Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05137106 |
Other study ID # |
University of Gran Rosario |
Secondary ID |
Reference number |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2018 |
Est. completion date |
March 1, 2021 |
Study information
Verified date |
November 2021 |
Source |
University of Gran Rosario |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to evaluate the effects of active dry needling (aDN) in the treatment
of myofascial trigger points of the infraspinatus muscle (MTP). For this purpose, this
technique was compared to placebo dry needling (pDN) for short-term pain relief and increased
glenohumeral internal rotation range. The second objective is to explore whether improvements
in perceived pain and functional capacity correlate with changes in electromyographic
activity.
Description:
This study is a randomized, double-blind, placebo-controlled clinical trial comprising a
sample of 30 volunteers with unilateral shoulder pain of both sexes, aged 18 to 35 years.
They were clinically evaluated to assess inclusion and exclusion criteria. For inclusion in
the study, volunteers had unilateral shoulder pain for more than 3 months and were
symptomatic at the time of evaluation. The volunteers were randomized into two groups (G1:
active dry needling) versus (G2: placebo dry needling). The procedure was performed by one
investigator, while outcome measures (pressure pain thresholds, VAS, glenohumeral internal
rotation deficit, and muscle activity) were assessed by other investigators, ensuring a
double-blinded evaluation of the experiment. Volunteers were recruited through social
networks and emails. The study was conducted in two experimental sessions on separate days,
at least 48-72 hours apart to avoid carry-over effects. Primary and secondary outcomes were
assessed at baseline, immediately after and 48-72 hours after dry needling.
Assessment of infraspinatus and middle deltoid muscle activity was performed by
electromyography (EMG). For the EMG protocol, the patient remained standing while holding a
distal load, the magnitude of which depended on the patient's weight. In patients weighting
less than 68 kg, a load of 1.5 kg was used; those weighting more than 68 kg lifted 2.5 kg.
After a brief familiarization period, patients were asked to perform 5 repetitions of
shoulder elevation in a scapular plane with external rotation and elbow extended, ranging
from 30° to 90°. EMG recordings were taken during the ascent and descent, with a duration of
3 seconds at each stage. The movement was synchronized using a metronome so that there was as
little variability as possible between participants.
The study is original and there are no previously published data available. Thus, data
obtained from the pilot study were used for sample size calculation. The variable with the
lowest coefficient of determination (R-squared) was considered as a primary outcome (pain
perceived by visual analog scale), and applied as input for the calculation. The analysis was
performed with an effect size of 0.76, an alpha of 5% and a power of 95%. The results
indicated that a total of 22 volunteers were needed. Assuming a loss of 20%, each group
consists of 14 volunteers (with a total sample of 28 volunteers). The sample calculation was
performed using the G-Power 3.1.9.7 software.
The study was pre registered in the brazilian database (www.ensaiosclinicos.gov.br) before
starting data collection, although identifier were not provided.