NCT01022827

Brief Summary

The investigators investigated the effect and predictors of effectiveness of massage in the treatment of patients with posterior shoulder stiffness. This is a randomized controlled trial study- massage and control (hand touch) two times a week for 4 weeks. A total of 60 patients with posterior shoulder tightness were randomized into 2 groups; 52 of them completed this study (29 for the massage and 23 for the control). Patient sex, age, body mass index, glenohumeral internal rotation range of motion (ROM), duration of symptom, functional status, and muscle stiffness were recorded. Additionally, for the massage group, patients with glenohumeral internal rotation improvement of 20 degrees after massage were considered responsive, and the others were considered nonresponsive. The influences of the aftermentioned factors on the effectiveness of massage were analyzed by multivariate logistric regression. The overall mean internal rotation ROM increased significantly after massage (from 31.9° to 54.9°; P \< 0.001) compared to the control (from 28.7° to 34.9°; P \> 0.05). There were 22 patients in the responsive group and 7 in the nonresponsive group. Among the factors, duration of symptoms, FLEX-SF score, and posterior deltoid stiffness were significant predictors of effectiveness of massage. Massage was an effective treatment for subjects with posterior shoulder stiffness, but was less effective in patients with longer duration of symptoms, higher functional limitation, and less posterior deltoid stiffness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 5, 2012

Status Verified

November 1, 2011

Enrollment Period

1.2 years

First QC Date

November 25, 2009

Last Update Submit

January 3, 2012

Conditions

Keywords

stiff shouldermassagemuscle stiffness

Outcome Measures

Primary Outcomes (1)

  • Range of Motion

    pre and post-massage

Secondary Outcomes (2)

  • muscle stiffness

    pre and post-massage

  • functional disability

    pre and post-massage

Study Arms (2)

posterior shoulder stiffness massage group

EXPERIMENTAL

The inclusion criteria of patients with glenohumeral internal rotation limitation and posterior shoulder stiffness were: \[1\] limitation of internal rotation ROM compared to the sound side; \[2\] mild glenohumeral joint hypomobility according to joint play assessment; \[3\] stiffness in the posterior shoulder region.

Other: massage

posterior shoulder stiffness placebo group

PLACEBO COMPARATOR
Other: massage

Interventions

massageOTHER

For the massage group, a physical therapist with 8 years of clinical experience in manual therapy provided the massage on the posterior deltoid, infraspinatus, and teres minor of the involved shoulder for 18 minutes \[about 6 minutes for each muscle and order was random\] two times a week for 4 weeks. The techniques of massage included petrissage for 3 minutes and rolling for 3 minutes of soft tissues

posterior shoulder stiffness massage groupposterior shoulder stiffness placebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a limited ROM of internal rotation (internal rotation ROM \< 20% to the sound side), and
  • pain and stiffness in the shoulder region for at least 3 months.

You may not qualify if:

  • surgery on the particular shoulder,
  • rheumatoid arthritis,
  • stroke with residual shoulder involvement,
  • fracture of the shoulder complex,
  • rotator cuff deficiency, and
  • resting pain, intolerable pain, or muscle spasm during active and/or passive motion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Yang JL, Chen SY, Hsieh CL, Lin JJ. Effects and predictors of shoulder muscle massage for patients with posterior shoulder tightness. BMC Musculoskelet Disord. 2012 Mar 27;13:46. doi: 10.1186/1471-2474-13-46.

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • JIU-JENQ LIN, PhD

    School of Physical Therapy, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 1, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

January 5, 2012

Record last verified: 2011-11

Locations