Glenohumeral ArthritisNCT03958227
Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis
A study testing Manuel Therapy plus Exercise Intervention and Exercise Intervention in people with Glenohumeral Arthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the investigator's study is to compare the efficacy of manual therapy and exercise practices compared to exercise practice in patients with Glenohumeral Arthritis. Thirty volunteer patients will include into the study. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glenohumeral Arthritis
- What is being tested?
- Manuel Therapy plus Exercise Intervention and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years and older patients
- To be diagnosed with GHOA by specialist physician via MRI, US or radiography and physical examination
- Unilateral shoulder pain lasting more than 2 months seen during daily living activities and at rest
Who cannot join
- Patients with:
- Severe arthrosis
- Tumor
- Cervical radiculopathy
- Emotional or cognitive problems
- A neurological disease that causes muscle weakness on the shoulder
Show all 9Show fewer
- A skin disease that may affect upper extremity assessment.
- Frozen shoulder
- Thoracic outlet syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
The aim of the investigator's study is to compare the efficacy of manual therapy and exercise practices compared to exercise practice in patients with Glenohumeral Arthritis. Thirty volunteer patients will include into the study.
Read the detailed description
Patients will randomly divide into two groups. A common exercise program was applied to both groups during 15 sessions. Manual therapy techniques will apply to the manual therapy group in addition to exercise practices. Patients will evaluate in terms of functional status, pain, range of motion, muscle strength and health-related quality before and after 5 weeks of treatment. Also, patient's satisfaction from treatment will evaluate at the 5th week of the treatment. DASH and ASES forms for functional status, VAS for pain, digital goniometer for range of motion, manual muscle test for muscle strength, SF-12 for health-related quality of life, and Global Rating of Change (GRC) Scale for patient satisfaction will be used as evaluation criteria.
- Conditions
- Glenohumeral Arthritis
- Being tested
- Manuel Therapy plus Exercise Intervention, Exercise Intervention
- Keywords
- Glenohumeral Arthritis, Pain, Mobilisation, Physiotherapy, Rehabilitation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuel Therapy plus Exercise InterventionOther
Shoulder mobilization techniques include glenohumeral traction, anterior, posterior and inferior glide. We will also use anterior, posterior and inferior joint stretching exercises and scapular mobilization. Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.
Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.
| Study group | Role | What they receive |
|---|---|---|
| ''Manuel Therapy group'' | Experimental | This treatment group will be received Manuel Therapy techniques and exercise interventions. Receives: Other: Manuel Therapy plus Exercise Intervention |
| ''Exercise group'' | Experimental | This treatment group will be received only exercise interventions. Receives: Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Range of Motion (ROM)
The shoulder flexion, abduction, internal and external rotation ROM will be evaluated with digital goniometer while the patient will be in supine position.
Measured: Evaluation will be performed first time at baseline and second time will be performed after 5 weeks rehabilitation program. After treatment "change" will be assessed.
Secondary outcomes (6)
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Measured: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Visual Analogue Scale (VAS)
The levels of pain is felted at rest / activity / night will be measured using Visual Analogue Scale (VAS).Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
Measured: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Manual Muscle Test
Manual Muscle Test is a procedure for the evaluation of strength of individual muscle or muscles group, based upon the effective performance of a movement in relation to the forces of gravity or manual resistance through the available ROM.
Measured: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Short Form 12 (SF-12)
SF-12 will be used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Measured: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Global Rating of Change (GRC) Scale
Global Rating of Change (GRC) scale will be used to assess the overall satisfaction levels of the patients. Patients will be asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Measured: Evaluation will be performed after 5 weeks rehabilitation program.
The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.
Measured: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start20 May 2019
- Primary completion29 Nov 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glenohumeral ArthritisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Gayretli Atan, Istanbul University
- Investigators
- Sibel Gayretli Atan, Principal investigator, sssibel_38@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958227
- Sponsor's protocol ID
- ''IU''
- Status last verified
- Nov 2019
- First submitted
- 11 Apr 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gayretli Atan S, Analay Akbaba Y, Altun S. Are manual therapy applications an effective treatment approach in patients with glenohumeral arthritis? A randomized controlled trial. J Hand Ther. 2026 Apr 14:S0894-1130(25)00217-0. doi: 10.1016/j.jht.2025.12.016. Online ahead of print.
PubMed 41986176
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
- ClinicalTrials.gov ID
- NCT03958227
- Acronym / sponsor ID
- ''IU''
- Conditions
- Glenohumeral Arthritis
- Keywords
- Glenohumeral Arthritis, Pain, Mobilisation, Physiotherapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the investigator's study is to compare the efficacy of manual therapy and exercise practices compared to exercise practice in patients with Glenohumeral Arthritis. Thirty volunteer patients will include into the study.
Detailed description
Patients will randomly divide into two groups. A common exercise program was applied to both groups during 15 sessions. Manual therapy techniques will apply to the manual therapy group in addition to exercise practices. Patients will evaluate in terms of functional status, pain, range of motion, muscle strength and health-related quality before and after 5 weeks of treatment. Also, patient's satisfaction from treatment will evaluate at the 5th week of the treatment. DASH and ASES forms for functional status, VAS for pain, digital goniometer for range of motion, manual muscle test for muscle strength, SF-12 for health-related quality of life, and Global Rating of Change (GRC) Scale for patient satisfaction will be used as evaluation criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ''Manuel Therapy group'' | Experimental | Other: Manuel Therapy plus Exercise InterventionThis treatment group will be received Manuel Therapy techniques and exercise interventions. |
| ''Exercise group'' | Experimental | Other: Exercise InterventionThis treatment group will be received only exercise interventions. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years and older patients
- To be diagnosed with GHOA by specialist physician via MRI, US or radiography and physical examination
- Unilateral shoulder pain lasting more than 2 months seen during daily living activities and at rest
Key exclusion criteria (9 listed)
- Severe arthrosis
- Tumor
- Cervical radiculopathy
- Emotional or cognitive problems
- A neurological disease that causes muscle weakness on the shoulder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manuel Therapy plus Exercise InterventionShoulder mobilization techniques include glenohumeral traction, anterior, posterior and inferior glide. We will also use anterior, posterior and inferior joint stretching exercises and scapular mobilization. Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises. | Other | ''Manuel Therapy group'' |
| Exercise InterventionExercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises. | Other | ''Exercise group'' |
Primary outcome
Shoulder Range of Motion (ROM)
Time frame: Evaluation will be performed first time at baseline and second time will be performed after 5 weeks rehabilitation program. After treatment "change" will be assessed.
The shoulder flexion, abduction, internal and external rotation ROM will be evaluated with digital goniometer while the patient will be in supine position.
6 secondary outcomes
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Visual Analogue Scale (VAS)
Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Manual Muscle Test
Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Short Form 12 (SF-12)
Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Global Rating of Change (GRC) Scale
Time frame: Evaluation will be performed after 5 weeks rehabilitation program.
The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Derived from this study: PubMed 41986176Gayretli Atan S, Analay Akbaba Y, Altun S. Are manual therapy applications an effective treatment approach in patients with glenohumeral arthritis? A randomized controlled trial. J Hand Ther. 2026 Apr 14:S0894-1130(25)00217-0. doi: 10.1016/j.jht.2025.12.016. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Gayretli Atan principal investigator
sssibel_38@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manuel Therapy plus Exercise Intervention and Exercise Intervention in people with Glenohumeral Arthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Range of Motion (ROM) (time frame: Evaluation will be performed first time at baseline and second time will be performed after 5 weeks rehabilitation program. After treatment "change" will be assessed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03958227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.