Shoulder PainNCT05956288
The Hypoalgesic Effects of BFR Training in Nonspecific Shoulder Pain.
A study testing Blood flow restriction (BFR) with low load resistance training in people with Shoulder Pain and BFR, run by European University Cyprus at 1 site in Cyprus.
Trial summary
The primary objective of the present study is to evaluate if a single acute BFR low load- exercise bout would reduce pain in patients with nonspecific shoulder pain and whether the potential hypoalgesia will be maintained after a 45-minute physical therapy shoulder exercise session. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Shoulder Pain, BFR, Shoulder Impingement
- What is being tested?
- Blood flow restriction (BFR) with low load resistance training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCyprus
- Study dates
- 27 Feb 2024to 21 Nov 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >18≤40 years considering that the prevalence for degenerative rotator cuff tendinopathy increases from the age of 40 and above
- Shoulder pain intensity > 4/10 NPRS when performing active glenohumeral abduction and/or isometric resistance to glenohumeral external rotation from 0° of abduction.
- Duration of symptoms > 3 weeks (to avoid an inflammatory clinical picture).
Who cannot join
- Positive drop arm test (important indication for rotator cuff tear)
- Cervical radiculopathy having a positive specific spurling test or neurological symptoms in the upper limb
- Passive deficit in range of motion (ROM) > 2 levels of motion, where according to the literature it is an indication of frozen shoulder
- Body Mass Index (BMI) > 28
- Previous shoulder surgery
- Previous humerus fracture
Show all 20Show fewer
- Cancer
- Rheumatic diseases
- Systemic pathologies (e.g. diabetes, rheumatism, fibromyalgia)
- History of previous neurological diseases
- History of thrombosis
- Cardiovascular pathologies
- Neurological diseases
- Long-term use of corticosteroids
- Injury or surgery < 1 month related to the shoulder girdle
- Hypertension (> 140/90mmHg)
- Anti-inflammatory treatment in the last 2 weeks
- Injectable therapy (last 3 months)
- Previous experience/knowledge of the BFR technique
- Inability to write and read Greek
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Hypoalgesic Effects of BFR Training in Nonspecific Shoulder Pain. A Study Protocol of a Crossover Randomized Controlled Clinical Trial
The primary objective of the present study is to evaluate if a single acute BFR low load- exercise bout would reduce pain in patients with nonspecific shoulder pain and whether the potential hypoalgesia will be maintained after a 45-minute physical therapy shoulder exercise session. BFR exercise will be compared to a sham BFR exercise protocol. We hypothesize that the participants in the BFR group in will experience reduced pain and will be able to complete a scapula and rotator cuff muscles exercise loading program with reduced pain until the end of the exercise program.
Read the detailed description
Shoulder pathologies are the 3rd most common musculoskeletal condition encountered by health professionals in their day-to-day clinical practice, followed by low back pain and neck pain. It is noteworthy that approximately 40%-54% of patients report ongoing pain lasting between 1-3 years , causing a huge economic burden both on the national health care system but also to the patients. The pathologies associated with development of shoulder pain are numerous, however, in recent years the research community dealing with musculoskeletal shoulder pain has emphasized the need to break free from diagnostic terminologies that refer to precise clinical diagnosis, since such a thig is nearly impossible to happen, due to the low validity and diagnostic accuracy of the special tests available to the clinician. In addition, the need to detach from diagnostic labels becomes even more intense if one takes into account the inability to correlate symptoms and clinical status with pathological findings in diagnostic tests. Nonspecific shoulder pain is an umbrella term that includes non-traumatic musculoskeletal disorders of the shoulder.
Therapeutic exercise is the mainstay of conservative treatment and appears to be a powerful tool in the hands of clinicians to improve pain, mobility, and function of the shoulder in individuals with nonspecific shoulder pain . There are several mechanisms that are hypothesized to explain the benefits of exercise in nonspecific shoulder pain. The neuromuscular mechanism is the most frequently mentioned and is commonly explained as strengthening of the rotator cuff inhibiting pain. Other mechanisms proposed are: tissue factors (e.g. tendon remodeling, blood flow improvement etc.), neuro-endocrine-immune (e.g. exercise induced hypoalgesia, central and peripheral nervous system adaptations etc) and physiological mechanisms (e.g. improvements in self-efficacy and coping with pain etc).
