Clinical trial NCT04782349: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Adhesive Capsulitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Pain intensity
timeFrame: change from base line at three weeks
Secondary outcomes:
measure: pain pressure threshold
timeFrame: change from baseline at three weeks
measure: Shoulder range of motion (flexion, abduction, and external rotation)
timeFrame: change from baseline at three weeks
measure: Disability of Arm Shoulder Hand (DASH):
timeFrame: change from baseline at three weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
References:
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.
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.
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.