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Completed

NCT Number: NCT02569281

US-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain

Scientific evidence of conservative management of subacromial pain syndrome is conflicting. There is evidence that eccentric exercise programs are effective at medium term for this pain condition. The inclusion of other therapeutic modalities is still controversial. A recent study suggests that the inclusion of US-guided percutaneous electrolysis combined with eccentric exercises can be effective at short-term for this condition. The objective of this randomized clinical trial is to determine the effectiveness at short- and long-term of the inclusion of US-guided percutaneous electrolysis (EPE®) into a eccentric exercise protocol for the management of patients with subacromial pain syndrome for pain, function, disability and pressure pain sensitivity.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28921, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • unilateral shoulder complaints with duration of at least 3 months;
  • an intensity of at least 4 on an 11-point numerical pain rating scale (NPRS) during arm elevation;
  • a positive painful arc test during abduction
  • at least one positive of the following tests: Hawkins-Kennedy test, Neer's sig, empty can test, drop arm or lift-off test

Exclusion criteria

  • bilateral shoulder symptoms
  • younger than 18 or older than 65 years
  • history of shoulder fractures or dislocation
  • cervical radiculopathy
  • previous interventions with steroid injections
  • fibromyalgia syndrome
  • previous history of shoulder or neck surgery
  • any type of intervention for the neck-shoulder area during the previous year

Treatment and study plan

US-guided percutaneous electrolysis

Other

US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon.

Eccentric exercise

Other

An eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles will be learned by the patients allocated to this group

Primary outcomes

  1. Changes in disability before and after the intervention

    Time frame: Baseline, one week after the last session, 3 months and 6 months after the last session

    The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain

Secondary outcomes

  1. Changes in pain intensity before and after the intervention

    Time frame: Baseline, one week after the last session, 3 months and 6 months after the last session

    A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area.

  2. Changes in functionality before and after the intervention

    Time frame: Baseline, one week after the last session, 3 months and 6 months after the last session

    The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain

  3. Changes in pressure pain sensitivity before and after the intervention

    Time frame: Baseline, one week after the last session, 3 months and 6 months after the last session

    Pressure pain thresholds will be assessed over the cervical spine, the hand, the deltoid muscle and the tibialis muscle

  4. Self-perceived improvement

    Time frame: Baseline, one week after the last session, 3 months and 6 months after the last session

    A Global Rating of Change (GROC) from -7 (a very great deal worse) to +7 (a very great deal better) will be used to assess self-perceived improvement

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Effectiveness of the Inclusion of US-guided Percutaneous Electrolysis (EPE®) in Subacromial Pain Syndrome

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 6, 2015
Registry last updated
Oct 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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