My Health Wellness center, Peshawar
Peshawar, KPK, Pakistan
Location status: Recruiting
NCT Number: NCT07808476
This is a randomized control trial aims to evaluate the efficacy of gross myofascial release with neural mobilization versus neural mobilization alone on pain, functional limitations, and cervical range of motion in cervical radiculopathy. Cervical radiculopathy, is characterized by neck pain, pain radiating down the arm, numbness, tingling, weakness of muscles and functionality limitations with compression or irritation of the cervical nerve root due to cervical spondylosis, cervical disc herniations or degeneration of the cervical spine leading to cervical radiculopathy and the diminished quality of life from decreased day-to-day functional capacity and productivity at work. The study will evaluate pain, functional limitations, and cervical range of motion.
Interested in participating?
Request Info25 year–55 year
All sexes
Interventional
Not applicable
Peshawar, KPK, Pakistan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants allocated to the experimental group will receive Gross Myofascial Release (GMFR) followed by median nerve neural mobilization. The GMFR intervention will include a gross stretch of the posterior cervical musculature and an upper-quarter (arm pull) fascial stretch. The stretch will be maintained for 90 seconds or until a palpable release of fascial tension is appreciated. Neural mobilization will be performed using the median nerve slider technique.. Neural mobilization will be performed by simultaneously moving the shoulder into greater abduction while the cervical spine is moved into contralateral side flexion to facilitate median nerve sliding(1 set of 10 repetitions with a 3-second hold per repetition). Each treatment session will also include a 10-minute hot pack before treatment and 10 minutes of TENS after treatment. The total session duration will be approximately 40 minutes, administered 3 sessions per week on alternate days for 4 weeks (12 sessions).
Participants allocated to the control group will receive neural mobilization technique. The intervention will be performed with the participant in the supine position, with the shoulder abducted and externally rotated, elbow extended, forearm supinated, and wrist, fingers, and thumb maintained in extension. Neural mobilization will be applied by simultaneously increasing shoulder abduction while moving the cervical spine into contralateral side flexion to facilitate median nerve sliding. Each treatment session will also include a 10-minute hot pack before treatment and 10 minutes of TENS after treatment. The treatment will be administered in 3 sets of 10 repetitions, with each repetition held for 3 seconds and a 60-second rest interval between sets, The total session duration will be approximately 40 minutes, administered 3 sessions per week on alternate days for 4 weeks (12 sessions).
Time frame: Baseline to 4th week
The Universal Goniometer (UG) will used in this study to measure active cervical range of motion (ROM), is a simple, inexpensive, and portable clinical instrument that provides objective measurements of joint movement in degrees. Cervical range of motion is recorded in degrees (°) for each movement direction. Lower ROM values indicate greater movement restriction and functional impairment, whereas higher values reflect improved cervical mobility.
Time frame: Baseline to 4th week
The Neck Disability Index (NDI) will used in this study to evaluate the level of functional disability associated with cervical radiculopathy. The NDI is one of the most widely accepted patient-reported outcome measures for assessing the impact of neck pain on daily functioning. The questionnaire consists of 10 items, including pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreational activities. Each item is scored from 0 to 5, The total NDI score ranges from 0 to 50, with higher scores representing greater functional disability. For clinical interpretation, scores are commonly classified as follows: 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), and 35-50 (complete disability). A reduction in the total score following treatment indicates an improvement in functional status and a decreased impact of neck pain on daily activities.
Time frame: Baseline to 4th week
The intensity of the pain will be measured with the help of the Visual Analogue Scale (VAS). The VAS is a 10-cm horizontal line with two opposite endpoints marked with the following words: "no pain" at one end and "worst imaginable pain" at the other. The patient will then mark a point on the line that they feel most accurately reflects their current pain. The distance in centimeters or millimeters between the "no pain" point and the patient's mark will be taken as the measure of the patient's pain.
Time frame: Baseline to 4th week
Magnetic Resonance Imaging (MRI) of the cervical spine was used in this study to confirm the diagnosis cervical radiculopathy before participant enrollment. It enables accurate identification of disc herniation, foraminal stenosis, nerve root compression, and other degenerative changes associated with cervical radiculopathy.
Contact information is provided by the study sponsor or research team.
Salma Bibi, DPT, MS OMPT
CONTACT
komal hameed, MSPT
CONTACT
Ibadat International University, Islamabad
Other
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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