NCT05331430

Brief Summary

Effectiveness of dry needling and stretching on joint range and myofascial pain at the cervical level in people with fibromyalgia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 27, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

4 days

First QC Date

April 8, 2022

Last Update Submit

June 21, 2022

Conditions

Keywords

Dry needlingStretchFibromyalgiaPhysical Therapy

Outcome Measures

Primary Outcomes (3)

  • Goniometer measurement

    Measurement of the joint range of the contralateral cervical tilt using a goniometer. Measurement of the lateral tilt range in degrees.Values may vary from zero to 45 degrees.

    One month

  • Measurement of pain with an algometer.

    Measurement of cervical myofascial trigger point pain with an algometer. Measurement of pain in kilograms per square centimetre. Values may vary from zero to 10 kilograms.

    One month

  • Visual analogue scale (VAS)

    Measurement of the degree of pain using the visual analogue scale. Measured from zero to ten, zero corresponds to no pain and ten corresponds to worst pain imaginable.

    One month

Study Arms (3)

Experimental group 1: Dry needling on cervical trigger point

EXPERIMENTAL

Dry needling of the trigger point of the upper fibres of the trapezius muscle. Using the Hong technique.

Other: Dry needling on cervical trigger point

Experimental group 2: Trapezius muscle stretch

EXPERIMENTAL

Manual passive stretching of the upper trapezius muscle fibres.

Other: Dry needling on cervical trigger point

Control group: Informative talks

NO INTERVENTION

Informative talks on breathing techniques, relaxation techniques and posture hygiene.

Interventions

One experimental group will receive dry needling treatment on the upper trapezius fibres using the Hong technique and the other experimental group will receive passive muscle stretching treatment on the upper trapezius fibres.

Also known as: Trapezius muscle stretch
Experimental group 1: Dry needling on cervical trigger pointExperimental group 2: Trapezius muscle stretch

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of fibromyalgia at least six months before the start of the study.
  • Be of legal age.
  • Report at least one episode of neck pain in the last six months.

You may not qualify if:

  • Surgical interventions or scars at cervical level.
  • Dizziness or vertigo.
  • Dermatological problems.
  • Severe psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Murcia

Murcia, 300100, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Angel Martínez Carrasco, PhD

    Universidad de Murcia

    STUDY DIRECTOR
  • Jose Quereda Ruiz, Graduated

    Universidad de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Masked participants. Masked data analyst
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor PhP

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 15, 2022

Study Start

May 27, 2022

Primary Completion

May 31, 2022

Study Completion

June 13, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations