NCT06739694

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

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

January 2, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

December 8, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

exercisemanual therapyshoulder painpain neuroscience education

Outcome Measures

Primary Outcomes (2)

  • Pain

    Reduction in pain intensity using the Shoulder Pain and Disability Index (SPADI)

    Baseline and 5 weeks.

  • Disability

    Improving functionality using the Shoulder Pain and Disability Index (SPADI)

    Baseline and five weeks.

Secondary Outcomes (1)

  • kinesiophobia

    Baseline and 5 weeks.

Other Outcomes (1)

  • catastrophizing

    Baseline and 5 weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants will receive 4 sessions of PNE and 5 sessions of manual therapy and exercises.

Behavioral: PNEProcedure: Manual therapy

Control group

ACTIVE COMPARATOR

Participants will receive 5 sessions of manual therapy and exercises.

Procedure: Manual therapy

Interventions

PNEBEHAVIORAL

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).

Also known as: Manual therapy, Exercise
Experimental group

5 sessions of Mulligan´s Mobilization with Movement and 4 sessions of strenght exercises

Control groupExperimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva

León, Spain, 24196, Spain

Location

Related Publications (1)

  • Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.

    PMID: 30178503BACKGROUND

MeSH Terms

Conditions

Shoulder PainMotor Activity

Interventions

Musculoskeletal ManipulationsExercise

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eva Prado Robles

    Universidad de León

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and clinical Professor

Study Record Dates

First Submitted

December 8, 2024

First Posted

December 18, 2024

Study Start

January 2, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

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

Locations