Clinical trial NCT04468594: Rigid Taping Versus Scapular Stabilizing Exercises in Subacromial Impingement Syndrome
Official title: The Effect of Rigid Taping Versus Scapular Stabilizing Exercises on Pain and Function in Patients With Shoulder Subacromial Impingement Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impingement Syndrome of Ankle
Keywords: Impingement Syndrome- rigid tape-scapular stabilizing
Lead sponsor: University of Hail
Sponsor class: OTHER
Collaborators: name: Taif University
First posted: 2020-07-13
Enrollment: 45
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized controlled trial
Primary purpose: TREATMENT

Brief summary: the current study tends to compare the effect of two different treatment techniques used in the rehabilitation of shoulder impingement syndrome. rigid tapping and scapular stabilizing exercises will be applied and the level of function and pain intensity will be measured before and after the intervention and at 3 months follow up. while both methods of treatment used previously, the comparison between their effects is not yet investigated and no data is available regarding the superiority of one over the other.

Detailed description: Patients will be recruited through a verbal and written announcement from the customers of a local out-patient clinic. The appropriate number of patients, diagnosed with SIS, who will meet the inclusion criteria and accept to sign a consent form will join the study.

patients will be assigned randomly into three equal groups using permuted blocks of variable sizes. The first group rigid tape (RT) group will receive rigid taping plus a standard physical therapy protocol. The second group scapular stabilizing exercises (SSE) group will receive scapular stabilizing exercises plus the same standard protocol, and the third group (control group) will receive the standard protocol only.

The inclusion criteria were: positive 4 out of the following clinical signs: empty can test, Hawkins sign, Neer' sign, tenderness upon palpation of the greater tuberosity of the humerus, and painful movement between 60°_ and 120°(painful arc) Patients will be excluded if they demonstrate a previous history of shoulder surgery, cervical spine involvement, upper-limb fracture, adhesive capsulitis, joint instability, intraarticular corticosteroids injections within the last 2 months During the first interview, all patients will be checked for inclusion criteria. then undergo baseline assessment for pain level using a validated version of the Visual Analog Scale (VAS). Moreover, the functional level of the shoulder will be assessed using shoulder pain and disability index (SPADI). SPADI is a valid and reliable scale. it has a score ranging from 0 (normal) to 100 (complete disability). Pain and functional level will be assessed again after the end of the treatment period and after 3 months (following up) 12 weeks-rehabilitation program will be implemented for all patients with a frequency of 3 sessions/week. The RT group will receive a bilateral rigid taping technique using zinc oxide tape and along with the protective tape. With the participant assuming a relaxed standing position, the tape will be applied bilaterally starting from the first to the last thoracic vertebra. then, a second tape will be applied to the scapula while it assumes a position of scapular depression and retraction. This tape will be applied bilaterally and extended from the midpoint of the spine of the scapula to the last thoracic vertebra. This taping was applied for 12 weeks and changes every 2 days (3times per week) In addition to the rigid tape, a standard physical therapy protocol will be introduced. This standard protocol will consist of progressive strengthening exercises for rotator cuff muscles. The resistance will be applied first by a red-colored elastic Thera-band. Then progressed, using the green-colored band. Each exercise will be performed 10 times /session, Self-stretching exercises for levator scapula, posterior deltoid, pectoralis minor, and latissimus dorsi muscles. Five repetitions of stretching will be performed for each muscle per session In addition to the standard protocol, the SSE group will receive scapular stabilizing exercises in the form of wall slides with squat, Wall push-ups with ipsilateral leg extension, lawnmower with diagonal squat, resisted retraction to scapula with opposite leg squat robbery with squat. ten repetitions / exercises/ session were performed .

The CG will receive the standard protocol only Statistical analysis: SPSS (Version 16) for Windows will be used to analyze the obtained data. Mean± SD and percentage of differences will be calculated.

the current study tends to compare the effect of two different treatment techniques used in the rehabilitation of SIS. Rigid tapping and scapular stabilizing exercises will be applied then the level of function, and pain intensity will be measured before and after the intervention and at 3 months follow-up.

