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Assessment of Effectiveness of Dry Needling for Treating Shoulder Pain

Primary Purpose

Chronic Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Active Dry Needling
Sham Dry needling
Sponsored by
University of Gran Rosario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Shoulder Pain

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Gran Rosario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Dry Needling

Sham Dry needling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Pain intensity
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".

Secondary Outcome Measures

Change in Pressure Pain Threshold
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.
Changes in Range of motion
The examiners assessed both shoulder's internal rotation range of motion with an inclinometer.
Changes in EMG activity
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.

Full Information

First Posted
November 10, 2021
Last Updated
November 23, 2021
Sponsor
University of Gran Rosario
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1. Study Identification

Unique Protocol Identification Number
NCT05137106
Brief Title
Assessment of Effectiveness of Dry Needling for Treating Shoulder Pain
Official Title
Assessment of Effectiveness of Dry Needling for Treating Shoulder Pain: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gran Rosario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Active Dry Needling Sham Dry Needling
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participants and Outcomes Assessor)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Dry Needling
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Dry needling
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active Dry Needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain intensity
Description
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".
Time Frame
At baseline, immediately after the intervention, 72 hours after the intervention
Secondary Outcome Measure Information:
Title
Change in Pressure Pain Threshold
Description
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.
Time Frame
At baseline, immediately after the intervention, 72 hours after the intervention
Title
Changes in Range of motion
Description
The examiners assessed both shoulder's internal rotation range of motion with an inclinometer.
Time Frame
At baseline, immediately after the intervention, 72 hours after the intervention
Title
Changes in EMG activity
Description
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.
Time Frame
At baseline, immediately after the intervention, 72 hours after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Gran Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Assessment of Effectiveness of Dry Needling for Treating Shoulder Pain

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