BSMWM: The Effect of Biomechanical Scapular Mobilization With Movement and Motor Learning

• Sponsor: Pharos University in Alexandria (Other)
• Overall Status: Completed
• CT.gov ID: NCT04701814
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

the study about new mobilization technique used in shoulder impingement syndrome patient to increase the range of motion of elevation, decrease the pain, and increasing the function level, this technique is based on normal mechanics that occur inside the joint during certain movement.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Impingement Syndrome	Other: biomechanical scapular mobilization with movement and motor learning	N/A

Detailed Description

The study is about a new technique of mobilization based on normal biomechanics that occurs during the movements of a joint. For example, shoulder abduction or elevation needs the scapula to move upward rotation with posterior tilt and external rotation. Moreover, needs glenohumeral (GH) joint glide inferior and posterior these movements occur normally to permit us to elevate our shoulder without any restriction and the full range of motion(ROM). so in the patients with shoulder problems and have difficulties reaching full ROM of elevation the investigators applied mobilization of scapula toward upward rotation with external rotation and posterior tilt and by using mobilization belt applied posterior and inferior glide to GH joint. However, mobilization techniques have a short-term effect to enhance this effect, the investigators adding a motor learning approach to achieve a long-term effect and prevent recurrent .the investigators applied this technique 3 times per week for 3 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients were divided randomly in two equal groups (A and B): Group A (controlled group): They were received traditional physical therapy program including: passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM), strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). Group B (study group): they have received the same physical therapy program as in group A, in addition to Biomechanical scapular mobilization with movement and motor learning.Patients were divided randomly in two equal groups (A and B): Group A (controlled group):They were received traditional physical therapy program including: passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM), strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). Group B (study group): they have received the same physical therapy program as in group A, in addition to Biomechanical scapular mobilization with movement and motor learning.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Biomechanical Scapular Mobilization With Movement and Motor Learning in Shoulder Impingement Patients
• Actual Study Start Date: May 5, 2021
• Actual Primary Completion Date: Oct 22, 2021
• Actual Study Completion Date: Nov 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A (controlled group) received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.	Other: biomechanical scapular mobilization with movement and motor learning; the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.
Active Comparator: group B(Study group) All patients in group B received biomechanical scapular mobilization with movement and motor learning and traditional methods.	Other: biomechanical scapular mobilization with movement and motor learning; the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale [3 weeks]

   1. Visual Analogue Scale: was used to evaluate the intensity of pain, which The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10 centimetres in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10 centimetres).

2. Universal Goniometer [3 weeks]

   Universal goniometer: was used to measure the available range of motion at a joint. where used to measure an available range of motion of abduction and flexion of the shoulder joint.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

clinical diagnosis: shoulder impingement syndrome.

1. History of shoulder pain when they elevated their arm.

2. Limited range of motion due to the pain.

3. Pain localized at the painful point at proximal anterolateral shoulder region or medical diagnosis of shoulder impingement syndrome with at least 2 positive impingement tests including Neer, Hawkins, or Jobe test.

Exclusion Criteria:

• Fibromyalgia.

• Fracture, dislocation, or subluxation of the shoulder.

• history of trauma.

• shoulder surgery.

• numbness or tingling in the upper limb.

• Corticosteroids injection within 1 year.

• systemic illness.

• ligamentous laxity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharos university in Alexandria	Alexandria		Egypt

Sponsors and Collaborators

• Pharos University in Alexandria

Investigators

• Study Chair: Moataz A. Mohamed, (B.Sc.P.T.), Pharos University in Alexandria

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Oct 13, 2019

More Information

Publications

None provided.

• Responsible Party: Moataz Abdelaal, Demonstrator in Faculty of Physical Therapy, Pharos University, Alexandria, Egypt., Pharos University in Alexandria
• ClinicalTrials.gov Identifier: NCT04701814
• Other Study ID Numbers: PUA 201901013
• First Posted: Jan 8, 2021
• Last Update Posted: May 18, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Shoulder Impingement Syndrome

Study Results

Participant Flow

Arm/Group Title	Group A (Controlled Group)	Group B(Study Group)
Arm/Group Description	received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.	All patients in group B received same treatment as group A with adding biomechanical scapular mobilization with movement and motor learning. biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.
Period Title: Overall Study
STARTED	20	18
COMPLETED	15	15
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Group A (Controlled Group)	Group B(Study Group)	Total
Arm/Group Description	received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.	All patients in group B received same treatment as group A with biomechanical scapular mobilization with movement and motor learning. biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	35.1 (8.123)	35.3 (7.943)	35.2 (8)
Sex: Female, Male (Count of Participants)
Female	10 66.7%	10 66.7%	20 66.7%
Male	5 33.3%	5 33.3%	10 33.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Egypt	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analogue Scale
Description	1. Visual Analogue Scale: was used to evaluate the intensity of pain, which The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10 centimetres in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10 centimetres).
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A (Controlled Group)	Group B(Study Group)
Arm/Group Description	received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.	All patients in group B received same treatment as group A but adding biomechanical scapular mobilization with movement and motor learning to treatment. biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	4.2 (1.474)	0.9 (1.280)

2. Primary Outcome

Title	Universal Goniometer
Description	Universal goniometer: was used to measure the available range of motion at a joint. where used to measure an available range of motion of abduction and flexion of the shoulder joint.
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A (Controlled Group)	Group B(Study Group)
Arm/Group Description	received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks. biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.	All patients in group B received biomechanical scapular mobilization with movement and motor learning and traditional methods. biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.
Measure Participants	15	15
Abduction	85.7 (9.083)	130.9 (8.302)
Flexion	131.7 (10.761)	173.4 (6.544)

Adverse Events

Time Frame	5 months
Adverse Event Reporting Description	The study isn't including serious adverse events: Adverse events that are not Serious Adverse Events. the study is depend on manual therapy that its evidence base to occur any adverse effect is very low may be occur with manipulation technique more than mobilization. when we check the patients after technique to record any adverse events, we found nothing so there is no any adverse event. Also, we have not found any study recorded adverse event due to using mobilization technique in shoulder.
Arm/Group Title	Group A (Controlled Group)		Group B(Study Group)
Arm/Group Description	received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.		All patients in group B received same treatment as group A but adding biomechanical scapular mobilization with movement and motor learning to treatment. biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.
All Cause Mortality
	Group A (Controlled Group)		Group B(Study Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Serious Adverse Events
	Group A (Controlled Group)		Group B(Study Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Group A (Controlled Group)		Group B(Study Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
Shoulder Pain	1/2 (50%)	1	0/1 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.