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Completed

NCT Number: NCT05213351

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Graded motor imagery

Other

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

Other

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

Primary outcomes

  1. Change from baseline The Shoulder Pain and Disability Index at 6th and 8th week

    Time frame: Baseline,6th week 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.

Secondary outcomes

  1. Change from baseline NPRS at 6th and 8th week

    Time frame: Baseline,6th week 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.

  2. Change from baseline range of motion at 6th and 8th week

    Time frame: Baseline,6th week and 8th week

    Range of motion is the capability of a joint to go through its complete spectrum of movements.

  3. Change from baseline QuickDASH at 6th and 8th week

    Time frame: Baseline,6th week 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.

  4. Change from baseline two-point discrimination at 6th and 8th week

    Time frame: Baseline,6th week 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.

  5. Change from Pain Catastrophizing Scale at 6th and 8th week

    Time frame: Baseline,6th week 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.

  6. Change from SF-12 at 6th and 8th week

    Time frame: Baseline,6th week 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2022
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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