NCT02217540

Brief Summary

Objective: To pilot the methods proposed for conducting a full randomised clinical trial to evaluate the effect of Mulligan concept mobilization with movement on shoulder functionality in older adults with shoulder dysfunction. Design: Pilot randomised, single-blinded clinical trial. Setting: Three nursing homes, Toledo, Spain. Participants: 44 older adults with shoulder dysfunction. Interventions: Participants will be randomly allocated into control group (n=22) treated with a physiotherapy standard protocol proposed by the Spanish Rheumatology Society; and experimental group (n=22) treated with the same physical therapy standard protocol and Mulligan concept mobilisation with movement. Both interventions will take place three times a week for 2 consecutive weeks. Main outcomes: Primary outcome is shoulder functionality measured with Shoulder Disability Questionnaire (S-SDQ) Spanish version, and secondary outcomes are active glenohumeral range of motion and pain intensity. Data will be collected at baseline, after each group intervention, and 1 and 3 months after finishing interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
Last Updated

December 4, 2023

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

August 13, 2014

Last Update Submit

December 1, 2023

Conditions

Keywords

Shoulder, disability evaluation, physiotherapy modalities

Outcome Measures

Primary Outcomes (1)

  • Spanish-Shoulder Disability Questionnaire

    SDQ is mostly used in research and clinical practice in several countries and its score can range from minimum \[0=no functional limitation\] to maximum \[100= affirmative to all items\], so higher scores mean higher disability

    baseline and 3 times after interventions

Secondary Outcomes (1)

  • Range of motion and pain

    baseline and 3 times after intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental Group consist of the physiotherapy standard protocol and active movement plus accessory mobilizations of the humeral head using Mulligan Concept Mobilisation with Movement.

Other: Standard protocolOther: Mulligan Concept Mobilisation with Movement

Control Group

ACTIVE COMPARATOR

Standard protocol proposed by the Spanish Rheumatology Society for shoulder dysfunction

Other: Standard protocol

Interventions

Control group intervention is the physiotherapy treatment standard protocol proposed by the Spanish Rheumatology Society for shoulder dysfunction

Also known as: Standard protocol for shoulder pain of Spanish Rheumatology Society
Control GroupExperimental Group

The internal hand of the physiotherapist stabilises participants´ shoulder girdle and with the thenar eminence of the other hand, performs a posterior-lateral glide of the humeral head. Participants are asked to raise the affected arm in the point of pain onset while the physiotherapist sustains the gliding force to humeral head. The physiotherapist tries to maintain the glide at right angles to the plane of movement throughout the entire range while participants are requested to perform an active elevation. Participants are instructed that the mobilisation procedure, including shoulder movement, had to be pain free

Experimental Group

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • to be over 65 years old
  • diagnosed with shoulder dysfunction (shoulder pain and/or limited AROM in the last 4 weeks) by their physician
  • dependent on at least 1 ADL
  • with a limited glenohumeral AROM of 25% - 75%
  • resident in the nursing homes where the study took place.

You may not qualify if:

  • subjects with moderate or severe cognitive impairment
  • specific rheumatic diseases, osteoarthritis, neoplasms
  • shoulder joint instability
  • circulatory disorders (hemophilia, clotting problems)
  • skin problems aggravated by contact with the skin
  • traumas in the past month
  • bilateral shoulder disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mensajeros de la Paz

Villarrubia de Santiago, Toledo, 45360, Spain

Location

Related Publications (18)

  • Knebl JA, Shores JH, Gamber RG, Gray WT, Herron KM. Improving functional ability in the elderly via the Spencer technique, an osteopathic manipulative treatment: a randomized, controlled trial. J Am Osteopath Assoc. 2002 Jul;102(7):387-96.

    PMID: 12138953BACKGROUND
  • van den Dolder PA, Roberts DL. A trial into the effectiveness of soft tissue massage in the treatment of shoulder pain. Aust J Physiother. 2003;49(3):183-8. doi: 10.1016/s0004-9514(14)60238-5.

    PMID: 12952518BACKGROUND
  • Mulligan BR. Manual Therapy 'NAGS', 'SNAGS', 'MWMS' etc. 6 ed. Wellington: Orthopedic Physical Therapy Products; 2010

    BACKGROUND
  • 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.

