Clinical trial NCT05987683: The Efficacy of Thread Embedding Acupuncture on Pain Score, Neck Disability Index, and Pressure Pain Threshold for Myofascial Pain Therapy in the Upper Trapezius Muscle
Official title: The Efficacy of Thread Embedding Acupuncture on Pain Score, Neck Disability Index, and Pressure Pain Threshold for Myofascial Pain Therapy in the Upper Trapezius Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain of Upper Trapezius Muscle
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myofascial pain is characterized by myofascial trigger points, considered as a major cause of neck and shoulder pain in the working population. Thread-embedding acupuncture is a new acupuncture modality that can provide long-term stimulation aimed at prolonging its therapeutic effect that is similar to conventional acupuncture, such as analgesic effects. The goal of this randomized controlled trial is to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. The primary aim of this study is to investigate whether thread-embedding acupuncture therapy gives better and last longer results for myofascial pain of the upper trapezius muscle than sham thread-embedding acupuncture.

Detailed description: This is a clinical trial study to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. The subjects are 44 males/female with myofascial pain in the upper trapezius muscle and will be randomly assigned to 2 groups: (1) thread-embedding acupuncture and (2) Sham thread-embedding acupuncture. The subjects will receive a single treatment. The outcome will be assessed before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment. Patients and the outcome assessors will be blinded to the group allocation.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-59 years.
* Subject with myofascial pain in the upper trapezius muscle.
* VAS score of 30-70 mm from 100 mm during activities (everyday activities or light exercise).
* Pain \> 3 months.
* Willing to participate in this research to completion and sign informed consent.

Exclusion Criteria:

* Fibromyalgia.
* Have had cervical spine surgery.
* Have done Dry needling therapy on the upper trapezius muscle in the last 9 days
* Have done thread acupuncture on the upper trapezius muscle in the last 6 months.
* Have performed pharmacopuncture on the upper trapezius muscle in the last 6 months.
* VAS score is more than 70 mm than 100 mm at resting.
* History of anti-inflammatory drug treatment in the previous 2 weeks.
* History of intra-articular steroid injections in the previous 3 months.
* There is a tumor, wound, or skin infection at the needle insertion area.
* Fever (≥ 37.5 oC).
* There is a hypersensitivity reaction in previous acupuncture therapy (metal allergy, severe atopy, keloids, or other skin hypersensitivity).
* Suffering from a blood disorder or taking blood thinners (anti-platelet or anti-coagulant drugs).
* Have a heart condition or uncontrolled diabetes.
* Blood glucose level (GDS) ≥200 mg/dL is checked by capillary blood using a glucometer.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
Secondary outcomes:
measure: Neck Disability Index
timeFrame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
measure: Pressure Pain Threshold
timeFrame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Persahabatan Hospital
state: DKI Jakarta
Study officials:
affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
name: KEPK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: