Effectiveness and Safety of Myofascial-meridian Release Acupuncture (MMRA) for Chronic Neck Pain

Effectiveness and Safety of Myofascial-meridian Release Acupuncture (MMRA) for Chronic Neck Pain: A randomized, patient and assessor-blinded, sham controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001573

Enrollment

Registered

2015-07-15

Start date

2015-09-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : All treatments will be carried out by Korean Medicine Doctors with over 2 years of clinical experience and in accordance with predefined protocol and Standard Operating Procedures. Th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females aged 19 to 75 years 2) Suffering from neck pain for at least 3 months (* Neck pain is defined as pain and stiffness around the cervical spine and it can be aggravated with movement or pressure) 3. Classified as Grade I,II (no radiculopathy or structural pathology) according to The Bone and Joint Decade (2000-2010) Task Force on Neck Pain 4. A score = 4 on PI-NRS 4 at time of recruitment 5. Provided with explanation regarding the purpose and characteristics of this study and agreed to written informed consent

Exclusion criteria

Exclusion criteria: 1. Radiating pain or upper limb symptoms at areas excluding neck (scapula included) 2. Neurological abnormalities such as cervical nerve function, deep tendon reflexes, sensory function, etc. 3. Malignant tumors, fractures, inflammations or tuberculosis of the spine 4. History of surgery or other congenital abnormalities of the cervical spine 5. Receiving treatment for psychiatric conditions such as epilepsy, depressive disorder, panic disorder. etc. 6. Suffering from pain in another area greater then neck pain 7. Received acupuncture, medication, physical therapy, or manipulation therapy for neck pain within the last 2 weeks 8. Known hypersensitive reaction after acupunture treatment or an inability to cooperate with the acupuncture procedure 9. Pregnant, breast-feeding, or expecting a pregnancy during study period 10. Others that have been deemed inadequate for participation by research investigators

Design outcomes

Secondary

Measure	Time frame
PI-NRS; 11-point pain intensity numerical rating scale;Clinical relevance (ratio of change greater than 1.5 in PI-NRS, decrease greater than 30% and 50% in PI-NRS);Neck Disability Index (NDI) ;Cervical Range of Motion (CROM) ;Heart Rate Variability (HRV) ;Perceived Stress Scale (PSS);EQ-5D ;Patient Global Impression of Change (PGIC);Pressure pain threshold (PPTs);Consumption of rescue medicine;Days of restricted activity ;Inflammatory/immunologic and stress markers;Adverse events	—

Measure

Time frame

PI-NRS; 11-point pain intensity numerical rating scale;Clinical relevance (ratio of change greater than 1.5 in PI-NRS, decrease greater than 30% and 50% in PI-NRS);Neck Disability Index (NDI) ;Cervical Range of Motion (CROM) ;Heart Rate Variability (HRV) ;Perceived Stress Scale (PSS);EQ-5D ;Patient Global Impression of Change (PGIC);Pressure pain threshold (PPTs);Consumption of rescue medicine;Days of restricted activity ;Inflammatory/immunologic and stress markers;Adverse events

—

Primary

Measure	Time frame
PI-NRS; 11-point pain intensity numerical rating scale	—

Countries

Korea, Republic of

Contacts

Public ContactSeunghoon Lee

Kyung Hee University Oriental Medical Center

aimforyou@hanmail.net

Outcome results