Fenerbahçe Üniversitesi
Ataşehir, Istanbul, 34734, Turkey (Türkiye)
Location status: Recruiting
Location contact
Burcu AKKURT, Assistant Professor
CONTACT
Burcu AKKURT, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07150143
This randomized, double-blinded controlled trial aims to investigate the comparative effects of connective tissue massage and physical modalities, when combined with cervical and scapulothoracic stabilization exercises, in individuals with chronic non-specific neck pain. A total of 51 participants aged 18-65 years will be randomly assigned into three groups. Group 1 will perform stabilization exercises alone, Group 2 will receive stabilization exercises plus connective tissue massage, and Group 3 will receive stabilization exercises plus electrotherapy modalities (infrared, continuous ultrasound, and TENS). The interventions will be conducted twice weekly for 8 weeks, and participants will also perform home-based exercises daily. Primary outcomes include pain, disability, and endurance, while secondary outcomes focus on quality of life, cervical range of motion, and scapular function.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Ataşehir, Istanbul, 34734, Turkey (Türkiye)
Location status: Recruiting
Burcu AKKURT, Assistant Professor
CONTACT
Burcu AKKURT, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
Chronic non-specific neck pain is a prevalent musculoskeletal disorder that adversely affects pain, functional capacity, and quality of life. Stabilization-based exercise programs are commonly recommended; however, the added benefits of connective tissue massage and physical modalities require further investigation.
This randomized, double-blinded controlled trial is designed to compare the effects of (1) stabilization exercises alone, (2) stabilization exercises combined with connective tissue massage, and (3) stabilization exercises combined with electrotherapy modalities (infrared therapy, continuous ultrasound, and TENS) on clinical outcomes in individuals with chronic non-specific neck pain.
A total of 51 participants between 18 and 65 years of age will be randomly allocated into three equal groups. All groups will receive supervised exercise sessions twice weekly for 8 weeks, each lasting 50 minutes (10 minutes of warm-up, 30 minutes of cervical and scapulothoracic stabilization, and 10 minutes of cool-down). Additionally, participants will be instructed to perform a one-hour home exercise program daily, supported with illustrated brochures.
The primary outcomes are:
The secondary outcomes are:
By comparing these approaches, the study aims to determine whether the addition of connective tissue massage or physical modalities enhances the therapeutic effects of stabilization exercises on pain, function, and endurance in patients with chronic non-specific neck pain.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each exercise session lasts 50 minutes, consisting of a 10-minute warm-up, 30 minutes of stabilization exercises, and a 10-minute cool-down. Stabilization exercises are selected from an exercise pool according to the individual's needs, with progression ensuring throughout the program. The exercises will be administered face-to-face twice a week for eight weeks, and participants will be provided with illustrated brochures and instructed to perform a one-hour home exercise program daily.
Connective tissue massage will be applied, starting from the basic regions and gradually incorporating other regions.
Infrared therapy will be applied for 20 minutes
Continuous ultrasound will be applied to the right and left sides for 7 minutes each at an intensity of 2 W/cm².
20 minutes of conventional TENS will be administered to the painful area.
Time frame: From enrollment to the end of treatment at 8 weeks
To assess disability in neck pain, only the Neck Disability Index (NDI), which evaluates current pain and disability, was used. The NDI consists of 10 items grouped into 6 subdomains. Each item is scored on a scale from 0 to 5, with higher scores indicating greater levels of disability.
Time frame: From enrollment to the end of treatment at 8 weeks.
To evaluate deep neck flexor muscle endurance, the Deep Cervical Flexor Test was used. This test assesses the maximal contraction capacity of the deep cervical flexor muscles. It is performed in the supine position, with the participant lifting the head approximately 2.5 cm off the surface while maintaining chin retraction. The examiner places a hand under the participant's occiput. The test is terminated when cervical flexion is lost or the participant's head touches the examiner's hand, and the duration is recorded in seconds.
Time frame: From enrollment to the end of treatment at 8 weeks
Cervical range of motion was assessed using a universal goniometer. The participant was seated in an upright position, and measurements were taken for cervical flexion, extension, right and left rotation, and right and left lateral flexion. For flexion and extension, the acromion was accepted as the pivot point, with the stationary arm held parallel to the ground and the movable arm aligned with the ear line. For rotation, a straight rod was placed between the participant's teeth, the midline of the head was accepted as the pivot point, the stationary arm was kept parallel to the ground, and the movable arm was aligned with the rod. For lateral flexion, the spinous process of C7 was accepted as the pivot point, the stationary arm was positioned parallel to the ground, and the movable arm was aligned with the spinous processes of the cervical vertebrae. Care was taken to ensure that the head was not rotated during the measurements.
Time frame: From enrollment to the end of treatment at 8 weeks.
For pain assessment, the Bournemouth Neck Questionnaire, which focuses on the participant's current symptoms over the past week, was used. The questionnaire evaluates aspects such as onset, localization, duration, type and characteristics of pain, aggravating and relieving factors, history of previous treatments, and accompanying symptoms. The Bournemouth Neck Questionnaire consists of 7 items, each scored on a scale from 0 to 10. The maximum score is 70, with higher scores indicating greater disability.
Time frame: From enrollment to the end of treatment at 8 weeks.
The World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) was used to assess the quality of life of the participants. The WHOQOL-BREF was developed by the World Health Organization and consists of six domains. Since each domain independently reflects the quality of life within its own scope, domain scores are calculated on a scale ranging from 4 to 20. Higher scores indicate better quality of life.
Time frame: From enrollment to the end of treatment at 8 weeks.
The Lateral Scapular Slide Test (LSST) is a clinical assessment used to evaluate scapular positioning and detect scapular dyskinesis by measuring the distance between the inferior angle of the scapula and the spinous process at various arm positions.
Time frame: From enrollment to the end of treatment at 8 weeks.
In the Scapular Dyskinesis Test, a load of 2.3 kg is used for individuals weighing 68.1 kg or more, and a load of 1.4 kg is used for those weighing less than 68.1 kg. Participants are instructed to hold the weights with the thumbs pointing upward, elbows extended, and shoulders in a neutral position, and to actively perform bilateral shoulder flexion and abduction. Each movement is repeated five times, during which scapular motion is observed. The presence of scapular winging or dysrhythmia during the movements is recorded as either "dyskinesis present" or "dyskinesis absent".
Time frame: From enrollment to the end of treatment at 8 weeks.
The Scapular Retraction Test is used to grade the strength of the supraspinatus muscle. The test begins with the traditional Empty Can Test, in which the patient's shoulder is placed in internal rotation, 90 degrees of flexion, and the scapular plane position ("scaption"). The examiner applies a downward force to the patient's arm while the patient resists. The test is then repeated with the examiner manually stabilizing the scapula in a retracted position. To achieve this, the examiner's fingers firmly grasp the patient's anterior shoulder over the clavicle, while the forearm is positioned along the medial border of the scapula. The test is considered positive if rotator cuff strength is restored, as indicated by the patient's improved ability to resist the examiner's downward force compared with the traditional Empty Can Test.
Contact information is provided by the study sponsor or research team.
Fenerbahce University
Other
Comparative Effects of Connective Tissue Massage and Physical Modalities Added to Cervical and Scapulothoracic Stabilization Exercises on Pain, Function, and Endurance in Individuals With Chronic Neck Pain
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