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Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
blood flow restriction trainin
exercise
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive capsulitis, Blood flow restriction training, Range of motion

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shahab orthopedic general hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental interventional group A (Blood flow restriction training)

Control group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

shoulder flexion
measures the shoulder flexion range of motion through goniometry
Shoulder extension
measures the shoulder extension range of motion through goniometry
shoulder abduction
measures the shoulder abduction range of motion through goniometry
shoulder adduction
measures the shoulder adduction range of motion through goniometry
shoulder internal rotation
measures the shoulder internal rotation range of motion through goniometry
shoulder external rotation
measures the shoulder external rotation range of motion through goniometry

Full Information

First Posted
August 26, 2023
Last Updated
September 14, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06019780
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
February 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive capsulitis, Blood flow restriction training, Range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental interventional group A (Blood flow restriction training)
Arm Type
Experimental
Arm Description
Following exercise will be performed Side lying external rotation Prone horizontal abduction Standing scaption with pneumatic cuff for blood flow restriction
Arm Title
Control group B
Arm Type
Active Comparator
Arm Description
Following exercise will be performed Side lying external rotation Prone horizontal abduction Standing scaption without blood flow restriction
Intervention Type
Other
Intervention Name(s)
blood flow restriction trainin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
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 Outcome Measure Information:
Title
shoulder apin
Description
the shoulder pain will be measured by NPRS, it has 11 points with 0 no pain and 10 extreme pain.
Time Frame
baseline to 4th to 8 weeks
Title
Shoulder flexors strength
Description
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply flexion force against isometric resistance.
Time Frame
baseline to 8 weeks
Title
Shoulder extensors strength
Description
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply extension force against isometric resistance.
Time Frame
baseline to 8 weeks
Title
Shoulder abductors strength
Description
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply abduction force against isometric resistance.
Time Frame
baseline to 8 weeks
Title
Shoulder rotation strength
Description
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply rotation force against isometric resistance.
Time Frame
baseline to 8 weeks
Title
Shoulder disability (SPADI)
Description
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.
Time Frame
baseline to 8 weeks
Secondary Outcome Measure Information:
Title
shoulder flexion
Description
measures the shoulder flexion range of motion through goniometry
Time Frame
baseline to 8 weeks
Title
Shoulder extension
Description
measures the shoulder extension range of motion through goniometry
Time Frame
baseline to 8 weeks
Title
shoulder abduction
Description
measures the shoulder abduction range of motion through goniometry
Time Frame
baseline to 8 weeks
Title
shoulder adduction
Description
measures the shoulder adduction range of motion through goniometry
Time Frame
baseline to 8 weeks
Title
shoulder internal rotation
Description
measures the shoulder internal rotation range of motion through goniometry
Time Frame
baseline to 8 weeks
Title
shoulder external rotation
Description
measures the shoulder external rotation range of motion through goniometry
Time Frame
baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PHD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aisha Razzaq, MSPT-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahab orthopedic general hospital
City
Peshawar
State/Province
KPK
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aisha Razzaq, MSPT-OMPT
Phone
03015030784
Email
aisha.razzaq@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
HINA Yasmeen, MSPT-OMPT*

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis

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