Clinical trial NCT06814808: Comparison of Three Different Myofascial Trigger Point Treatments in Chronic Non-Specific Neck Pain
Official title: Comparison of Three Different Myofascial Trigger Point Treatments on Pain, Range of Motion, Joint Position Sense and Quality of Life in Chronic Non-specific Neck Pain
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Non-specific Neck Pain
Keywords: Strain Counterstrain
Integrated Neuromuscular Inhibition Technique
Ischaemic compression
Chronic non-specific neck pain
Manual therapy
Exercise
Conventional physiotherapy programme
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the efficacy of ischaemic compression (IC), positional relaxation (Strain Counterstrain \[SCS\]), and integrated neuromuscular inhibition technique (INIT) applications on pain intensity, pressure pain threshold, range of motion, joint position sense, disability, kinesiophobia, quality of life and patient satisfaction in addition to conventional treatment for chronic non-specific neck pain.

It is planned to include 51 patients in the study. The included patients will be divided into 3 groups: Group 1 (HR Group), Group 2 (SCS Group) and Group 3 (INIT Group). All three groups will receive a conventional physiotherapy programme 5 times a week for 4 weeks and the same exercise programme 3 days a week for 4 weeks.

Detailed description: Chronic neck pain is one of the most common musculoskeletal problems in the general population and is the second most common type of pain after low back pain worldwide. Electrophysiological agents, therapeutic exercise and trigger point therapy techniques are frequently used in chronic non-specific neck pain. There is insufficient evidence in the current literature regarding which trigger point therapy technique is more effective. The aim of this study was to compare the efficacy of ischaemic compression (IC), positional relaxation (Strain Counterstrain \[SCS\]), and integrated neuromuscular inhibition technique (INIT) on pain intensity, pressure pain threshold, range of motion, joint position sense, disability, kinesiophobia, quality of life and patient satisfaction in addition to conventional treatment for chronic non-specific neck pain. The study was planned to include 51 patients between the ages of 18-65 years who applied to Gebze Medicalpark Hospital and met the inclusion criteria. The included patients will be randomised and divided into 3 groups: Group 1 (HR Group), Group 2 (SCS Group) and Group 3 (INIT Group). All three groups will receive a conventional physiotherapy programme (TENS, therapeutic ultrasound, hot pack) 5 times a week for 4 weeks and the same exercise programme 3 days a week for 4 weeks. In addition to conventional treatment, Group 1 will receive HR for upper trapezius, levator scapulae, splenius capitus and lower trapezius muscles, Group 2 will receive SCS for upper trapezius, levator scapulae, splenius capitus and lower trapezius muscles and Group 3 will receive INIT for upper trapezius, levator scapulae, splenius capitus and lower trapezius muscles 3 sessions per week for 4 weeks (12 sessions in total). As evaluation criteria, visual analogue scale will be used to evaluate the intensity of pain felt at rest, activity and at night, and algometer will be used to objectively measure pain threshold and tolerance. Cervical range of motion and joint position sense will be assessed using CROM III-Cervical Range of Motion device. Disability level will be assessed using the Neck Disability Scale, fear of movement using the Tampa Kinesiophobia Scale, quality of life using the Short Form-12, and Global Change Scale to assess patient satisfaction. Assessments will be made before starting the treatment programme and after the completion of the 4-week treatment programme.

Eligibility criteria: Inclusion Criteria:

* The patient is between 18 and 65 years of age,
* The patient presents to the outpatient clinic with a complaint of neck pain that has been persisting for at least 3 months,
* Pain intensity higher than 3.5/10 cm according to the Visual Analogue Scale,
* Active trigger point in at least one of the upper trapezius, levator scapulae, splenius capitus, lower trapezius muscles that may cause neck pain,
* Neck Disability Index total score higher than 15,
* Having the ability to read and write in Turkish was determined as the inclusion criteria.

Exclusion Criteria:

* Has had a neck, spine or shoulder injury within the last 6 months,
* The patient has neck pain caused by inflammatory, hormonal, neurological disorders or after trauma,
* Positive radicular findings compatible with nerve root compression, history of spinal fracture, spinal tumours and related malignancies, congenital spinal anomalies,
* History of neck, upper thoracic spine and shoulder surgery,
* Scoliosis surgery or a health problem that causes limitation in spinal mobility,
* Diagnosed with any malignant condition, systemic, neurological or rheumatological disease,
* Having a skin disease or hearing-vision problem that may affect the assessment process,
* Uncontrolled hypertension, uncontrolled diabetes mellitus, meniere's disease and vertigo,
* Physiotherapy sessions for neck pain in the last month,
* Pregnancy,
* Use of any analgesic or psychotropic agent was determined as exclusion criteria.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 4 weeks
measure: Algometer
timeFrame: 4 weeks
measure: Cervical Joint Position Sense
timeFrame: 4 weeks
measure: Cervical Range of Motion
timeFrame: 4 weeks
measure: Neck Disability Scale
timeFrame: 4 weeks
measure: Tampa Kinesiophobia Scale
timeFrame: 4 weeks
measure: Short Form-12/ SF-12
timeFrame: 4 weeks
measure: Global Change Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Biruni University
state: Zeytinburnu
Study officials:
affiliation: Medeniyet University, Health Sciences Faculty Department
name: Tansu Birinci Olgun, Asst prof.
role: STUDY_CHAIR
affiliation: Medical Park Gebze
name: Maryam Zare, MD
role: STUDY_CHAIR
affiliation: Biruni University, Health Sciences Faculty Department
name: Pınar Atamert, MSc
role: PRINCIPAL_INVESTIGATOR
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