NCT04782349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

January 25, 2023

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 1, 2021

Last Update Submit

January 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    change from base line at three weeks

Secondary Outcomes (3)

  • pain pressure threshold

    change from baseline at three weeks

  • Shoulder range of motion (flexion, abduction, and external rotation)

    change from baseline at three weeks

  • Disability of Arm Shoulder Hand (DASH):

    change from baseline at three weeks

Study Arms (3)

high intensity laser group

EXPERIMENTAL
Other: mulligan mobilization with low level laser therapy and traditional physical therapy exercises

low intensity laser group

EXPERIMENTAL
Other: low level laser therapy and traditional physical therapy exercises

control group

OTHER
Other: physical therapy exercises

Interventions

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

high intensity laser group

patients in this group will receive low level laser and traditional physical exercises as described before for group (A)

low intensity laser group

The patients will receive traditional physical therapy exercises only as described before for group (A)

control group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, 12613, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 26793036BACKGROUND
  • 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.

    PMID: 26284892BACKGROUND
  • 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.

    PMID: 26045677BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Low-Level Light TherapyExercise Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistance professor doctor

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

December 15, 2021

Primary Completion

July 25, 2022

Study Completion

August 15, 2022

Last Updated

January 25, 2023

Record last verified: 2021-03

Locations