NCT04599127

Brief Summary

This study conducted to see the effect of adding mobilization with movement to conventional physical therapy to the subject with shoulder impingement syndrome. The shoulder impingement syndrome is often described as anterior lateral shoulder pain that provoked during shoulder elevation. The pain occurs during shoulder elevation and causes limited range of motion. Moreover, the patients with shoulder impingement syndrome commonly had a forward head posture and slouching shoulder. There is a theory that illustrates the mechanical factors lead to the injury of the bursa or rotator cuff tendons below the subacromial space which is highly related to the posture and scapular movement. Various treatments for shoulder impingement syndrome including medical treatments such as anti-inflammatory drugs, subacromial decompression, and acromion resection surgery. Conventional physical therapy treatments for shoulder impingement syndrome included modalities, exercises and manual therapy. Exercise has been showed to give a significant effect to decrease the pain intensity, increasing the range of motion and shoulder function. There is evidence that supports the use of manual therapy on shoulder impingement, the recent technique introduced by Brian Mulligan is mobilization with movement. Mobilization with movement is a manual therapy technique that uses the active movement while the physical therapist applies an accessory force to align the positional fault of the joint. A previous study investigated the effect of mobilization with movement that uses the mobilization with movement in shoulder impingement syndrome showed different outcomes in the measurement of pain intensity and shoulder range of motion. As the posture may be related to shoulder impingement syndrome, this research will measure the cervical posture, shoulder posture, and muscle strength. Therefore, the purposes of this study will be to compare the effects of conventional physical therapy treatments and the conventional therapy treatments plus the mobilization with movement on pain intensity, shoulder range of motion, cervical and shoulder posture, shoulder muscle strength and shoulder function. The study hypothesis was that mobilization with movement is more effective in improving the investigated outcomes in individuals with shoulder impingement syndrome than the conventional physical therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

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

Study Start

First participant enrolled

August 12, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2020

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

May 10, 2020

Last Update Submit

October 21, 2020

Conditions

Keywords

Shoulder impingement syndromeMobilization with movementConventional physical therapyPain intensityVisual analogue scaleRange of motionInclinometerShoulder pain and disability indexPostural assessment softwareCraniovertebral angleSagittal shoulder postureHand held dynamometer

Outcome Measures

Primary Outcomes (2)

  • Pain intensity change between time

    Visual analogue scale, 0 mean no pain at all until 10 scale mean the worst pain

    Baseline, at the week 1, week 2, week 3, and week 4

  • Shoulder function change between time

    Shoulder pain and disability index, this index is consist of 13 items with 0 score mean no pain and 10 score mean the worst pain imaginable, the scoring calculation is that the total score / 130 x 100 = \_\_\_%

    Baseline, at the week 2, and week 4

Secondary Outcomes (3)

  • Range of motion change between time

    Baseline, at week 1, week 2, week 3, and week 4

  • Muscle strength change between time

    Baseline, at week 2 and week 4

  • Postural assessment change between time

    Baseline, at week 2 and week 4

Study Arms (2)

Mobilization with movement

EXPERIMENTAL

Mobilization with movement on the shoulder abduction and external rotation

Other: Mobilization with movementOther: Conventional physical therapy

Conventional physical therapy

PLACEBO COMPARATOR

Postural correction exercise and muscle strengthening of the rotator cuff muscle and surrounding muscle on the subacromial region

Other: Conventional physical therapy

Interventions

The physical therapist will adjust the active movement of the shoulder joint during the arm elevation or abduction and shoulder external rotation

Also known as: Mulligan techniques
Mobilization with movement

The exercise is tailor-made and each participant will be performing some of the exercises based on the list that physical therapist prescription

Also known as: Postural correction exercise
Conventional physical therapyMobilization with movement

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anterior and/or lateral shoulder pain (between the acromion and glenoid)
  • Score 4 - 7 cm on the 0 - 10 visual analog scale
  • Experienced shoulder pain at least 3 months
  • Positive combination 2 of 3 impingement test (painful arc, empty can, and external rotation test)
  • Negative at least one of rotator cuff test (isometric infraspinatus and subscapularis muscle test)

You may not qualify if:

  • History of shoulder, cervical, or thoracic surgery
  • History of neurological conditions (stroke, brachial plexus injury)
  • Postural deformity and musculoskeletal condition that affects the shoulder movement
  • History of shoulder major trauma on the affected side (fracture, dislocation, tendon rupture and/or lateral torn)
  • Having bilateral shoulder impingement syndrome
  • Recently using muscle relaxants, pain killer, or corticosteroid injection
  • Ligamentous laxity based on positive sulcus sign
  • Numbness or tingling in upper extremity
  • Systemic illness or widespread pain
  • Rheumatic disease
  • Having malfunction of the rotator cuff (e.g. cannot perform at all)
  • Having a passive limitation due to adhesive capsulitis
  • Positive of scapular retraction test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esa Unggul physical therapy clinic

Jakarta, Jakarta Barat, 11510, Indonesia

Location

Related Publications (18)

  • Linsell L, Dawson J, Zondervan K, Rose P, Randall T, Fitzpatrick R, Carr A. Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral. Rheumatology (Oxford). 2006 Feb;45(2):215-21. doi: 10.1093/rheumatology/kei139. Epub 2005 Nov 1.

    PMID: 16263781BACKGROUND
  • Singla D, Veqar Z, Hussain ME. Photogrammetric Assessment of Upper Body Posture Using Postural Angles: A Literature Review. J Chiropr Med. 2017 Jun;16(2):131-138. doi: 10.1016/j.jcm.2017.01.005. Epub 2017 Mar 18.

    PMID: 28559753BACKGROUND
  • Dong W, Goost H, Lin XB, Burger C, Paul C, Wang ZL, Zhang TY, Jiang ZC, Welle K, Kabir K. Treatments for shoulder impingement syndrome: a PRISMA systematic review and network meta-analysis. Medicine (Baltimore). 2015 Mar;94(10):e510. doi: 10.1097/MD.0000000000000510.

  • Ho CY, Sole G, Munn J. The effectiveness of manual therapy in the management of musculoskeletal disorders of the shoulder: a systematic review. Man Ther. 2009 Oct;14(5):463-74. doi: 10.1016/j.math.2009.03.008. Epub 2009 May 21.

  • Teys P, Bisset L, Vicenzino B. The initial effects of a Mulligan's mobilization with movement technique on range of movement and pressure pain threshold in pain-limited shoulders. Man Ther. 2008 Feb;13(1):37-42. doi: 10.1016/j.math.2006.07.011. Epub 2006 Oct 27.

  • Senbursa G, Baltaci G, Atay A. Comparison of conservative treatment with and without manual physical therapy for patients with shoulder impingement syndrome: a prospective, randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2007 Jul;15(7):915-21. doi: 10.1007/s00167-007-0288-x. Epub 2007 Feb 28.

  • DeSantis L, Hasson SM. Use of Mobilization with Movement in the Treatment of a Patient with Subacromial Impingement: A Case Report. J Man Manip Ther. 2006 Apr 18;14(2):77-87.

    RESULT
  • Delgado-Gil JA, Prado-Robles E, Rodrigues-de-Souza DP, Cleland JA, Fernandez-de-las-Penas C, Alburquerque-Sendin F. Effects of mobilization with movement on pain and range of motion in patients with unilateral shoulder impingement syndrome: a randomized controlled trial. J Manipulative Physiol Ther. 2015 May;38(4):245-52. doi: 10.1016/j.jmpt.2014.12.008. Epub 2015 Apr 30.

  • Guimaraes JF, Salvini TF, Siqueira AL Jr, Ribeiro IL, Camargo PR, Alburquerque-Sendin F. Immediate Effects of Mobilization With Movement vs Sham Technique on Range of Motion, Strength, and Function in Patients With Shoulder Impingement Syndrome: Randomized Clinical Trial. J Manipulative Physiol Ther. 2016 Nov-Dec;39(9):605-615. doi: 10.1016/j.jmpt.2016.08.001. Epub 2016 Nov 6.

