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Completed

NCT Number: NCT04440046

Real Versus Sham Manual Therapy for RCRSP

A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks.

The hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with RCRSP.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruben Fernandez-Matias

Alcalá de Henares, 28805, Spain

About this study

The objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain.

For this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied.

The investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • unilateral shoulder pain of non-traumatic origing lasting more than three months.
  • Pain evoked with active shoulder movements.
  • Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation.
  • Minimal or no rest pain (less than 3 points in a numeric pain rating scale).

Exclusion criteria

  • Other shoulder pathologies than RCRSP.
  • Systemic diseases.
  • Neural symptoms.
  • Neck pain.
  • Radiculopathy.
  • To have been treated for shoulder pain in the last three months.

Treatment and study plan

Manual therapy thoracic spine

Other

Manual therapy mobilization directed to the costovertebral joint.

Manual therapy glenohumeral joint

Other

Manual therapy mobilization directed to the glenohumeral joint.

Sham thoracic manual therapy

Other

Sham manual therapy directed to the costovertebral joint.

Sham glenohumeral manual therapy

Other

Sham manual therapy directed to the glenohumeral joint.

Therapeutic exercise

Other

Therapeutic exercise program consisting on isometric exercise with progressive load.

Primary outcomes

  1. Shoulder Pain and Disability Index (SPADI)

    Time frame: Change from Baseline at 17- week

    The SPADI points from 0 (no disability) to 130 (maximum degree of disability)

Secondary outcomes

  1. Pain intensity measured with a visual analogue scale

    Time frame: Change from Baseline at 17-week

    10-cm scale where 0 is no pain and 10 is the worst pain imaginable

  2. Pain-free range of movement of the shoulder

    Time frame: Change from Baseline at 17-week

    Flexion, extension, abduction, internal rotation and external rotation measured with a two-arm goniometer

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Real Versus Sham Manual Therapy in Addition to Therapeutic Exercise in the Treatment of Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2020
Registry last updated
Jun 29, 2021

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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