]>
IRCT20251018067674N1 IRCT 2025-11-26 Ahvaz University of Medical Sciences Comparison the effects of Cervical Collar and Multimodal Physiotherapy on pain, disability ,range of motion and neck muscles endurance for people with acute Cervical Radiculopathy: a Randomised Controlled Trial Comparison the effects of Cervical Collar and Multimodal Physiotherapy on pain, disability ,range of motion and neck muscles endurance for people with acute Cervical Radiculopathy: a Randomised Controlled Trial 2025-11-22 anticipated 57 Complete https://irct.ir/trial/86900 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process is performed using a random sequence generation software (Random Allocation Software). In this method, the three groups have equal sample sizes, and participants are matched based on age and gender. This approach corresponds to a stratified block randomization method. N/A Acute cervical radiculopathy. Intervention 1: Intervention group 1: The cervical collar used in this study will be a semi-rigid type, available in four standard sizes, and should fit the patient’s neck comfortably and appropriately. The collars will be provided free of charge by the researchers. Patients will be instructed to wear the collar continuously for four weeks, day and night, as much as tolerated. During the final week, they will be advised to gradually reduce collar use, and by the end of the fourth week, to discontinue it completely. Participants will be asked to record the date they began using the collar. Intervention 2: Intervention group 2: Physiotherapy, emphasizing a standardized multimodal rehabilitation approach, includes TENS, hot pack therapy, ultrasound, and strengthening and stretching exercises.TENS is a commonly used analgesic modality for pain control. A 2007 meta-analysis identified TENS as an effective method for reducing musculoskeletal pain. In patients with neck pain, pain reduction following TENS has been reported compared to control groups, particularly among those with milder symptoms. However, the effect of TENS is greater when combined with exercise therapy than when used alone.Exercise therapy during the acute phase of cervical radicular pain has shown beneficial effects in pain reduction compared to control groups, though no significant improvement in functional outcomes was observed.Treatment sessions will be conducted three times per week for four weeks (a total of 12 sessions). Conventional TENS will be administered at a frequency of 120 Hz and pulse duration of 100 microseconds for 20 minutes, while a hot pack will be applied to the affected area for 20 minutes.During weeks 1 and 2, patients will perform pain-relieving and foraminal-opening positions. In week 3, deep cervical flexor strengthening exercises will be introduced, with gradual increases in intensity and repetitions over sessions. In week 4, stretching exercises will be added to the strengthening program. Intervention 3: Control group: Participants in this group will not receive any intervention and will continue their usual daily activities without additional therapeutic procedures. No - There is not a plan to make this available Justification or reason for not sharing IPD is The person's information will be confidential and the results will be as collective statistics
public Behrouz Ghelichi
Physical therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733133 +98 61 3374 3101 Behrouzghelichy@gmail.com Ahvaz University of Medical Sciences scientific Shahin Goharpey
Physical therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733133 +98 61 3374 3101 goharpay-sh@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 60 years Reported neck or arm pain for less than one month Pain intensity exceeding 4 on the Visual Analog Scale (VAS) Cervical radiculopathy diagnosed by a neurosurgeon. 18 years 60 years Both Myelopathy neurological disorder tumor rheumatic disease Previous surgery in the cervical region M54.12 Radiculopathy, cervical region Rehabilitation Rehabilitation N/A Intervention group 1: The cervical collar used in this study will be a semi-rigid type, available in four standard sizes, and should fit the patient’s neck comfortably and appropriately. The collars will be provided free of charge by the researchers. Patients will be instructed to wear the collar continuously for four weeks, day and night, as much as tolerated. During the final week, they will be advised to gradually reduce collar use, and by the end of the fourth week, to discontinue it completely. Participants will be asked to record the date they began using the collar. Intervention group 2: Physiotherapy, emphasizing a standardized multimodal rehabilitation approach, includes TENS, hot pack therapy, ultrasound, and strengthening and stretching exercises.TENS is a commonly used analgesic modality for pain control. A 2007 meta-analysis identified TENS as an effective method for reducing musculoskeletal pain. In patients with neck pain, pain reduction following TENS has been reported compared to control groups, particularly among those with milder symptoms. However, the effect of TENS is greater when combined with exercise therapy than when used alone.Exercise therapy during the acute phase of cervical radicular pain has shown beneficial effects in pain reduction compared to control groups, though no significant improvement in functional outcomes was observed.Treatment sessions will be conducted three times per week for four weeks (a total of 12 sessions). Conventional TENS will be administered at a frequency of 120 Hz and pulse duration of 100 microseconds for 20 minutes, while a hot pack will be applied to the affected area for 20 minutes.During weeks 1 and 2, patients will perform pain-relieving and foraminal-opening positions. In week 3, deep cervical flexor strengthening exercises will be introduced, with gradual increases in intensity and repetitions over sessions. In week 4, stretching exercises will be added to the strengthening program. Control group: Participants in this group will not receive any intervention and will continue their usual daily activities without additional therapeutic procedures. Pain intensity. Timepoint: Before intervention, after completing treatment sessions, one month later. Method of measurement: Patients’ pain intensity will be assessed using the 10-point Visual Analogue Scale (VAS). In this scale, a score of 0 indicates no pain, while a score of 10 represents the most severe pain imaginable. Participants will be asked to mark the level of pain they experience during activity on a line graded from 0 to 10. Neck disability. Timepoint: Before intervention, after completing treatment sessions, one month later. Method of measurement: Using the Neck Disability Index (NDI) questionnaire: This questionnaire, translated into Persian and validated by Mousavi et al. (2007), evaluates the impact of neck pain on daily life and social activities. It assesses how neck pain interferes with activities such as reading, concentration, personal care, driving, sleeping, and lifting objects. The presence and severity of headaches are also assessed. Each item is rated on a 6-point scale (0–5), where a score of 0 indicates no disability and 50 represents complete disability or maximum functional limitation. Cervical range of motion. Timepoint: Before intervention, after completing treatment sessions, one month later. Method of measurement: In this test, the range of cervical motion, including flexion, extension, rotation, and lateral flexion, is assessed. The participant sits at the edge of a table and is asked to bend the head forward and backward, as well as to rotate and laterally flex the neck. The movements are measured and recorded using a cervical goniometer in degrees. Cervical muscle endurance. Timepoint: Before intervention, after completing treatment sessions, one month later. Method of measurement: In this test, the endurance of the cervical flexor muscles is evaluated. The participant lies in a supine position with knees bent and is asked to tuck the chin and flex the neck, lifting the head and neck approximately 2.5 cm above the table. The duration for which the participant can maintain this position is recorded in seconds using a stopwatch. Surface electromyography studies have shown that in this position, the activity of the longus colli and longus capitis muscles increases progressively, while the sternocleidomastoid and scalene muscles maintain constant activity. Therefore, this clinical test primarily emphasizes the endurance of the deep cervical flexors. Ahvaz University of Medical Sciences Approved 2025-08-30 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Deputy of Research and Technology, Jundishapur University of Medical Sciences, Ahvaz Ahzav Khouzestan Iran (Islamic Republic of)