Clinical trial NCT06520254: The Effectiveness of Massage Therapy in Patients With Shoulder Pain
Official title: The Effectiveness of Massage in Pain Reduction and Its Influence on the Range of Motion (ROM) of the Shoulder Complex in Patients With Shoulder Pain in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized, controlled, parallel, two-arm trial
Primary purpose: TREATMENT

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

Researchers will compare a dedicated massage protocol to a control group to see if the massage protocol works to treat shoulder pain.

Participants in the massage group will:

Take part in 6 massage sessions (twice a week for 3 weeks) in the

Participants in the control group will:

Take part in 2 massage sessions (after the first and second assessment)

Detailed description: The aim of the study was to evaluate the effectiveness of massage therapy based on tensegrity principle in pain reduction and its influence on the range of motion of the shoulder complex in shoulder pain. .

Eesearch questions:

1. Does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
2. Does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex?
3. Does the intercostal nerve entrapment affect the pressure sensitivity of the muscles including the shoulder complex?89
4. What potential mechanisms may be induced by tensegrity massage in diseases of the shoulder complex?

Patients with symptoms of shoulder pain will be recruited for the study by general practitioners.

The following parameters related to the function of shoulder will be assessed:

1. The active range of flexion, abduction and extension-adduction-rotation (hand behind back) of the upper limb were assessed.
2. Pain sensations by the visual analogue scale-VAS
3. The functional status of the shoulder complex by the UCLA scale (The University of California at Los Angeles Shoulder Score).
4. Pain treshold by an algometer, the pressure

The study will rely on the palpation assessment and the massage methodology described in the recommendations of the Polish Society of Physiotherapy, Polish Society of Family Medicine and College of Family Physicians in Poland.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the pain threshold of the shoulder after therapy compared to baseline
timeFrame: 1) baseline, 2) 3 weeks after the first massage session massage session
measure: Change in the The University of California at Los Angeles Shoulder Score after therapy compared to baseline
timeFrame: 1) baseline, 2) 3 weeks after the first massage session massage session
Secondary outcomes:
measure: Change in the Visual analog scale score after therapy compared to baseline
timeFrame: 1) baseline, 2) 3 weeks after the first massage session massage session
measure: Change in ROM after therapy compared to baseline
timeFrame: 1) baseline, 2) 3 weeks after the first massage session massage session
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw University of Health and Sport Sciences
Study officials:
affiliation: Idependent researcher
name: Anna Dobrzycka, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.