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Mulligan Mobilization With Laser for Shoulder Adhesive Capsulitis

Primary Purpose

Shoulder Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mulligan mobilization with low level laser therapy and traditional physical therapy exercises
low level laser therapy and traditional physical therapy exercises
physical therapy exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Adhesive Capsulitis

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant selected for the study were patients (both male and female).

  • Subjects diagnosed diagnosed by physicians with Magnetic Resonance Imaging (MRI).

    & referred by an Orthopedician with stage 2 Adhesive Capsulitis.

  • Age group of 40-60 years of old.
  • painful condition of at least 3 months with 50% restriction in passive shoulder flexion, abduction and external rotation, in a sagittal plane compared with opposite side.
  • The severity of pain on visual analogue scale was higher than three out of ten, pain aggravated by movements.
  • patients were suffering from pain and limitation in the motion for more than 3 month.

Exclusion Criteria:

  • Patients with any shoulder injury or trauma, surgical release of capsule.
  • Previous manipulation done under anaesthesia of the affected shoulder in the preceding 4 weeks.
  • Other conditions involving the shoulder (eg. rheumatoid arthritis, osteoarthritis, damage of the glenohumeral cartilage, osteoporosis, or malignancies in the shoulder region).
  • Pain or disorders of the cervical spine, elbow, wrist, or hand.
  • Presence of medical conditions such as cardiac disease, infections, coagulation disorder.
  • patients having any intra articular injection, or physiotherapy treatment in the affected shoulder during the last three months.
  • patients with musculoskeletal disorder (any type of fracture), any history of surgery on that shoulder and patients with tendon calcification, patients with cervical rib, rotator cuff tear patients.
  • Patients have insulin-dependent diabetes mellitus.
  • Bilateral Frozen Shoulder
  • systemic inflammatory joint disease (such as rheumatoid arthritis or polymyalgia rheumatica).

Sites / Locations

  • Faculty of Physical Therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

high intensity laser group

low intensity laser group

control group

Arm Description

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensity will be measured with Visual Analog Scale (VAS). The patient will be asked to mark the severity of pain on a 100-mm line with "no pain" on one end and "most unbearable pain" on the other end

Secondary Outcome Measures

pain pressure threshold
- The most sensitive point will be located over the anterior aspect of the shoulder by manual palpation and will be marked with a permanent marker so that the same point could be used for pre- and post-condition application measures. This process will be repeated three times with a 30-s rest period between each measurement.
Shoulder range of motion (flexion, abduction, and external rotation)
A universal goniometer will be used to measure the ROM. patient in supine lying with shoulder neutral. Flexion ROM will be measured with the stationary arm of goniometer parallel to the trunk, and the moving arm parallel with the affected arm. Fulcrum will be placed in the point of lateral aspect of acromion process. For measurement of shoulder abduction, the fulcrum of the goniometer will be placed anterior to acromion process, stationary arm parallel to midline of sternum and movable arm will be placed at the midline of humerus. The patient is asked to abduct the arm as much as possible and the reading of the goniometer will be noted. For external rotation of the shoulder, patient is positioned in supine lying and arm abducted to 90 degree and elbow at 90 degree. Fulcrum of goniometry over olecranon and stationary arm perpendicular to floor, moving arm is aligned parallel to the ulna. The patient is asked to rotate externally as much as possible.
Disability of Arm Shoulder Hand (DASH):
- The functional index designed to determine the symptoms and limitations that participant was experiencing while performing daily activities. This scale consists of 30 items in the form of activities of daily living with each item scoring from 0 to 4, where 0 is no difficulty in performing that activity and 4 is unable to do that activity. The DASH score is expressed as a percentage.

Full Information

First Posted
March 1, 2021
Last Updated
January 21, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04782349
Brief Title
Mulligan Mobilization With Laser for Shoulder Adhesive Capsulitis
Official Title
Additive Effect of Mulligan Mobilization With Low Level Laser Therapy for Treatment of Patients With Shoulder Adhesive Capsulitis: Double Blinded, Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Adhesive capsulitis (frozen shoulder) is a condition of uncertain etiology characterized by pain and progressive loss of both active and passive shoulder motion. Shoulder pain and stiffness are accompanied by disability. It is thought that the incidence is 3 to 5% in the general population. Laser therapy is widely used for treating different musculoskeletal diseases, because of its ability to reduce pain and improve the physical function. Also, MWM when used for shoulders with limited range of motion because of pain had shown improvement in range of motion and pressure pain threshold. Previous studies have investigated the efficacy of combining different manual technique with LLLT for treating pain in some body parts. However, up till now the combined effect of MWM with LLLT for treatment of patients with shoulder adhesive capsulitis have not been investigated. So, the present randomized controlled study will be conducted to investigate the effect of adding mulligan mobilization with movement to low level laser therapy in treatment of patients with shoulder adhesive capsulitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Adhesive Capsulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high intensity laser group
Arm Type
Experimental
Arm Title
low intensity laser group
Arm Type
Experimental
Arm Title
control group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
mulligan mobilization with low level laser therapy and traditional physical therapy exercises
Intervention Description
for mulligan mobilization: for improving the limited range of motion of shoulder joint, the therapist will apply posterolateral mobilization for the shoulder joint. Three sets of painless glides of 10 repetitions will be applied with a rest interval of 30 s between each set. For low level laser application: Laser specifications is as follows: 850 nm wave length and pulsed application with 8 W applied for 20 minutes. laser will be applied over painful points of the shoulder. For traditional physical therapy exercises: the patients will receive the following exercise program: self stretching exercises for shoulder joint, pully exercises, back climbing exercises, finger ladder exercises, circumduction exercises and pendulum exercises
Intervention Type
Other
Intervention Name(s)
low level laser therapy and traditional physical therapy exercises
Intervention Description
patients in this group will receive low level laser and traditional physical exercises as described before for group (A)
Intervention Type
Other
Intervention Name(s)
physical therapy exercises
Intervention Description
The patients will receive traditional physical therapy exercises only as described before for group (A)
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured with Visual Analog Scale (VAS). The patient will be asked to mark the severity of pain on a 100-mm line with "no pain" on one end and "most unbearable pain" on the other end
Time Frame
change from base line at three weeks
Secondary Outcome Measure Information:
Title
pain pressure threshold
Description
- The most sensitive point will be located over the anterior aspect of the shoulder by manual palpation and will be marked with a permanent marker so that the same point could be used for pre- and post-condition application measures. This process will be repeated three times with a 30-s rest period between each measurement.
Time Frame
change from baseline at three weeks
Title
Shoulder range of motion (flexion, abduction, and external rotation)
Description
A universal goniometer will be used to measure the ROM. patient in supine lying with shoulder neutral. Flexion ROM will be measured with the stationary arm of goniometer parallel to the trunk, and the moving arm parallel with the affected arm. Fulcrum will be placed in the point of lateral aspect of acromion process. For measurement of shoulder abduction, the fulcrum of the goniometer will be placed anterior to acromion process, stationary arm parallel to midline of sternum and movable arm will be placed at the midline of humerus. The patient is asked to abduct the arm as much as possible and the reading of the goniometer will be noted. For external rotation of the shoulder, patient is positioned in supine lying and arm abducted to 90 degree and elbow at 90 degree. Fulcrum of goniometry over olecranon and stationary arm perpendicular to floor, moving arm is aligned parallel to the ulna. The patient is asked to rotate externally as much as possible.
Time Frame
change from baseline at three weeks
Title
Disability of Arm Shoulder Hand (DASH):
Description
- The functional index designed to determine the symptoms and limitations that participant was experiencing while performing daily activities. This scale consists of 30 items in the form of activities of daily living with each item scoring from 0 to 4, where 0 is no difficulty in performing that activity and 4 is unable to do that activity. The DASH score is expressed as a percentage.
Time Frame
change from baseline at three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant selected for the study were patients (both male and female). Subjects diagnosed diagnosed by physicians with Magnetic Resonance Imaging (MRI). & referred by an Orthopedician with stage 2 Adhesive Capsulitis. Age group of 40-60 years of old. painful condition of at least 3 months with 50% restriction in passive shoulder flexion, abduction and external rotation, in a sagittal plane compared with opposite side. The severity of pain on visual analogue scale was higher than three out of ten, pain aggravated by movements. patients were suffering from pain and limitation in the motion for more than 3 month. Exclusion Criteria: Patients with any shoulder injury or trauma, surgical release of capsule. Previous manipulation done under anaesthesia of the affected shoulder in the preceding 4 weeks. Other conditions involving the shoulder (eg. rheumatoid arthritis, osteoarthritis, damage of the glenohumeral cartilage, osteoporosis, or malignancies in the shoulder region). Pain or disorders of the cervical spine, elbow, wrist, or hand. Presence of medical conditions such as cardiac disease, infections, coagulation disorder. patients having any intra articular injection, or physiotherapy treatment in the affected shoulder during the last three months. patients with musculoskeletal disorder (any type of fracture), any history of surgery on that shoulder and patients with tendon calcification, patients with cervical rib, rotator cuff tear patients. Patients have insulin-dependent diabetes mellitus. Bilateral Frozen Shoulder systemic inflammatory joint disease (such as rheumatoid arthritis or polymyalgia rheumatica).
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Giza
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
26793036
Citation
Lirio Romero C, Torres Lacomba M, Castilla Montoro Y, Prieto Merino D, Pacheco da Costa S, Velasco Marchante MJ, Bodes Pardo G. Mobilization With Movement for Shoulder Dysfunction in Older Adults: A Pilot Trial. J Chiropr Med. 2015 Dec;14(4):249-58. doi: 10.1016/j.jcm.2015.03.001. Epub 2015 Nov 24.
Results Reference
background
PubMed Identifier
26284892
Citation
Noten S, Meeus M, Stassijns G, Van Glabbeek F, Verborgt O, Struyf F. Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):815-25. doi: 10.1016/j.apmr.2015.07.025. Epub 2015 Aug 15.
Results Reference
background
PubMed Identifier
26045677
Citation
Ip D, Fu NY. Two-year follow-up of low-level laser therapy for elderly with painful adhesive capsulitis of the shoulder. J Pain Res. 2015 May 25;8:247-52. doi: 10.2147/JPR.S84376. eCollection 2015.
Results Reference
background

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Mulligan Mobilization With Laser for Shoulder Adhesive Capsulitis

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