NCT05956288

The Hypoalgesic Effects of BFR Training in Nonspecific Shoulder Pain.

The Hypoalgesic Effects of BFR Training in Nonspecific Shoulder Pain. A Study Protocol of a Crossover Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: European University Cyprus · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Shoulder Pain
• BFR
• Shoulder Impingement

Interventions

Type	Name	Description
DEVICE	Blood flow restriction (BFR) with low load resistance training	Combination of low load resistance exercise in the upper limb with the addition of blood flow restriction or sham-blood flow restriction.

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-11-21
• Completion: 2024-11-21
• First posted: 2023-07-21
• Last updated: 2024-12-17

Locations

1 site across 1 country: Cyprus