Anatomical Evaluation of Supraspinatus Through Ultrasonography and Biomechanical Measurements Following Different Combinations of Physical Therapies in Patients of Supraspinatus Tendinitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorSehat Medical Complex

About this trial

A randomized controlled trial will be conducted to get the expected outcomes. Patients of both gender groups with unilateral shoulder pain will be selected with age range 40-60 years from Sehat medical complex and randomly allocated into four groups (Group A, B, C and D) of two different trials (Trial I and Trial II). The sample size will be 120 patients for both trials. Musculoskeletal ultrasound, goniometry, pain pressure threshold, dynamometer and functional indices will be used to measure the tendon thickness, range of motion, pain, muscle strength and function level. The group A will get BFRT, Group B will get ESWT, group c will get the combination of both and group D will be the Control group (Routine physical therapy). In Trial II the group A will get BFRT, Group B will get Eccentric Training, Group C will get combination of both A \& B and group D will be control group. data will be collected at baseline, 4th week, 8th week and 12 week of interventions. For data analysis SPSS version 25 will be used. Repeated measures ANOVA will be applied to compare the quantitative data within and between the groups. Post-Hoc test Tukey and Bonferroni correction will be used. The level of significance will be set at 5% (P\<0.05).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

unilateral shoulder pain

both gender group

two positive tests of (Neer impingement test, Hawkins-Kendy test, Empty can test),

shoulder pain history up to 3 months

Disqualifiers

referred shoulder pain

limited shoulder ROM less then 90 degree

previous shoulder surgery, intra articular injection or nerve block last 6 months.

patient with 180 mmHg blood pressure/uncontrolled BP

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood flow Restriction therapy

    Other intervention

    BFRT 4 Sets of exercise with restriction cuff 30,15,15,15 with cable system pulley ESWT 10 minutes shocks of 2000 J/session

  • ESWT

    Device

    10 minutes shocks of 2000 J/session

  • Control

    Other intervention

    Electric heating pad (Besmed, Taiwan) 10 minutes, TENS (Comfy Stim, Taiwan Model #: EV-806) 10 minutes

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Group A (Blood Flow Restriction Therapy)Experimental treatment 1 intervention
Group B: Group B (Extracorporeal Shock wave therapy)Experimental treatment 1 intervention
Group C: Group C (Combination of BFRT+ESWT)Experimental treatment 2 interventions
Group D: Control Group DSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Shoulder Joint Range of Motion from 0-180 degree

shoulder joint ROM will be measured by Goniometer having 360 degree or inclinometer

Time frame
12 weeks
2

MSK Ultrasound for shoulder

tendon thickness in long (mm) and short axis (mm)

Time frame
12 weeks
3

Shoulder Functional scale

Quick-DASH (Quick-Disability of arm shoulder and hand) functional scale, it is 11 items scale with response range 0-5 on. 0 is no disability and 100 shows severe disability. The scale have 5 response options much worse, somewhat worse, unchanged, somewhat better, much better

Time frame
12 weeks
4

Shoulder Joint PAIN

NPRS 0-10 , 10 is the worse imaginable pain and 0 is no pain

Time frame
12 WEEKS

Secondary outcomes

Other outcomes

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