- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05331430
Effectiveness of Dry Needling and Stretching in People With Fibromyalgia.
June 21, 2022 updated by: Angel Martínez Carrasco, Universidad de Murcia
Effectiveness of Dry Needling and Stretching on Joint Range and Myofascial Pain at the Cervical Level in People With Fibromyalgia.
Effectiveness of dry needling and stretching on joint range and myofascial pain at the cervical level in people with fibromyalgia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
-
Murcia, Spain, 300100
- Universidad de Murcia
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group 1: Dry needling on cervical trigger point
Dry needling of the trigger point of the upper fibres of the trapezius muscle.
Using the Hong technique.
|
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.
Other Names:
|
|
Experimental: Experimental group 2: Trapezius muscle stretch
Manual passive stretching of the upper trapezius muscle fibres.
|
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.
Other Names:
|
|
No Intervention: Control group: Informative talks
Informative talks on breathing techniques, relaxation techniques and posture hygiene.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goniometer measurement
Time Frame: One month
|
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.
Time Frame: One month
|
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)
Time Frame: One month
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Angel Martínez Carrasco, PhD, Universidad de Murcia
- Principal Investigator: Jose Quereda Ruiz, Graduated, Universidad de Murcia
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)
May 27, 2022
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
June 13, 2022
Study Registration Dates
First Submitted
April 8, 2022
First Submitted That Met QC Criteria
April 11, 2022
First Posted (Actual)
April 15, 2022
Study Record Updates
Last Update Posted (Actual)
June 22, 2022
Last Update Submitted That Met QC Criteria
June 21, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JQR-2022-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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