Subacromial Pain SyndromeNCT05524870
The Effect of Manual Therapy on Central Sensitization
A study testing Mobilization in people with Subacromial Pain Syndrome and Central Sensitisation, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Subacromial pain syndrome (SIS) is a common cause of shoulder pain, estimated to be the cause for up to half of incident cases. Typically, pain is generated with elevation of the arm above the head though it can occur with rest in patients with SIS.There is evidence of central sensitization in those who experience… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Pain Syndrome, Central Sensitisation
- What is being tested?
- Mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 5 Feb 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have confirmed unilateral subacromial pain (positive testing at Neer Impingement and Hawkins-Kennedy tests),
- To have <40 score in central sensitization inventory.
Who cannot join
- To have bilateral subacromial pain,
- To have any pathology (except subacromial pain) that give rise to central sensitization (This pathologies are summarized in central sensitization inventory - part B)
- To have severe osteoarthritis or subluxation in shoulder joint,
- To have adhesive capsulitis,
- Being treated with physiotherapy for this disorder at least one month before the start of the study.
- To have severe cervical or lumbar radiculopathy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Movement With Mobilization Technic Plus Exercising Versus Exercising Alone for Central Sensitization in Patients With Subacromial Pain: a Sham-controlled Randomized Clinical Trial
Subacromial pain syndrome (SIS) is a common cause of shoulder pain, estimated to be the cause for up to half of incident cases. Typically, pain is generated with elevation of the arm above the head though it can occur with rest in patients with SIS.There is evidence of central sensitization in those who experience chronic shoulder pain from SIS. Central sensitization is an augmentation of the nociceptive pathways of the central nervous system that is characterized by local and generalized lowered pain thresholds and an exaggerated pain response to painful and non painful stimulation.Mobilization with movement (MWM) technic is a kind of manual therapy and it is often used by clinicians for the treatment of musculoskeletal diseases. Usually manual therapy is used for its peripheral effects, however it also produces central analgesic effects activating descending anti-nociceptive pathways for a short period of time (30 - 35 mins.). Some speculate that repeated sessions of manual therapy may result in a long term activation of descending anti-nociceptive pathways. However, there is no evidence of this mechanism available yet. Therefore, the aim of this study is to investigate the effect of MWM on central sensitization (primary aim) and shoulder functions (secondary aim) in patients with SIS.
- Conditions
- Subacromial Pain Syndrome, Central Sensitisation
- Being tested
- Mobilization
- Keywords
- Manual therapy, Shoulder pain, Mobilization
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilizationOther
Movement with mobilization plus exercise
| Study group | Role | What they receive |
|---|---|---|
| Mobilization | Experimental | Mobilization with movement plus exercise. Receives: Other: Mobilization |
| Sham mobilization | Placebo comparator | Sham mobilization with movement plus exercise Receives: Other: Mobilization |
| Control | Active comparator | Exercise alone Receives: Other: Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization Inventory
The central sensitization inventory (CSI), a patient reported outcome measure, is a reliable and valid comprehensive screening instrument for identification of central sensitization. The CSI inventory comprises of two sections - Part A and Part B. Part A consisted of 25-item self-report questionnaire with each item assessed on a 5-point Likert scale (0=never and 4=always), with total scores ranging from 0-100. Part B evaluates health-related symptoms that are common to central sensitization syndromes.Higher scores indicate more severe central sensitization. A CSI cut-off score of 40 exhibited good sensitivity in identifying central sensitization.
Measured: Baseline, 3 weeks: change from baseline central sensitization at 3 weeks, 3 months: change from central sensitization at 3 months.
Pressure-Pain Threshold-Algometer
Pressure pain threshold (PPT) is defined as the minimal amount of pressure where a sense of pressure first changes to pain. A mechanical pressure algometer is used in this study to assess PPT. This device consists of a round rubber disk (area,1 cm2 ) attached to a pressure (force) gauge. The gauge displays values in kilograms. Because the surface of the rubber tip is 1 cm2, the readings are expressed in kilograms per square centimeter. The range of the algometer is 0 to 10 kg with 0.1-kg divisions. Higher scores indicate high PPT.
Measured: Baseline, 3 weeks: change from baseline pressure pain threshold at 3 weeks, 3 months: change from pressure pain threshold at 3 months.
Secondary outcomes (1)
Quick Disabilities of the Shoulder, Arm and Hand Questionnaire
The Quick Disabilities of the Shoulder, Arm and Hand Questionnaire assesses physical functioning and symptoms of the upper limb, yielding a result between 0 and 100% (0% being the best and 100% being the worst outcomes).
Measured: Baseline, 3 weeks: change from baseline shoulder functions at 3 weeks, 3 months: change from shoulder functions at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start15 Feb 2022
- Primary completion1 Feb 2023
- Study completion5 Feb 2023
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 Subacromial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Deniz, PT, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524870
- Sponsor's protocol ID
- 107/82
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deniz V, Kelle B. Mobilization with movement plus exercise versus exercise alone for patients with central sensitization associated with chronic subacromial pain syndrome: a sham-controlled randomized clinical trial. BMC Complement Med Ther. 2025 Jul 28;25(1):289. doi: 10.1186/s12906-025-05028-0.
PubMed 40722073
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement With Mobilization Technic Plus Exercising Versus Exercising Alone for Central Sensitization in Patients With Subacromial Pain: a Sham-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05524870
- Acronym / sponsor ID
- 107/82
- Conditions
- Subacromial Pain Syndrome, Central Sensitisation
- Keywords
- Manual therapy, Shoulder pain, Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 1 Sep 2022 (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.
Subacromial pain syndrome (SIS) is a common cause of shoulder pain, estimated to be the cause for up to half of incident cases. Typically, pain is generated with elevation of the arm above the head though it can occur with rest in patients with SIS.There is evidence of central sensitization in those who experience chronic shoulder pain from SIS. Central sensitization is an augmentation of the nociceptive pathways of the central nervous system that is characterized by local and generalized lowered pain thresholds and an exaggerated pain response to painful and non painful stimulation.Mobilization with movement (MWM) technic is a kind of manual therapy and it is often used by clinicians for the treatment of musculoskeletal diseases. Usually manual therapy is used for its peripheral effects, however it also produces central analgesic effects activating descending anti-nociceptive pathways for a short period of time (30 - 35 mins.). Some speculate that repeated sessions of manual therapy may result in a long term activation of descending anti-nociceptive pathways. However, there is no evidence of this mechanism available yet. Therefore, the aim of this study is to investigate the effect of MWM on central sensitization (primary aim) and shoulder functions (secondary aim) in patients with SIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobilization | Experimental | Other: MobilizationMobilization with movement plus exercise. |
| Sham mobilization | Placebo comparator | Other: MobilizationSham mobilization with movement plus exercise |
| Control | Active comparator | Other: MobilizationExercise alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To have confirmed unilateral subacromial pain (positive testing at Neer Impingement and Hawkins-Kennedy tests),
- To have <40 score in central sensitization inventory.
Key exclusion criteria (6 listed)
- To have bilateral subacromial pain,
- To have any pathology (except subacromial pain) that give rise to central sensitization (This pathologies are summarized in central sensitization inventory - part B)
- To have severe osteoarthritis or subluxation in shoulder joint,
- To have adhesive capsulitis,
- Being treated with physiotherapy for this disorder at least one month before the start of the study.
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 |
|---|---|---|
| MobilizationMovement with mobilization plus exercise | Other | Control, Mobilization, Sham mobilization |
Primary outcome
Central Sensitization Inventory
Time frame: Baseline, 3 weeks: change from baseline central sensitization at 3 weeks, 3 months: change from central sensitization at 3 months.
The central sensitization inventory (CSI), a patient reported outcome measure, is a reliable and valid comprehensive screening instrument for identification of central sensitization. The CSI inventory comprises of two sections - Part A and Part B. Part A consisted of 25-item self-report questionnaire with each item assessed on a 5-point Likert scale (0=never and 4=always), with total scores ranging from 0-100. Part B evaluates health-related symptoms that are common to central sensitization syndromes.Higher scores indicate more severe central sensitization. A CSI cut-off score of 40 exhibited good sensitivity in identifying central sensitization.
Pressure-Pain Threshold-Algometer
Time frame: Baseline, 3 weeks: change from baseline pressure pain threshold at 3 weeks, 3 months: change from pressure pain threshold at 3 months.
Pressure pain threshold (PPT) is defined as the minimal amount of pressure where a sense of pressure first changes to pain. A mechanical pressure algometer is used in this study to assess PPT. This device consists of a round rubber disk (area,1 cm2 ) attached to a pressure (force) gauge. The gauge displays values in kilograms. Because the surface of the rubber tip is 1 cm2, the readings are expressed in kilograms per square centimeter. The range of the algometer is 0 to 10 kg with 0.1-kg divisions. Higher scores indicate high PPT.
1 secondary outcome
Quick Disabilities of the Shoulder, Arm and Hand Questionnaire
Time frame: Baseline, 3 weeks: change from baseline shoulder functions at 3 weeks, 3 months: change from shoulder functions at 3 months.
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 18 Nov 2023.
- Derived from this study: PubMed 40722073Deniz V, Kelle B. Mobilization with movement plus exercise versus exercise alone for patients with central sensitization associated with chronic subacromial pain syndrome: a sham-controlled randomized clinical trial. BMC Complement Med Ther. 2025 Jul 28;25(1):289. doi: 10.1186/s12906-025-05028-0.
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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 Mobilization in people with Subacromial Pain Syndrome and Central Sensitisation, run by Cukurova 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 2 inclusion and 6 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 18 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Central Sensitization Inventory (time frame: Baseline, 3 weeks: change from baseline central sensitization at 3 weeks, 3 months: change from central sensitization at 3 months.). 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?
On the ClinicalTrials.gov record for NCT05524870, 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 18 Nov 2023.