The Hypoalgesic Effects of BFR Training in Nonspecific Shoulder Pain.

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05956288
• Other study ID #: EUC
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: European University Cyprus
• Contact: Kyriakos Pavlou, PhD(cand.)
• Phone: +35797656596
• Email: kyr.pavlou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: October 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Adults presenting with nonspecific shoulder pain will be recruited using the following eligibility criteria:

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Shoulder Impingement
• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

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.

Locations

Country	Name	City	State
Cyprus	European University	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
European University Cyprus

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure pain detection threshold assessment	PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas	Baseline
Primary	Pressure pain detection threshold assessment	PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas	15 minutes (1st session)
Primary	Pressure pain detection threshold assessment	PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas	1 hour (1st session)
Primary	Pressure pain detection threshold assessment	PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas	2nd session (> 72 hours after 1st session)
Primary	Pressure pain detection threshold assessment	PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas	15 minutes (2nd session)
Primary	Pressure pain detection threshold assessment	PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas	1 hour (2nd session)
Primary	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.	Baseline
Primary	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.	15 minutes (1st session)
Primary	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.	1 hour (1st session)
Primary	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.	2nd session (> 72 hours after 1st session)
Primary	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.	15 minutes (2nd session)
Primary	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.	1 hour (2nd session)
Secondary	Pain during active shoulder Abduction	Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale	Baseline (1st session)
Secondary	Pain during active shoulder Abduction	Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale	15 minutes (1st session)
Secondary	Pain during active shoulder Abduction	Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale	1 hour (1st session)
Secondary	Pain during active shoulder Abduction	Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale	2nd session (> 72 hours after 1st session)
Secondary	Pain during active shoulder Abduction	Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale	15 minutes (2nd session)
Secondary	Pain during active shoulder Abduction	Pain during active shoulder abduction (0 to 180°) in standing in a NPRS scale	1 hour (2nd session)
Secondary	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)	15 minutes (1st session)
Secondary	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)	1 hour (1st session)
Secondary	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)	2nd session (> 72 hours after 1st session)
Secondary	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)	15 minutes (2nd session)
Secondary	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)	1 hour (2nd session)
Secondary	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).	Baseline
Secondary	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).	2nd session (> 72 hours after 1st session)
Secondary	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 ).	15 minutes (1st session)
Secondary	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 ).	15 minutes (2nd session)