The BFR method is a type of training with parallel partial restriction of arterial inflow and complete venous outflow restriction in muscle tissue that is usually combined with parallel execution of low-load resistance exercises. Blood flow restriction is achieved by using special cuffs applied to both the upper and lower extremities. During the last decade the popularity of this technique seems to be growing rapidly due to its beneficial effects on increasing muscle strength and muscle hypertrophy in healthy adults and clinical population but also its acute hypoalgetic effect on healthy population by significantly increasing the patient pain thresholds. However, to date there is only one published study examining the acute hypoalgetic effects of BFR training in a clinical population, showing beneficial adaptations in reducing pain in people with patellofemoral pain
The primary objective of the present study is to evaluate if a single acute BFR low load- exercise bout would reduce pain in patients with nonspecific shoulder pain and whether the potential hypoalgesia will be maintained after a 45-minute physical therapy shoulder exercise session. BFR exercise will be compared to a sham BFR exercise protocol. We hypothesize that the participants in the BFR group in will experience reduced pain and will be able to complete a scapula and rotator cuff muscles exercise loading program with reduced pain until the end of the exercise program.
- Conditions
- Shoulder Pain, BFR, Shoulder Impingement
- Being tested
- Blood flow restriction (BFR) with low load resistance training
- Keywords
- Shoulder pain, BFR
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction (BFR) with low load resistance trainingDevice
Combination of low load resistance exercise in the upper limb with the addition of blood flow restriction or sham-blood flow restriction.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction (BFR) with low load resistance training | Experimental | A single BFR exercise (Biceps curl with dumbell) will be perform. The initial resistance load for performing the above exercise will correspond to 5% of the body weight of each participant (±0.250 kg). Participants will be asked to perform 4 sets of bicep curls. The first set will consist of repetitions until failure (inability to follow the rhythm or inability to perform an additional contraction) followed by 3 sets of 15 repetitions with 30 seconds rest between sets. In case that for any of the participants will not be able to complete all the repetitions, or they are unable to follow the pace of the metronome, the resistance load will be reduced by 0.5 kg. Vascular Occlusion Pressure will be set at 50-60% of the complete occlusion pressure for the intervention group .Five minutes after the execution of the biceps curl exercise, each participant will receive a specific training which will consist of six therapeutic exercises targeting in loading the rotator cuff and scapula muscles Receives: Device: Blood flow restriction (BFR) with low load resistance training |
| Sham-Blood flow restriction (sham-BFR) with low load resistance training | Placebo comparator | Same procedure as experimental . The only difference between the two groups regarding the intervention will be the percentage of blood flow restriction cuff pressure. In the sham BFR group, as much pressure as 2 fingers can penetrate the cuff will be automatically applied via MADUP®, where based on the literature seems not to promote adaptations related to the use of the method. Receives: Device: Blood flow restriction (BFR) with low load resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain detection threshold assessment
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Measured: Baseline
Pressure pain detection threshold assessment
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Measured: 15 minutes (1st session)
Pressure pain detection threshold assessment
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Measured: 1 hour (1st session)
Pressure pain detection threshold assessment
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Measured: 2nd session (> 72 hours after 1st session)
Pressure pain detection threshold assessment
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Measured: 15 minutes (2nd session)
Pressure pain detection threshold assessment
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Measured: 1 hour (2nd session)
Maximal pain and strength in isometric shoulder external rotation
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Measured: Baseline
Maximal pain and strength in isometric shoulder external rotation
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Measured: 15 minutes (1st session)
Maximal pain and strength in isometric shoulder external rotation
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Measured: 1 hour (1st session)
Maximal pain and strength in isometric shoulder external rotation
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Measured: 2nd session (> 72 hours after 1st session)
Maximal pain and strength in isometric shoulder external rotation
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Measured: 15 minutes (2nd session)
Maximal pain and strength in isometric shoulder external rotation
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Measured: 1 hour (2nd session)
Secondary outcomes (15)
Pain during active shoulder Abduction
Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale
Measured: Baseline (1st session)
Pain during active shoulder Abduction
Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale
