Assessment of Effectiveness of Dry Needling for Treating Shoulder Pain

NCT ID: NCT05137106

Last Updated: 2021-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-03-01

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.

Conditions

Chronic Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active Dry Needling

Intervention Type: OTHER

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 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.

Group Type: SHAM_COMPARATOR

Sham Dry needling

Intervention Type: OTHER

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.

Interventions

Active Dry Needling

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

Sham Dry needling

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gran Rosario

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Intelangelo

Head of the University Center for Assistance, Teaching and Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Gran Rosario

Rosario, Santa Fe Province, Argentina

Countries

Argentina

Other Identifiers

Reference number 19/17

Identifier Type: REGISTRY

Identifier Source: secondary_id

University of Gran Rosario

Identifier Type: -

Identifier Source: org_study_id