NCT05614830

Brief Summary

myofascial pain syndrome is considered to be a chronic condition due to sensitive pressure points within the muscle recognized as trigger points Generally the aim of this study will be :

  • To investigate the effectiveness of dry needling on trigger point in trapezius muscle
  • Evaluate the pain level before and after the applications of dry needling on trigger points
  • compare between the effects of dry needling and physical therapy exercise program

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

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

November 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

November 6, 2022

Last Update Submit

November 6, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain level

    Will be determined using the visuals analogue scale (VAS)

    6 weeks

  • Neck disability index

    questionnaire contains 10 items aiming to evaluate the limitation because of neck pain

    6 weeks

Secondary Outcomes (2)

  • Depression

    6 weeks

  • Neck Range of motion

    6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: Dry needling ,

Control group

ACTIVE COMPARATOR

Usual physical therapy protocol 4 sessions, two sessions per week each session will include a group of therapeutic exercises

Other: usual physical therapy program

Interventions

The intervention group will receive sessions of dry needling to relief myofacial pain on trapezius

Intervention group

Therapeutic exercise

Control group

Eligibility Criteria

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

You may qualify if:

  • Clinically active trigger point and expression of symptoms of neck pain in trapezius which had lasted for at least 3 months.
  • Having a pain level higher than 4 and lower than 8 on Visual Analogue Scale ( VAS )
  • Did not receive any other form of neck treatment during the previous month.

You may not qualify if:

  • Presence of cardiopulmonary disease , the application process requires the subject to be in prone position to expose the area of treatment, this position is un-preferable for cardiopulmonary patients
  • History of neck surgery
  • Trigger point treatment in the last 30 days
  • Any contraindications for dry needling such as local infection, skin disease ,severe postural disorder , tumor , rheumatoid arthritis, cervical spine stenosis and bilateral upper extremity symptoms
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

November 6, 2022

First Posted

November 14, 2022

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

November 14, 2022

Record last verified: 2022-11