This study aims to compare the effects of blood flow restriction training and routine physical therapy on clinical and functional outcomes in patients with lateral epicondylitis.
Design
Parallel groups randomized clinical trial with blinded outcome assessment
Settings and conduct
This clinical trial is conducted at Wasim General & Orthopaedic Hospital Gojra. The patients in control group have received routine physical therapy treatment including application of TENS, moist heat pad and stretching exercises (06 reps with10 secs hold) and strengthening exercises (10 reps with 10 secs of resistance application). The patients in experimental group have received blood flow restriction resistance training in addition to routine physical therapy treatment. In this training, limb occlusion pressure (LOP) is measured of affected upper limb. BP cuff is applied at deltoid level to restrict the blood flow at 30% LOP and then patient is asked to perform resistance exercises in 04 sets with 30 reps in 1st set and 15 reps in other 03 sets. Each participant(of both group)has 03 session per week for 06 weeks. Only data assessor is blinded.
Participants/Inclusion and exclusion criteria
Patients of both genders having diagnosed unilateral tennis elbow in 20-50 years of age are included in the study.
Patients who received steroid injections for tennis elbow in last 06 months, patients having cardiovascular diseases, bleeding disorders, peripheral diseases, hypertension, hypotension, tumor, trauma, systematic or skin diseases are excluded from the study.
Intervention groups
There are two intervention groups. The control group is receiving routine physical therapy treatment alone and experimental group is receiving blood flow restriction training along with routine physical therapy treatment.
Main outcome variables
The study outcome variables are pain, range of motion, functional disability and quality of life.
General information
Reason for update
Acronym
BRF Training
IRCT registration information
IRCT registration number:IRCT20220904055878N1
Registration date:2022-11-30, 1401/09/09
Registration timing:retrospective
Last update:2022-11-30, 1401/09/09
Update count:1
Registration date
2022-11-30, 1401/09/09
Registrant information
Name
Syeda Ambrin Naz
Name of organization / entity
.
Country
Pakistan
Phone
+92 305 6389206
Email address
msptm02183017@student.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-01, 1401/03/11
Expected recruitment end date
2022-07-31, 1401/05/09
Actual recruitment start date
2022-07-18, 1401/04/27
Actual recruitment end date
2022-08-20, 1401/05/29
Trial completion date
2022-10-20, 1401/07/28
Scientific title
Effects of blood flow restriction training and routine physical therapy on clinical outcomes in patients with lateral epicondylitis
Public title
Blood Flow Restriction Training Treatment in Tennis Elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with unilateral tennis elbow
20-50 years of age among both genders
Exclusion criteria:
Patients who received steroid injections for tennis elbow in last 06 months
Cardiovascular diseases
Bleeding disorders and peripheral vascular diseases
History of hypertension or hypotension
Tumor
Trauma
Systematic diseases
Skin diseases
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Concealed envelops were used for the randomization of the participants into intervention and control groups
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor and data analyzer are blinded by labelling the experimental and control groups with unidentifying symbols
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee The University of Lahore
Street address
1-Km Defence Road, near Bhuptian Chowk, Lahore, Punjab, Pakistan
City
Lahore
Postal code
54590
Approval date
2022-07-18, 1401/04/27
Ethics committee reference number
REC-UOL-/174-07/2022
Health conditions studied
1
Description of health condition studied
The Lateral Epicondylitis (Tennis Elbow)
ICD-10 code
M77.1
ICD-10 code description
Tennis Elbow, Lateral Epicondylitis, Blood Flow Restriction Training Treatment
Primary outcomes
1
Description
Pain
Timepoint
At the baseline, at the end of 3rd week, at the end of 6th week
Method of measurement
Visual Analogue Pain Scale
2
Description
Ranges of Motion (including wrist flexion, wrist extension, supination, pronation and elbow flexion)
Timepoint
At baseline, at the end of 3rd week and at the end of 6th week
Method of measurement
Goniometer
3
Description
Functional Disability
Timepoint
At the baseline, at the end of 3rd week and at the end of 6th week