Pulsed Radiofrequency vs Dry Needling in Myofascial Pain

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

pulsed radiofrequency

Dry needling

About this trial

This is an interventional treatment trial for Myofascial Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged between 18 and 70 years old. Chronic (>3 months) myofascial pain in the neck, shoulder, and upper back region. Myofascial pain will be diagnosed based on Simons and Travell's criteria: taut band palpable, exquisite spot tenderness of a nodule in a taut band, patient's recognition of current pain complaint by pressure on the tender nodule, and painful limit to full stretch range of motion. Have at least a pain VAS score of 40 mm; thus, a minimal clinically significant change is detectable. Exclusion Criteria: History of receiving DN or PRF treatment or currently undergoing other pain-related treatments (acupuncture, laser, infrared therapy, etc.). Presence or history of trauma, surgery, or infection in the pain region. Current or history of taking moderate to strong analgesics, such as tramadol and morphine. Severe systemic disease (eg. severe hepatic or renal dysfunction), coagulopathy, or medications affecting the coagulation system. Allergy to medications used. Pregnancy, psychiatric disease, medical background, inability to cooperate, or refusal to participate. Withdrawn Criteria: Unwilling to continue participation or unable to follow the treatment plan. Unable to obtain the primary outcome data due to any reason.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pulsed radiofrequency

Dry needling

Arm Description

Outcomes

Primary Outcome Measures

Pain VAS score

Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.

Secondary Outcome Measures

Pain VAS score

Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.

NDI

Neck disability index

PHQ9

patient health questionnaire

GAD7

generalized anxiety disorder (GAD-7) scale

Sleep status

Likert scale 1 to 5, 1 indicates very bad, 5 indicates very good

SF36

health related quality of life short form 36 scale

Mechanical pain threshold

Mechanical pain threshold will be tested by pressing the pain point with an ergometer for three times and calculated the mean value of the pressure.

Full Information

NCT ID

NCT05637047

First Posted

November 27, 2022

Last Updated

May 3, 2023

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05637047

Brief Title

Pulsed Radiofrequency vs Dry Needling in Myofascial Pain

Official Title

Ultrasound-guided Pulsed Radiofrequency Versus Dry Needling for Pain Management in Chronic Neck and Shoulder Myofascial Pain Patients at a Tertiary Hospital in China: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2023 (Anticipated)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Myofascial pain (MPS) is the leading cause of chronic and persistent regional pain, affecting as many as 85% of the general population. A variety of treatment methods for myofascial pain have been investigated, including injection of saline, local anesthetics and steroids, dry needle, mini-scalpel, rich platelet plasma and radiofrequency ablation. Ultrasound guided dry needle (DN) and pulsed radiofrequency ablation (PRF) of the trigger point have been considered as two effective and promising treatments for myofascial pain. As far as searched, we failed to identify any study comparing the effects of DN and PRF in myofascial pain patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myofascial Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

pulsed radiofrequency

Arm Type

Experimental

Arm Title

Dry needling

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

pulsed radiofrequency

Intervention Description

ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation

Intervention Type

Procedure

Intervention Name(s)

Dry needling

Intervention Description

ultrasound-guided intramuscular and interfascial dry needling

Primary Outcome Measure Information:

Title

Pain VAS score

Description

Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.

Time Frame

Postoperative six months

Secondary Outcome Measure Information:

Title

Pain VAS score

Description

Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.

Time Frame

postoperaitve day 0 and postoperative 1 and 3 months

Title

NDI

Description

Neck disability index

Time Frame