AzTrials
AzTrials

Subacromial Impingement SyndromeTENSICNCT02110030

Effectiveness of Two Electrotherapy Techniques to Treat Subacromial Impingement Syndrome

A study testing Transcutaneous nerve stimulation and Interferential Currents in people with Subacromial Impingement Syndrome, run by Camilo Jose Cela University at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Subacromial Impingement Syndrome
What is being tested?
Transcutaneous nerve stimulation and Interferential Currents
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteSpain
Study dates
Apr 2014to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • The use of X-ray, ultrasonography and magnetic resonance imaging permitted objective diagnoses of shoulder impingement syndrome and the exclusion of patients with other shoulder pathologies.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Health Center Almendrales

    Madrid, 28926

Other trials in Spain

About this study

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.

Read the detailed description

Subjects

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. The use of X-ray, ultrasonography and magnetic resonance imaging permitted objective diagnoses of SIS and the exclusion of patients with other shoulder pathologies. With these inclusion criteria, a total of 63 patients were recruited for the experiment. 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 SIS with another method; patients with previous surgery or intra-articular injections; individuals with contraindications against electrotherapy. Ethical approval for this experiment was previously obtained by the local Institutional Review and all participants signed an informed consent prior to enrolling in the investigation.

Treatment groups

The experimental design was a randomized and double-blind clinical trial. After preliminary examination, the patients were randomly assigned into two groups: transcutaneous electrical nerve stimulation (TENS) and interferential currents (IC). A set of sealed and sequentially numbered opaque envelopes was used for group assignment. The study was double-blind because the examiner had no contact with the patient during the duration of the treatment and patients were not informed about the electrotherapy technique they received during the investigation.

Intervention

For both experimental groups, the treatments were applied over a period of 3 weeks, including a total of 15 sessions (approximately 5 sessions per week). In each session, the electrical stimulation technique was administered for 30 minutes while the subjects were comfortable seated in an adjustable chair. 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. 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). The treatments were administered by an experienced physiotherapist blinded to the aim of this investigation.

Outcome measurements

Shoulder pain was evaluated before and the day after the end of treatments by using a 100 mm visual analog pain scale. Functional status in the shoulder joint was evaluated two days before, after 8 sessions of treatment and the day after the end of the treatment 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. Within the objective evaluation, the range of motion during internal and external rotation, arm flexion and lateral elevation (all measured by using an inclinometer) amounted to 10% each of the total score. Strength was measured using the muscular balance system by Daniels30 and counted for 25% of the total score. Thus, a young and healthy patient can have a maximal punctuation of 100 points. The pre-to-post treatment shoulder evaluation was performed by the same independent experimenter using the same instruments. This experimenter was blinded to the treatment assigned to each participant.

Statistical analysis

All the data were analyzed using SPSS v.20 statistical package. Descriptive statistics were calculated for each group (mean and standard deviation). Normality was tested with the Shapiro-Wilk test. All the variables presented a normal distribution in this test (P > 0.05). Baseline characteristics were compared using the analysis of variance (ANOVA) for measuring independent data. Pre-to-post treatment data and the comparison between groups were performed by using two-way ANOVA (group x time). After a significant F test, differences between means were identified using Tukey's HSD post hoc procedure. The level of significance was established at P < 0.05.

Being tested
Transcutaneous nerve stimulation, Interferential Currents
Keywords
Transcutaneous electrical nerve stimulation (TENS), Ultrasound, Interferential current therapy, Rehabilitation, Shoulder pain
Medical subject headings
Shoulder Impingement Syndrome, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous nerve stimulationDevice

    Also called TENS

    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.

  • Interferential CurrentsDevice

    Also called IC

    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).

Study groups in NCT02110030
Study groupRoleWhat they receive
Transcutaneous nerve stimulationExperimentalThe 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).
Receives: Device: Transcutaneous nerve stimulation
Interferential CurrentsActive comparatorThe 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).
Receives: Device: Interferential Currents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before and after the 3 weeks of electrotherpy treatment

  2. Shoulder pain

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

    Measured: Before and after the 3 weeks of electrotherpy treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionMay 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02110030
Sponsor's protocol ID
UCJC-13
Acronym
TENSIC
Status last verified
Jul 2019
First submitted
4 Apr 2014
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18218327

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous nerve stimulation and Interferential Currents in people with Subacromial Impingement Syndrome, run by Camilo Jose Cela University at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder functionality (time frame: Before and after the 3 weeks of electrotherpy treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02110030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in