Shoulder PainNCT07885215
Effects of Respiratory Muscle Strengthening and Diaphragmatic Breathing on Shoulder Pain and Disability
A study testing shoulder rehabilitation and respiratory muscle strengthening exercises and diaphragmatic breathing exercises in people with Shoulder Pain and Sleep Quality, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Shoulder Pain, Sleep Quality, Lung Cavity
- What is being tested?
- shoulder rehabilitation and respiratory muscle strengthening exercises and diaphragmatic breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2025to 25 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zonguldak Level Hospital
Zonguldak
zeynep Erdem, +90 372 261 3365, zsyamakoglu@gmail.com
Sanem ŞENER, 05535918396, sanemsener@yahoo.com
About this study
Official title: The Effect of Applying Respiratory Muscle Strengthening and Diaphragmatic Breathing Exercises On Pain Levels, Sleep Quality, and Lung Capacity In Participants With Shoulder Pain and Disability
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.
Read the detailed description
The control group will undergo shoulder rehabilitation, while the experimental group will receive shoulder rehabilitation in addition to respiratory muscle strengthening and diaphragmatic breathing exercises. Spirometric measurements will be taken before and after the treatment for both groups. Scales to assess shoulder pain levels and sleep quality will also be applied.
- Conditions
- Shoulder Pain, Sleep Quality, Lung Cavity, Pain Intensity
- Being tested
- shoulder rehabilitation, respiratory muscle strengthening exercises and diaphragmatic breathing exercises
- Keywords
- shoulder pain, lung capacity, breathing exercise, pain intensity, sleep quality
- Medical subject headings
- Shoulder Pain, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder rehabilitationOther
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.
respiratory muscle strengthening exercises and diaphragmatic breathing exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: shoulder rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 weeks after baseline
Secondary outcomes (11)
Change in Shoulder Pain Intensity (VAS)
Pain intensity at rest, during activity, and at night, measured using a 0-10 cm Visual Analog Scale. Higher values indicate greater pain.
Measured: Baseline and 3 weeks after baseline
Change in Pulmonary Function (FVC)
Forced vital capacity measured by spirometry, expressed in liters.
Measured: Baseline and 3 weeks after baseline
Change in Pulmonary Function (FEV1)
Forced expiratory volume in one second, measured by spirometry, expressed in liters.
Measured: Baseline and 3 weeks after baseline
Change in FEV1/FVC Ratio
Ratio of forced expiratory volume in one second to forced vital capacity, expressed as a percentage.
Measured: Baseline and 3 weeks after baseline
Change in Peak Expiratory Flow (PEF)
Peak expiratory flow measured using spirometry.
Measured: Baseline and 3 weeks after baseline
Change in Shoulder Range of Motion
Active and passive shoulder range of motion measured using a universal goniometer, expressed in degrees.
Measured: Baseline and 3 weeks after baseline
Change in Modified Constant-Murley Score
Shoulder pain, daily activities, range of motion, and strength assessed on a 0-100 scale. Higher scores indicate better shoulder function.
Measured: Baseline and 3 weeks after baseline
Change in Western Ontario Shoulder Instability Index (WOSI) Score
The Western Ontario Shoulder Instability Index (WOSI) will be used to assess shoulder-related physical symptoms, sports/recreation/work, lifestyle, and emotional functioning. The questionnaire consists of 21 items, with a total score ranging from 0 to 2100. Higher scores indicate greater shoulder-related impairment and poorer quality of life.
Measured: Baseline and 3 weeks after baseline
Change in Pittsburgh Sleep Quality Index (PSQI)
Sleep quality assessed using the PSQI global score, ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: Baseline and 3 weeks after baseline
Change in Pectoral Muscle Shortness
Pectoral muscle shortness measured using anatomical landmark distances, expressed in centimeters.
Measured: Baseline and 3 weeks after baseline
Change in Cervical and Lumbar Range of Motion
Cervical and lumbar range of motion measured using goniometry, expressed in degrees.
Measured: Baseline and 3 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start25 Nov 2025
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Sude Erdem, Zonguldak Bulent Ecevit University
- Investigators
- Zeynep Erdem, Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885215
- Sponsor's protocol ID
- ZYamakoglu
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.