Two Different Exercise Training in Frozen Shoulder Treatment

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213351
• Other study ID #: 16.01.2022
• Status: Completed
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: July 2023
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 20, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

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.
• Exercise
Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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