Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis

NCT06019780 | Completed

• 1 other identifier: RiphahIU Hina Yasmeen
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis

Keywords

Adhesive capsulitis; Blood flow restriction training; Range of motion

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• shoulder flexion

  baseline to 8 weeks

• Shoulder extension

  baseline to 8 weeks

• shoulder abduction

  baseline to 8 weeks

• shoulder adduction

  baseline to 8 weeks

• shoulder internal rotation

  baseline to 8 weeks

Study Arms (2)

Experimental interventional group A (Blood flow restriction training)

EXPERIMENTAL

Following exercise will be performed 1. Side lying external rotation 2. Prone horizontal abduction 3. Standing scaption with pneumatic cuff for blood flow restriction

Other: blood flow restriction trainin

Control group B

ACTIVE COMPARATOR

Following exercise will be performed 1. Side lying external rotation 2. Prone horizontal abduction 3. Standing scaption without blood flow restriction

Other: exercise

Interventions

blood flow restriction trainin OTHER

Following exercise will be performed 1. Side lying external rotation 2. Prone horizontal abduction 3. 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.

Experimental interventional group A (Blood flow restriction training)

exercise OTHER

Following exercises will be performed without application of pneumatic cuff 1. Side lying external rotation 2. Prone horizontal abduction 3. 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)

Control group B

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Shahab orthopedic general hospital

Peshawar, KPK, 46000, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aisha Razzaq, MSPT-OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: August 31, 2023
• Study Start: September 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 25, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)