NCT06520254

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of massage in pain reduction and its influence on the range of motion of the shoulder complex in SP. The main questions it aims to answer are:

  1. 1.Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
  2. 2.Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 20, 2024

Last Update Submit

July 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in the pain threshold of the shoulder after therapy compared to baseline

    Measuring device: The Wagner FPXTM Algometer produced by The Wagner Instruments, Greenwich CT, USA, Change = (Value after therapy - baseline)

    1) baseline, 2) 3 weeks after the first massage session massage session

  • Change in the The University of California at Los Angeles Shoulder Score after therapy compared to baseline

    Measuring device: UCLA scale (The University of California at Los Angeles Shoulder Score) , Change = (Value after therapy - baseline)

    1) baseline, 2) 3 weeks after the first massage session massage session

Secondary Outcomes (2)

  • Change in the Visual analog scale score after therapy compared to baseline

    1) baseline, 2) 3 weeks after the first massage session massage session

  • Change in ROM after therapy compared to baseline

    1) baseline, 2) 3 weeks after the first massage session massage session

Study Arms (2)

Massage group

EXPERIMENTAL

Participants in the massage group will receive 6 massage sessions (twice a week for 3 weeks).

Other: Massage therapy

Control group

NO INTERVENTION

Participants in the control group will receive 2 massage sessions, first one at the baseline, second one after 3 weeks.

Interventions

A 30-minute massage session will be applied in the following structures: * Flexor hallucis longus muscle, * Flexor digitorum longus muscle, * Tibialis posterior muscle, * Semitendinosus muscle, * Semimembranosus muscle, * Gluteus maximus muscle, * Longissimus muscle, * Levator costarum muscles 1-5 During the massage session basic Swedish massage techniques were used.

Massage group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 40 years,
  • written consent to participate in the study,
  • pain in the shoulder girdle area lasting at least 3 months,
  • no medical contraindication of massage therapy;

You may not qualify if:

  • Injuries, congenital defects in the chest area, cancer, deep vein thrombosis, heart attack in the last 5 years,
  • Presence of inflammatory conditions in the respiratory, digestive, and genitourinary systems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw University of Health and Sport Sciences

Wroclaw, Poland

Location

Related Publications (2)

  • Artus M, Holt TA, Rees J. The painful shoulder: an update on assessment, treatment, and referral. Br J Gen Pract. 2014 Sep;64(626):e593-5. doi: 10.3399/bjgp14X681577. No abstract available.

  • Kassolik K, Jaskolska A, Kisiel-Sajewicz K, Marusiak J, Kawczynski A, Jaskolski A. Tensegrity principle in massage demonstrated by electro- and mechanomyography. J Bodyw Mov Ther. 2009 Apr;13(2):164-70. doi: 10.1016/j.jbmt.2007.11.002. Epub 2007 Dec 21.

MeSH Terms

Conditions

Shoulder Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Anna Dobrzycka, Phd

    Idependent researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a randomized, controlled, parallel, two-arm trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2024

First Posted

July 25, 2024

Study Start

September 1, 2019

Primary Completion

January 30, 2020

Study Completion

March 20, 2020

Last Updated

July 29, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations