Clinical trial NCT05593848: Intratissue Percutaneous Electrolysis vs Dry Needling in Myofascial Pain Syndrome of Shoulder Pain
Official title: Comparative Study of the Effects of Intratissue Percutaneous Electrolysis vs. Dry Needling in the Treatment of Myofascial Pain Syndrome in Subjects With Non-specific Shoulder Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Myofascial Pain Syndrome
Keywords: Intratissue Percutaneous Electrolysis
Dry Needling
Myofascial trigger points
infraspinatus muscle
non-specific shoulder pain
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a parallel-group randomised clinical trial:

Primary purpose: To analyse the clinical changes produced by two different physiotherapy treatments (Intratissue Percutaneous Electrolysis and Dry Needling) for myofascial trigger points in the infraspinatus muscle in subjects with non-specific shoulder pain.

Hypothesis: A physiotherapy treatment including Intratissue Percutaneous Electrolysis therapy present greater benefits in terms of pain reduction and increased mobility and functionality rather than Dry Needling treatment in subjects with non-specific shoulder pain.

The intervention consisted of 3 treatment sessions, different according to the group, once a week. Seven evaluation points were performed, two pre-intervention evaluations one week apart and after the second one the first treatment session was performed. The third and fourth assessments were prior to the second and third treatment sessions, one week apart. The fifth, sixth and seventh assessments were conducted one week, one month and two months after the last treatment session in each group.


Eligibility criteria: Inclusion Criteria:

* Both male and female patients suffering from shoulder pain during at least three months before intervention protocol starts.
* Patients with free passive range of movement and at least 15 degrees active external rotation in the affected shoulder.
* Patients willing to participate in the study and return for all scheduled follow-up visits.
* Patient is capable of giving, and has given, written informed consent.

Exclusion Criteria:

* Patients with a previous medical diagnosis (tendon rupture, bursitis, etc.) or a traumatic history that justifies shoulder pain.
* Patients with unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias.
* Patients allergic to metal or those who have needle phobia.
* Patient that has participated in any other shoulder pain treatment research study within 30 days prior.
* Patients that had prior shoulder surgery.
* Patients that are currently being treated with a narcotic or NSAIDs and/or has used analgesics or NSAIDs within the 72 hours prior.
* Patients that has a known bleeding disorder or that are currently being treated with anticoagulant therapy.
* Pregnant women.

Primary outcomes:
measure: Changes in Pain intensity, before, during and after the intervention
timeFrame: 4 months (7 points)
Secondary outcomes:
measure: Changes in Shoulder flexion range of motion, before, during and after the intervention
timeFrame: 4 months (7 points)
measure: Changes in Shoulder external rotation range of motion, before, during and after the intervention
timeFrame: 4 months (7 points)
measure: Changes in Pressure pain threshold at proximal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention
timeFrame: 4 months (7 points)
measure: Changes in Pressure pain threshold at distal myofascial trigger point of the infraspinatus muscle, before, during and after the intervention
timeFrame: 4 months (7 points)
measure: Changes in Strength in shoulder external rotation before, during and after the intervention
timeFrame: 4 months (7 points)
measure: Changes in Hand grip strength, before, during and after the intervention
timeFrame: 4 months (7 points)
measure: Changes in Disability and functionality of the upper limb, before, during and after the intervention
timeFrame: 4 months (7 points)
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University of Salamanca
Study officials:
affiliation: University of Salamanca
name: Roberto Méndez-Sánchez
role: PRINCIPAL_INVESTIGATOR
References: