Shoulder PainNCT07184242
Strength Training and Proprioceptive Stimulation on Pain, Function, Quality of Life, Sleep Quality, and Psychosocial Factors in Older Adults With Shoulder Pain
A study testing Shoulder Exercise & Proprioceptive Training Program in people with Shoulder Pain, run by University of Jaén at 1 site in Spain.
Trial summary
A single-blind randomized clinical trial with a pretest posttest design is proposed in adults over 60 years of age with chronic shoulder pain due to rotator cuff involvement. Participants will be divided into an experimental group that will receive a multi-joint strength exercise program along with proprioceptive… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Shoulder Exercise & Proprioceptive Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2025to 19 Dec 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People over 60 years of age.
- Be able to understand the instructions and answer the questionnaires designed for this study, as well as participate in the established physical tests.
- People with rotator cuff-related shoulder pain (RCSRP) of at least 3 months' duration.
- Sign informed consent to participate in the study.
- Possible medical diagnoses to categorize you as RCSRP:
- Subacromial syndrome or subacromial pain syndrome.
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- Subacromial impingement.
- Rotator cuff tendinopathy/tendinitis/tendinosis.
- Subdeltoid/subacromial bursitis.
- Non-traumatic partial tears of a rotator cuff tendon affecting less than 50% of the tendon thickness.
- Mild/moderate intrasubstance rotator cuff tears.
Who cannot join
- Complete/massive rotator cuff tears.
- Corticosteroid injections within the last 6 weeks.
- Recent surgery on that shoulder or planned surgery within the next 3 months.
- Bilateral shoulder pain.
- Presence of glenohumeral fractures or osteoarthritis confirmed by radiographic examination.
- Psychiatric illnesses or central or peripheral neurological disorders that make it difficult to grasp, cooperate, or follow instructions during the procedure.
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- Individuals with an absolute contraindication to moderate-to-high-intensity physical exercise based on prior medical testing.
- Presence of severe difficulties with gait, balance, or functional activity, or hearing or vestibular disorders that prevent the performance of the prescribed exercises.
- Visual disturbances that cannot be corrected with glasses, contact lenses, or surgery.
- Being enrolled in another physical exercise or treatment program during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-joint Strength Exercises and Proprioceptive Somatosensory Stimulation on Pain, Function, Quality of Life, Sleep Quality, and Psychosocial Factors in Patients Over 60 Years of Age With Chronic Rotator Cuff-related Shoulder Pain
A single-blind randomized clinical trial with a pretest posttest design is proposed in adults over 60 years of age with chronic shoulder pain due to rotator cuff involvement. Participants will be divided into an experimental group that will receive a multi-joint strength exercise program along with proprioceptive somatosensory stimulation plus conventional treatment for 12 weeks and a control group that will only receive conventional treatment. Assessments will be performed at the beginning and end of the intervention by measuring pain with the NPRS and BPI SF scales, psychosocial factors with PCS FABQ PVAQ and TSK 11, functional disability with the Shoulder Rating Questionnaire, sleep quality with the Pittsburgh Index, and physical function with the Back Scratch Test, goniometry and inclinometer, shoulder dynamometry, and manual grip. It is expected that the combined intervention will significantly improve pain, associated psychosocial factors, quality of life, sleep, and functional capacity of participants.
- Conditions
- Shoulder Pain
- Being tested
- Shoulder Exercise & Proprioceptive Training Program
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder Exercise & Proprioceptive Training ProgramOther
The study includes two intervention modalities. The experimental group will combine conventional treatment with a structured 12-week therapeutic exercise program, with two supervised group sessions per week (50-60 minutes), which will include proprioceptive somatosensory work, multi-joint strength exercises, and adapted specific movements. Progression will be individually adjusted based on each participant's pain tolerance, physical condition, and clinical progress, complemented by home activities and supporting educational materials.
The control group will receive only conventional treatment provided at their rehabilitation center and general guidelines on the benefits of physical activity according to WHO recommendations for people over 60 years of age.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | A control group (CG) will be evaluated in the pre- and post-study phases. Participants assigned to this group will continue their usual conventional treatment in the rehabilitation service to which they are assigned. They will also receive general advice on the positive effects of regular physical activity on their therapeutic process, based on the World Health Organization guidelines for those over 60 years of age. |
| Experimental Group | Experimental | The experimental group will participate in a 12-week therapeutic exercise program designed to complement conventional treatment. Following an initial evaluation and informed consent, participants will attend two supervised group sessions per week, each lasting 50-60 minutes. These sessions will combine proprioceptive somatosensory exercises, multi-joint strength training, and specific complementary movements. Exercise loads will be carefully individualized, taking into account each participant's pain threshold, physical characteristics, clinical stage, and symptoms. A structured progression will be ensured by applying progressive overload through systematic changes in repetitions, external resistance, and range of motion. To reinforce the supervised training, participants will also carry out two to three additional home sessions per week, supported with educational materials, a personal logbook, and an adherence diary to encourage continuity and engagement throughout the intervention. Receives: Other: Shoulder Exercise & Proprioceptive Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS)
The NPRS is an 11-point numeric scale (0-10) used to assess pain intensity. Participants indicate their current level of pain, with 0 representing "no pain" and 10 representing "worst imaginable pain." It will be applied to capture the sensory-discriminative dimension of pain.
Measured: Up to twelve weeks
Brief Pain Inventory - Short Form (BPI-SF)
The BPI-SF is a self-administered questionnaire that evaluates pain severity and pain interference with daily activities. It complements the NPRS by covering affective and functional dimensions of the pain experience.
Measured: Up to twelve weeks
Algometry (Pressure Pain Thresholds)
Pressure algometry will be used to determine pain thresholds to pressure stimuli. It allows the quantification of mechanical sensitivity and the evaluation of changes in pain perception.
Measured: Up to twelve weeks
Pain Catastrophizing Scale (PCS)
The PCS is a validated questionnaire that measures catastrophic thinking related to pain through three subscales: rumination, magnification, and helplessness. Higher scores indicate greater pain catastrophizing.
Measured: Up to twelve weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
The FABQ evaluates fear-avoidance beliefs regarding physical activity and work. It identifies how fear of pain may influence behavior and functional limitations.
Measured: Up to twelve weeks
Pain Vigilance and Awareness Questionnaire (PVAQ-9)
The PVAQ-9 assesses hypervigilance and attentional focus on pain sensations. It quantifies the degree to which individuals monitor, detect, and are alert to pain-related stimuli.
Measured: Up to twelve weeks
Tampa Scale for Kinesiophobia (TSK-11)
The TSK-11 short version is a self-reported questionnaire measuring kinesiophobia, i.e., the fear of movement due to pain or risk of injury. It captures cognitive and emotional aspects of avoidance behavior.
Measured: Up to twelve weeks
Shoulder Rating Questionnaire (SRQ)
The SRQ is a disease-specific tool validated in Spanish that measures functional disability related to shoulder pain. It evaluates domains such as pain, daily activity limitations, and overall shoulder function.
Measured: Up to twelve weeks
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a widely used questionnaire to assess sleep quality over the previous month. It includes seven components (subjective sleep quality, latency, duration, efficiency, disturbances, medication use, and daytime dysfunction), providing a global score of sleep quality.
Measured: Up to twelve weeks
Back Scratch Test
The Back Scratch Test evaluates shoulder flexibility and range of motion by measuring the distance between the hands behind the back. It is a simple field test for functional shoulder mobility.
Measured: Up to twelve weeks
Goniometry (Shoulder Range of Motion)
A goniometer will be used to measure active range of motion in flexion, abduction, and rotations of the shoulder. The inclinometer option will ensure precise angular assessment.
Measured: Up to twelve weeks
Handheld Dynamometry
Isometric muscle strength of the main shoulder movements (flexion, abduction, rotation) and handgrip strength will be measured with a handheld dynamometer, providing objective data on functional capacity.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start18 Sep 2025
- Primary completion23 Sep 2025
- Study completion19 Dec 2025
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184242
- Sponsor's protocol ID
- UUJA
- Status last verified
- Mar 2026
- First submitted
- 13 Sep 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-joint Strength Exercises and Proprioceptive Somatosensory Stimulation on Pain, Function, Quality of Life, Sleep Quality, and Psychosocial Factors in Patients Over 60 Years of Age With Chronic Rotator Cuff-related Shoulder Pain
- ClinicalTrials.gov ID
- NCT07184242
- Acronym / sponsor ID
- UUJA
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 19 Sep 2025 (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.
A single-blind randomized clinical trial with a pretest posttest design is proposed in adults over 60 years of age with chronic shoulder pain due to rotator cuff involvement. Participants will be divided into an experimental group that will receive a multi-joint strength exercise program along with proprioceptive somatosensory stimulation plus conventional treatment for 12 weeks and a control group that will only receive conventional treatment. Assessments will be performed at the beginning and end of the intervention by measuring pain with the NPRS and BPI SF scales, psychosocial factors with PCS FABQ PVAQ and TSK 11, functional disability with the Shoulder Rating Questionnaire, sleep quality with the Pittsburgh Index, and physical function with the Back Scratch Test, goniometry and inclinometer, shoulder dynamometry, and manual grip. It is expected that the combined intervention will significantly improve pain, associated psychosocial factors, quality of life, sleep, and functional capacity of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –A control group (CG) will be evaluated in the pre- and post-study phases. Participants assigned to this group will continue their usual conventional treatment in the rehabilitation service to which they are assigned. They will also receive general advice on the positive effects of regular physical activity on their therapeutic process, based on the World Health Organization guidelines for those over 60 years of age. |
| Experimental Group | Experimental | Other: Shoulder Exercise & Proprioceptive Training ProgramThe experimental group will participate in a 12-week therapeutic exercise program designed to complement conventional treatment. Following an initial evaluation and informed consent, participants will attend two supervised group sessions per week, each lasting 50-60 minutes. These sessions will combine proprioceptive somatosensory exercises, multi-joint strength training, and specific complementary movements. Exercise loads will be carefully individualized, taking into account each participant's pain threshold, physical characteristics, clinical stage, and symptoms. A structured progression will be ensured by applying progressive overload through systematic changes in repetitions, external resistance, and range of motion. To reinforce the supervised training, participants will also carry out two to three additional home sessions per week, supported with educational materials, a personal logbook, and an adherence diary to encourage continuity and engagement throughout the intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- People over 60 years of age.
- Be able to understand the instructions and answer the questionnaires designed for this study, as well as participate in the established physical tests.
- People with rotator cuff-related shoulder pain (RCSRP) of at least 3 months' duration.
- Sign informed consent to participate in the study.
- Possible medical diagnoses to categorize you as RCSRP:
Key exclusion criteria (10 listed)
- Complete/massive rotator cuff tears.
- Corticosteroid injections within the last 6 weeks.
- Recent surgery on that shoulder or planned surgery within the next 3 months.
- Bilateral shoulder pain.
- Presence of glenohumeral fractures or osteoarthritis confirmed by radiographic examination.
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 |
|---|---|---|
| Shoulder Exercise & Proprioceptive Training ProgramThe study includes two intervention modalities. The experimental group will combine conventional treatment with a structured 12-week therapeutic exercise program, with two supervised group sessions per week (50-60 minutes), which will include proprioceptive somatosensory work, multi-joint strength exercises, and adapted specific movements. Progression will be individually adjusted based on each participant's pain tolerance, physical condition, and clinical progress, complemented by home activities and supporting educational materials. The control group will receive only conventional treatment provided at their rehabilitation center and general guidelines on the benefits of physical activity according to WHO recommendations for people over 60 years of age. | Other | Experimental Group |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: Up to twelve weeks
The NPRS is an 11-point numeric scale (0-10) used to assess pain intensity. Participants indicate their current level of pain, with 0 representing "no pain" and 10 representing "worst imaginable pain." It will be applied to capture the sensory-discriminative dimension of pain.
Brief Pain Inventory - Short Form (BPI-SF)
Time frame: Up to twelve weeks
The BPI-SF is a self-administered questionnaire that evaluates pain severity and pain interference with daily activities. It complements the NPRS by covering affective and functional dimensions of the pain experience.
Algometry (Pressure Pain Thresholds)
Time frame: Up to twelve weeks
Pressure algometry will be used to determine pain thresholds to pressure stimuli. It allows the quantification of mechanical sensitivity and the evaluation of changes in pain perception.
Pain Catastrophizing Scale (PCS)
Time frame: Up to twelve weeks
The PCS is a validated questionnaire that measures catastrophic thinking related to pain through three subscales: rumination, magnification, and helplessness. Higher scores indicate greater pain catastrophizing.
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Up to twelve weeks
The FABQ evaluates fear-avoidance beliefs regarding physical activity and work. It identifies how fear of pain may influence behavior and functional limitations.
Pain Vigilance and Awareness Questionnaire (PVAQ-9)
Time frame: Up to twelve weeks
The PVAQ-9 assesses hypervigilance and attentional focus on pain sensations. It quantifies the degree to which individuals monitor, detect, and are alert to pain-related stimuli.
Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Up to twelve weeks
The TSK-11 short version is a self-reported questionnaire measuring kinesiophobia, i.e., the fear of movement due to pain or risk of injury. It captures cognitive and emotional aspects of avoidance behavior.
Shoulder Rating Questionnaire (SRQ)
Time frame: Up to twelve weeks
The SRQ is a disease-specific tool validated in Spanish that measures functional disability related to shoulder pain. It evaluates domains such as pain, daily activity limitations, and overall shoulder function.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Up to twelve weeks
The PSQI is a widely used questionnaire to assess sleep quality over the previous month. It includes seven components (subjective sleep quality, latency, duration, efficiency, disturbances, medication use, and daytime dysfunction), providing a global score of sleep quality.
Back Scratch Test
Time frame: Up to twelve weeks
The Back Scratch Test evaluates shoulder flexibility and range of motion by measuring the distance between the hands behind the back. It is a simple field test for functional shoulder mobility.
Goniometry (Shoulder Range of Motion)
Time frame: Up to twelve weeks
A goniometer will be used to measure active range of motion in flexion, abduction, and rotations of the shoulder. The inclinometer option will ensure precise angular assessment.
Handheld Dynamometry
Time frame: Up to twelve weeks
Isometric muscle strength of the main shoulder movements (flexion, abduction, rotation) and handgrip strength will be measured with a handheld dynamometer, providing objective data on functional capacity.
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 6 Mar 2026.
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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 Shoulder Exercise & Proprioceptive Training Program in people with Shoulder Pain, run by University of Jaén at 1 site in Spain.
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 11 inclusion and 10 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 6 Mar 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 Spain. 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?
Numerical Pain Rating Scale (NPRS) (time frame: Up to twelve weeks). The study lists 12 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 6 Mar 2026.