NCT07885215

Brief Summary

The aim of the study is to investigate the effects of respiratory muscle strengthening and diaphragmatic breathing on pain levels, respiratory capacity and sleep quality in participants with shoulder pain and disability.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2025Dec 2026

Study Start

First participant enrolled

November 25, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

1.1 years

First QC Date

October 8, 2026

Last Update Submit

October 15, 2026

Conditions

Keywords

shoulder painlung capacitybreathing exercisepain intensitysleep quality

Outcome Measures

Primary Outcomes (1)

  • Change in Shoulder Pain and Disability Index (SPADI) Score

    Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The SPADI consists of 13 items divided into two subscales: pain (5 items) and disability (8 items). The total score ranges from 0 to 100, with higher scores indicating greater pain and disability. Assessments will be performed at baseline and at the end of the three-week intervention.

    Baseline and 3 weeks after baseline

Secondary Outcomes (11)

  • Change in Shoulder Pain Intensity (VAS)

    Baseline and 3 weeks after baseline

  • Change in Pulmonary Function (FVC)

    Baseline and 3 weeks after baseline

  • Change in Pulmonary Function (FEV1)

    Baseline and 3 weeks after baseline

  • Change in FEV1/FVC Ratio

    Baseline and 3 weeks after baseline

  • Change in Peak Expiratory Flow (PEF)

    Baseline and 3 weeks after baseline

  • +6 more secondary outcomes

Study Arms (2)

breathing exercise group

EXPERIMENTAL

After the spirometric measurements, the effects on shoulder pain levels, functionality, and quality of life will be evaluated in the experimental group. In addition to shoulder rehabilitation, respiratory muscle strengthening exercises and diaphragmatic breathing will be applied. Finally, spirometric measurements will be taken again, and the impact of respiratory muscle strengthening exercises on lung capacity will be assessed.

Other: respiratory muscle strengthening exercises and diaphragmatic breathing exercises

control group

ACTIVE COMPARATOR

After the spirometric measurements, the effects on shoulder pain levels, functionality, and quality of life will be evaluated in the control group. Shoulder rehabilitation will be applied. Finally, spirometric measurements will be taken again.

Other: shoulder rehabilitation

Interventions

Exercises and mobilizations aimed at reducing shoulder pain and increasing range of motion, when applicable, will be implemented. Spirometric measurements will be taken before and after the treatment.

control group

The effects of strengthening the respiratory muscles and applying diaphragmatic breathing exercises on pain levels, lung capacity, and sleep quality will be examined in individuals with shoulder pain. Spirometric measurements will be taken.

breathing exercise group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary participation in the study.
  • Male and female participants.
  • Aged between 40 and 65 years.
  • Shoulder pain lasting for at least three months.
  • No participation in a pulmonary rehabilitation program within the previous six months.

You may not qualify if:

  • Presence of neuromuscular diseases.
  • History of shoulder subluxation or dislocation.
  • Presence of pulmonary diseases.
  • History of shoulder surgery.
  • Current use of analgesic medications.
  • History of thoracic surgery.
  • Presence of spinal deformities.
  • History of endocrine diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Level Hospital

Zonguldak, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder PainSleep Initiation and Maintenance DisordersPain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Zeynep Erdem

    Zonguldak Bulent Ecevit University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

October 8, 2026

First Posted

October 21, 2026

Study Start

November 25, 2025

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations