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NCT Number: NCT06814808

Comparison of Three Different Myofascial Trigger Point Treatments in Chronic Non-Specific Neck Pain

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.

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Key information

Conditions

Chronic Non-specific Neck Pain Behavior Motor Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional Therapy

Other

All three groups will receive a conventional physiotherapy program (TENS, therapeutic ultrasound, hot pack) 5 times a week for 4 weeks and the same exercise program 3 days a week for 4 weeks.

Ischemic Compression Group

Other

The ischemic compression group will receive ischemic compression therapy for the upper trapezius, levator scapulae, splenius capitis, and lower trapezius muscles.

Strain-Counter Strain

Other

The strain counterstrain technique will be applied to the upper trapezius, levator scapulae, splenius capitis, and lower trapezius muscles.

Integrated Neuromuscular Inhibition Technique (INIT)

Other

This group will be subjected to INIT for the upper trapezius, levator scapulae, splenius capitis, and lower trapezius muscles, 3 sessions per week for 4 weeks (12 sessions in total).

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 4 weeks

    The intensity of pain felt in the neck area at rest, during activity (cervical flexion, extension, right and left lateral flexion, right and left rotation) and at night will be evaluated numerically using a visual analogue scale (VAS). Individuals will be told that the number '0' on a 10 cm horizontal line indicates 'no pain' and the number '10' indicates 'unbearable pain'. The place marked by the individual will be determined as pain intensity in cm.

  2. Algometer

    Time frame: 4 weeks

    An Algometer (Baseline Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) will be used to objectively measure pain threshold and tolerance. Before measuring with the algometer, a pressure will be applied to the pulp of the thumb of the hand, which is the control point. Then, a force will be applied to the same point to cause pain so that the subject can distinguish between the sensation of pressure and the sensation of pain. Then, at the C2 spine level, the pressure will be applied vertically to the muscle tissue from the midpoint of the right-left paraspinal muscles and the right-left upper trapezius muscles, increasing the pressure by 1kg/cm2 every three seconds until the subject feels pain. The subject will be told to report when he/she feels pain while applying force with the device (kg/ cm²). This process will be repeated three times and the average value will be calculated.

  3. Cervical Joint Position Sense

    Time frame: 4 weeks

    Cervical joint position sense will be evaluated by head repositioning test using CROM III-Cervical Range of Motion (Performance Attainment Associates, Lindstrom, MN) device. The target position will be 25° flexion, extension, right-left lateral flexion, right-left rotation respectively. The subject will sit on a chair with a straight back, knees flexed 90 degrees and feet flat on the floor. The subject will be asked to close his/her eyes. Then, the subject's neck will be passively flexed 25° in a slow rhythm, and the position will be maintained for 5 seconds. The subject will be asked to remember this position. Afterwards, the subject's neck will be passively moved to the neutral position in a slow rhythm. The subject will then be instructed to actively move his/her neck and reposition himself/herself in the target position. The subject will signal by saying 'yes' when repositioned to the target position. The deviation in the repositioning test result will be evaluated as joint positi

  4. Cervical Range of Motion

    Time frame: 4 weeks

    Cervical region flexion-extension, right-left lateral flexion and right-left rotation range of motion will be evaluated using the CROM III-Cervical Range of Motion (Performance Attainment Associates, Lindstrom, MN) device. The device has undergone a reliability study and has been reported as a clinically reliable tool for assessing normal range of motion in the cervical region. The subject will be positioned in an upright sitting position on a chair with back support, with the middle and lower back in contact with the chair, feet on the floor and arms comfortably supported on both sides of the chair. The subject will be asked to look straight ahead. After checking the alignment of the nose, mouth, chin and earlobe and making sure that the cervical region is in the anatomical position, the subject will be commanded to start the movement. Each evaluation will be repeated three times and the average value will be recorded.

  5. Neck Disability Scale

    Time frame: 4 weeks

    It will be evaluated with the Neck Disability Scale. The Neck Disability Scale is based on the Oswestry Low Back Pain Disability Index and consists of 10 items. It includes pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/study, driving, sleep and social activities. Each question has 6 answer options that measure the severity of pain or limitation. Scoring is done between 0-5. The total score is between 0-50. According to the total score, 0-4 points are classified as no limitation; 5-14 as mild limitation; 15-24 as moderate limitation; 25-34 as severe limitation; 34 and above as completely limited. Turkish validity and reliability study was conducted.

  6. Tampa Kinesiophobia Scale

    Time frame: 4 weeks

    Tampa Kinesiophobia Scale (TKS) will be used. TQS is a scale developed to measure the fear of movement/reinjury. It consists of a total of 17 questions. It includes injury/reinjury and fear-avoidance parameters in work-related activities. It consists of 17 questions in total. Total score varies between 17-68. High scores indicate a high level of kinesiophobia. Turkish validity and reliability study was conducted.

  7. Short Form-12/ SF-12

    Time frame: 4 weeks

    Short Form-12 (SF-12) will be used to assess quality of life. SF-12 has 2 total measurements including physical (PCS-12) and mental (MCS-12) components, and high scores indicate good health status. This assessment is a shortened version of SF-36. Turkish validity and reliability studies were conducted.

  8. Global Change Scale

    Time frame: 4 weeks

    It will be evaluated using the Global Change Scale (GTS). In order to evaluate the perceived effect of the treatment applied to the patients, it is used to determine the amount of change considering the current health status after the treatment.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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