Efficacy of Electrotherapy in Subacromial Impingement Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Fundacio Espai Salut.
Recruitment status was  Active, not recruiting
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

February 22, 2010
July 6, 2011
February 2010
January 2011   (final data collection date for primary outcome measure)
Variation of pain intensity [ Time Frame: 12 sessions (1 month) ] [ Designated as safety issue: Yes ]
Evaluation after 12 sessions of intervention (1 month)
Same as current
Complete list of historical versions of study NCT01073956 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy of Electrotherapy in Subacromial Impingement Syndrome
Efficacy of Electrotherapy in Subacromial Impingement Syndrome: Randomised Placebo-controlled Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Shoulder Impingement Syndrome
  • Procedure: Medium-wave 448 kHz therapy
    0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove
    Other Name: Monopolar radiofrequency
  • Procedure: Ultrasonic therapy
    Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove
    Other Name: Ultrasound electrotherapy
  • Procedure: Inactive electrotherapy
    Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.
  • Placebo Comparator: Inactive electrotherapy
    Inactive electrotherapy is applied to the painful points
    Intervention: Procedure: Inactive electrotherapy
  • Active Comparator: Ultrasound
    Ultrasound electrotherapy is applied to the painful points
    Intervention: Procedure: Ultrasonic therapy
  • Active Comparator: Monopolar radiofrequency
    Monopolar radiofrequency electrotherapy is applied to the painful points
    Intervention: Procedure: Medium-wave 448 kHz therapy
Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;(2):CD004258. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
92
December 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01073956
FES-2009-01
Not Provided
Conxita Closa Rusinés, Corporación Fisiogestión
Fundacio Espai Salut
  • Corporación Fisiogestión S.A.
  • Hospital Clinic of Barcelona
  • Agència d'Avaluació de Tecnologia i Recerca Mèdiques (AATRM)
Principal Investigator: Conxita Closa, MD Corporación Fisiogestión S.A.
Fundacio Espai Salut
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP