Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

Official title:

Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019780
• Other study ID #: RiphahIU Hina Yasmeen
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 25, 2024

Study information

• Verified date: September 2023
• Source: Riphah International University
• Contact: Imran Amjad, PHD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 25, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Other:
• blood flow restriction trainin
Following exercise will be performed Side lying external rotation Prone horizontal abduction Standing scaption Individual 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
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)

Locations

Country	Name	City	State
Pakistan	Shahab orthopedic general hospital	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shoulder apin	the shoulder pain will be measured by NPRS, it has 11 points with 0 no pain and 10 extreme pain.	baseline to 4th to 8 weeks
Primary	Shoulder flexors strength	this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply flexion force against isometric resistance.	baseline to 8 weeks
Primary	Shoulder extensors strength	this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply extension force against isometric resistance.	baseline to 8 weeks
Primary	Shoulder abductors strength	this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply abduction force against isometric resistance.	baseline to 8 weeks
Primary	Shoulder rotation strength	this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply rotation force against isometric resistance.	baseline to 8 weeks
Primary	Shoulder disability (SPADI)	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.	baseline to 8 weeks
Secondary	shoulder flexion	measures the shoulder flexion range of motion through goniometry	baseline to 8 weeks
Secondary	Shoulder extension	measures the shoulder extension range of motion through goniometry	baseline to 8 weeks
Secondary	shoulder abduction	measures the shoulder abduction range of motion through goniometry	baseline to 8 weeks
Secondary	shoulder adduction	measures the shoulder adduction range of motion through goniometry	baseline to 8 weeks
Secondary	shoulder internal rotation	measures the shoulder internal rotation range of motion through goniometry	baseline to 8 weeks
Secondary	shoulder external rotation	measures the shoulder external rotation range of motion through goniometry	baseline to 8 weeks