Neuroscience Education in Shoulder Pain: Clinical Trial

December 12, 2024 updated by: Eva Prado Robles, Universidad de León

The Efficacy of a Pain Neuroscience Education Programme in Shoulder Pain: a Randomised Clinical Trial

Objectives: The purpose of this study was to assess the efficacy of a pain neuroscience education programme applied to patients with shoulder pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomised controlled trial was performed. Fifty-five patients satisfied eligibility criteria, agreed to participate, and were randomized into an experimental group (n = 27) or control group (n =28). A manual therapy and exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session).

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • León, Spain, 24196
        • Eva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being 18-70 years of age.
  • History of shoulder pain of more than 3 months duration.
  • Presence of a painful arc
  • Medical diagnosis of shoulder pain with at least 2 positive impingement tests including Neer, Hawkins, or Jobe test

Exclusion Criteria:

  • Diagnosis of fibromyalgia.
  • Pregnancy.
  • A history of traumatic onset of shoulder pain.
  • Other histories of shoulder injury.
  • Torn tendons.
  • Ligamentous laxity based on a positive Sulcus and apprehension tests.
  • Numbness or tingling in the upper extremity.
  • Previous shoulder or cervical spine surgery.
  • Systemic illness.
  • Corticosteroid injection on the shoulder within 1 year of the study.
  • Physical therapy 6 months before the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Participants will receive 4 sessions of PNE and 5 sessions of manual therapy and exercises.
Behavioral: PNE
A manual therapy(Mulligan´s Mobilization with Movement) and 4 sessions of strenght exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session).
Other Names:
  • Exercise
  • Manual therapy
Procedure: Manual therapy
5 sessions of Mulligan´s Mobilization with Movement and 4 sessions of strenght exercises
Active Comparator: Control group
Participants will receive 5 sessions of manual therapy and exercises.
Procedure: Manual therapy
5 sessions of Mulligan´s Mobilization with Movement and 4 sessions of strenght exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Baseline and 5 weeks.
Reduction in pain intensity using the Shoulder Pain and Disability Index (SPADI)
Baseline and 5 weeks.
Disability
Time Frame: Baseline and five weeks.
Improving functionality using the Shoulder Pain and Disability Index (SPADI)
Baseline and five weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
kinesiophobia
Time Frame: Baseline and 5 weeks.
Tampa Scale of Kinesiophobia (TSK11)
Baseline and 5 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
catastrophizing
Time Frame: Baseline and 5 weeks.
Pain catastrophizing scale (PCS)
Baseline and 5 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de León

Investigators

  • Principal Investigator: Eva Prado Robles, Universidad de León

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

December 8, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALUD DOCTORADO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data will not be shared due to ethical and legal restrictions on the privacy of participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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