Detailed Description: Patients will be recruited through a verbal and written announcement from the customers of a local out-patient clinic. the appropriate sample size of patients diagnosed with SIS who will meet the inclusion criteria will join the study after signing the consent form.

patients will be assigned randomly into three equal groups using permuted blocks. The first group (RTG) received rigid taping plus a standard physical therapy protocol. The second group (SSEG) received scapular stabilizing exercises plus the same standard protocol, and the third group (control group) received the standard protocol only The inclusion criteria were: positive 4 out of the clinical signs: empty can test, Hawkins sign, Neer' sign, tenderness upon palpation of the greater tuberosity of the humerus, and painful movement between 60°_ and 120°(painful arc) Subjects will be excluded if they have a previous history of shoulder surgery, cervical spine involvement, upper-limb fracture, adhesive capsulitis, joint instability, intraarticular corticosteroids injections within the last 2 months During the first interview, all subjects will be checked for inclusion criteria. Eligible subjects will be assessed for pain level using a validated version of the Visual Analog Scale (VAS). Moreover, the functional level of the shoulder will be assessed using shoulder pain and disability index (SPADI). It is a valid and reliable scale with a score ranging from 0 (normal) to 100 (complete disability). Pain and functional level were assessed again after the end of the treatment period and after 3months (following up) 12 weeks-rehabilitation program will be implemented for all participants with a frequency of 3 sessions/week. The RT group will receive a bilateral rigid taping technique using zinc oxide tape and along with the protective tape. With the participant assuming a relaxed standing position, the tape will be applied bilaterally starting from the first to the last thoracic vertebra. then, a second tape will be applied to the scapulae while it assumes a position of scapular depression and retraction. This tape will be applied bilaterally and extended from the midpoint of the spine of the scapula to the last thoracic vertebra. This taping will be applied for 12 weeks and will be changed every 2 days (3times per week) In addition to the rigid tape, a standard physical therapy protocol will be conducted. This protocol will consist of progressive strengthening exercises for rotator cuff muscles. The resistance was applied first by a red-colored elastic Thera-band. Then progressed, using the green-colored band. Each exercise will be performed 10 times /session,( Self-stretching exercises for levator scapula, posterior deltoid, pectoralis minor, and latissimus dorsi muscles. Five repetitions of stretching will be performed for each muscle per session In addition to the standard protocol, the SSE group will receive scapular stabilizing exercises in the form of wall slides with squat, Wall push-ups with ipsilateral leg extension, lawnmower with diagonal squat, resisted retraction to scapula with opposite leg squat robbery with squat. ten repetitions / exercises/ session were performed .

The CG will receive the standard protocol only Statistical analysis: SPSS (Version 16) for Windows will be used to analyze the obtained data. Mean± SD and percentage of differences will be calculated.

Eligibility criteria: Inclusion Criteria:

Subjects having positive results to at least 4 of the following tests:

1. Neer impingement sign
2. Hawkins sign
3. pain during supraspinatus empty can test
4. the painful arc between 60⁰_ and 120⁰
5. tenderness when palpating the greater tuberosity of the humerus -

Exclusion Criteria:

Subjects will be excluded if they have;

* cervical spine involvement;
* the presence of a glenohumeral joint adhesive capsulitis, or instability;
* a history of previous shoulder surgery;
* upper-limb fracture;
* had systemic illnesses,
* receiving another physiotherapy treatment of this disorder in the past 6 weeks; or
* receiving steroid injection into or around the shoulder in the past 2 months.

Primary outcomes:
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from Baseline Shoulder pain and function at 3 months"
Secondary outcomes:
measure: pain (visual analouge scale)
timeFrame: Change from Baseline Shoulder pain at 3 months"
Other outcomes:
Locations:
city: Ha'il
country: Saudi Arabia
facility: University of Hail
state: Hail
Study officials:
affiliation: physical therapy dep, College of Applied Medical Sciences, Taif University, S.A
name: Ibrahim M dewir, Assist .prof
role: PRINCIPAL_INVESTIGATOR
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