Effectiveness of Two Electrotherapy Techniques to Treat Subacromial Impingement Syndrome

NCT02110030 | Completed

• 1 other identifier: UCJC-13
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The investigators aimed to compare the effectiveness of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IC) to improve shoulder functionality and to reduce perceived pain in patients with subacromial impingement syndrome (SIS). Design: Thirty-six patients with unilateral shoulder pain and diagnosed as having SIS were randomly assigned into two groups: TENS (n=18; 51±7 years) and IC (n=18; 47±6 years). Patients in both groups received fifteen 30-min sessions of the assigned treatment for a period of 3 weeks. Before and after the treatment, shoulder pain was measured using a 100-mm visual analog scale and shoulder functionality was measured using the Constant-Murley scale.

Conditions

Subacromial Impingement Syndrome

Keywords

Transcutaneous electrical nerve stimulation (TENS); Ultrasound; Interferential current therapy; Rehabilitation; Shoulder pain

Outcome Measures

Primary Outcomes (2)

• Shoulder functionality

  Functional status in the shoulder joint was evaluated by using the Constant-Murley scale. This scale is valid to assess the overall functionality of a normal, a diseased or a treated shoulder. In this scale, 35% of the total value was allocated from subjective assessments of pain (20%) and self-evaluation of activities of daily living (15%; including shoulder pain during sleeping, dysfunction during free time or sports and dysfunction during working activities). The remaining 65% of the total value came from objective measures of range of movement and shoulder strength. Shoulder functionality was measured by using a 0-100 point scale. The pre-to-post treatment shoulder evaluation was performed by the same independent experimenter using the same instruments.

  Before and after the 3 weeks of electrotherpy treatment

• Shoulder pain

  Shoulder pain was evaluated before and the day after the end of treatments by using a 100 mm visual analog pain scale.

  Before and after the 3 weeks of electrotherpy treatment

Study Arms (2)

Transcutaneous nerve stimulation

EXPERIMENTAL

The group with transcutaneous nerve stimulation (TENS) received electrical stimulation for 15 sessions at a frequency of 80 Hz and with a pulse width of 150 ns. The group with TENS received electrical stimulation by using an approved electrotherapy device (Endomed 182, Enraf-nonius, Germany). The TENS was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: supraspinatus fossa and the insertion of the rotator cuff (channel 1) and "V" deltoid " (channel 2).

Device: Transcutaneous nerve stimulation

Interferential Currents

ACTIVE COMPARATOR

The group with Interferential Currents (IC) received a base frequency of 4000 Hz by using the same approved electrotherapy device than the TENS group (Endomed 182, Enraf-nonius, Germany).

Device: Interferential Currents

Interventions

Transcutaneous nerve stimulation DEVICE

The group with TENS received electrical stimulation (Endomed 182, Enraf-nonius, Germany) at a frequency of 80 Hz and with a pulse width of 150 ns. The TENS was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: supraspinatus fossa and the insertion of the rotator cuff (channel 1) and "V" deltoid " (channel 2). The current intensity was set 3 times during each session according to each patient's sensitivity. Current was strong but it did not exceed the threshold of pain.

Also known as: TENS

Transcutaneous nerve stimulation

Interferential Currents DEVICE

The group with IC received a base frequency of 4000 Hz (Endomed 182, Enraf-nonius, Germany) with an amplitude-modulated frequency (AMF) and slope of 1/1 in tetrapolar mode, as previously indicated. For IC, the same number and type of surface electrodes (5x5 cm Prim-Trode, Spain) were placed onto the anterior and posterior deltoid, supraspinatus fossa and "V" deltoid. Similarly, the intensity of the current was set 3 times per session and the stimulation was strong but comfortable (without exceeding the threshold of pain).

Also known as: IC

Interferential Currents

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects for this study were recruited from a waiting list from patients with acute shoulder pain at the Almendrales Medicine and Physiotherapy Center (Madrid, Spain).
• To be included in the list they had to be older than 18 years and have had unilateral shoulder pain for more than 1 month.
• Potential participants were then examined by an independent specialist and the diagnosis of SIS was made according to the Hawkins and Jobe tests.

You may not qualify if:

• The following participants were excluded from the investigation: individuals with rotator cuff tears or calcification; individuals with the presence of acute trauma; patients who were receiving treatment for their shoulder pain with another method; patients with previous surgery or intra-articular injections; individuals with contraindications against electrotherapy

Sponsors & Collaborators

• Camilo Jose Cela University: lead
• Public Health Service of Madrid: collaborator

Study Sites (1)

Health Center Almendrales

Madrid, 28926, Spain

Location

Related Publications (1)

• Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.

  PMID: 18218327 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Juan Del Coso, PhD

  Camilo Jose Cela University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 10, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

ES (1)