Assessment of Effectiveness of Dry Needling for Treating Shoulder Pain

NCT05137106 | Completed DMC

• 2 other identifiers: University of Gran RosarioReference number 19/17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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".

  At baseline, immediately after the intervention, 72 hours after the intervention

Secondary Outcomes (3)

• Change in Pressure Pain Threshold

  At baseline, immediately after the intervention, 72 hours after the intervention

• Changes in Range of motion

  At baseline, immediately after the intervention, 72 hours after the intervention

• Changes in EMG activity

  At baseline, immediately after the intervention, 72 hours after the intervention

Study Arms (2)

Active Dry Needling

EXPERIMENTAL

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.

Other: Active Dry Needling

Sham Dry needling

SHAM COMPARATOR

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.

Other: Sham Dry needling

Interventions

Active Dry Needling 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.

Active Dry Needling

Sham Dry needling 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.

Sham Dry needling

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with unilateral shoulder pain
• Glenohumeral internal rotation deficit
• Presence of active myofascial trigger point in the infraspinatus muscle

You may not qualify if:

• Previous surgery in the upper limb
• Previous physiotherapy treatments in the shoulder
• Dry needling contraindications
• Previous dry needling experience to mantain the blinding

Sponsors & Collaborators

• University of Gran Rosario: lead

Study Sites (1)

University of Gran Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participants and Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the University Center for Assistance, Teaching and Research

Model Details: Active Dry Needling Sham Dry Needling

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 30, 2021
• Study Start: October 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

AR (1)