Frozen ShoulderNCT06469502
Comparison of the Effectiveness of Stretching and Strengthening Exercises in Patients With Frozen Shoulder
A study testing Stretching Exercises and Strengthening Exercises in people with Frozen Shoulder, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Stretching Exercises and Strengthening Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2024to 28 Jan 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 40-65
- Clinical and radiologic diagnosis of unilateral primary frozen shoulder
- Being in frozen shoulder stages 2 and 3
- Having an ROM of less than 50% in one or more directions of shoulder flexion, abduction, external rotation compared to the unaffected shoulder
- Giving informed consent and volunteering
- To have the ability to understand evaluation scales
Who cannot join
- Neurological, cardiovascular, cerebrovascular disease
- Those with severe mental illness or impaired consciousness
- Upper extremity fractures and tumors
- Rheumatic disease
- Pathologies of cervical origin
- Untreated shoulder trauma
- Severe osteoporosis
- Previous treatment for the current complaint (physiotherapy and rehabilitation, intra-articular injection, surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Stretching and Strengthening Exercises on Pain, Functional Status, Range of Motion and Psychosocial Factors in Patients With Frozen Shoulder
The aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.
Read the detailed description
Frozen shoulder is a common disorder characterized by spontaneous shoulder pain, progressive inflammation and fibrosis of the joint capsule and loss of both active and passive glenohumeral range of motion.Exercise reduces pain, increases range of motion and function in patients with frozen shoulder. When investigators examine the literature, stretching and strengthening exercises are frequently encountered in the content of multimodal exercise programs applied clinically and at home in frozen shoulder. However, they have not been compared in isolation. Stretching is known to increase flexibility, while strengthening is often used to increase strength capacity and hypertrophy.Both exercise methods produce mechanical tension, known as a factor that stimulates anabolic metabolism and increases protein synthesis.Therefore, the aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.According to the power analysis result, 56 patients will be randomized into two groups (Group 1 =28, Group 2=28). The treatment will last for a total of 6 weeks and the follow-up period will be 6 weeks. Group 1 will be included in the program consisting of stretching exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of stretching exercises (3 times a week) under the supervision of a physiotherapist. Group 2 will be included in the program consisting of strengthening exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of strengthening exercises (3 times per week) under the supervision of a physiotherapist. Each intervention consisted of a 6-week supervised exercise phase followed by a 6-week home-exercise phase, for a total intervention period of 12 weeks. The primary outcomes are the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH) and the Numeric Pain Rating Scale (NPRS), while the secondary outcomes are the American Shoulder and Elbow Surgeons Standardized Shoulder Evaluation (ASES), Shoulder range of motion, Brief Pain Inventory-Short Form (BFI-SF) and Pain Catastrophizing Scale (PCS).
- Conditions
- Frozen Shoulder
- Being tested
- Stretching Exercises, Strengthening Exercises
- Keywords
- frozen shoulder, exercise, stretching, strengthening
- Medical subject headings
- Bursitis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching ExercisesProcedure or surgery
Participants in Group 1 received a 6-week supervised stretching exercise program consisting of 18 sessions (3 sessions per week) under the supervision of a physiotherapist, followed by a 6-week home-based stretching exercise phase. Participants also received the same standardized patient education and advice on ice application throughout the study.
Strengthening ExercisesProcedure or surgery
Participants in Group 2 received a 6-week supervised strengthening exercise program consisting of 18 sessions (3 sessions per week) under the supervision of a physiotherapist, followed by a 6-week home-based strengthening exercise phase. The strengthening exercises incorporated a slow, controlled eccentric phase of approximately 10-15 seconds per repetition.Participants also received the same standardized patient education and advice on ice application throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Stretching Group | Experimental | Exercise program consisting of supervised stretching exercises Receives: Procedure: Stretching Exercises |
| Group 2-Strengthening Group | Experimental | Exercise program consisting of supervised strengthening exercises Receives: Procedure: Strengthening Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick DASH
Quick Disabilities of the Arm, Shoulder, and Hand: The Quick DASH is a 11-item questionnaire used to assess upper limb functionality. The score ranges from 0 (no disability) to 100 (most severe disability).
Measured: Baseline, after 6 weeks, and after 12 weeks
NPRS
Numeric Pain Rating Scale: The pain was measured using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable). Pain was assessed at rest, during activity, and at night.
Measured: Baseline, after 6 weeks, and after 12 weeks
Secondary outcomes (4)
ASES
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment: The ASES score ranges from 0-100. Higher scores indicate better functional ability
Measured: Baseline, after 6 weeks, and after 12 weeks
Shoulder Range of Motion (ROM)
Shoulder ROM measurements of forward flexion, abduction, and scapular plane external -internal rotation were taken using a standard goniometer. Pain-free active ROM and passive ROM were assesment.
Measured: Baseline, after 6 weeks, and after 12 weeks
BPI-SF
Brief Pain Inventory-Short Form: The BPI is a two-factor instrument that measures pain severity and pain interference. The pain severity factor has four items, all rated on a 0-to-10 Likert scale: 0 corresponds to "no pain" and 10 corresponds to "pain as bad as you can imagine". The pain interference factor has seven items, all rated on a 0-to-10 Likert scale: 0 corresponds to "does not interfere" and 10 corresponds to "interferes completely".
