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Early Mobilization Following Arthroscopic Rotator Cuff Repair

13. oktober 2021 oppdatert av: University of Alberta

Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial

Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation.

This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups:

Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only.

Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery.

Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

211

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2H9
        • Glen Sather Sports Medicine clinic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Patient is over 18 years of age
  2. Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
  3. Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)

Exclusion Criteria:

  1. Patient has a full-thickness tear of the subscapularis and/or teres minor
  2. Patient has undergone previous RC surgery to the affected shoulder
  3. Patient has major joint trauma, infection, or avascular necrosis
  4. Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
  5. Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
  6. Patient has a psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
  7. Patient has a major medical illness where life expectancy is less than 2 years
  8. Patient does not speak/read/understand English
  9. Patient has no fixed address or means of contact
  10. Surgeon or patient has decided to cancel surgery
  11. Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)
  12. Patient unwilling to complete necessary follow-ups

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group A (early ROM)
Group A (early ROM) will use the sling for comfort only
Fremgangsmåte: No Sling
Early range of motion
Aktiv komparator: Group B (usual care)
Group B (usual care) will be immobilized in a sling for 6 weeks.
Fremgangsmåte: Sling
Patients will use the sling for 6 weeks, as per usual care

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Western Ontario Rotator Cuff Index (WORC)
Tidsramme: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Range of Motion (ROM)
Tidsramme: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Measured flexion, abduction, external rotation in 90 degrees abduction [ER(90)], internal rotation in 90 degrees abduction [IR(90)], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout
baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Strength
Tidsramme: Baseline, 6 months, 12 months, 24 months
strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT). Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion. External and internal rotation were measured in 90 degrees of abduction. Peak values were recorded during each contraction which was held for 3 seconds. Values were expressed as raw values.
Baseline, 6 months, 12 months, 24 months
The Short Form (36) Health Survey
Tidsramme: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
The Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health. Each scale ranges between 0 (completely disable) to 100 (completely able).
baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Adverse Events
Tidsramme: 2 weeks, 6 weeks, 3 months, 6months

The following complications were monitored throughout study:

  • Medical related: urinary, gastrointestinal, cardiac, pulmonary, metabolic
  • Surgical related: nerve injury, superficial or deep infection, dislocation, frozen shoulder, hematoma, biceps rupture, failure of tendon healing, dermatitis, reflex sympathetic dystrophy (RSD), persistent pain, re-injury.
  • Other

The surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling).
2 weeks, 6 weeks, 3 months, 6months
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Tidsramme: baseline, 6 weeks, 3, 6, 12, 24 months
Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)
baseline, 6 weeks, 3, 6, 12, 24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alberta

Etterforskere

  • Hovedetterforsker: David Sheps, MD,MSc,FRCSC, University of Alberta

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2011

Primær fullføring (Faktiske)

1. april 2015

Studiet fullført (Faktiske)

2. mai 2018

Datoer for studieregistrering

Først innsendt

8. april 2011

Først innsendt som oppfylte QC-kriteriene

8. april 2011

Først lagt ut (Anslag)

12. april 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RES0005824

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