- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05137106
Assessment of Effectiveness of Dry Needling for Treating Shoulder Pain
Assessment of Effectiveness of Dry Needling for Treating Shoulder Pain: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Santa Fe
-
Rosario, Santa Fe, Argentina, 2000
- University of Gran Rosario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with unilateral shoulder pain
- Glenohumeral internal rotation deficit
- Presence of active myofascial trigger point in the infraspinatus muscle
Exclusion Criteria:
- Previous surgery in the upper limb
- Previous physiotherapy treatments in the shoulder
- Dry needling contraindications
- Previous dry needling experience to mantain the blinding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Dry Needling
Active dry needling (ADN).
Intramuscular insertion Intervention/treatment.
All participants in this group received an ADN session with an intramuscular insertion of a 25 mm X 0.22 mm JEMCO acupuncture needle into the infraspinatus muscle.
The dry needling was performed with the rapid entry and exit technique.
|
All participants in this group received an ADN session with an intramuscular insertion of a 25 mm X 0.22 mm acupuncture needle into the infraspinatus muscle.
The dry needling was performed with the rapid entry and exit technique.
|
Sham Comparator: Sham Dry needling
Sham dry needling (SDN).
All participants in this group received one session of SDN with a 25 mm X 0.22 mm JEMCO acupuncture needle over the infraspinatus region.
To ensure that the blunt needles did not puncture the skin during the experimental session (and for patient comfort), each needle was individually cut and polished and checked for sharpness against the investigator's fingertip.
As a precaution against infection, each patient was treated with a separate dummy needle.
|
All participants in this group received one session of SDN with a 25 mm X 0.22 mm acupuncture needle over the infraspinatus region.
To ensure that the blunt needles did not puncture the skin during the experimental session (and for patient comfort), each needle was individually cut and polished and checked for sharpness against the investigator's fingertip.
As a precaution against infection, each patient was treated with a separate dummy needle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain intensity
Time Frame: At baseline, immediately after the intervention, 72 hours after the intervention
|
The Visual Analogue Scale (VAS) was used to assess pain intensity.
This scale consists of a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
|
At baseline, immediately after the intervention, 72 hours after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pressure Pain Threshold
Time Frame: At baseline, immediately after the intervention, 72 hours after the intervention
|
Pressure Pain Thresholds (PPT) were quantified bilaterally through a pressure algometer at the medial portion of the infraspinatus muscle and at the medial portion of the deltoid muscle.
Three measurements were taken at intervals of 30 seconds and the mean value was recorded.
To determine PPT, the pressure was increased at a rate of approximately 1 kg/second.
Patients were asked to raise their arm when they perceived the pressure changing to pain, stopping the estimation at this point.
|
At baseline, immediately after the intervention, 72 hours after the intervention
|
Changes in Range of motion
Time Frame: At baseline, immediately after the intervention, 72 hours after the intervention
|
The examiners assessed both shoulder's internal rotation range of motion with an inclinometer.
|
At baseline, immediately after the intervention, 72 hours after the intervention
|
Changes in EMG activity
Time Frame: At baseline, immediately after the intervention, 72 hours after the intervention
|
Electrical activity from infraspinatus and deltoid muscles was recorded using surface electromyography (sEMG).
The signal was normalized using the maximal isometric voluntary contraction (MIVC).
The sEMG data were collected during a shoulder elevation task.
Electrode placement, data collection and processing were performed according to Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles standards.
|
At baseline, immediately after the intervention, 72 hours after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Gran Rosario
- Reference number 19/17 (Registry Identifier: Ethics Committee for Research in Humans of the Instituto Universitario Italiano de Rosario)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Shoulder Pain
-
Mohamed R El TahanCompletedUnilateral Chronic Shoulder Pain | Bilateral Chronic Shoulder PainEgypt
-
Uşak UniversityCompleted
-
National Taiwan University HospitalMinistry of Science and Technology, Taiwan; National Health Research Institutes...RecruitingRehabilitation | Pain, Chronic | Pain, ShoulderTaiwan
-
Helping Hand Institute of Rehabilitation SciencesRecruitingShoulder Injuries | Shoulder Capsulitis | Shoulder Arthritis | Shoulder Impingement | Shoulder Bursitis | Shoulder Pain ChronicPakistan
-
University of Southern DenmarkRegion of Southern Denmark; The Danish Rheumatism Association; Esbjerg MunicipalityCompletedHypermobility Syndrome Shoulder | Shoulder Pain ChronicDenmark
-
University of Southern DenmarkRegion of Southern Denmark; The Danish Rheumatism Association; Esbjerg Municipality and other collaboratorsCompletedHypermobility Syndrome Shoulder | Shoulder Pain Chronic | Shoulder LuxationDenmark
-
Gramercy Pain CenterRecruiting
-
Assiut UniversityCompletedChronic Shoulder PainEgypt
-
Oslo Metropolitan UniversityOslo University Hospital; Diakonhjemmet Hospital; Keele University; National Institute...Completed
-
Bursa Yüksek İhtisas Education and Research HospitalCompleted
Clinical Trials on Active Dry Needling
-
Federal University of Health Science of Porto AlegreCompleted
-
Brigham Young UniversityUnknownMyofascial Pain Syndrome | Myofascial Trigger Point PainUnited States
-
Army-Baylor University Doctoral Program in Physical...Brooke Army Medical CenterCompletedChronic Pain | Shoulder Pain | Musculoskeletal InjuryUnited States
-
Youngstown State UniversityRecruiting
-
Universidad de ZaragozaCompleted
-
Institute of Technology, CarlowCompleted
-
Universidad de ZaragozaUnknownHip OsteoarthritisSpain
-
Universitat Internacional de CatalunyaRecruitingMyofascial Trigger Point PainSpain
-
University of HaifaCompleted
-
Texas Woman's UniversityActive, not recruitingShoulder Pain | Dry NeedlingUnited States