  • Kachingwe AF, Phillips B, Sletten E, Plunkett SW. Comparison of manual therapy techniques with therapeutic exercise in the treatment of shoulder impingement: a randomized controlled pilot clinical trial. J Man Manip Ther. 2008;16(4):238-47. doi: 10.1179/106698108790818314.

  • Menek B, Tarakci D, Algun ZC. The effect of Mulligan mobilization on pain and life quality of patients with Rotator cuff syndrome: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(1):171-178. doi: 10.3233/BMR-181230.

  • Surenkok O, Aytar A, Baltaci G. Acute effects of scapular mobilization in shoulder dysfunction: a double-blind randomized placebo-controlled trial. J Sport Rehabil. 2009 Nov;18(4):493-501. doi: 10.1123/jsr.18.4.493.

  • Ludewig PM, Cook TM. Alterations in shoulder kinematics and associated muscle activity in people with symptoms of shoulder impingement. Phys Ther. 2000 Mar;80(3):276-91.

  • Seitz AL, Podlecki LA, Melton ER, Uhl TL. NEUROMUSCULAR ADAPTIONS FOLLOWING A DAILY STRENGTHENING EXERCISE IN INDIVIDUALS WITH ROTATOR CUFF RELATED SHOULDER PAIN: A PILOT CASE-CONTROL STUDY. Int J Sports Phys Ther. 2019 Feb;14(1):74-87.

  • Ellenbecker TS, Cools A. Rehabilitation of shoulder impingement syndrome and rotator cuff injuries: an evidence-based review. Br J Sports Med. 2010 Apr;44(5):319-27. doi: 10.1136/bjsm.2009.058875.

  • Moezy A, Sepehrifar S, Solaymani Dodaran M. The effects of scapular stabilization based exercise therapy on pain, posture, flexibility and shoulder mobility in patients with shoulder impingement syndrome: a controlled randomized clinical trial. Med J Islam Repub Iran. 2014 Aug 27;28:87. eCollection 2014.

  • Satpute KH, Bhandari P, Hall T. Efficacy of Hand Behind Back Mobilization With Movement for Acute Shoulder Pain and Movement Impairment: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2015 Jun;38(5):324-34. doi: 10.1016/j.jmpt.2015.04.003. Epub 2015 Jun 20.

  • Brudvig TJ, Kulkarni H, Shah S. The effect of therapeutic exercise and mobilization on patients with shoulder dysfunction : a systematic review with meta-analysis. J Orthop Sports Phys Ther. 2011 Oct;41(10):734-48. doi: 10.2519/jospt.2011.3440. Epub 2011 Sep 4.

MeSH Terms

Conditions

Shoulder Impingement SyndromePainShoulder Pain

Interventions

Movement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgia

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wunpen Chansirinukor, Dr.

    Mahidol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The participant will be blinded by unknowing the randomization of the group allocation using a sealed envelope. The physical therapy (S) who treats the participants using mobilization with movement will be blinded by unknowing the group allocation of the participants. The physical therapy (E) who treats the participants using conventional physical therapy will be blinded by unknowing the group allocation because all of the participants will be treated using conventional physical therapy. The examiner (AH) and (FN) will be blinded by unknowing the participant group and the sequence of assessments will be randomized.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All of the eligible participants will be divided into two groups; conventional physical therapy and conventional physical therapy plus mobilization with movement
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2020

First Posted

October 22, 2020

Study Start

August 12, 2019

Primary Completion

May 31, 2020

Study Completion

June 4, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

The study protocols and the participant's data record with only initial or code

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be available in May 2020 and will be held until two years after the data collection is done
Access Criteria
The access for the data will be shared using the Mahidol University Physical therapy e-library and anyone can get access by contacting the administrator
More information

Available IPD Datasets

Study Protocol (MU-CIRB 2019/206.06.08)Access

Locations