Measured: Baseline, after 6 weeks, and after 12 weeks
PCS
Pain Catastrophizing Scale: Each item is scored from 0 (never) to 4 (always), giving a total score ranging from 0 to 52. Higher scores indicate higher levels of pain catastrophizing.
Measured: Baseline, after 6 weeks, and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start30 Jun 2024
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Celik, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469502
- Sponsor's protocol ID
- DR2024
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Stretching and Strengthening Exercises on Pain, Functional Status, Range of Motion and Psychosocial Factors in Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT06469502
- Acronym / sponsor ID
- DR2024
- Conditions
- Frozen Shoulder
- Keywords
- frozen shoulder, exercise, stretching, strengthening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 21 Jun 2024 (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 study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.
Detailed description
Frozen shoulder is a common disorder characterized by spontaneous shoulder pain, progressive inflammation and fibrosis of the joint capsule and loss of both active and passive glenohumeral range of motion.Exercise reduces pain, increases range of motion and function in patients with frozen shoulder. When investigators examine the literature, stretching and strengthening exercises are frequently encountered in the content of multimodal exercise programs applied clinically and at home in frozen shoulder. However, they have not been compared in isolation. Stretching is known to increase flexibility, while strengthening is often used to increase strength capacity and hypertrophy.Both exercise methods produce mechanical tension, known as a factor that stimulates anabolic metabolism and increases protein synthesis.Therefore, the aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.According to the power analysis result, 56 patients will be randomized into two groups (Group 1 =28, Group 2=28). The treatment will last for a total of 6 weeks and the follow-up period will be 6 weeks. Group 1 will be included in the program consisting of stretching exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of stretching exercises (3 times a week) under the supervision of a physiotherapist. Group 2 will be included in the program consisting of strengthening exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of strengthening exercises (3 times per week) under the supervision of a physiotherapist. Each intervention consisted of a 6-week supervised exercise phase followed by a 6-week home-exercise phase, for a total intervention period of 12 weeks. The primary outcomes are the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH) and the Numeric Pain Rating Scale (NPRS), while the secondary outcomes are the American Shoulder and Elbow Surgeons Standardized Shoulder Evaluation (ASES), Shoulder range of motion, Brief Pain Inventory-Short Form (BFI-SF) and Pain Catastrophizing Scale (PCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1-Stretching Group | Experimental | Procedure: Stretching ExercisesExercise program consisting of supervised stretching exercises |
| Group 2-Strengthening Group | Experimental | Procedure: Strengthening ExercisesExercise program consisting of supervised strengthening exercises |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being between the ages of 40-65
- Clinical and radiologic diagnosis of unilateral primary frozen shoulder
- Being in frozen shoulder stages 2 and 3
- Having an ROM of less than 50% in one or more directions of shoulder flexion, abduction, external rotation compared to the unaffected shoulder
- Giving informed consent and volunteering
Key exclusion criteria (8 listed)
- Neurological, cardiovascular, cerebrovascular disease
- Those with severe mental illness or impaired consciousness
- Upper extremity fractures and tumors
- Rheumatic disease
- Pathologies of cervical origin
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 |
|---|---|---|
| Stretching ExercisesParticipants in Group 1 received a 6-week supervised stretching exercise program consisting of 18 sessions (3 sessions per week) under the supervision of a physiotherapist, followed by a 6-week home-based stretching exercise phase. Participants also received the same standardized patient education and advice on ice application throughout the study. | Procedure or surgery | Group 1-Stretching Group |
| Strengthening ExercisesParticipants in Group 2 received a 6-week supervised strengthening exercise program consisting of 18 sessions (3 sessions per week) under the supervision of a physiotherapist, followed by a 6-week home-based strengthening exercise phase. The strengthening exercises incorporated a slow, controlled eccentric phase of approximately 10-15 seconds per repetition.Participants also received the same standardized patient education and advice on ice application throughout the study. | Procedure or surgery | Group 2-Strengthening Group |
Primary outcome
Quick DASH
Time frame: Baseline, after 6 weeks, and after 12 weeks
Quick Disabilities of the Arm, Shoulder, and Hand: The Quick DASH is a 11-item questionnaire used to assess upper limb functionality. The score ranges from 0 (no disability) to 100 (most severe disability).
NPRS
Time frame: Baseline, after 6 weeks, and after 12 weeks
Numeric Pain Rating Scale: The pain was measured using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable). Pain was assessed at rest, during activity, and at night.
4 secondary outcomes
ASES
Time frame: Baseline, after 6 weeks, and after 12 weeks
Shoulder Range of Motion (ROM)
Time frame: Baseline, after 6 weeks, and after 12 weeks
BPI-SF
Time frame: Baseline, after 6 weeks, and after 12 weeks
PCS
Time frame: Baseline, after 6 weeks, and after 12 weeks
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 7 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching Exercises and Strengthening Exercises in people with Frozen Shoulder, 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 6 inclusion and 8 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 7 Oct 2026. 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?
Quick DASH (time frame: Baseline, after 6 weeks, and after 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.