Two Different Exercise Training in Frozen Shoulder Treatment

Comparison of the Effectiveness of Two Different Exercise Training in Frozen Shoulder Treatment

The aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Other: Graded Motor Imagery; Other: Exercise

Detailed Description

After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double-blind manner in a 1:1 (participant and investigator) to graded motor imagery or exercise group.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul University-Cerrahpaşa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged >60 years
• Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear;
• Patients with ability to follow simple orders; iii)
• Patients with ability to sign to provide informed consent

Exclusion Criteria:

• Normal passive ROM
• External ROM < 30
• To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint
• Pain < 3 according to the numbered pain assessment scale

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Graded Motor İmagery; Graded Motor İmagery (GMI) group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, traditional exercises and home exercises.	Other: Graded Motor Imagery; Graded Motor Imagery program will be performed two times a week for six consecutive weeks and will include the following three steps: laterality training, imagined movements, and mirror therapy.; Right-left discrimination training (lateralization training); Imagination of hand movements (motor imagery):; Mirror therapy Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.
Active Comparator: Exercise; Exercise group will receive training involves mobilizations, stretching, specific exercises for the frozen shoulder.	Other: Exercise; Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline The Shoulder Pain and Disability Index at 6th and 8th week	The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.	Baseline,6th week and 8th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline NPRS at 6th and 8th week	The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.	Baseline,6th week and 8th week
Change from baseline range of motion at 6th and 8th week	Range of motion is the capability of a joint to go through its complete spectrum of movements.	Baseline,6th week and 8th week
Change from baseline QuickDASH at 6th and 8th week	The purpose of the QuickDASH is to use 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.	Baseline,6th week and 8th week
Change from baseline two-point discrimination at 6th and 8th week	The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception.	Baseline,6th week and 8th week
Change from Pain Catastrophizing Scale at 6th and 8th week	The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.	Baseline,6th week and 8th week
Change from SF-12 at 6th and 8th week	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.	Baseline,6th week and 8th week

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Derya Çelik, Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: January 16, 2022
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: exercise; frozen shoulder; graded motor imagery
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: 16.01.2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No