Recruiting

Frozen Shoulder

Sponsor:

Allevio Pain Management Clinic

Code:

NCT04687735

Conditions

Frozen Shoulder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention after nerve block

Study Details

Brief summary:

The purpose of this study is to evaluate the effect of combination of brachial plexus block plus physical therapy on quality of life improvement in patients with frozen shoulder condition via standard questionnaires.

Conditions

Frozen Shoulder

Study ID

NCT04687735

Start date

Jan 1, 2021

Status verified date

Jan, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosis of unilateral or bilateral frozen shoulder, defined as greater than 50% limitation of passive ROM relative to the non affected side in one or more of three movement directions (i.e., abduction in the frontal plane, forward flexion in the sagittal plane, or external rotation in 0° of abduction) with a hard end feel
  • Symptoms of frozen shoulder that had lasted for at least 3 months.
  • Willing and able to provide informed consent and perform home-based exercises as instructed.
  • Willing and able to complete study questionnaires

Exclusion Criteria:

  • Previous manipulation of the affected shoulder under anesthesia in the last year;
  • Other rheumatic conditions involving the shoulder (e.g., rheumatoid arthritis, ankylosing Spondylitis,
  • Fracture or dislocation of the affected shoulder;
  • Previous shoulder surgery;
  • Hill-Sachs lesion, severe osteoporosis, or malignancies in the shoulder region);
  • Neurologic deficits affecting shoulder function;
  • History of allergy to lidocaine;
  • Corticosteroid injection in the affected shoulder during the receding 4 weeks.
  • Non-English speakers;
  • Active non- controlled mental disorders
  • Multiple complete tear in ligaments of rotator cuff
  • Any infection including COVID-19

Study Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention arm

Patients with frozen shoulders at any stage

Interventions

Intervention after nerve block

Brachial plexus block + Physical therapy

Primary outcome measure

  • changes in disability score [ Time Frame: 12 months ]
  • changes in disability score [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Ramin Safakish, MD, FRCPC

6474788462Ramin.Safakish@AllevioClinic.com

Michael Lehr, D.C

6474788462Michael.Lehr@AllevioClinic.com

Locations

Allevio Pain Management

Recruiting

Toronto, Ontario, Canada, M3B 3S6

Contacts

Ramin Safakish, MD, FRCPC

6474788462Ramin.Safakish@Allevioclinic.com

Michael Lehr, D.C., Dip.Ac., Hons.BSc

6474788462Michael.Lehr@Allevioclinic.com

More Information

Sponsor

Allevio Pain Management Clinic

Last update posted

Jun 23, 2022

Last verified

Jan, 2022

Keywords

  • Brachial Plexus Block
  • Physical Therapy
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allevio Pain Management Clinic on 2022-06-23.