Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06457542 |
| Other study ID # |
TUF\DR\SA\MSPP\2024\384 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 17, 2024 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
June 2024 |
| Source |
University of Faisalabad |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Shoulder impingement syndrome is primary cause of discomfort and restricted range of motion
while reaching above in shoulder region. It is third most common illness affecting
musculoskeletal system. The aim of this study will be to analyse comparative effects of
active release technique and soft tissue mobilization on pain, range of motion and disability
in shoulder impingement syndrome. The study will be a randomized clinical trial. A random
sample of 40 subjects with shoulder impingement from Allied hospital, Faisalabad will be
evaluated. Subjects who will meet selection criteria will be allocation into two groups by
computerized generated allocation method. In addition to ultrasound as baseline treatment
group a will receive active release technique while in group B soft tissue mobilization will
be administrated for 4 weeks. Treatment session will be 12 session (3 sessions in one week).
Baseline, at 2nd week and at 4th week of treatment pain, shoulder elevation, external
rotation and shoulder disability will be measure by VAS, goniometer and SPADI. For, data
analysis, we will use SPSS software version 23. Data was interrupted through independent t
test and repeated measurements ANOVA.
Description:
STUDY DESIGN A Randomized Clinical Trial was conducted. SETTING The data of this study was
collected from OPD of
- Allied Hospital Faisalabad
- District Headquarter Hospital Faisalabad STUDY DURATION The investigation will be
concluded within duration of 4 months subsequent to the acceptance of the synopsis.
STUDY POPULATION Individuals with shoulder impingement syndrome. SAMPLING TECHNIQUE Random
Sampling technique
SAMPLE SIZE For size of sample calculation open epi-tool was used by taking overhead reach as
main outcome measure (32), and the sample size calculated is 40. These 40 participants were
then divided in 2 groups (Group A=20 and group 20). 6 patients will be drop out.
INFORMED CONSENT A signed informed consent from was obtained from the participants before
inclusion into the study as it was one of selection criteria. Before obtaining consent all
patients in both groups were clearly informed about nature, objectives and duration of study
and were assured that their data would not be used for any commercial purpose.
ENROLLENT Availability of signed consent from was considered as the criteria for enrollment
to study.
DATA COLLECTION TOOls Visual analogue scale The visual analogue scale will be used to
evaluate the level of pain. VAS is dependable besides accurate self-assessment tool that
comprises a 10 cm long horizontal line. The scores on this scale range from zero (indicating
the absence of pain) to ten (representative the most severe pain possible). The participants
were instructed to provide information on the highest level of discomfort they had
encountered over the last twenty-four hours. A change of 1.5 points was deemed as the MCID
for the Visual Analogue Scale (VAS) The Shoulder Pain and Disability Index (SPADI) is a
self-administered survey considered to evaluate the level of pain besides functional
impairment caused by shoulder disease. Assessment has a total of thirteen items, divided into
two subscales: a pain subscale consisting of five items, and a disability subscale consisting
of eight items. The SPADI values ranges from zero to hundred, through a higher number
representative a higher level of impairment and disability. Persian iteration of the SPADI
questionnaire was used as a dependable and accurate tool, and shown sensitivity to
therapeutic modifications in individuals through shoulder ailments. The analysis included the
SPADI-pain score, SPADI-disability score, and SPADI-total score. The SPADI total score has
been reported to have a MCID ranging from 8 to 13.
Goniometer ROM of the shoulder will be assessed by using a goniometer. The standardized
goniometric measures demonstrated excellent consistency within the same rater. The upper
limits for shoulder elevation as well as external rotation will be determined.
The patients will be instructed to do maximal range of motion exercises for all arm motions,
disregarding any discomfort experienced. The participants will assume a supine position on an
examination table during the whole range of movements. Their hips and knees were flexed at an
angle of roughly 45°, ensuring that their feet remained level on the table to avoid any
curvature of their backs. The elevation was achieved by fully extending the elbow and leading
with the thumb. Rotation will be assessed when the shoulder was positioned at a 90° angle of
abduction and the elbow was flexed at a 90° angle. Additionally, the forearm will maintain in
a neutral position of supination.
SCREENING TESTS Hawkins Kennedy test The Hawkins Kennedy exam will be administered to the
patients. The patients will stand with their elbows bent to 90 degrees and their shoulders
flexed to 90 degrees, the examiner performs, through passively applying an internally
rotation force to arm. A positive result is obtained if the pain is experienced Neer test The
sensitivity of this test is 72% and the specificity is 60%. In order to execute the maneuver,
the therapist stabilizes the scapula, aligns the arm with the plane of the scapula, and then
raises the arm without any active effort from the individual. A positive test result occurs
when pain is triggered due to the impingement of the larger tuberosity on the acromion,
specifically at an angle between 70 and 110 degrees.
