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Completed

NCT Number: NCT06520254

The Effectiveness of Massage Therapy in Patients With Shoulder Pain

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)

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wroclaw University of Health and Sport Sciences

Wroclaw, Poland

About this study

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:

  • Does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
  • 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?
  • Does the intercostal nerve entrapment affect the pressure sensitivity of the muscles including the shoulder complex?89
  • 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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage therapy

Other

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.

Primary outcomes

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

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

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

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

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

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

Secondary outcomes

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

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

    Measuring device: VAS scale - Visual analog scale - a continuous scale comprised of a horizontal line, 100 mm in length, anchored by "no pain" (score of 0) and "worst imaginable pain" score of 10, Change = (Value after therapy - baseline)

  2. Change in ROM after therapy compared to baseline

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

    Measuring device: a goniometr, Change = (Value after therapy - baseline)

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 25, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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