Measured: 15 minutes (1st session)
Pain during active shoulder Abduction
Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale
Measured: 1 hour (1st session)
Pain during active shoulder Abduction
Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale
Measured: 2nd session (> 72 hours after 1st session)
Pain during active shoulder Abduction
Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale
Measured: 15 minutes (2nd session)
Pain during active shoulder Abduction
Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale
Measured: 1 hour (2nd session)
Patient-perceived pain change
patient-perceived pain change using a global rating of change scale (GROC) based on a 7-point Likert scale ranging from "Much better - a very important improvement" to "Much worse - an important aggravation" (Jaeschke, 1986)
Measured: 15 minutes (1st session)
Patient-perceived pain change
patient-perceived pain change using a global rating of change scale (GROC) based on a 7-point Likert scale ranging from "Much better - a very important improvement" to "Much worse - an important aggravation" (Jaeschke, 1986)
Measured: 1 hour (1st session)
Patient-perceived pain change
patient-perceived pain change using a global rating of change scale (GROC) based on a 7-point Likert scale ranging from "Much better - a very important improvement" to "Much worse - an important aggravation" (Jaeschke, 1986)
Measured: 2nd session (> 72 hours after 1st session)
Patient-perceived pain change
patient-perceived pain change using a global rating of change scale (GROC) based on a 7-point Likert scale ranging from "Much better - a very important improvement" to "Much worse - an important aggravation" (Jaeschke, 1986)
Measured: 15 minutes (2nd session)
Patient-perceived pain change
patient-perceived pain change using a global rating of change scale (GROC) based on a 7-point Likert scale ranging from "Much better - a very important improvement" to "Much worse - an important aggravation" (Jaeschke, 1986)
Measured: 1 hour (2nd session)
Shoulder Pain and Disability Index (SPADI) questionnaire
Shoulder Pain and Disability Index (SPADI) questionnaire which assesses the pain and difficulty experienced by the participant in daily activities of the upper extremity. The questionnaire is translated into Greek and cross-culturally weighted to the Greek population (Vrouva et al., 2016).
Measured: Baseline
Shoulder Pain and Disability Index (SPADI) questionnaire
Shoulder Pain and Disability Index (SPADI) questionnaire which assesses the pain and difficulty experienced by the participant in daily activities of the upper extremity. The questionnaire is translated into Greek and cross-culturally weighted to the Greek population (Vrouva et al., 2016).
Measured: 2nd session (> 72 hours after 1st session)
Participant's rating of perceived exertion (RPE)
RPE using a modified Borg's scale (Borg CR10) immediately following the blood flow restriction or sham- blood flow restriction exercise session. The scale has been shown to be an valid alternate tool for estimating the exertion and intensity levels during resistance training (Brandt, 2013 ).
Measured: 15 minutes (1st session)
Participant's rating of perceived exertion (RPE)
RPE using a modified Borg's scale (Borg CR10) immediately following the blood flow restriction or sham- blood flow restriction exercise session. The scale has been shown to be an valid alternate tool for estimating the exertion and intensity levels during resistance training (Brandt, 2013 ).
Measured: 15 minutes (2nd session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start27 Feb 2024
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyriakos Pavlou, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956288
- Sponsor's protocol ID
- EUC
- Status last verified
- Dec 2024
- First submitted
- 6 Jul 2023
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pavlou K, Savva C, Constantinou A, Pamboris GM, Ploutarchou G, Kyriakou P, Rentzias P, Karagiannis C, Korakakis V. Acute Effects of Blood Flow Restriction on Shoulder Pain and Strength in Nonspecific Shoulder Pain-A Randomised Crossover Trial. J Pain. 2026 Oct 16:106472. doi: 10.1016/j.jpain.2026.106472. Online ahead of print.
PubMed 42887660Pavlou K, Savva C, Korakakis V, Pamboris GM, Karagiannis C, Ploutarchou G, Constantinou A. Blood Flow Restriction Training in Nonspecific Shoulder Pain: Study Protocol of a Crossover Randomised Controlled Trial. Sports (Basel). 2023 Oct 9;11(10):197. doi: 10.3390/sports11100197.
PubMed 37888524
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hypoalgesic Effects of BFR Training in Nonspecific Shoulder Pain. A Study Protocol of a Crossover Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05956288
- Acronym / sponsor ID
- EUC
- Conditions
- Shoulder Pain, BFR, Shoulder Impingement
- Keywords
- Shoulder pain, BFR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 21 Jul 2023 (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 primary objective of the present study is to evaluate if a single acute BFR low load- exercise bout would reduce pain in patients with nonspecific shoulder pain and whether the potential hypoalgesia will be maintained after a 45-minute physical therapy shoulder exercise session. BFR exercise will be compared to a sham BFR exercise protocol. We hypothesize that the participants in the BFR group in will experience reduced pain and will be able to complete a scapula and rotator cuff muscles exercise loading program with reduced pain until the end of the exercise program.
Detailed description
Shoulder pathologies are the 3rd most common musculoskeletal condition encountered by health professionals in their day-to-day clinical practice, followed by low back pain and neck pain. It is noteworthy that approximately 40%-54% of patients report ongoing pain lasting between 1-3 years , causing a huge economic burden both on the national health care system but also to the patients. The pathologies associated with development of shoulder pain are numerous, however, in recent years the research community dealing with musculoskeletal shoulder pain has emphasized the need to break free from diagnostic terminologies that refer to precise clinical diagnosis, since such a thig is nearly impossible to happen, due to the low validity and diagnostic accuracy of the special tests available to the clinician. In addition, the need to detach from diagnostic labels becomes even more intense if one takes into account the inability to correlate symptoms and clinical status with pathological findings in diagnostic tests. Nonspecific shoulder pain is an umbrella term that includes non-traumatic musculoskeletal disorders of the shoulder.
Therapeutic exercise is the mainstay of conservative treatment and appears to be a powerful tool in the hands of clinicians to improve pain, mobility, and function of the shoulder in individuals with nonspecific shoulder pain . There are several mechanisms that are hypothesized to explain the benefits of exercise in nonspecific shoulder pain. The neuromuscular mechanism is the most frequently mentioned and is commonly explained as strengthening of the rotator cuff inhibiting pain. Other mechanisms proposed are: tissue factors (e.g. tendon remodeling, blood flow improvement etc.), neuro-endocrine-immune (e.g. exercise induced hypoalgesia, central and peripheral nervous system adaptations etc) and physiological mechanisms (e.g. improvements in self-efficacy and coping with pain etc).
The BFR method is a type of training with parallel partial restriction of arterial inflow and complete venous outflow restriction in muscle tissue that is usually combined with parallel execution of low-load resistance exercises. Blood flow restriction is achieved by using special cuffs applied to both the upper and lower extremities. During the last decade the popularity of this technique seems to be growing rapidly due to its beneficial effects on increasing muscle strength and muscle hypertrophy in healthy adults and clinical population but also its acute hypoalgetic effect on healthy population by significantly increasing the patient pain thresholds. However, to date there is only one published study examining the acute hypoalgetic effects of BFR training in a clinical population, showing beneficial adaptations in reducing pain in people with patellofemoral pain
The primary objective of the present study is to evaluate if a single acute BFR low load- exercise bout would reduce pain in patients with nonspecific shoulder pain and whether the potential hypoalgesia will be maintained after a 45-minute physical therapy shoulder exercise session. BFR exercise will be compared to a sham BFR exercise protocol. We hypothesize that the participants in the BFR group in will experience reduced pain and will be able to complete a scapula and rotator cuff muscles exercise loading program with reduced pain until the end of the exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction (BFR) with low load resistance training | Experimental | Device: Blood flow restriction (BFR) with low load resistance trainingA single BFR exercise (Biceps curl with dumbell) will be perform. The initial resistance load for performing the above exercise will correspond to 5% of the body weight of each participant (±0.250 kg). Participants will be asked to perform 4 sets of bicep curls. The first set will consist of repetitions until failure (inability to follow the rhythm or inability to perform an additional contraction) followed by 3 sets of 15 repetitions with 30 seconds rest between sets. In case that for any of the participants will not be able to complete all the repetitions, or they are unable to follow the pace of the metronome, the resistance load will be reduced by 0.5 kg. Vascular Occlusion Pressure will be set at 50-60% of the complete occlusion pressure for the intervention group .Five minutes after the execution of the biceps curl exercise, each participant will receive a specific training which will consist of six therapeutic exercises targeting in loading the rotator cuff and scapula muscles |
| Sham-Blood flow restriction (sham-BFR) with low load resistance training | Placebo comparator | Device: Blood flow restriction (BFR) with low load resistance trainingSame procedure as experimental . The only difference between the two groups regarding the intervention will be the percentage of blood flow restriction cuff pressure. In the sham BFR group, as much pressure as 2 fingers can penetrate the cuff will be automatically applied via MADUP®, where based on the literature seems not to promote adaptations related to the use of the method. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age >18≤40 years considering that the prevalence for degenerative rotator cuff tendinopathy increases from the age of 40 and above
- Shoulder pain intensity > 4/10 NPRS when performing active glenohumeral abduction and/or isometric resistance to glenohumeral external rotation from 0° of abduction.
- Duration of symptoms > 3 weeks (to avoid an inflammatory clinical picture).
