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Effectiveness of Dry Needling and Stretching in People With Fibromyalgia.

Primary Purpose

Dry Needling, Stretch, Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling on cervical trigger point
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Needling focused on measuring Dry needling, Stretch, Fibromyalgia, Physical Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Universidad de Murcia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental group 1: Dry needling on cervical trigger point

Experimental group 2: Trapezius muscle stretch

Control group: Informative talks

Arm Description

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

Manual passive stretching of the upper trapezius muscle fibres.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2022
Last Updated
June 21, 2022
Sponsor
Universidad de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT05331430
Brief Title
Effectiveness of Dry Needling and Stretching in People With Fibromyalgia.
Official Title
Effectiveness of Dry Needling and Stretching on Joint Range and Myofascial Pain at the Cervical Level in People With Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Effectiveness of dry needling and stretching on joint range and myofascial pain at the cervical level in people with fibromyalgia
Detailed Description
A randomised clinical trial will be conducted in which there will be 3 groups. One control group and 2 experimental groups; one of them will undergo dry needling of the upper trapezius fibres and the other will undergo passive stretching of the upper trapezius fibres. Both groups will have the joint range of cervical lateral tilt, pain measurement by algometer and visual analogue scale (VAS) measured. All these measurements will be taken before and after treatment. The participants of the study will be people who have been diagnosed with fibromyalgia at least 6 months before the start of the study, who are members of the FIBROFAMUR association. Association of Fibromyalgia, Chronic Fatigue, Rheumatic and Musculoskeletal Diseases of Murcia. The data collected will be: socio-demographic data, age, sex, measurement of cervical joint range using a goniometer and measurement of pain using an algometer and visual analogue scale (VAS). As undesirable effects, in exceptional cases, the dry needling technique may produce residual discomfort in the puncture area that may last between 1 and 3 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Needling, Stretch, Fibromyalgia
Keywords
Dry needling, Stretch, Fibromyalgia, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantOutcomes Assessor
Masking Description
Masked participants. Masked data analyst
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1: Dry needling on cervical trigger point
Arm Type
Experimental
Arm Description
Dry needling of the trigger point of the upper fibres of the trapezius muscle. Using the Hong technique.
Arm Title
Experimental group 2: Trapezius muscle stretch
Arm Type
Experimental
Arm Description
Manual passive stretching of the upper trapezius muscle fibres.
Arm Title
Control group: Informative talks
Arm Type
No Intervention
Arm Description
Informative talks on breathing techniques, relaxation techniques and posture hygiene.
Intervention Type
Other
Intervention Name(s)
Dry needling on cervical trigger point
Other Intervention Name(s)
Trapezius muscle stretch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Goniometer measurement
Description
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.
Time Frame
One month
Title
Measurement of pain with an algometer.
Description
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.
Time Frame
One month
Title
Visual analogue scale (VAS)
Description
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.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Surgical interventions or scars at cervical level. Dizziness or vertigo. Dermatological problems. Severe psychiatric disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angel Martínez Carrasco, PhD
Organizational Affiliation
Universidad de Murcia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jose Quereda Ruiz, Graduated
Organizational Affiliation
Universidad de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Murcia
City
Murcia
ZIP/Postal Code
300100
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Dry Needling and Stretching in People With Fibromyalgia.

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