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Efficacy of Electrotherapy in Subacromial Impingement Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Corporación Fisiogestión S.A.
Hospital Clinic of Barcelona
Agència d'Avaluació de Tecnologia i Recerca Mèdiques (AATRM)
Information provided by:
Fundacio Espai Salut
ClinicalTrials.gov Identifier:
NCT01073956
First received: February 22, 2010
Last updated: July 6, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Shoulder Impingement Syndrome
 Procedure: Medium-wave 448 kHz therapy
Procedure: Ultrasonic therapy
Procedure: Inactive electrotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Efficacy of Electrotherapy in Subacromial Impingement Syndrome: Randomised Placebo-controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundacio Espai Salut:

Primary Outcome Measures:
  • Variation of pain intensity [ Time Frame: 12 sessions (1 month) ] [ Designated as safety issue: Yes ]
    Evaluation after 12 sessions of intervention (1 month)


Secondary Outcome Measures:
  • Variation at pain intensity [ Time Frame: 18 sessions (1.5 months) ] [ Designated as safety issue: Yes ]
    Evaluation at 1.5 months

  • Variation at pain intensity [ Time Frame: 6 months after intervention ] [ Designated as safety issue: Yes ]
    Follow-up evaluation


Enrollment: 92
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Inactive electrotherapy
Inactive electrotherapy is applied to the painful points
 Procedure: Inactive electrotherapy
Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.
Active Comparator: Ultrasound
Ultrasound electrotherapy is applied to the painful points
 Procedure: Ultrasonic therapy
Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove
Other Name: Ultrasound electrotherapy
Active Comparator: Monopolar radiofrequency
Monopolar radiofrequency electrotherapy is applied to the painful points
 Procedure: Medium-wave 448 kHz therapy
0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove
Other Name: Monopolar radiofrequency

Detailed Description:

Among the different diagnoses covered by the concept of shoulder pain, the most common is subacromial impingement syndrome, which represents 44%-60% of the total.Specific supervised exercises obtain improvements in the range of movement and muscular function by restoring the shoulder's mobility and stability. Physiotherapeutic options include several electrotherapy techniques.

Ultrasound is no more beneficial than exercise alone. Likewise, the results of some more recent studies evaluating the application of ultrasound alone versus placebo, showed that ultrasound alone in physiotherapy treatment of shoulder pain is only effective in patients with calcific tendonitis of the shoulder. All the authors, however, suggest that effectiveness can vary, depending on application conditions, dosage and timing.

The primary objective of the trial is to analyze the efficacy of electrotherapy treatment (monopolar radiofrequency or ultrasound) coadjuvant to mobility and exercise therapy in the reduction of pain intensity in subacromial impingement syndrome.

The secondary objectives of this study are to determine the differences between three intervention groups: monopolar radiofrequency, ultrasound and inactive radiofrequency, in improvement of performance status, quality of life and global impression of improvement.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073956

Locations
Spain
Centro de Recuperación Funcional (CRF)
Barcelona, Spain, 08037
Instituto de Rehabilitación Tres Torres -IR3T
Barcelona, Spain, 08017
Sponsors and Collaborators
Fundacio Espai Salut
Corporación Fisiogestión S.A.
Hospital Clinic of Barcelona
Agència d'Avaluació de Tecnologia i Recerca Mèdiques (AATRM)
Investigators
Principal Investigator: Conxita Closa, MD Corporación Fisiogestión S.A.
  More Information

Publications:

Responsible Party: Conxita Closa Rusinés, Corporación Fisiogestión
ClinicalTrials.gov Identifier: NCT01073956     History of Changes
Other Study ID Numbers: FES-2009-01
Study First Received: February 22, 2010
Last Updated: July 6, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundacio Espai Salut:
Subacromial Impingement Syndrome
Shoulder Pain
Physical therapy
 Electrotherapy
Ultrasonic therapy
Medium-wave 448 kHz therapy

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013