Neck Pain Clinical Trial
Official title:
Effectiveness of Dry Needling on the Upper Trapezius and the Levator Scapulae in Patients With Chronic Neck Pain: Randomized Clinical Trial
The investigators study the efficacy of a combination of dry needling plus manual therapy against sham dry needling plus manual therapy in the treatment of chronic neck pain. The investigators identify the most active trigger point in the upper trapezius and levator scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days after the first intervention. The primary outcome is the Visual Analogue Scale of Pain. Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and range of motion.
A prospective single-blind randomized controlled trial, designed to assess the efficacy of
dry needling in the treatment of chronic neck pain. The treatment regimes simulate the
standard physiotherapy administered in real clinical settings. Patients in the intervention
group receive a combination of manual therapy and dry needling (40mmx0,32 guided needles).
There are two control groups. In the first one, patients receive a combination of manual
therapy and sham dry needling. In the second control group, patients receive no treatment in
order to assess the natural history of the disease.
Patients receive two treatment sessions with an interval of 7 days and are followed up after
30 days. The primary outcome is subjective pain assessed with a Visual Analogue Scale (VAS).
Secondary outcomes are pressure pain threshold (assessed with a manual algometer), neck
range of motion (assessed with a goniometer) and the Neck Disability Index (a standardized
questionnaire). Measurements are taken pre and post-test after the first and the second
treatment sessions, plus once more at the follow-up, except for the Neck Disability Index
(only at the beginning and after the second treatment). In the non-treated group, patients
were measured at the same time intervals.
The sample size was calculated to detect a VAS difference of 2 points, the minimally
clinically important difference established in the literature. Then it was doubled in order
to avoid possible dropouts. The trial takes place in a private practice in Madrid (Physios,
c/Valverde 26). Patients are randomized by a computer program.
Patients are explored for active trigger points in the upper trapezius and the levator
scapulae. They should meet the criteria of identification established by Travell & Simons in
their Trigger point manual. The investigators also seek for trigger points following Travell
& Simons' pain maps for these two muscles, where they identify five trigger point areas. The
investigators select the most active, taking pressure pain threshold measurements of all the
active trigger point, normalizing the values according to normal thresholds for each of the
five areas in the two muscles. The normal thresholds were assessed in a pilot study with
healthy patients. The investigators administer either dry or sham dry needling to the most
active (the one with the lowest pain threshold) throughout the trial.
Dry needling is applied following Hong's technique with 40mmx0,32 guided needles, by a
physiotherapist with 4 years of experience in the technique.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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