    PMID: 17070090BACKGROUND
  • Eggermont LH, Leveille SG, Shi L, Kiely DK, Shmerling RH, Jones RN, Guralnik JM, Bean JF. Pain characteristics associated with the onset of disability in older adults: the maintenance of balance, independent living, intellect, and zest in the Elderly Boston Study. J Am Geriatr Soc. 2014 Jun;62(6):1007-16. doi: 10.1111/jgs.12848. Epub 2014 May 13.

  • Chard MD, Hazleman R, Hazleman BL, King RH, Reiss BB. Shoulder disorders in the elderly: a community survey. Arthritis Rheum. 1991 Jun;34(6):766-9. doi: 10.1002/art.1780340619.

  • Vermeulen J, Neyens JC, van Rossum E, Spreeuwenberg MD, de Witte LP. Predicting ADL disability in community-dwelling elderly people using physical frailty indicators: a systematic review. BMC Geriatr. 2011 Jul 1;11:33. doi: 10.1186/1471-2318-11-33.

  • Koh ES, Jae-Young L. The management of shoulder pain in the elderly: focusing on clinical characteristics and conservative treatment. J Korean Geriatr Soc 2013;17(1):1-6

    RESULT
  • Chester R, Shepstone L, Lewis JS, Jerosch-Herold C. Predicting response to physiotherapy treatment for musculoskeletal shoulder pain: protocol for a longitudinal cohort study. BMC Musculoskelet Disord. 2013 Jun 21;14:192. doi: 10.1186/1471-2474-14-192.

  • 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.

  • Camarinos J, Marinko L. Effectiveness of manual physical therapy for painful shoulder conditions: a systematic review. J Man Manip Ther. 2009;17(4):206-15. doi: 10.1179/106698109791352076.

  • de Vries NM, van Ravensberg CD, Hobbelen JS, Olde Rikkert MG, Staal JB, Nijhuis-van der Sanden MW. Effects of physical exercise therapy on mobility, physical functioning, physical activity and quality of life in community-dwelling older adults with impaired mobility, physical disability and/or multi-morbidity: a meta-analysis. Ageing Res Rev. 2012 Jan;11(1):136-49. doi: 10.1016/j.arr.2011.11.002. Epub 2011 Nov 11.

  • Chou CH, Hwang CL, Wu YT. Effect of exercise on physical function, daily living activities, and quality of life in the frail older adults: a meta-analysis. Arch Phys Med Rehabil. 2012 Feb;93(2):237-44. doi: 10.1016/j.apmr.2011.08.042.

  • Hurschler C, Wulker N, Mendila M. The effect of negative intraarticular pressure and rotator cuff force on glenohumeral translation during simulated active elevation. Clin Biomech (Bristol). 2000 Jun;15(5):306-14. doi: 10.1016/s0268-0033(99)00088-1.

  • Vicenzino B, Paungmali A, Teys P. Mulligan's mobilization-with-movement, positional faults and pain relief: current concepts from a critical review of literature. Man Ther. 2007 May;12(2):98-108. doi: 10.1016/j.math.2006.07.012. Epub 2006 Sep 7.

  • 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.

  • Alvarez-Nemegyei J, Puerto-Ceballos I, Guzman-Hau W, Bassol-Perea A, Nuno-Gutierrez BL. Development of a Spanish-language version of the Shoulder Disability Questionnaire. J Clin Rheumatol. 2005 Aug;11(4):185-7. doi: 10.1097/01.rhu.0000173229.50674.31.

  • Jones KR, Fink R, Hutt E, Vojir C, Pepper GA, Scott-Cawiezell J, Mellis BK. Measuring pain intensity in nursing home residents. J Pain Symptom Manage. 2005 Dec;30(6):519-27. doi: 10.1016/j.jpainsymman.2005.05.020.

MeSH Terms

Interventions

AIEOP acute lymphoblastic leukemia protocolMovement

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cristina Lirio Romero, MsC

    University of Alcala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc. PhD student

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

December 4, 2023

Record last verified: 2014-08

Locations