Comparison of Two Treatments on Nonspecific Neck Pain

Comparison of the Effectiveness of Ischemic Compression and Instrument Assisted Soft Tissue Mobilization on Pain and Function in Patients With Nonspecific Neck Pain

The purpose of this study was to evaluate the impact of Ischemic Compression (IC) and Instrument Assisted Soft Tissue Mobilization (IASTM) on pain, functionality, cervical range of motion, pressure pain threshold, and quality of life in patients suffering from nonspecific neck pain.

Study Overview

• Status: Active, not recruiting
• Conditions: Neck Pain
• Intervention / Treatment: Other: Ischemic compression; Other: Exercise and workplace modifications; Other: Instrument assisted soft tissue mobilization Group

Detailed Description

Chronic nonspecific neck pain affects approximately 67% of the global population at least once in their lifetime. This type of neck pain, which is not linked to any specific cause or disease but often associated with the musculoskeletal system, can result from muscle strain or spasms in the neck. It causes functional limitations and decreases quality of life for those affected. Individuals frequently turn to healthcare services and pain-relieving medications in their efforts to manage this discomfort. Chronic nonspecific neck pain is recognized as a significant public health challenge due to its considerable socioeconomic impact. Several studies have indicated that myofascial trigger points in the neck region are associated with nonspecific neck pain and that myofascial trigger point therapy can reduce pain. Therefore, the role of myofascial trigger point therapy in the treatment of nonspecific neck pain has been emphasized in studies.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Büyükçekmece
    • Istanbul, Büyükçekmece, Turkey, 34
      • Faculty of Health Sciences, Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Having nonspecific neck pain and at least 3 myofascial trigger points in the back and neck muscles,
2. Pain duration exceeding 3 months,
3. Working with a computer for at least 20 hours per week for at least 1 year,
4. Pain intensity rated as at least 3 on the Visual Analog Scale (VAS),
5. Age between 18 and 50 years

Exclusion Criteria:

1. Use of anti-inflammatory, analgesic, anticoagulant, muscle relaxant, or antidepressant medications at the start of the study or within 1 week prior to the study,
2. History of cervical spine surgery or trauma,
3. Neck pain, including inflammatory rheumatic diseases,
4. Malignancy or structural deformity,
5. Coagulation disorders,
6. Presence of cervical radiculopathy or myelopathy,
7. Individuals who have undergone any physical therapy and rehabilitation interventions to the neck and back regions in the last three months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ischemic compression GROUP; This group will receive 90 seconds of ischemic compression on myofascial trigger points in the trapezius, levator scapulae, supraspinatus, infraspinatus, and splenius cervicis, along with exercises and suggestions for workplace modifications.	Other: Ischemic compression; Participants will received a total of 12 treatment sessions over 6 weeks, with 2 sessions per week.; Other: Exercise and workplace modifications; Participants will receive stretching and strengthening exercises for neck and scapular stabilizer muscles as a 6-week home program.
Active Comparator: Instrument assisted soft tissue mobilization Group; This group will receive 40 seconds of sweeping and 60 seconds of swiveling by instrument-assisted soft tissue mobilization on myofascial trigger points in the trapezius, levator scapulae, supraspinatus, infraspinatus, and splenius cervicis muscles, along with exercises and suggestions for workplace modifications.	Other: Exercise and workplace modifications; Participants will receive stretching and strengthening exercises for neck and scapular stabilizer muscles as a 6-week home program.; Other: Instrument assisted soft tissue mobilization Group; Participants will received a total of 12 treatment sessions over 6 weeks, with 2 sessions per week.
Experimental: Control Group; This group will only receive exercises and suggestions for workplace modifications.	Other: Exercise and workplace modifications; Participants will receive stretching and strengthening exercises for neck and scapular stabilizer muscles as a 6-week home program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale(VAS)	VAS is a measurement tool commonly used to assess the intensity of pain or other symptoms. It consists of a horizontal line labeled with descriptive anchors at each end (e.g., 'no pain' to 'worst pain imaginable'). Patients mark on the line to indicate their subjective perception of symptom severity, with the distance from the starting point to the mark providing a quantitative measure. As the value on the scale increases, the perceived pain or symptom intensity also increases	Six weeks
Neck Disability Index (NDI)	NDI is a measurement tool used to assess functional limitations in the neck region. It is commonly employed in individuals experiencing neck pain to evaluate the extent of restrictions in daily activities. NDI allows patients to subjectively assess how much their neck pain affects their daily lives. The score on the scale indicates the degree of functional impairment experienced by the patient and is used to evaluate treatment outcomes. When the score decreases, it indicates a reduction in limitations.	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Work Role Functioning Questionnaire (WRFQ)	WRFQ evaluates functionality and work capacity by assessing individuals' roles and functions in the workplace. It covers aspects such as work performance, job retention, and job-related functionality. The questionnaire identifies both constraints and strengths in the workplace, offering insights into employees' perceptions of their job performance and role. It is widely used to assess return to work readiness and overall work ability, with higher scores indicating improved work performance.	Six weeks
Cervical range of motion	Individuals' active cervical range of motion includes flexion, extension, right-left lateral flexion, and rotation will measured with a universal goniometer.	Six weeks
Pain pressure threshold	The pressure algometer (model: JTECH USA Commander) will be applied perpendicularly to the trigger point. Participants will be instructed to report the onset of discomfort. Compression will be halted upon their report, and the measurement displayed on the algometer screen will be documented. Three readings will be taken with a 30-second interval between each trial, and the average value will be recorded for analysis.	Six weeks
SF- 12 quality of life	SF-12 Quality of Life (SF-12 QoL) is a standardized survey tool used to measure health-related quality of life in individuals. It consists of 12 questions that assess physical and mental health, daily functioning, emotional well-being, and overall perception of health status. The survey provides scores for physical and mental health components, reflecting the individual's perceived quality of life across these domains. SF-12 QoL is widely used in research and clinical settings to evaluate health outcomes, monitor changes in health status over time, and assess the impact of interventions on quality of life.	Six weeks
Global Rating of Change (GROC)	The satisfaction levels of the participants will be evaluated using the 5-point GROC scale at the end of 6 weeks. The scale ranges from -2 to +2, where -2 indicates "I am much worse," -1 indicates "I am worse," 0 indicates "I am the same," +1 indicates "I am better," and +2 indicates "I am much better."	Six weeks

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Principal Investigator: Mouna Khosravi, MSc, aculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece/Istanbul, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Physical therapy; Neck pain; Trigger point; Manual therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: IstanbulUC-FTR-MK-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No