Clinical trial NCT06019780: Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis
Official title: Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Adhesive capsulitis
Blood flow restriction training
Range of motion
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: shoulder apin
timeFrame: baseline to 4th to 8 weeks
measure: Shoulder flexors strength
timeFrame: baseline to 8 weeks
measure: Shoulder extensors strength
timeFrame: baseline to 8 weeks
measure: Shoulder abductors strength
timeFrame: baseline to 8 weeks
measure: Shoulder rotation strength
timeFrame: baseline to 8 weeks
measure: Shoulder disability (SPADI)
timeFrame: baseline to 8 weeks
Secondary outcomes:
measure: shoulder flexion
timeFrame: baseline to 8 weeks
measure: Shoulder extension
timeFrame: baseline to 8 weeks
measure: shoulder abduction
timeFrame: baseline to 8 weeks
measure: shoulder adduction
timeFrame: baseline to 8 weeks
measure: shoulder internal rotation
timeFrame: baseline to 8 weeks
measure: shoulder external rotation
timeFrame: baseline to 8 weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Shahab orthopedic general hospital
state: KPK
Study officials:
affiliation: Riphah International University
name: Aisha Razzaq, MSPT-OMPT
role: PRINCIPAL_INVESTIGATOR
References: