NCT06157554

Brief Summary

The study aimed to investigate the effect of breathing exercises in addition to conventional treatment on pain, normal joint movement and quality of life in patients with frozen shoulder. A simple random number table will randomly divide participants into two groups. The study group (20 participants) will be given 15 sessions of respiratory exercises in addition to the 15 sessions of physiotherapy provided routinely for treatment. The control group (20 participants) will receive 15 sessions of physiotherapy services in addition to the routine 15 sessions of the physiotherapy department.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

November 21, 2023

Last Update Submit

December 4, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    In this study, the severity of shoulder pain will be evaluated with the Visual Analogue Scale. According to the VAS, pain intensity is graded as "no pain" 0 points and "worst unbearable pain" 10 points (10 cm scale).

    3 weeks

  • The Short Form-36 Quality of Life Questionnaire

    The Short Form-36, frequently used to assess quality of life, will be used. SF-36 consists of eight subscales including physical function, physical role, emotional function, social function, general health, mental health, pain and wellness. Each subscale scores between 0-100, and the scale is directly proportional to quality of life. A score of 100 indicates the best health status and a score of 0 indicates the worst health status.

    3 weeks

  • Range of motion

    In the study, a digital goniometer, which has been validated and reliable, was used to objectively evaluate the normal range of motion of the shoulder. Normal range of motion of the shoulder will be evaluated by measuring the range of motion of shoulder flexion, extension, abduction, internal rotation and external rotation movements.

    3 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Respiratory exercises will be applied in addition to conventional treatment for frozen shoulder patients.

Other: Breathing ExercisesOther: Conventional treatment

Control Group

OTHER

For frozen shoulder patients, 15 conventional treatment programs will be applied.

Other: Conventional treatment

Interventions

During the exercise sessions, participants will be seated in a chair. In the first five and last five minutes of the session, they will be instructed to focus on their breathing and the sensations produced in the body while sitting comfortably in a relaxed position with all joints in the chairs with their eyes closed. After the initial 5 minutes of relaxed breathing, participants will be instructed to perform diaphragmatic and costal breathing for 10 minutes. After 5 minutes of diaphragmatic breathing, the patient will be rested for 1 minute and then 5 minutes of costal breathing will be performed. While doing coastal breathing, patients will be asked to place their hands on their costas, take a deep breath and inflate the bottom of their hands; then they will be asked to exhale the breath they take in a longer (1:2) time.

Intervention group

Ultrasound, hotpack and TENS will be applied to both control and study groups as physical therapy modality. Then 15 sessions of Codman exercises, normal range of motion exercises and stretching exercises will be applied to both groups.

Control GroupIntervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18-65
  • Having a diagnosis of a frozen shoulder,
  • Volunteering to participate in the study
  • Not having any problem that may prevent respiratory exercise.

You may not qualify if:

  • Not volunteering to participate in the study,
  • Having undergone upper extremity surgery,
  • History of previous shoulder surgery, shoulder subluxation or dislocation,
  • Any mental or sensory problems,
  • Acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc. origin,
  • Having any respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Balıkesir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BursitisPain

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 21, 2023

First Posted

December 6, 2023

Study Start

January 10, 2023

Primary Completion

December 10, 2023

Study Completion

January 10, 2024

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations