Contact information is provided by the study sponsor or research team.
University of Alcala
Other
The Importance of Muscle Position in the Effectiveness of Dry Needling Technique
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