NCT03709797

Brief Summary

Shoulder pain in people with spinal cord injury is one of the most prevalent in acute and chronic patients because of weakness in shoulder periarticular muscles, and also because of overuse of these part of the body in assistive devices. This study aims to evidence if dry needling (a physiotherapy technique) is also useful in patients with spinal cord injury, and how long it could hold out without or less pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

November 9, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

October 8, 2018

Last Update Submit

February 2, 2019

Conditions

Spinal Cord InjuriesMyofascial Pain SyndromeShoulder PainPuncture

Keywords

Spinal Cord InjuryShoulder PainMyofascial Pain SyndromeDry Needling

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand Spanish version (DASHe).

    In upper limb pathology this test evaluates functional activities in relation to the difficulty involved in performing them with a score between 1 and 5. The DASHe questionnaire consists of a main part of 30 items, and two specific modules for people who work with musical instruments / sports or for the workplace. In this study, only the main part has been used. The 30 items have a score of 1 to 5, with 5 being the maximum of the valued symptom, and at least 27 questions of 3 must be answered. The disability / symptom score will therefore be between 0 (best possible score) and 100 (worst possible score).

    Change from baseline and one week later.

Secondary Outcomes (5)

  • Pressure Pain Thershold (algometry).

    Change from baseline, immediately after intervention and one week later.

  • McGill Pain Questionnaire (Spanish version).

    Change from baseline and one week later.

  • Visual Analog Scale (VAS)

    Change from baseline and one week later.

  • Shoulder Pain And Disability Index Spanish version (SPADIe).

    Change from baseline and one week later.

  • Range Of Movement (ROM)

    Change from baseline, immediately after intervention and one week later.

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group will receive dry needling treatment.

Procedure: Dry needling in infraspinatus muscle

Control group

SHAM COMPARATOR

Control group will receive sham dry needling treatment.

Procedure: Dry needling in infraspinatus muscle

Interventions

Dry needling in infraspinatus musclePROCEDURE

Dry needling technique with multiple rapid needle insertion.

Control groupExperimental group

Eligibility Criteria

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

You may qualify if:

  • At least one year after Spinal Cord Injury (chronic patients).
  • Spinal Cord Injury under C5-C6 spinal level with American Spinal Injury Association (ASIA) classification.
  • Patients with shoulder pain and at least one active trigger point in infraspinatus muscle.

You may not qualify if:

  • Be apprehensive to the needles (belonephobia).
  • Immunosuppression.
  • Drug instability.
  • Other medical causes that, under medical prescription, dry needling in the shoulder are discouraged.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandra Palacios Alfonso

Burgos, 09007, Spain

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesMyofascial Pain SyndromesShoulder Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesArthralgiaJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Sandra Ms Palacios Alfonso

CONTACT

+34650667306sandra.palac@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 17, 2018

Study Start

November 9, 2018

Primary Completion

January 1, 2020

Study Completion

October 1, 2020

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

ES(1)