The Hypoalgesic Effects of BFR Training in Nonspecific Shoulder Pain.

NCT05956288 | Completed

• 1 other identifier: EUC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Pain; BFR; Shoulder Impingement

Keywords

Shoulder pain; BFR

Outcome Measures

Primary Outcomes (12)

• Pressure pain detection threshold assessment

  PPDT's will assess using a hand-held mechanical pressure algometer in local and remote areas

  Baseline

• 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)

• 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)

• 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)

• 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)

• 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)

• 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

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (15)

• Pain during active shoulder Abduction

  Baseline (1st session)

• Pain during active shoulder Abduction

  15 minutes (1st session)

• Pain during active shoulder Abduction

  1 hour (1st session)

• Pain during active shoulder Abduction

  2nd session (> 72 hours after 1st session)

• Pain during active shoulder Abduction

  15 minutes (2nd session)

Study Arms (2)

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

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.

Device: Blood flow restriction (BFR) with low load resistance training

Interventions

Blood flow restriction (BFR) with low load resistance training DEVICE

Combination of low load resistance exercise in the upper limb with the addition of blood flow restriction or sham-blood flow restriction.

Blood flow restriction (BFR) with low load resistance training; Sham-Blood flow restriction (sham-BFR) with low load resistance training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• European University Cyprus: lead

Study Sites (1)

European University

Nicosia, 2404, Cyprus

Location

Related Publications (1)

• Pavlou 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.

  PMID: 37888524 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 21, 2023
• Study Start: February 27, 2024
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

CY (1)