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Completed

NCT Number: NCT06019780

Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis

The aim of this research is to determine the effect of blood flow restriction training on shoulder pain, range of motion, muscle strength and shoulder. Randomized controlled trials will be done at Lady Reading Hospital Peshawar and Shahab Orthopedic General Hospital. The sample size is 36. The subjects will be divided in two groups, 18 subjects in BFR group and 18 in no BFR group. Study duration is 6 months. Sampling technique applied was non probability connivance sampling technique. Tools used in the study are SPADI shoulder score, NPRS, hand held dynamometer, sphygmomanometer and goniometer.

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shahab orthopedic general hospital

Peshawar, KPK, 46000, Pakistan

About this study

Frozen shoulder is painful shoulder condition associated with stiffness and shoulder disability. It is associated with reduction in forward elevation and marked external rotation. Frozen shoulder is common condition effecting population between ages 30 to 60 years. Prevalence is more common in women than on men There are four stages of adhesive capsulitis, stage1, stage 2 (freezing stage), stage 3 (frozen stage) and stage 4 (thawing stage). Patient have sharp pain at end range of motion, sleep disturbances and early loss of external rotation. When compared to asymptomatic subjects, patients with adhesive capsulitis have higher upper trapezius to lower trapezius EMG ratios during arm elevation, indicating a muscular imbalance. The scapula eventually migrates upward before 60 degrees of abduction in individuals with adhesive capsulitis, resulting in the recognizable "shrug sign" during shoulder elevation.

Blood flow is restricted in a controlled form of vascular occlusion using external tourniquet. A recent study demonstrated that augmentation of low load resistance with blood flow restriction (L-L BFR) to contractile tissue can produce hypertrophy and strength gains, using loads as low as 30% 1RM. BFR exercise may stimulate skeletal muscle growth and strength gains through a number of different methods. These could include an increase in hormone levels, an increase in the motor pathway or other intracellular signaling pathways for muscle protein synthesis, an increase in satellite cell activity biomarkers, and apparent patterns in fibre type recruitment.

The purpose of this study is to provide the effects of blood flow restriction training on shoulder discomfort, range of motion, muscle strength and disability in patients with adhesive capsulitis. Due to pain and decrease range of motion individual with adhesive capsulitis experience muscle weakness in shoulder joint. Blood flow restriction training has positive effect on improvement of muscle strength and range of motion in shoulder region. Blood flow restriction training has also positive effect on bone healing and bone density. Therefore the study is aimed to improve the muscles strength and capsule inflammation in individual with adhesive capsulitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Frozen shoulder (stage 2 and 3 of Kisner and Colby's classification system)
  • Male and female
  • Patients whose age lies between 40 and 60
  • Ranges restriction in forward flexion (scaption) less than 100 degree and reduction of external and internal rotation to less than 50% of the normal

Exclusion criteria

  • • History of Cardiovascular diseases
  • DVT patients
  • Hypertensive patients
  • Patients having neurological disease
  • Fracture of humerus

Treatment and study plan

blood flow restriction trainin

Other

Following exercise will be performed

  • Side lying external rotation
  • Prone horizontal abduction
  • Standing scaption İndividual in the group will be having two session per week, 16 session of exercise training for 8 weeks.50% of arterial occlusion pressure (60 to 80 mmHg) will be applied for total duration of 15mins. Occlusion pressure will be calculated according to formula for each patient [Pressure=0.4x(systolic BP)+2.7x(shoulder circumference)+62].4 sets with one set of 30 repetition and three sets of 15 repetition. After each set subject will have 30 seconds of rest with cuff inflated.

Exercise

Other

Following exercises will be performed without application of pneumatic cuff

  • Side lying external rotation
  • Prone horizontal abduction
  • Standing scaption Conventional treatment will include: Hot pack 5 mins Maitland grade 3 and 4 mobilization: inferior glide (10reps x3sets), posterior glide (10reps x 3sets), anterior glide (10 reps x 3sets) Home plan: wand exercise, pendulum exercise, wall walking exercise (10reps x 2sets each)

Primary outcomes

  1. shoulder apin

    Time frame: baseline to 4th to 8 weeks

    the shoulder pain will be measured by NPRS, it has 11 points with 0 no pain and 10 extreme pain.

  2. Shoulder flexors strength

    Time frame: baseline to 8 weeks

    this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply flexion force against isometric resistance.

  3. Shoulder extensors strength

    Time frame: baseline to 8 weeks

    this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply extension force against isometric resistance.

  4. Shoulder abductors strength

    Time frame: baseline to 8 weeks

    this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply abduction force against isometric resistance.

  5. Shoulder rotation strength

    Time frame: baseline to 8 weeks

    this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply rotation force against isometric resistance.

  6. Shoulder disability (SPADI)

    Time frame: baseline to 8 weeks

    measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.

Secondary outcomes

  1. shoulder flexion

    Time frame: baseline to 8 weeks

    measures the shoulder flexion range of motion through goniometry

  2. Shoulder extension

    Time frame: baseline to 8 weeks

    measures the shoulder extension range of motion through goniometry

  3. shoulder abduction

    Time frame: baseline to 8 weeks

    measures the shoulder abduction range of motion through goniometry

  4. shoulder adduction

    Time frame: baseline to 8 weeks

    measures the shoulder adduction range of motion through goniometry

  5. shoulder internal rotation

    Time frame: baseline to 8 weeks

    measures the shoulder internal rotation range of motion through goniometry

  6. shoulder external rotation

    Time frame: baseline to 8 weeks

    measures the shoulder external rotation range of motion through goniometry

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2023
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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