NCT01073956

Brief Summary

The purpose of this study is to determine the efficacy of electrotherapy as a coadjuvant in mobility and exercise treatment in the reduction of pain intensity in subacromial impingement syndrome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

11 months

First QC Date

February 22, 2010

Last Update Submit

July 6, 2011

Conditions

Shoulder Impingement Syndrome

Keywords

Subacromial Impingement SyndromeShoulder PainPhysical therapyElectrotherapyUltrasonic therapyMedium-wave 448 kHz therapy

Outcome Measures

Primary Outcomes (1)

  • Variation of pain intensity

    Evaluation after 12 sessions of intervention (1 month)

    12 sessions (1 month)

Secondary Outcomes (2)

  • Variation at pain intensity

    18 sessions (1.5 months)

  • Variation at pain intensity

    6 months after intervention

Study Arms (3)

Inactive electrotherapy

PLACEBO COMPARATOR

Inactive electrotherapy is applied to the painful points

Procedure: Inactive electrotherapy

Ultrasound

ACTIVE COMPARATOR

Ultrasound electrotherapy is applied to the painful points

Procedure: Ultrasonic therapy

Monopolar radiofrequency

ACTIVE COMPARATOR

Monopolar radiofrequency electrotherapy is applied to the painful points

Procedure: Medium-wave 448 kHz therapy

Interventions

Medium-wave 448 kHz therapyPROCEDURE

0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove

Also known as: Monopolar radiofrequency
Monopolar radiofrequency
Ultrasonic therapyPROCEDURE

Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove

Also known as: Ultrasound electrotherapy
Ultrasound
Inactive electrotherapyPROCEDURE

Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.

Inactive electrotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over 18 years of age
  • Shoulder pain secondary to subacromial impingement syndrome
  • Pain at rest and/or with free movement and/or with movement against resistance with a score on the visual analogue scale of 3 or higher.
  • Documented X-ray (XR), ultrasound (US) and/or magnetic resonance imaging (MRI) evidence of cuff injury involving oedema, tendonitis, fibrosis or torn tendon.
  • Potentially available for the next six months.

You may not qualify if:

  • Documented US and/or MRI evidence of complete tearing of the cuff and clinical inability to lift the arm (drop arm sign)
  • Radiological findings of tumour lesions, avascular necrosis, glenoid development defects, acromial bone, severe degenerative signs affecting inter-articular space and fractures
  • Limited range of passive movement with capsular pattern
  • Recent history of trauma (contusion, falls or sudden jarring)
  • Ischaemic cardiopathy in subacute phase
  • History of more than five infiltrations and/or shoulder surgery
  • History of rehabilitation treatment for the same reason in the last 12 months
  • Cognitive deficit, psychiatric alterations or behavioural disorders that might compromise the patient's collaboration
  • Unsuitable for electrotherapy: pregnancy, epilepsy, pacemaker, osteosynthesis, undergoing treatment with Sintrom
  • Patients in litigation or in the process of making work-related claims
  • Failure to understand Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto de Rehabilitación Tres Torres -IR3T

Barcelona, Barcelona, 08017, Spain

Location

Centro de Recuperación Funcional (CRF)

Barcelona, Barcelona, 08037, Spain

Location

Related Publications (1)

  • Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.

    PMID: 12804509BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Officials

  • Conxita Closa, MD

    Corporación Fisiogestión S.A.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2011

Study Completion

December 1, 2011

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

ES(2)