Key exclusion criteria (20 listed)
- Positive drop arm test (important indication for rotator cuff tear)
- Cervical radiculopathy having a positive specific spurling test or neurological symptoms in the upper limb
- Passive deficit in range of motion (ROM) > 2 levels of motion, where according to the literature it is an indication of frozen shoulder
- Body Mass Index (BMI) > 28
- Previous shoulder surgery
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 |
|---|---|---|
| Blood flow restriction (BFR) with low load resistance trainingCombination of low load resistance exercise in the upper limb with the addition of blood flow restriction or sham-blood flow restriction. | Device | Blood flow restriction (BFR) with low load resistance training, Sham-Blood flow restriction (sham-BFR) with low load resistance training |
Primary outcome
Pressure pain detection threshold assessment
Time frame: Baseline
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Pressure pain detection threshold assessment
Time frame: 15 minutes (1st session)
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Pressure pain detection threshold assessment
Time frame: 1 hour (1st session)
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Pressure pain detection threshold assessment
Time frame: 2nd session (> 72 hours after 1st session)
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Pressure pain detection threshold assessment
Time frame: 15 minutes (2nd session)
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Pressure pain detection threshold assessment
Time frame: 1 hour (2nd session)
PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas
Maximal pain and strength in isometric shoulder external rotation
Time frame: Baseline
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Maximal pain and strength in isometric shoulder external rotation
Time frame: 15 minutes (1st session)
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Maximal pain and strength in isometric shoulder external rotation
Time frame: 1 hour (1st session)
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Maximal pain and strength in isometric shoulder external rotation
Time frame: 2nd session (> 72 hours after 1st session)
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Maximal pain and strength in isometric shoulder external rotation
Time frame: 15 minutes (2nd session)
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
Maximal pain and strength in isometric shoulder external rotation
Time frame: 1 hour (2nd session)
The MVIC of shoulder external rotation will be assessed using a hand held dynamometer. Additionally, the maximum value from 3 successful trials (no >15% difference between the 3 trials) will be used for statistical analysis. In addition, participants will be asked to rate their pain based on the NPRS scale (0-10) during the test.
15 secondary outcomes
Pain during active shoulder Abduction
Time frame: Baseline (1st session)
Pain during active shoulder Abduction
Time frame: 15 minutes (1st session)
Pain during active shoulder Abduction
Time frame: 1 hour (1st session)
Pain during active shoulder Abduction
Time frame: 2nd session (> 72 hours after 1st session)
Pain during active shoulder Abduction
Time frame: 15 minutes (2nd session)
Pain during active shoulder Abduction
Time frame: 1 hour (2nd session)
Patient-perceived pain change
Time frame: 15 minutes (1st session)
Patient-perceived pain change
Time frame: 1 hour (1st session)
Patient-perceived pain change
Time frame: 2nd session (> 72 hours after 1st session)
Patient-perceived pain change
Time frame: 15 minutes (2nd session)
Patient-perceived pain change
Time frame: 1 hour (2nd session)
Shoulder Pain and Disability Index (SPADI) questionnaire
Time frame: Baseline
Shoulder Pain and Disability Index (SPADI) questionnaire
Time frame: 2nd session (> 72 hours after 1st session)
Participant's rating of perceived exertion (RPE)
Time frame: 15 minutes (1st session)
Participant's rating of perceived exertion (RPE)
Time frame: 15 minutes (2nd session)
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 17 Dec 2024.
- Derived from this study: PubMed 42887660Pavlou K, Savva C, Constantinou A, Pamboris GM, Ploutarchou G, Kyriakou P, Rentzias P, Karagiannis C, Korakakis V. Acute Effects of Blood Flow Restriction on Shoulder Pain and Strength in Nonspecific Shoulder Pain-A Randomised Crossover Trial. J Pain. 2026 Oct 16:106472. doi: 10.1016/j.jpain.2026.106472. Online ahead of print.
- Derived from this study: PubMed 37888524Pavlou K, Savva C, Korakakis V, Pamboris GM, Karagiannis C, Ploutarchou G, Constantinou A. Blood Flow Restriction Training in Nonspecific Shoulder Pain: Study Protocol of a Crossover Randomised Controlled Trial. Sports (Basel). 2023 Oct 9;11(10):197. doi: 10.3390/sports11100197.
- Individual participant dataSharing planned: Undecided
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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 Blood flow restriction (BFR) with low load resistance training in people with Shoulder Pain and BFR, run by European University Cyprus at 1 site in Cyprus.
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 20 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 17 Dec 2024. 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 Cyprus. 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?
Pressure pain detection threshold assessment (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT05956288, which also lists 2 linked publications.
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 17 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.