DATA COLLECTION PROCEDURE Subject will screen on basis of inclusion and exclusion criteria.
Individuals who have positive screening test and sign consent form will be allocation in to
two groups by computerized generated allocation method. Both Group A and B will be given US
(Ultrasound) therapy to the subscapularis muscle insertion at the shoulder region, as a
baseline treatment. The frequency used is 3 MHz, the intensity used was 0.5 watt/ Cmsq, and
the time of the treatment of US was 10 minutes In addition to ultrasound as baseline
treatment group a will receive active release technique while in group B soft tissue
mobilisation will be administrated for 4 weeks. Treatment session will be 12 session (3
sessions in one week). Baseline, at 2nd week and at 4th week of treatment pain, shoulder
elevation, external rotation and shoulder disability will be measure by VAS, goniometer and
SPADI.
TREATMENT PLAN Active release technique (ART) Group A will undergo active release therapy,
which involves instructing the patient to sit and then positioning their shoulder in
90-degree abduction. The therapist will provide assistance to the patient's arm and then
examine the supraspinous fossa by applying pressure with a finger. The patient will be
instructed to gradually bring the arm towards the body as the therapist manipulates the
muscle plane. This procedure should be repeated for a duration of 10 minutes, 3 times per
week, over a duration of four weeks.
Soft tissue mobilization (STM) Group B will receive soft tissue mobilization (STM) targeting
the subscapularis muscle. The participants will be placed in a position where their upper arm
bone (humerus) is raised at a 45° angle, with the elbow bent at a 90° angle. Additionally,
the humerus will be rotated outward to a position that is normally around 20° to 25° of
external rotation. The subscapularis muscle remained examined by touch in the armpit area to
locate regions of limited mobility due to myofascial limitations, trigger points or tense
bands. The identified limitations remained addressed with STM, which included applying
prolonged manual pressure and slow deep stroke to the subscapularis myofascial. This
treatment was performed for a period of 7 minutes, three times a week, over a period of four
weeks SCHEDULE FOR MEASURING OUTCOMES First at baseline then at 2nd week and at 4th week of
treatment.
FOLLOW-UPS AND TREATMENT SESSIONS:
Total 12 treatment sessions were done, 3 sessions in one week. STATISTICAL ANALYSIS Using
version 23 of SPSS, we will evaluate all of the data. The Shapiro-Wilk test and kurtosis,
skewness will be used to evaluate the assumption of data normality. If the data is normally
distributed, a parametric test will be used; otherwise, a nonparametric test will be used if
the data does not meet the normality assumption.
The current study shows the effects of active release technique (ART) over soft tissue
mobilization (STM).The aim of this study was to find out the effects of active realease
technique, to find out the effects of soft tissue mobilization and to compare the effects of
active release technique and soft tissue mobilization for the patients with shoulder
impingment syndrome. This study was a randomized clinical trail (RCT) conducted on a sample
convenient sample of 34 shoulder impingment syndrome patients reporting at Allied Hospital
Faisalabad from Febuary, 2024 till April, 2024. This study was a Randomized Clinical Trial
(RCT) included patients of shoulder impingment syndrome (SIS) selected on the basis on
inclusion criteria, patient included into study after filling assessment form that was formed
on the basis of inclusion and exclusion criteria, consent was taken from patient and after
assessment of patients were randomly allocated into two groups i.e. Group A (Active Release
Technique) and Group B (Soft Tissue Moblization). Both groups were followed for the duration
of one month, 12 treatment sessions was done. Data collected from the patients were, shoulder
pain, ROM of shoulder elevation, external rotation and SPADI questionnaire. Treatment was
done to check the effects of interventions for reduction pain and improvement of functional
abilities and range of motion of patients of shoulder impingment syndrome, one questionnaire
were used for evaluation of pain and functional activities, visual analogue scale for pain,
gonimeter for ROM. Primary outcome i.e pain were taken 3 times i.e. at baseline, at 2nd week
and after 4th week, while secondary outcome i.e. function and ROM were taken at baseline, at
2nd week and at 4th week. Both treatments are equally effective in decreasing pain and
disability. The active release technique and soft tissue mobilization have previously been
used for the cure of shoulder pain in clinical settings and in several research studies and
always been considered as the best treatment protocol for shoulder pain.
